The world s first 3 lead 14 day continuous ECG and remote event device.

Transcription

1 Patient Instruction Bklet The world s first 3 lead 14 day continuous ECG and remote event device. A very positive and quick way to get diagnosed.

2 The Zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (singleuse disposable Intelesens Zensor electrode) which in turn is in contact with the patient s body. The device is to be used in the patient s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The Zensor Monitoring System provides full disclosure ECG and cardiac event monitoring for adult patients (18 years+). The physiological parameters monitored include ECG and respiration waveforms, heart rate and respiration rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The Zensor monitoring device has the option to store full disclosure ECG & respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens Zensor online system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens Zensor + (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician. Any events or variations in physiological readings are not intended to be used to summon emergency care Zensor TM Device PN 1265 Rev A

3 The Zensor Device What is the Zensor TM Device The Zensor device is a wireless patient monitor that records every heartbeat. Each time you press the button or if the Zensor device automatically detects an irregular heart rhythm, your data will be stored. Alternatively, the arrhythmia (the irregular or abnormal heart rhythm) can be transmitted (via the dedicated Mobile Wi-Fi unit) to the Zensor device monitoring station and your healthcare provider will receive a report detailing the arrhythmia. Initially, your healthcare provider will Set up the Zensor device Apply the first set of Zensor device patches Go through the operating instructions with you Contact your healthcare provider if you need more patches or if you have any questions Zensor TM Device PN 1265 Rev A 3

4 Zensor TM Device Monitoring System The Zensor device monitoring system consists of the following components: Zensor electronic unit and two batteries (rechargeable) Custom made Zensor TM patches Accessories required to charge and transmit your heart rhythm data includes: Charging dock with power supply and mains lead Mobile Wi-Fi, charging cable and three-pin plug Only use the accessories supplied with the Zensor Device Monitoring System. A very positive and quick way to get diagnosed Zensor TM Device PN 1265 Rev A

5 Zensor TM Device Electronic Unit and Rechargable Battery 1 On/Off Button and Event Button 2 Status Light 3 Status Light 4 Battery 5 Five Connection Studs (Electronic Unit) 6 Charging Dock (with Battery) **Not Pictured: Power supply and mains lead for battery charger Zensor TM Device PN 1265 Rev A 5

6 Zensor TM Device Patch Units RA LA 7 Right Patch (RA) 8 Left Patch (LA) 9 Larger Patch (LL) 10 Five Connection Studs (embedded on LL marked patch) LL RA LA When wearing the system, you should have the three patches placed on your chest and abdomen with the Zensor electronic unit attached this is your Zensor device. 11 Mobile Wi-Fi Unit 11 Screen 12 On/Off button **Not Pictured: Charger cable and three pin plug Zensor TM Device PN 1265 Rev A

7 2018 Zensor TM Device PN 1265 Rev A 7

8 Using your Zensor TM Device RA LA DETERMINE PATCH LOCATION 1 Plan position of where patches will be placed before removing the liners. The patches should only be placed on healthy, intact skin. SKIN PREPARATION Inspect the area to ensure the skin is: Intact Hairless 2 If required, remove chest hair. If required, clean skin using soap and water. Allow skin to dry completely. :10 APPLYING ZENSOR DEVICE PATCHES RA LA Remove the patch liners to expose the adhesive. Place patches in the recommended position. 3 Press firmly across each patch for 10 seconds. If required, coil and tape the excess wire to the skin. ATTACH ZENSOR ELECTRONIC UNIT RA LA Line up the Zensor electronic unit studs with the magnetic studs on the patch. Connect the Zensor electronic unit to the patch. 4a 4b Gently lift the edges of the electronic unit to confirm all five connections are made. (Step 4a) Turn on the device with a single press of the BLUE button. (Step 4b) EVERYTIME A SYMPTOM IS FELT RA LA Press the BLUE button once. There will be a single beep. 5 Remain still for 30 secs while the Zensor device records your heart rhythm Zensor TM Device PN 1265 Rev A

