User Manual

FCC ID: 2ARNZ-1003

Users Manual

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Vpatch System ECG Remote Event Monitor Instructions for Use (User Manual) WRH-N-06232-04

Table of Contents 1.0 Equipment Supplied....................................................................................................... 2 2.0 General Description of Vpatch System.......................................................................... 2 3.0 Indications for Use ......................................................................................................... 2 3.1 Contraindications ....................................................................................................... 2 3.2 Warnings .................................................................................................................... 3 4.0 Vpatch System Equipment ............................................................................................ 3 4.1 REM Biosensor Array ................................................................................................ 3 4.2 Vpod and Vcell Devices ............................................................................................. 3 5.0 Conditions of Use .......................................................................................................... 4 6.0 System Operation .......................................................................................................... 5 6.1 Device Preparation and Charging ............................................................................. 5 6.2 Charging .................................................................................................................... 5 6.3 Cleaning ..................................................................................................................... 5 6.4 Skin Preparation ........................................................................................................ 5 6.5 Biosensor Array Application ...................................................................................... 6 6.6 Vcentral ...................................................................................................................... 7 6.7 Device Operation ....................................................................................................... 7 6.8 To Begin Monitoring................................................................................................. 11 6.9 Frequently Used Functions During the Monitoring Period....................................... 11 6.8.1 Pressing the Event Button ................................................................................... 11 6.9.2 Out of Range Indicators ....................................................................................... 11 6.9.3 Low Battery Alarms.............................................................................................. 11 6.9.4 Restarting the Vpod and Vcell ............................................................................. 12 6.10 Viewing the Patient’s ECG Data .............................................................................. 12 7.0 Transmission of Data ................................................................................................... 12 8.0 Specifications ............................................................................................................... 13 8.1 EMC Compliance ........................................................................................................... 15 8.2 FCC Compliance ............................................................................................................ 16 9.0 Storage and Transport Conditions............................................................................... 17 9.1 Maintenance................................................................................................................... 17 10.0 Disposal ....................................................................................................................... 18 11.0 Explanation of Symbols Used on Vpatch System Documentation .............................. 19 11.1 Vpatch System Model/Serial Numbers .................................................................... 19 12.0 Start-Up Guide ............................................................................................................. 20 13.0 Indicator Guide ............................................................................................................ 21 14.0 Troubleshooting Guide ................................................................................................ 23 15.0 Standards .................................................................................................................... 25 16.0 Warranty ...................................................................................................................... 25 17.0 Distributor Details ........................................................................................................ 26 18.0 Manufacturer Details.................................................................................................... 26 19.0 Authorized Representative in the European Community ............................................ 26 1

1.0 Equipment Supplied 1 Vpod device 1 Vcell device 1 Mascot Type 2240 Li-Ion battery charger (4.2V) 1 Quick Start Guide Note: The Vpatch Biosensor Array (BSA) is essential and supplied separately. This User Manual is available electronically, for viewing or download, at www.vpatchcardio.com. 2.0 General Description of Vpatch System The Vpatch System is a Remote Event Monitoring (REM) system that records a patient’s ECG signals and detects whether one of the following arrhythmias is present:  Bradyarrhythmia  Ventricular Tachycardia  Supraventricular Tachycardia  Ventricular Fibrillation  Atrial Flutter  Atrial Fibrillation  First Degree Heart Block  Second Degree Heart Block  Third Degree Heart Block This small battery operated portable system consists of the Vpod (a body-worn device), the Vcell (a portable device) and the REM Biosensor Array (Biosensor). The Vpod is connected to the REM Biosensor, which is worn by the patient. The Vpod is pre-programmed to monitor ECG signals on a continuous basis using the Biosensor Array. If an event is detected by the Vpod or triggered by the user (by pressing the Event Button), the relevant ECG data is sent via a wireless link to the Vcell. Cellular communication technology is used to send the data to a remote device/receiving station for analysis by the patient’s clinician. Note: This device is NOT a life saving device nor can it be used in any way to summon first responders to administer first aid or emergency care. If there is a concern regarding the health of the individual (i.e. chest pain or any other health concerns) when wearing the device; the individual or nearest bystander should contact a medical professional or emergency services IMMEDIATELY. 3.0 Indications for Use The Vpatch System is intended for patients requiring ambulatory monitoring and is controlled via a central point by a clinician. The system is suitable for patients experiencing symptomatic or asymptomatic cardiac arrhythmias. 3.1 Contraindications  The Biosensor Array (and therefore the Vpatch System) should not be applied to patients with a skin disorder or patients with known sensitivities to hydrogels or adhesives.  The Vpatch System including the BSA has not been tested or approved for use to during an MRI scan and therefore MUST be REMOVED from the patient prior to the MRI procedure being performed.  Patients fitted with an “active” implantable medical device such as a pacemaker or ICD should not use the Vpatch System due to the presence of magnetic studs on the 2

