Instructions for use. When the bowel works, life works

Transcription

1 Instructions for use When the bowel works, life works

2 Navina Smart personal information Navina Smart control unit: Code to unlock settings: Start date: Expected date for new control unit: Water container start dates: Tubes set start dates: uses uses Personal recommendations from healthcare professional: TAI frequency: TAI day and time: Balloon size: Recommended Maximum Water volume: Water flow rate: Navina Smart app: Yes No Bowel medications (name, dose and frequency): Other information: Contact tel #: Next follow-up visit: 2

3 Table of contents IMPORTANT INFORMATION: Please charge your Navina Smart control unit when you receive it or at the latest by the date found on the customer box label ( ). See instruction page 14. Navina Smart personal information... 2 Table of contents... 3 Thank you for choosing Navina Systems... 4 Important safeguards... 7 Component list... 9 Navina Smart control unit Instructions for use Accessories Frequently asked questions (FAQ) Troubleshooting Signs and symbols Warranty...40 Technical specification Navina Smart system Quick guide...47 We value your opinion Contact information Navina Systems Doc. No. PD-2921-I Revised March 24,

4 Thank you for choosing Navina Systems Wellspect HealthCare is proud to present Navina Systems A new and smarter way of benefiting from transanal irrigation (TAI). Navina Systems has been developed in close cooperation with users and healthcare professionals, to facilitate TAI and make it available for more people, with different needs. The objective of the treatment is to create a bowel management routine which will facilitate your lifestyle and for many dramatically reduce the time and energy spent on bowel management. Much of the information regarding TAI in this instruction for use, is based on discussions with healthcare professionals, experts in the TAI field, as well as the article Consensus review of best practice of transanal irrigation in adults (Emmanuel AV et al. Spinal Cord (2013), Navina Systems Navina Systems a complete TAI system for easy learning, usage and follow-up The Navina Systems comprise of Navina Smart and Navina Classic, a comprehensive educational program for healthcare professionals and users as well as the Navina Smart app an application for mobile devices. We understand that TAI treatment is very individual and demands patience while your body adapts to the therapy and your optimal personal settings are found (for some it may take 4-12 weeks). This is why all the systems elements work together to facilitate the successful introduction of TAI. Navina Smart has an electrical control unit which documents your TAI treatments. Your data can be transferred to and analyzed by the Navina Smart app. This unique follow-up tool will help you and your healthcare professional to implement a good bowel routine. This is what we like to call smart TAI. When we talk about smart TAI, we mean TAI using Navina Smart. The classic TAI is performed with Navina Classic. The Navina Classic is fully manual-controlled. The Navina Smart and Navina Classic control units are interchangeable to allow personalized solutions for each unique individual. Transanal irrigation (TAI) The TAI treatment instills water into the colon to promote evacuation of the con tents of the lower colon and rectum. Water is instilled through a catheter with an inflatable balloon which is inserted into the rectum (back passage). The Navina Systems can be used at home, away from home, whilst travelling or in a healthcare setting. TAI with Navina Systems should be carried out while sitting on the toilet. 4

5 Training with healthcare professionals Navina Smart and Navina Classic should always be handled with utmost caution. Training sessions in smart TAI with a healthcare professional are mandatory before using the Navina Smart on your own. After adequate training and recommendations from your healthcare professional, you should be able to handle the Navina Smart on your own or with your carer if required. The frequency of treatment varies between individuals and will be recommended by your healthcare professional. It is usual to start using TAI on a daily basis for the first days. Gradually you and your bowel will get used to the treatment and then the TAI procedure frequency may possibly be reduced to every second or third day. Indications/who can use Navina Systems Navina Systems from Wellspect HealthCare are developed to help adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. The user may be wheel chair bound and/or have reduced motoric hand function. By instilling water up into the lower part of the colon, the peristaltic muscles in the bowel can be triggered and start to evacuate the colon and rectum. Contraindications You should not use Navina Smart or Navina Classic system if you have one or more of the following: Known anal or colorectal stenosis Active inflammatory bowel disease. Acute diverticulitis. Colorectal cancer. Ischemic colitis. Within three months of anal or colorectal surgery. You are within 4 weeks of previous endoscopic polypectomy. As the list of contraindications may not be exhaustive, healthcare professionals will always consider individual user factors as well. Precautions Always consult a healthcare professional specialized in TAI before using Navina Systems. This product is NOT recommended for: Children. Pregnant women. Special care must be taken if you have or have had any of the following: Fecal impaction If you are heavily constipated an initial clean out of your bowel must be performed before starting the irrigation treatment. Painful anorectal conditions any condition which may cause pain or bleeding, e.g. anal fissure, anal fistula third or fourth grade of haemorrhoids. 5

6 Severe diverticulosis or diverticular abscess. Irradiation therapy in the abdominal or pelvic region. Previous anal or colorectal surgery. Previous major pelvic surgery. Severe autonomic dysreflexia. Changed stool pattern such as sudden diarrhea. The cause of diarrhea must be identified. Increased risk of hemorrhage or using anticoagulant therapy (not including aspirin or clopidogrel). Long term corticosteroid therapy. Rectal medication, since the effect of the medication may be changed by using anal irrigation. Warning Bowel per foration is a very rare (1 out of 500,000 irrigations or % 1 ) yet extremely serious complication of TAI. It is a medical emergency and requires immediate medical attention. Symptoms of bowel perforation include severe or sustained abdominal or back pain or significant rectal bleeding (not just smearing of blood on the rectal catheter which is very common and is not a concern). Training and education for healthcare professionals and users For more information, educational and training material about Wellspect HealthCare, Navina Smart and Navina Classic, please call Wellspect HealthCare customer service (see contact information page 51) or visit 1. Christensen P, Krogh K, Perrouin-Verbe B, et al. Global audit on bowel perforations related to transanal irrigation. Tech Coloproctol. Feb 2016;20(2):