9 RA WHEN SHOWERING Remove the Zensor electronic unit from the patches. LA Keep patches on the body. 6 Turn the Zensor electronic unit off by pressing and holding the ON/ OFF button for 10 seconds. Shower for a short period (5 minutes) only. Keep your back to the shower as much as possible. Keep soaps/shamp away from the patches. Dry the patches with a gentle patting motion. Return the Zensor electronic unit to the magnetic stud patch and turn unit back on by pressing the ON/OFF button. CHANGING BATTERIES ON THE ZENSOR DEVICE 7b 7a Turn the Zensor electronic unit off. Press and hold the BLUE button for 10 seconds. All LED lights will now turn off. Detach the Zensor TM electronic unit from the body. Remove the battery from the electronic unit. (Step 7a) Place the depleted battery in the charging dock. (Step 7b) Connect the mains lead to the wall socket and turn on the mains power. A red LED will light up on the power supply to indicate charging. Note: Please follow the sequence below to ensure the battery charges successfully: a. Place the battery into the charging dock BEFORE connecting to the mains power. b. Do not remove the battery from the charging dock until fully charged - as indicated by green light on the power cable. :10 TURN ZENSOR DEVICE OFF (OR END OF WEAR) Press and hold the BLUE button for 10 seconds. All LED lights will now turn off. 8 RETURNING THE ZENSOR DEVICE TO YOUR DOCTOR 9 Ensure the Zensor electronic unit, batteries, charging cables etc. are placed back in the case and bring back to your doctor who prescribed the Zensor device for you Zensor TM Device PN 1265 Rev A 9

10 Charging the Zensor TM Battery :10 Turn Zensor Device Off Hold the blue button on the electronic unit down for 10 seconds. You will hear three descending beeps. The lights will go from blue and green to off. Remove Battery Holding the electronic unit and battery, slide the battery away from the electronic unit. TIP TIP Charge Battery 1. Place the low charged battery in the charging dock, pushing down to ensure a gd connection. 2. Connect the power supply to the back of the charging dock and insert the mains lead into the power supply. a. Connect the mains lead to the wall socket in your home and turn on the power at the mains. Place the battery into the charging dock BEFORE connecting to the mains power b. Check that the light on the power supply is red to indicate charging. The battery will take around 4 hours to recharge. The light on the power supply will change to GREEN to indicate that it is fully charged. Insert Battery Slide a fully charged battery onto the electronic unit until secured in place. It is easier to see the guides on the electronic unit when the magnetic connectors are facing upwards. Turn Zensor Device On Ensure the battery is connected and press the blue button. You will hear three ascending beeps. The lights will turn orange and then green. Green tells you that Zensor device is ready to record your data and is operating normally Zensor TM Device PN 1265 Rev A

11 Troubleshting the Zensor TM Device Troubleshting On/Off Button and Event Button (blue button) 2 Orange to Green LED 3 Blue LED (on while waiting to transmit data) 2018 Zensor TM Device PN 1265 Rev A 11

12 The Zensor TM device provides visual and audible status indications as follows: Ascending Tone 1 Beep Device turning on No sound Normal operation Slow Flash Fast Flash No sound No sound Device connecting to Wi-Fi Data transferring via Wi-Fi No sound Data stored on device that has not transmitted 1 Beep Pressing the ON/OFF and EVENT button Repeated Long Beep Low battery Slow Flash Repeated Long Beep Critical battery* Slow Flash Repeated Short Beep Error indication** Descending Tone Device turning off * Device is no longer monitoring. Change battery. **This indication may last approximately 6 seconds. If the error still exists after 6 seconds the indication will be repeated. In this instance, switch the device off and remove the battery. After 10 seconds reinsert the battery, and switch the device on. Monitoring should then be continued. If the error persists, contact your clinician Zensor TM Device PN 1265 Rev A

13 Troubleshting: Zensor TM Device Zensor device did not follow normal start-up sequence Indication The LEDs did not turn on The LED stayed orange Other indication Solutions Remove and reinsert the battery. Press the blue button again for approximately 1 second. Wait for 30 seconds. If it remains orange, turn Zensor electronic unit off and remove battery. After 10 seconds re-insert the battery and turn back on. If the error persists, contact your clinician. Review the Zensor device indications table and the rest of the troubleshting section to determine if the indication is covered. If not, contact your clinician to report unexpected operation. Zensor electronic unit will not switch on Possible Causes The battery is not inserted correctly The battery is flat The blue button wasn't pressed Solutions Remove and reinsert the battery. When sliding the battery on, it is easier to see the guides on the device when it is turned so the label is facing upwards. Confirm the battery is flat by placing in the charging dock. The LED should turn red if charging. Press the blue button on the front of the device. An ascending tone should be heard when the button is pressed. Zensor electronic unit will not switch off Possible Causes The blue button has not been held down for a long enough period No obvious cause Solutions Hold the blue button down on the device for over 10 seconds. Remove the battery from the device Zensor TM Device PN 1265 Rev A 13