biosensor array. The presence of these magnetic studs may affect the performance of the implanted device. 3.2 Warnings  The device must be issued by health care professional. The issuing health care professional must ensure that the person wearing the device, or their carer is capable of and instructed in how to change the Vpod batteries and recharge the Vcell as per the instructions outlined in Section 6.5, and Table 5 in Section 8.0  Care should be taken to ensure that the Vpod and Vcell devices do not come into contact with water or any other liquids. The Biosensor Array should not be submerged in water, for example during a bath or while swimming.  A biosensor array has a shelf-life of 28 days once it is removed from the sealed plastic pouch.  The Vpod should only be opened to replace discharged batteries or at the completion of the monitoring period or if the batteries have discharged. DO NOT remove the coin cell batteries from the Vpod during monitoring.  The Vcell should be used in accordance with restrictions that apply to the use of cellular mobile telephones.  Care should be taken when changing the CR3032 coin cell batteries in the Vpod as they may present a choking hazard.  The CR3032 coin cell should be disposed of correctly as described in Section 10.0 on page 18  The Vpatch electronics should only be operated at temperatures between 0 °C and 40 °C (32 °F and 104 °F). Exceeding the recommended storage conditions and conditions for use can result in impaired system performance. 4.0 Vpatch System Equipment 4.1 REM Biosensor Array The REM Biosensor Array (BSA) provides quality ECG measurements to facilitate event analysis, as well as being flexible and comfortable to wear. 4.2 Vpod and Vcell Devices The Vpod and Vcell are shown below in Figure 1. The Vpod monitors ECG signals when connected to the Biosensor Array on the patient’s body. A Event Button/Pairing Button B Release Clips C Charging Port D On/Off Button E LED F Pairing Button Figure 1: Vpod and Vcell Devices 3

5.0 Conditions of Use The patient should adhere to the following conditions while using the Vpatch System:  The Vpatch System is to be operated under the restrictions which apply to the use of cellular/mobile telephones.  Only use a genuine Biosensor that is supplied with the device or sourced from an approved agent.  The Biosensor should be within its shelf life.  Biosensors are single-use only and should not be used if they are damaged.  The use of damaged or unsuitable Biosensors may lead to poor results or unnecessary skin irritation.  Excessive exercise and perspiration may decrease the length of time that the Biosensor Array can be worn.  Avoid touching or rubbing the Biosensor Array once it has been applied.  Apply a new Biosensor Array if reduced adhesion is observed.  A slight reddening of the skin or minor irritation underneath and/or immediately adjacent to the Biosensor Array border is normal. If this is uncomfortable for the person wearing the device, it is recommended they contact the issuing Healthcare professional for consideration of discontinuation, replacement or re-positioning of the BSA.  The Vpatch System including the BSA has not been tested or approved for use to during an MRI scan and therefore MUST be REMOVED from the patient prior to the MRI procedure being performed.  The Biosensor (BSA) is not defibrillation-proof and therefore MUST be REMOVED prior to the use of a cardiac defibrillator on the patient.  The Biosensor Array can be worn in the shower (excluding power showers) with the Vpod device disconnected. The Biosensor Array should be gently dabbed dry with a lint free cloth and the Vpod device cleaned and reconnected as soon as possible thereafter.  The Vpod device can be worn during sleep.  The Vpatch devices and accessories should be kept out of the reach of children and pets.  The Vpatch Devices are designed to be resistant to normal environmental conditions such as lint, dust and light including sunlight. All care should be taken to minimise exposure. If required cleaning instructions are included in section 6.3 Cleaning of these Instructions for Use.  There are no user serviceable parts. 4