7 Important safeguards Read all instructions before use These instructions are only a reminder and should be seen as complementary to what your healthcare professional has told you. They do not replace the need for training with a healthcare professional. Product Only use Navina Smart for its intended use, as described in this instruction manual. The rectal catheter is a single-use product. If reused, Wellspect HealthCare cannot guarantee the functionality nor the safety of the product. Reuse may lead to infection. Navina Smart is for a single user and should not be shared by other people. A training session with a healthcare professional specialized in TAI and familiar with the Navina Systems is mandatory before using the Navina Smart system. Careful medical history and a digital rectal examination are mandatory. In the case of previous anal, colorectal or pelvic surgery, an endoscopy or comparable examination should be performed to exclude other additional disorders that would contraindicate the use of TAI. The first irrigation should be performed under supervision of a healthcare professional. If you are at risk of autonomic dysreflexia (individuals with spinal cord injury above the sixth vertebra), supervised first irrigation with close follow-up is mandatory. Bowel perforation is a very rare (1 out of 500,000 irrigations or % 1 ) but a very serious and potentially lethal complication to anal irrigation that requires immediate medical care, hospitalization, and often surgery. Seek medical care immediately if you experience severe or sustained abdominal pain, back pain or anal bleeding during or after anal irrigation. Electricity When using electrical devices, basic safety precautions should always be followed: Make sure to charge the Navina Smart control unit by the latest date indicated on the package label and at least once a year. Make sure the voltage of the charger is compatible with the power source. Always unplug electrical devices immediately after use. Keep the charger and the power cable away from heated surfaces. Never operate an electrical device if it has a damaged power cable or plug, if it is not working properly and/or if it has been damaged or dropped into water. Do not spray or pour liquid directly onto the charger. Do not use the charger outdoors. Do not use the charger in the bathroom. Do not connect the charger to any other equipment than the supplied power adapter. Use only the accompanying charger, charging support and power adapter to charge Navina Smart control unit. If you have a pacemaker or other implanted device, consult your doctor or the manufacturer of the implanted device before using the charger. 7

8 Use Do not store the Navina Smart system s components in direct sunlight. Only use Wellspect HealthCare s original accessories. Check all components for wear or damage before usage. Do not use if damaged. There are no user-serviceable parts inside the Navina Smart control unit. Do not attempt to repair the Navina Smart control unit yourself. Make sure to connect the tubes following the instructions, color coding and symbols. Make sure the tubes are not blocked. Make sure the safety valve on the water container lid is not blocked. Make sure to personalize your settings in the Navina Smart control unit following your healthcare professionals recommendation. Make sure to insert the catheter to the handle to ensure the balloon is inflated at the right place inside your rectum. Do not insert the handle into your rectum. Make sure the balloon is deflated before removing the catheter. Never insert the catheter with force. If you experience resistance, follow the steps in the troubleshooting section. Do not turn off the Navina Smart control unit during irrigation! The Navina Smart control unit should not be turned off until all tubes are disconnected! As long as the Navina Smart control unit is on, it prevents a backflow of water from the rectal catheter into the tubes. If you have impaired sensation in your anal area and you wish to use the grip rings, make sure your healthcare professional shows you where the ring should be placed on the tube in order to insert the catheter to its handle and no further. Store the Navina Smart system away from the reach of small children. Supervise children if they are in proximity of the Navina Smart system to avoid risk of strangulation with the tubes and suffocation with the plastic bag or in the event that small components get loose from the product. Keep this instruction for use for further reference. 8

9 Component list Accessory set Navina tube set Navina water container Navina catheter Navina Smart control unit 9

10 Navina Systems component lifetimes Warning: If the components are used more times or for a longer period than indicated in the table below, Wellspect HealthCare cannot guarantee the functionality nor the safety of the product. # Product REF Lifetime Disposal 1. Navina Smart instructions for use 2921 Household waste/ paper recycle 2. Navina Smart control unit 3. Charger, charging support and power adapter uses or 2 years from the date of the first use, whichever comes first uses or 2 years from the date of the first use, whichever comes first Navina tube set uses. Tubes can be ordered separately Household waste 5. Navina water container uses Household waste 6. Navina catheter regular The rectal catheter is single use only Household waste 7. Navina case 2844 Household waste 8. Navina positioning strap Household waste 9. Navina Smart control unit positioning clip Household waste 10. Navina grip rings Household waste 11. Navina lanyard Household waste 1 This product contains recyclable materials. Do not dispose this product as unsorted municipal waste. Please contact your local municipality for the nearest collection point. For Europe: Separate disposal for electrical and electronic waste according to the Waste Electrical and Electronic Equipment (WEEE Directive). Note: the components of the Navina Smart system are not manufactured with latex. All components of the Navina Smart system, with the exception of the charger cable and the wire insulation inside the Navina Smart control unit, are not manufactured with PVC and phthalates. 10

11 Navina Smart control unit The Navina Smart control unit will make it possible to personalize your smart TAI routine to make your management convenient and consistent. By setting the unit parameters together with your healthcare professional, and entering your personal maximum settings, the unit will function safely in order to suit your own bowel habits. The buttons on the Navina Smart control unit respond to touch, this means that water flow will stop when the button is released. As a safety feature, if the Navina Smart control unit is switched off the water pump will stop and the balloon will deflate automatically. This will give you full control through the whole TAI procedure. Read the instructions carefully and keep this manual close to hand. Overview 1. Connector to the water container Connector to the rectal catheter 3. On/off Note: The on/off and Settings buttons must be held a little while before they respond. This is to avoid the possibility to turn off or enter settings by mistake Settings 5. Instillation of water button 1 (in setting mode: Step down) Note: Two Instillation of water buttons are available and can be set, after discussion with your healthcare professional, according to your own personal needs. This will give you the possibility to use two different water flows during an irrigation without having to enter the setting mode. 6. Instillation of water button 2 (in setting mode: Step up) Inflation of balloon (in setting mode: Increase values +) 8. Deflation of balloon (in setting mode: Decrease values ) Loop to attach the lanyard for hands-free handling 10. Display (blue during activation, white during TAI) 9 Additional feature automatic bowel diary You can keep record of your TAI treatments by downloading the free Navina Smart app on the App Store or Google Play. The Navina Smart app will automatically compile a bowel diary for you with data from the Navina Smart control unit, let you evaluate the TAI sessions, present the data to facilitate the identification of your optimal personal settings and easier follow-up with your healthcare professional if you should so desire. 11