14 Zensor electronic unit is beeping Possible Causes One long beep every second: The battery is low One short beep every second with orange and blue alternate flashing LEDs: Error indication Solutions Replace the battery with a charged battery and insert the low battery in the charger If the indication does not stop after 6 seconds, turn Zensor electronic unit off, remove battery. After 10 seconds re-insert the battery and turn back on. If the error persists, contact your clinician. Cannot remove the battery from the device Possible Causes The grips on the side of the battery have not been used Do not have the required strength to remove the battery Solutions Use the grips on the side of the battery to help to remove it. Seek assistance from a friend or family member to help remove the battery. Zensor electronic unit exposed to water (bath or shower, etc.) Possible Causes Zensor electronic unit is not to come into contact with water Solutions Contact your clinician. Cannot connect Zensor electronic unit to the patch Possible Causes Unable to line the device up with the patch The patch is not on the flattest surface of the abdomen (stomach) area. Solutions Use a mirror to help with stud alignment. Line two of the studs up carefully and the rest of the studs should find themselves more easily. If still unsuccessful, seek assistance from a friend or family member. Apply a new patch ensuring the studs are on the flattest area of the body Zensor TM Device PN 1265 Rev A

15 Troubleshting: Zensor TM Patches Electrode was submerged in water (bath, swimming, etc.) Indication Electrode is not to be submerged in water Solutions Replace all the Zensor device patches. Consistently pr electrode adhesion Possible Causes Skin type is resulting in adhesion not lasting as long as normal Solutions If happy to do so, keep replacing the patches when appropriate. The patches are causing a bad skin reaction Possible Causes Skin has reacted against the patch causing bad irritation Solutions If required, discuss the irritation with the clinician in charge. Troubleshting: Zensor TM Electronic Unit Battery Charging Difficulty charging the battery Indication Order of battery charging instructions were not followed The battery is not inserted into the charger correctly The cables are not connected correctly The power is not switched on at the mains Solutions Turn the power off and on at the mains switch. Remove the battery and reinsert ensuring gd connection. Putting slight downward pressure on the battery can help to ensure adequate battery connection with the charger. Remove and reinsert all the charger connections ensuring each one is connected securely. Turn the power on at the mains switch Zensor TM Device PN 1265 Rev A 15

16 Troubleshting: Mobile Wi-Fi Wi-Fi Indication The Mobile Wi-Fi has a battery life of 10 hrs. It is recommended that you leave the Mobile Wi-Fi unit plugged in and charging when you are at home. See table below for explanation of Mobile Wi-Fi display symbols 4G/3G R 100% Indicates signal strength of the current network Indicates successful network connection Indicates you are roaming Indicates Wi-Fi status Displays the remaining battery power Mobile Wi-Fi Safety information Keep the device away from water, fire, humidity or hot environments Do not attempt to disassemble, repair or modify the device Do not use damaged charger or USB cable to charge the device Do not use the device where wireless devices are not allowed Zensor TM Device PN 1265 Rev A

17 Frequently Asked Questions What is the Zensor device doing? The Zensor device is recording every heartbeat. Your doctor will use this information to determine your medical treatment. How long do I have to wear the Zensor device? Wear the Zensor device for the number of days prescribed by your doctor. How do I know the Zensor device is working? A continuous green LED will be visible on the Zensor device. Occasionally, you may notice a second blue LED. This is all part of the normal Zensor device operation. Can I go about my normal day-to-day routine? Yes, but activities that cause you to sweat excessively may shorten the wear time of the Zensor device patches. How often should I change the patches? The patches may stay on for an average of 2-7 days, depending on each individual s skin type. However, excessive sweating can cause the patches to become lse. If this happens and the patches lift off the skin by more than 1cm, replace all the patches. Remove each patch slowly, taking care not to damage the skin. Follow the instructions on the quick start guide when applying new patches. Frequently Asked Questions Can I wear the Zensor device in the shower? No, the Zensor electronic unit is not waterprf and it must be removed prior to showering. However, the patches may be worn in the shower. Turn off the Zensor device and remove the electronic unit from the patch. After you shower, dry the patches with a gentle patting motion. Reconnect the Zensor electronic unit to the lower large patch and turn back on Zensor TM Device PN 1265 Rev A 17

18 Can I go swimming/have a bath with the Zensor device? No, the Zensor electronic unit is not waterprf and cannot be worn whilst swimming or in the bath. Also, if the patches are submerged (swimming or in the bath), they may stop functioning correctly or detach from the skin. What should I do if I feel a symptom? Press the blue button (see Your Zensor Electronic Unit image at beginning of the troubleshting section of this bklet) as shown on the Zensor electronic unit picture. How often should I change the battery? Change the battery every 24 hrs. Then, place the used battery in the battery charger to allow it to recharge (see Charging the Battery under Your Zensor Device section of this bklet). Will the Mobile Wi-Fi show any lights or make any sounds? No, the Mobile Wi-Fi will not make any sounds. See the Troubleshting section of this bklet for an explanation of the screen symbols. How often should I charge the Mobile Wi-Fi? Charge the Mobile Wi-Fi unit when you see the battery indicator running less than 50% the battery usually lasts 10 hrs. It is recommended that you plug the Mobile Wi-Fi in each day to charge, similar to how you would charge a mobile phone. When I leave my home, do I have to bring the Mobile Wi-Fi with me? No, it is not necessary to bring the Mobile Wi-Fi with you. If you feel any symptoms, just press the blue button on the Zensor device and it will store or mark the event data. When you return home, the Zensor device will automatically talk to the Mobile Wi-Fi, and transmit the data to the Zensor device monitoring station Zensor TM Device PN 1265 Rev A