12 Overview display To save power the display will go on power save mode when no buttons have been activated for five minutes (the blue light at the on/off button will flash slowly to indicate the power save mode). To re-activate the display press mode the Navina Smart control unit will automatically turn itself off.. After 75 minutes on power save There are four main modes/screen types on your Navina Smart control unit. Welcome page/data transfer mode This is the only mode where your data can be transferred to the Navina Smart app if you wish to use it. Bluetooth is only active when you are in data/transfer mode Battery level 2. Software version 3. Serial number 4. Bluetooth Setting mode This mode allows you to personalize your Navina Smart control unit and select maximum settings for increased convenience and safety. Note: When using Navina Smart you can always choose to stop the irrigation before you reach the maximum settings. You are always fully in control Note: For safety purpose, to be able to change the rectal catheter maximum balloon size setting, the balloon must be completely deflated. Select the parameter with / (up/down). Select the level with / (+/-). If you enter the setting mode while the catheter balloon is inflated, the maximum catheter balloon setting will not be displayed. 12

13 Activation mode In this mode you empty the air from the system and activate the hydrophilic surface on the catheter Battery level 2. Max amount of water 3. Max size of balloon 4. You can enter instillation mode by pressing the balloon deflation button For safety reasons, the Navina Smart control unit must register water flowing through the control unit before you can proceed to instillation mode Once the control unit has registered water flow, the balloon deflation button will appear at the bottom of the screen (4) to remind you that you can press it to go to instillation mode. Instillation mode This mode is used during the actual irrigation Battery level 2. Max amount of water 3. Max size of balloon 4. Actual flow rate 5. Actual balloon size 6. Amount of water instilled Get started Please note that the Navina Smart Control unit is NOT fully charged when you receive it. The Navina Smart Control unit needs to be FULLY charged before its first use. Note: Your first irrigation should be supervised by a healthcare professional. 13

14 Charging the Navina Smart control unit The Navina Smart control unit comes with an inductive charger and a charging support that fits the Navina Smart control unit. You should place the inductive charger in the charging support as shown in the illustration below. The Navina Smart control unit uses inductive, or wireless, charging which means that there are no electrical connections into the Navina Smart control unit. Plug the power adapter cable into the charger and place it on a flat surface. Note: Make sure the logotype on the charger is facing the front and the connection for the power cable is to the left. 1. Place the inductive charger unit in the charging support. 2. Plug the power adapter into the mains socket. 3. Plug the power adapter cable into the charger. 4. Place the Navina Smart control unit on the charging support. When the Navina Smart control unit is on the charger, the display will go on power save mode and the blue light indicator on the on/off button will let you know how the charging is proceeding. If there is not enough power for one complete irrigation, the blue light will flash once every 4 seconds. Once the Navina Smart control unit has enough power to perform at least one complete irrigation, the blue light will flash twice every 4 seconds. When the unit is fully charged, the blue light will be lit continuously. A fully charged battery should last for at least 6 irrigations. As your irrigation regime is personal, the number of irrigations you can perform with a fully charged Navina Smart control unit may differ for you. The Navina Smart control unit will not start if there is not enough battery power to perform at least one complete irrigation. For better battery performance you should not charge the control unit after each irrigation but rather wait until the battery symbol light is red. To fully charge the battery takes approximately 7 hours. Charging for one irrigation should take approximately 1 hour. The Navina Smart control unit cannot be used during charging. The charger must not be used in the bathroom. When cleaning the charger, use only a moist soft cloth. Never flush the charger parts with water. WARNING: Only use the supplied charger to with the Navina Smart control unit. 14

15 Setting your Navina Smart control unit. 1. Press the on/off button. The display of the Navina Smart control unit will light up and a welcome screen is seen. The first time you turn on your Navina Smart control unit, you will after a few seconds be automatically redirected to setting mode. Otherwise to enter the setting mode press Note: As a safety precaution the factory settings on the Navina Smart control unit are set very low. You will need to personalize the settings together with your healthcare professional. 2. Set the size of the inflated balloon (1-5). The catheter balloon is inflated in 5 separate steps. 1 Balloon size diameter (in mm) ,5 ± 5 40,5 ± 5 49 ± 5 57 ± 5 65 ± 5 Note: These diameters reflect the size of the balloon when inflated outside the bowel. When the balloon is inflated inside the bowel, it will adapt its shape and the diameter can differ slightly. 3. Set the amount of instilled water ( liter). The amount of water can be set in steps of 0.1 l. Usually a TAI procedure for an adult will use l Set the flow rate for button 1 (1-5). The factory setting for the button is 100 ± 50 ml/min (1 in the 1-5 scale) Water flow (ml/min) 100 ± ± ± ± ± Set the flow rate for button 2 (1-5). The factory setting for the button is 200 ± 50 ml/min (2 in the 1-5 scale) Water flow (ml/min) 100 ± ± ± ± ± 50 Note: The flow rates above represent default conditions outside the bowel, i.e. where the water container is placed 50 cm below the rectal catheter. The actual flow rate during irrigation, will be shown on the display above the catheter. The flow rate on the display shows the water flow in l/min. 15

16 Instructions for use Note: Read the entire instruction. Empty your bladder before irrigation. Follow instruction of your healthcare professional. Overview 1. Charging 2. Setting 3. Preparation 4. Activation 1. Place the inductive charger unit in the charging support. 2. Plug the power adapter into the mains socket. 3. Plug the power adapter cable into the charger. 4. Place the Navina Smart control unit on the charging support. 1. Enter settings by pressing. 2. Select maximum balloon size. 3. Select maximum water volume to instill. 4. Select flow rate for button Select flow rate for button Select pin code if desired. 7. Exit setting by pressing. 1. Fill water container. 2. Connect the water container tube between water container and control unit (dark blue). 3. Connect the catheter tube between control unit and catheter (light blue/white). 1. Turn on the Navina Smart control unit by pressing. 2. Press any button to go to the activation mode ( / / / ). 3. Press / to pump water until the catheter tube is covered. 4. Press when you are ready to insert the catheter to proceed to the Instillation mode. WARNING: No modification of this equipment is allowed Note: A training session with a healthcare professional specialized in TAI and familiar with the Navina Systems is mandatory before using the Navina Smart system. Make sure you have chosen your personal settings. These settings will set the maximum values to which you can inflate the balloon and instill water. 16

17 5. Instillation 6. Evacuation 7. Disassembly 8. Transfer data 1. Insert the rectal catheter to the handle. 2. Press to inflate the catheter balloon until the desired balloon size is reached. 3. Gently pull catheter slightly down to seal the rectum. 4. Instill water by pressing /. Note: do not turn off the control unit until the disassembly stage. 1. Press to deflate the balloon. 2. Remove catheter. 3. Allow bowels to empty. 1. Open water container lid. 2. Disconnect tubes from control unit. 3. Empty water from tubes. 4. Turn off the Navina Smart control unit and empty water from control unit. 5. Disconnect catheter and dispose in household waste. 6. Disconnect tube from water container and empty water. 7. Rinse, clean and dry system. 1. Turn on Navina Smart control unit and stay on welcome page. 2. Open Navina Smart app. 3. The first time, you will have to confirm the control unit identity to pair it with your app. 4. Select Synchronize in main menu in the app. 5. The Navina Smart control unit will turn itself off automatically once the data is transferred. 6. Rate the new irrigations uploaded in the app. Note: Fecal impaction should be excluded and treated before starting TAI. If you suffer from constipation, the efficiency of TAI may be improved by having a clear colon before you start with the TAI therapy. Furthermore, your healthcare professional might want to optimize your stool form by adapting your diet or with the use of laxative medication. 17

18 Preparation 1. Open the lid and unwrap the water container by releasing the handle and expanding the container. Fill the container with lukewarm clean water to the upper mark of the container F C Note: It is much easier to expand the water container when the lid is open. Note: Always fill the container to the upper mark! You may not use all of the water during TAI, but a full container will make it easier to create pressure within the Navina Smart system and allow you to use the inverted scale to see how much water you have instilled in your body. Note: Always use lukewarm water. Water that is too cold can be unpleasant and you may experience cramps. Water that is too hot may irritate the delicate lining in your rectum and colon. 2. Gently close the lid of the container until your hear/feel a click (different ways of doing this are illustrated below). IMPORTANT: Make sure that the safety valve on the lid is not blocked during the whole TAI procedure. Note: You can place the container wherever is most convenient for you during the TAI procedure; standing on the floor, hanging by the handle or placed on a shelf or in the sink. 18

19 3. Connect the tube with dark blue connectors to the dark blue connector on the water container. Lock the connection by turning it clockwise until it stops. Note: If you plan to hang the water container, be sure to place the handle behind the tube. Note: All the Navina Smart connections are designed to be easy to assemble. You do not need to align the tube and connection holes exactly. By turning the tube the initial connection will be made when the holes are aligned. When you push the tube in place, the connection will hold so that you can twist and lock the connection to complete stop. 4. Remove the protective caps the first time you use the Navina Smart control unit. 5. Connect the tube with dark blue connector to the dark blue connection and the symbol on the Navina Smart control unit. Lock the connection by turning it clockwise until it stops. 6. Connect the tube with the light blue connector to the light blue connection and the symbol on the Navina Smart control unit. Lock the connection by turning it clockwise until it stops. 19

20 7. Peel the catheter packaging open 2-3 cm to expose the rectal catheter connection. Do not remove the catheter from the packaging at this stage. Attach the tube with the white connection to the catheter. Lock the connection by turning it clockwise until it stops. Note: Don t open the packaging too far, as it will later be filled with water to activate the hydrophilic surface of the catheter. The hydrophilic surface is the coating on the catheter. It attracts water, which makes the catheter slippery. Do not use gel on the catheter. Note: The catheter connection is half-moon shaped to help you connect it correctly. 8. Attach the packaging to a vertical surface by the adhesive patch or place it in the sink or in a tall glass. This way, the incoming water will remain in the package itself and the hydrophilic surface on the catheter will be activated. Ensure that the placement of the catheter is within easy reach when you are sitting on the toilet. 20

21 Activation (of the hydrophilic surface of the catheter) 1. Turn on the Navina Smart control unit by pressing the on/ off button. The blue light will indicate that the device is on. The display will show the welcome screen. Press to enter activation mode: showing the water container and the catheter pointing down in its packaging on a blue background. To empty the tubes of air and activate the slippery surface on the catheter, press and hold or. Water will pour into the catheter packaging and activate the hydrophilic surface of the catheter. Release the button when the water has reached ¾ of the length of the catheter. Once you are ready to insert the catheter, press the instillation mode. to proceed to Note: The hydrophilic coating on the catheter is activated immediately and is ready to use. Note: For safety reasons, the Navina Smart control unit must register water flowing through the control unit before you can proceed to instillation mode. Once the control unit has registered water flow, the balloon deflation button will appear at the bottom of the screen (4) to remind you that you can press it to go to instillation mode. Note: The system allows a maximum of 200 ml of water to activate the catheter. 21