19 Will I experience any adverse effects from wearing the Zensor device? It is normal for some people to experience minor itching or slight skin redness in response to wearing the device patches. If the patches become very itchy and uncomfortable to wear, please remove them carefully. Return the Zensor device kit to your doctor and ask your nurse/doctor to check your skin. Can I travel with the Zensor device? Yes, you can fly while wearing your Zensor device. Simply remove the Zensor electronic unit, turn the device OFF, and place in the security bin whilst you go through security. Leave the patches on your body (similar to procedure you would follow with the device when having a shower). Also turn off the Mobile Wi-Fi unit during flight. Keep both devices OFF until you have completed your flight. Then after your flight, turn back on the Zensor electronic unit and place back on your body. Turn back on the Mobile Wi-Fi unit which is enabled for roaming in the USA & Europe. What will I tell airport security staff if asked about my Zensor device wear? You can explain to staff that you were prescribed the Zensor device by your doctor to monitor your heart. You can show airport security staff the statement at the back page of this bklet which describes that this device has been prescribed by your doctor to monitor your heart Zensor TM Device PN 1265 Rev A 19

20 Zensor TM Device PN 1265 Rev A

21 Additional Information Things to be Aware of When Wearing Zensor TM Device Contact your healthcare provider to obtain more patches if required. Occasional itchiness and some redness of the skin are normal when wearing the patches. If you experience a more severe reaction, remove the patch and contact your healthcare provider. Do not use lotion or moisturizer where the patches will be placed before or during monitoring as this may prevent the patches from staying on your skin. If you no longer wish to wear the patch, remove and return the equipment to your healthcare provider at the next arranged appointment. Keep the patches out of reach of small children and babies as the patch wires may cause strangulation. Advise your healthcare provider if you intend to use Zensor device in an environment where there is likely to be low or high temperatures. The electronic unit and patches should be removed prior to undergoing defibrillation, MRI scan, or surgical procedure. Do not expose the monitor to excessive dust or to extreme temperatures. The device should be operated between 0-45 C. Avoid using the system in close proximity to heavy electrical equipment or other sources of electromagnetic interference such as electric blankets, heating pads, microwaves etc. Place the battery charging dock in a suitable location, where it will be protected from damage, liquid ingress, moisture or extreme temperature. Clean the studs on the electronic unit with a soft dry cloth to make sure they are free from dirt or debris. Avoid touching the contacts on the Zensor battery. Do not leave the battery connected to the monitor when it is not in use. This device is not intended to be used to summon emergency care. Additional Information 2018 Zensor TM Device PN 1265 Rev A 21

22 AIRPORT SECURITY SCREENING STATEMENT This person is wearing a Zensor Device, which is continuously monitoring their heart rate and rhythm. The patches which are placed on the body contain magnetic studs and may cause your security screening system to alarm. The device has been prescribed by a doctor and it should only be removed under their guidance. If you have any questions, please contact the person s doctor. Patient Feedback A very positive and quick way to get diagnosed. After a day or two I did not notice wearing it. I felt confident using the device. Patient feedback disclosed in this bklet was captured as part of a Zensor TM device evaluation at South Eastern Health and Social Care Trust, Northern Ireland and a Stroke Prevention: Atrial Fibrillation in potentially high prevalence cohorts study Zensor TM Device PN 1265 Rev A

23 0120 The copyright of this document is the sole property of Renew Health Ltd. This document is not to be reproduced or disclosed to any third party without the written acknowledgement and consent of Renew Health Ltd. Wi-Fi is a registered trademark of Wi-Fi Alliance. Patient Instruction Bklet Manufactured by: Intelesens Ltd, 17 Heron Road, Belfast, BT3 9LE, N. Ireland, UK For: Renew Health Ltd, IDA Business & Technology Park, Garrycastle, Dublin Rd, Athlone, Co Westmeath, N37 F786, Ireland 2018 Zensor TM Device PN 1265 Rev A 23

24 If you require any further assistance in relation to the system or you want to report an unexpected operation or event, please use the healthcare provider contact details shown Zensor TM Device PN 1265 Rev A