22 Instillation 1. Insert the rectal catheter. Remove the catheter from its packaging. Keep the package for the disposal of the catheter. As instructed by your healthcare professional, hold the catheter s handle and insert the activated catheter carefully into your rectum so that your fingers and the handle reach your anus. You shouldn t need to use any force during the insertion. If you experience resistance when inserting the catheter, remove the catheter and make sure that your rectum is empty. Digital evacuation may be needed to ensure that the catheter can be safely and correctly inserted. This is particularly important during the early use of the system. When well established, your rectum will usually be empty when conducting TAI. However, if resistance continues do not force the catheter into your rectum. Stop using the irrigation. Seek help from your healthcare professional. Note: If you do not have sensation in your rectum and anal region, your healthcare professional will probably ask you to digitally check that your rectum is empty before you begin. Note: Grip rings are avilable as a handling aid. See page 28 for more information about the grip rings and other accessories available. Note: Make sure that you are not sitting on the tubes or blocking the water or air flow in the tubes in any way. 22

23 2. Inflate balloon. Inflate the balloon by pressing on the Navina Smart control unit. You can stop the inflation at any time by releasing the button. Inflate the balloon up to the size #, recommended by your healthcare professional. Then gently pull the catheter slightly down to seal off the rectum. Note: If you need to adjust the position of the catheter, deflate the balloon completely and reposition the catheter. Note: It is possible to deflate the balloon partially, but if you do not deflate the balloon completely, you will not be able to inflate it back to your maximum setting. This is because the air used in the first inflation will still count against your maximum total. The less than sign beside the balloon size number on the display < # indicates that the balloon was not deflated completely Irrigate/instill water. Press / to instill the water amount indicated by your healthcare professional into your bowel. On the display you can check the amount of instilled water under the water container symbol and the flow rate over the catheter. You can stop or pause the instillation at any time by releasing the button. 3 Note: Do not turn off the Navina Smart control unit during irrigation! The Navina Smart control unit should not be turned off until all tubes are disconnected! As long as the Navina Smart control unit is on, it prevents backflow of water from the catheter into the tubes. 4 23

24 Evacuation 4. Deflate ballon and remove catheter. Once you have instilled the desired amount of water, press until the balloon is totally empty. The catheter may slide out by itself. If not, pull out the catheter gently. Note: You can let the catheter rest on the inside of the toilet and keep it there until you flush or place the catheter back in its package. Select which ever is more convenient for you. 5 Note: The catheter should be removed after deflation. Do not remove the catheter from your rectum before the balloon is completely deflated. Note: If you experience resistance when removing the catheter try to press the again to make sure there is no air remaining in the balloon. If there is still resistance, make sure that the tube between the control unit and the catheter is not blocked. If there is still resistance, disconnect the tube from the Navina Smart control unit. 5. Evacuation. If your colon does not start to empty on its own, relax for minutes and then try to lean forward, cough, perform abdominal massage or move your upper body to start the emptying process. The evacuation time is individual and can vary from one day to another. Disassembling and cleaning 1. Open the lid of the water container to minimize the pressure in the system 24

25 2. Remove the light blue connection from the Navina Smart control unit. If the catheter is still hanging in the toilet, simply raise the tube to empty water from it into the toilet. Let the tube rest at the side of the toilet. If the catheter is already back in its package, empty the water through the light blue connection into the toilet. 3. Remove the tube with the dark blue connection from the Navina Smart control unit. Hold it high, so that the remaining water flows back to the water container. 25

26 4. Turn off the Navina Smart control unit by pressing the button. Turn it upside down into the toilet or sink to empty any remaining water from it. Note: If the display has gone to power save mode, press the to re-activate the display then press once more and hold a few seconds to turn off the Navina Smart control unit Remove the dark blue connection from the water container and empty the remaining water from the container. 6. Holding the tube with the white connection, place the catheter back in its packaging (if not already there) and disconnect it from the tube. Dispose of the single use catheter and the packaging with the normal household waste. Do not flush the catheter down the toilet. 7. Clean and dry the remaining parts of the system. All components, except the single-use catheter which should be disposed of after use, can be washed in mild soapy water. Note: The Navina Smart control unit can be wiped with mild soapy water. 26

27 8. If you use the Navina Smart app and want to transfer the data, restart the Navina Smart control unit and stay on the welcome screen on the display and start your Navina app to start the synchronizing. 1. Turn on Navina Smart control unit and stay on welcome page. 2. Open Navina Smart app. 3. The first time, you will have to confirm the control unit identity to pair it with your app. 4. Select Synchronize in main menu in the app. 5. The Navina Smart control unit will turn itself off automatically once the data is transferred. 6. Rate the latest irrigation uploaded in the app. Note: When you are on the welcome screen, Bluetooth will be active to allow you to transfer your data to your Navina Smart app if you wish. Bluetooth is only active while you are on the welcome screen. No data can be transferred while you are using the unit. 9. Recharge the Navina Smart control unit if necessary, or you may store it with all other parts in the Navina case. 27

28 Accessories Accessories are available to make using the Navina Smart system easier. To facilitate handling, the Navina Smart control unit can be attached to your thigh with the help of the positioning strap and the Navina Smart control unit positioning clip. Two different grip rings are available to facilitate the handling of the rectal catheter. A lanyard is available if you would like to let the control unit hang around your neck while you are not holding it. The accessories are included with the Navina Smart system. It is possible to order the accessory set separately if you need a replacement. Using the positioning strap 1. Thread the positioning strap with the Velcro facing down through the positioning clip. 2. Adjust the length of the positioning strap by folding the strap over itself and fixing it with the Velcro. 3. Place the positioning clip on the upper side of your thigh and secure the positioning strap around your leg. 4. Place the Navina Smart control unit in the positioning clip and slide it up until your hear/feel a click. Note: the positioning clip and strap can remain on the control unit when you are charging it. Adjust the grip rings 1. Place one of the rings (vertical or horizontal) on the catheter tube, close to the rectal catheter connector. Press until your hear/feel a click to secure the grip ring in place. Note: If you have impaired sensation in your anal area and you wish to use the grip ring, make sure your healthcare professional shows you where the ring should be placed on the tube in order to insert the catheter to the catheter handle and no further. 28

29 Using the lanyard 1. Thread the small loop through the bottom of the Navina Smart control unit and pass the connection through the thread loop. 2. Attach the connection on your lanyard. 3. The lanyard can then be used around your neck. 29

30 Frequently asked questions (FAQ) As stated earlier, TAI is a very individual therapy method. For some individuals the method will work after a couple of irrigations, for others it may take 4-12 weeks to create a working bowel management routine. What if I forgot the code to unlock my settings? Contact Wellspect HealthCare, see contact information page 51. Preparation How often should I perform TAI? Can I stop using stool modifying medicine when I start using Navina? How long does the procedure take? Can I add salt to the water? Is the water temperature important? At the start it is common to irrigate once every day for the first days. Later on the frequency may possibly be reduced to once every other day or every third day. Your frequency should be decided in consultation with your healthcare professional. TAI is usually part of a bowel management program. It is possible that you may be able to reduce the amount of laxative you are using eventually but you may have to continue using some to ensure your stools have the right consistency to ensure easy evacuation. It is best to continue with your current laxative regimen until you are getting regular results from TAI. Consult your healthcare professional before changing your regimen. It is very individual but the aim is that the bowel management routine will take less than one hour. For some people the results are fast and emptying of the bowel is complete. For others it will be more time consuming and the bowel empties intermittently. Navina Smart system can be used with a saline solution but the product needs to be rinsed thoroughly with clean water directly after use. You should always use lukewarm water (36-38 C/ F). Water that is too cold can be unpleasant and you may experience cramps. Water that is too hot may irritate the delicate lining of your rectum and colon. 30

31 Can I use gel on the catheter? Is the risk of bowel perforation higher the longer I irrigate? No, the catheter is hydrophilic and will become slippery when immersed in water. There is no need to add gel. No, the evidence shows that the risk of bowel perforation does not increase the longer you use TAI. Activation What water quality should I use? Only use clean tap water. If you do not have access to clean tap water, use bottled water. Instillation How much water should I instill? What water flow rate should I use? What balloon size is recommended? What if I cannot get to the instillation mode when I press the button? What if the balloon does not inflate when I press the button? What if I cannot fill the catheter balloon more when I press the balloon inflate button? Why cannot I inflate the balloon more than step 5? Your healthcare professional will advise you how much water to use. For adults it is common to start around 500 ml. Your healthcare professional will advise you. The water should be instilled at a rate fast enough to provide stimulation to the bowel wall but not too fast as it can cause abdominal cramps, pain or strong reflex contractions. Your healthcare professional will advise you of the appropriate balloon size. It should be just big enough to hold the catheter in place and seal the anal opening to minimize leakage during irrigation. Make sure that you have filled the water container with water, that the lid is closed and that you have pressed long enough so that water runs through the catheter and the catheter balloon deflation symbol is shown at the bottom of the screen. Make sure the Navina Smart control unit is on and that you are in the instillation mode. This is the only mode where the balloon can be inflated. Make sure the tubes are connected at the right place. Make sure the tubes are connected tightly so the air does not leak. Make sure the tubes are not blocked or kinked. You may have reached the maximum balloon size selected in your settings. If there is a < sign beside the balloon size on your display, it means you have deflated the balloon but not completely and then tried to inflate it again. For safety purposes only a limited amount of air can be filled in. Deflate the balloon completely and you will then be able to inflate it again up to your maximum setting. The maximum size of balloon inflation was selected after consultation with healthcare professional experts, to meet the anatomical needs and prevent over inflation of the balloon and the risk of balloon burst. 31

32 Can the balloon burst and, if so, is it dangerous? Can I stop inflation? Can I adjust the size of the balloon? Can I stop instillation What if the Navina Smart control unit does not start? What if the Navina Smart control unit does not charge? How do I go to the next mode on my Navina Smart control unit? What if no water is flowing when I press the water buttons? What if the water flow is too low? Yes, there is a risk of the balloon bursting and this is why the Navina Smart control unit has a maximum inflation size of the balloon already set. It is also possible to change the maximum balloon inflation size to a smaller size recommended by your healthcare professional. This is done simply by entering the setting mode and changing the maximum balloon inflation size setting. This minimizes both the risk of over inflation and of balloon bursting. You can stop the inflation of the balloon at any time by releasing the button. You can deflate the balloon by pressing. You can stop the instillation of water at any time by releasing the button /. If the control unit does not start when you press the on/off button, it is probably because there is not enough power left to complete an irrigation. Charge the control unit. The control unit cannot be used while being charged. If the control unit does not seem to be charging, make sure the inductive charger is correctly placed in the charging support. Make sure the charger is connected to the main socket. Make sure the Navina Smart control unit is properly placed in the charging support. Press any button under the display when you are in the welcome mode, to go to activation mode and press to go to the instillation mode when you are finished with the activation mode. Make sure the Navina Smart control unit is on and that you are in the activation or operation mode. Make sure there is water in the container. Make sure the lid of the water container is closed. Make sure the tubes are connected at the right places. Make sure the tubes are connected tightly so the air does not leak. Make sure the tubes are not blocked or kinked. Please check the flow rate selected in your settings. Make sure the lid of the water container is completely closed. Make sure the tubes are connected at the right place. Make sure the tubes are connected tightly so the air does not leak. Make sure the tubes are not blocked or kinked. Make sure you are not impacted and that your rectum is emptied. You may want to try placing the water container higher. The pressure in the system might have reached the maximum and the safety valve may be opened. Deflate the catheter and try to empty the bowel. If you do not feel completely empty, make sure you are not constipated and that your rectum is empty and repeat the irrigation procedure. 32

33 What if the water instilled on the display and the scale on the water container do not indicate the same amount of water instilled? What if debris from the catheter flow back in the tube? What if bleeding should occur? What should I do if I feel pain? What if I feel sweating, palpitations or dizziness during irrigation? What if there is leakage of water around the catheter? What if the catheter gets expelled before I have deflated the balloon? The display and the scale on the water bag have an accuracy of +/- 50 ml so due to rounding effect the two scales could show 100 ml (0.1 l) difference. Note that the amount of water is shown in l (litres) on the display. Do not turn off the Navina Smart control unit until you have disconnected the tubes from the control unit. If you do experience debris from the catheter flowing back in the tube, you can clean the tube by pumping water through it. New tubes can also be ordered separately if needed. A small amount of bleeding or smearing of blood on the catheter may occur and should not alarm you. More severe or sustained rectal bleeding with or without pain suggests a possible bowel perforation, which should be treated as a medical emergency and requires immediate medical attention. If cramps, discomfort or pain occur while instilling the water, pause instillation for a few moments and continue more slowly once the discomfort has subsided, ensure that the water is warm enough, at body temperature. If pain is severe or persistent stop the irrigation immediately. It could be perforation of the bowel which should be treated as a medical emergency. If you have a spinal cord injury this may be a sign of autonomic dysreflexia. Instill the water slowly and limit the time on the toilet depending on tolerance. If symptoms are bothersome, ensure that you are not alone when irrigating until symptoms at each TAI are reduced or minimized. If you are at risk of autonomic dysreflexia, you should have medication easily to hand in your home. If autonomic dysreflexia occurs, stop the irrigation immediately. Further assessment and possibly other treatments are required before continuing with TAI. Ensure that the catheter is properly located. Check water temperature. Increase balloon inflation up to your personal maximum setting. Instill water more slowly. Minimize inflation to avoid triggering reflexes. Instill the water more slowly. Contact your healthcare professional who will assess and treat any rectal impaction that may be causing the rectal expulsion. 33

34 Evacuation What if my bowel does not empty? What if I feel resistance when trying to remove the catheter/ the balloon does not deflate completely? Try to lean forward, cough or perform abdominal massage. If water and the bowel content still do not come out, you may be severely constipated and a manual clean-out of the rectum might be necessary. You might also be dehydrated, so remember to drink a lot of water and repeat the TAI procedure the day after. If you have been successfully using TAI for a while it might be that your colon is clear and this could be a first indication that the TAI frequency could be reduced. If you feel any resistance when removing the catheter, try to press again to make sure all air is removed from the balloon. If there is still resistance, make sure that the tube is free. If that does not help, disconnect the tube from the control unit, this should allow all the air to leave the balloon. Disassembling Can I reuse the catheters? How should I store my Navina system? Can I wipe the Navina Smart control unit display with alcohol? No, the rectal catheter is for single-use only. Dispose of it after use in the normal household waste. If reused, Wellspect HealthCare cannot guarantee the functionality nor the safety of the product. Reuse may lead to infection. After the components are cleaned and dried, you may store your Navina system in the Navina case and keep it out of direct sunlight. Also ensure that the tubes are not kinked and that the system is kept away from sharp objects. Keep away from children. No, only use mild soap and water as the alcohol may negatively affect the display and reduce visibility of the information on the display. 34

35 35

36 Troubleshooting Navina Smart control unit If an error message (Warning triangle with a three digit code) is shown in the display of the Navina Smart control unit, follow the recommended actions as suggested below. These warnings are divided in 3 types: 1. Warning codes Once warning read and/or corrective actions are taken, the treatment can resume by pressing the button. 2. Warning code Once warning read and/or corrective actions are taken, turn off the Navina Smart control unit and restart the unit. 3. Warning 204 and 304 The unit reached the end of its life and must be changed. It can be restarted but it can no longer be used. Error: type 1 Reason Action Water flow too high No water flow Balloon deflation malfunction 1. Check for blockage in the safety valve in the lid of the water container 2. Place the water container lower 3. Press balloon deflation button to proceed 4. Still problem? Contact Wellspect HealthCare 1. Check for free flow in all tubes 2. Check for enough water in the container 3. Ensure that the lid on the water container is closed 4. Press balloon deflation button to proceed 5. Still problem? Contact Wellspect HealthCare 1. Check for free flow in all tubes 2. Check that the air outlets on the back of the Navina Smart control unit (the area between the two white/grey buttons) are free 3. Press balloon deflation button to proceed 4. Still problem? Contact Wellspect HealthCare 36

37 End of life for Navina Smart control unit Bluetooth malfunction Replace your Navina Smart control unit Less than 50 irrigations remains Less tha 10 irrigations remains irrigations remains Less than 2 month lifetime left Less than 2 weeks lifetime left lifetime left Press balloon deflation button to proceed Note: Navina Smart control unit can still be used for irrigations but data cannot be transfered to Navina Smart app 1. Press balloon deflation button to proceed or restart the Navina Smart control unit and try again 3. Still problem and If using Navina Smart app? Contact Wellspect HealthCare Error: type 2 Reason Action Water pump malfunction 1. Release the water buttons and try again 2. Restart Navina Smart control unit and try again 3. Still problems? Contact Wellspect Heathcare Balloon malfunction Balloon malfunction 1. Check for free flow in all tubes 2. Check for blockage in the connections 3. Check for correct assembling of the tubes and catheter 4. Replace the catheter and try again 5. Restart Navina Smart control unit and try again 6. Still problem? Contact Wellspect HealthCare 1. Restart and try again 2. Still problem? Contact Wellspect HealthCare Device malfunction 1. Restart and try again 2. Still problem? Contact Wellspect HealthCare

38 Error: type 3 Reason Action No treatments left Replace Navina Smart control unit 204 No time left Replace Navina Smart control unit

39 Signs and symbols Manufacturer (Shelf box includes date of manufacture indicated as year, month and day) REF LOT SN Reference number. Article number representing the product when ordering Lot number Serial number (includes date of manufacture indicated as year, month and day) Use by Single use Follow instructions for use Consult instructions for use Caution WEEE Waste electrical and electronical equipment, indicates separate collection for electrical and electronic equipment IP65 IP class 65. IP65 is the Ingress Protection enclosure definied as dust tight and protected against low pressure jets of water Type BF applied part Non-ionized electromagnetic radiation FCC: 17VAN17 Federal Communications Commission Identification, Bluetooth ID US federal law restricts this device to sale by or on the order of a physician Charge by. This symbol on the packaging label indicates the date when the Navina Smart control unit should be charged by at the latest. -25 C +5 C C +35 C 93 % 1060 hpa Temperature limitation, indicates the range of temperature to which the medical device can be safely exposed during transport and storage Temperature limitation, indicates the range of temperature to which the medical device can be safely exposed during operation Humidity limitation, indicates the range of humidity to which the medical device can be safely exposed during transport and storage Atmospheric pressure limitation, indicates the range of atmospheric pressure to which the medical device can be safely exposed during transport and storage 39

40 Warranty Warranty This product is warranted by Wellspect HealthCare to the original purchaser to be free from defects in material and workmanship. The Navina Smart control unit is valid for up to 400 irrigations within two years from the date the product is first used. In the event of defect, contact your healthcare provider or your local Wellspect HealthCare office (see contact information page 51). If you wish to make a claim under this warranty you will need to return the products. Your healthcare provider or your local Wellspect HealthCare office will advise you on how the return should be made and how the replacement product will be delivered to you. This warranty does not apply if the products were not used in accordance to the instruction for use or have been subject to misuse, abuse or alteration. 40

41 Technical specification Navina Smart system Power - charging V, 50/60 Hz Charger mat: ZENS model: ZESC03B/00 Power adapter: HAMA model Battery 3,7 V, 2600 mah / Li-Ion Size 200 x 30 x 70 mm Weight 400 g Operation temperature +5 to +35 C Operation relative humidity 15-93% non-condensing Operation atmospheric pressure hpa Transport/storage temp. -25 to +70 C, up to 93 % rel. hum. non-condensing Transport/storage atmospheric pressure hpa Actual flow rate accuracy +/- 50 ml/min Balloon inflation Minimum size 31,5 ± 5mm Maximum size 65,0 ± 5mm Maximum balloon size levels, upper range When the setting BALLOON SIZE is set between 3-5 the balloon shall never exceed a diameter of 70 mm. Maximum balloon size levels, lower range When the setting BALLOON SIZE is set between 1-2 the balloon shall never exceed a diameter of 50 mm. System shall ensure emptying of the balloon When the system considers the balloon to be FULLY DEFLATED, the balloon diameter shall be less than 20 mm +/- 10%. Water pump controllability, start The water pump shall never start if there is no finger on any on the water pump buttons. 41

42 Water pump controllability, stop The water pump shall always stop within 700 ms when finger is lifted from any of the water pump buttons. Maximum water volume 1,5 liter Maximum pressure in water path Maximum pressure in water path: 160 mba The catheter is an applied part. Portable and mobile radio frequency communications equipment can affect the Navina Smart control unit. Navina Smart control unit needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Navina Smart control unit, including cables specified by the manufacturer, when using Navina Smart. Otherwise, degradation of the performance of this equipment could result. WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING: After transportation/storage, allow the Navina Smart control unit to reach the operating temperature before use. This can take up to 60 minutes. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. If the warnings above is not honored, the following malfunctions can occur: * The balloon might get too large. * Air can be pumped into the colon. * The balloon might not be able to fully deflate. Navina Smart is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. 42

43 Electro magnetic compatibility Electromagnetic emission Guidance and manufacturer s declaration electromagnetic emissions The Navina Smart is intended for use in the electromagnetic environment specified below. The customer or the user of the Navina Smart should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Group 1 Class B The Navina Smart 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. The Navina Smart is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity Navina Smart is intended for use in the electromagnetic environment specified below. The customer or the user of the Navina Smart should assure that it is used in such an environment. Immunity test IEC test level Electrostatic +/- 6 kv contact discharge (ESD) +/- 8 kv air IEC Compliance level +/- 6 kv contact +/- 8 kv air Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. 43

44 Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity Navina Smart is intended for use in the electromagnetic environment specified below. The customer or the user of the Navina Smart should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz Portable and mobile RF communications equipment should be used no closer to any part of Navina Smart than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 44

45 a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Navina Smart control unit is used exceeds the applicable RF compliance level above, the Navina Smart control unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Navina Smart control unit. b. Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations and walkietalkies can affect this equipment and should be kept at least at a distance according to the table below, away from the equipment. Recommended separation distances between portable and mobile RF communications equipment and the Navina Smart The Navina Smart is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Navina Smart can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Navina Smart as recommended below, according to the maximum output power of the communications equipment. 45

46 Rated maximum Separation distance according to frequency of transmitter output power of transmitter W 150 khz to 80 MHz d = 1,2 P 80 MHz to 800 MHz d = 1,2 P 800 MHz to 2,5 GHz d = 2,3 P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 46

47 4 Quick guide Note: Read the entire instruction for use. Empty your bladder before irrigation. Follow the instructions given by your healthcare professional. A training session with a healthcare professional specialized in TAI and familiar with the Navina Systems is mandatory before using the Navina Smart system. 1. Charging 1. Place the inductive charger unit in the charging support. 2. Plug the power adapter into the mains socket. 3. Plug the power adapter cable into the charger. 4. Place the Navina Smart control unit on the charging support. 2. Settings 1. Enter settings by pressing. 2. Select maximum balloon size. 3. Select maximum water volume to instill Select flow rate for button Select flow rate for button Select pin code if desired. 7. Exit setting by pressing. Select the parameter with / (up/down). Select the level with / (+/-). 47

48 Preparation 1. Fill water container. 2. Connect the water container tube between water container and control unit (dark blue). 3. Connect the catheter tube between control unit and catheter (light blue/white). 4. Activation 1. Turn on the Navina Smart control unit by pressing. 2. Press any button to go to the activation mode ( / / / ). 3. Press / to pump water until the catheter tube is covered. 4. Press when you are ready to insert the catheter to proceed to the Instillation mode. 5. Instillation 1. Insert the rectal catheter to the handle. 2. Press to inflate the catheter balloon until the desired balloon size is reached. 3. Gently pull catheter slightly down to seal the rectum. 4. Instill water by pressing /. 48