6.0 System Operation 6.1 Device Preparation and Charging  The device should be prepared by a suitably trained health care professional.  The issuing health care professional must ensure that on each occasion a device is fitted that the patient or their carer is issued with a fully charged Vcell and that new batteries are inserted into the Vpod.  The issuing health care professional must ensure that the person wearing the device, or their carer is capable of and instructed in how to change the Vpod batteries and recharge the Vcell as per the instructions outlined in Section 6.5, Page 11 and Table 5 in Section 8.0 on Page 15.  The patient must recharge the Vcell overnight and thereafter whenever the low battery alarm sounds (i.e. when there is one beep heard from the Vcell every 5 seconds).  When in use, the Vpod and Vcell can be up to 10 metres apart however they must be in ‘line of sight’. The distance may be reduced if there are physical obstructions between the two devices. 6.2 Charging  The Vcell must only be charged using the supplied charger.  The Vcell can be used while charging.  For charger and battery specifications see Section 8.0 To Charge: First plug the charger into the charging port of the Vcell, then plug the charger into the mains socket and turn it on. The indicator on the charger will turn red, indicating that it is in charging mode. The indicator light will turn green when the unit is charged. Charging can take up to 3 hours. When charging is complete, turn off the mains power and remove the plug from the Vcell charging port. A fully charged battery should provide up to 7 days operation in normal monitoring conditions. This can vary between patients depending on the amount of activity. Note: It is important that the charger be connected to the Vcell before turning on the mains power to ensure the charging function is activated correctly. 6.3 Cleaning  The system MUST be cleaned before and after each patient use. The device may be cleaned using an alcoholic or non-alcoholic wipe (without applying undue pressure) and dried with a lint-free cloth.  General Cleaning - Surfaces which do not have contact with a patient have no special cleaning requirements, however it is recommended that the instrument is wiped with a dry cloth once a week to reduce the build-up of dust in the device.  Patient Contact Surfaces - Clean patient contact surfaces between patients. Cleaning should be performed using any biofilm removing wipe. Discard wipe after use. Do not use any other chemical product. 6.4 Skin Preparation  The Biosensor Array must be applied to clean, dry skin that is free from body hair.  Body hair can be removed using hair removal cream, shaving or waxing. To prevent irritation due to hair re-growth, it may be acceptable to carefully trim chest hair if there 5

is not heavy coverage. It is important to ensure that any chest hair present does not prevent the Biosensor Array from adhering well to the skin.  To ensure the collection of diagnostic quality ECG recordings and to reduce the collection of “noise events” the skin MUST be cleaned using a non-alcoholic skin wipe ensuring that the skin surface is thoroughly dried BEFORE applying the Biosensor Array.  The Biosensor Array must be applied within two hours of skin preparation. 6.5 Biosensor Array Application  It is essential for the collection of clear event and episode recordings that a suitably trained healthcare professional apply the Biosensor Array to the patient for the first time.  It is the responsibility of this healthcare professional to provide education and instruction to the patient for replacing the Biosensor Array during the monitoring period.  The Vpod device should be placed onto the Biosensor Array after the array is applied to the patient’s chest.  It is advisable to determine the optimum electrode placement on the patient before removing the paper liners from the electrodes. NOTE: The Biosensor Array is a single-use product, which is recommended for use on the patient for a duration of up to 7 days, after which a new Biosensor Array is to be applied to the patient’s chest.  The Biosensor Array must be applied to the patient in the configuration as illustrated in Figure 2. Figure 2: Biosensor Array Placement  After removing the release liners to expose the adhesive foam, it is recommended the Health care professional instruct the patient to inhale and hold a deep breath while they position the Biosensor Array in place. This is done to maximize patient comfort during wear.  The health care professional must ensure that the Biosensor Array is securely fixed to the patient’s body by smoothing each adhesive area firmly to the skin ensuring that there are no creases.  Loose fitting outer clothing and minimal contact between the Biosensor Array and undergarments is highly recommended.  When removing the Vpod to replace batteries or prior to bathing or showering, remove one stud at a time while pressing down firmly on the Biosensor Array beside each stud. 6

NOTE: Incorrect Biosensor Array application may impair the quality of ECG recording. 6.6 Vcentral Once an event has been recorded, the data is sent to a central server for display on Vcentral. To modify this default setting the Vpatch Website must be accessed to create a custom setup. The default setting of a Vpatch System records up to 20 seconds of pre-and 30 seconds of post arrhythmia detection events (as listed in Section 2.0) or as a result of the person pressing the Event Button on the Vpod. The Vpatch website (V Central) allows the healthcare professional to:  Add new patients to the server database  Assign a Vpatch monitor to the patient  Specify the period of time that the patient will be monitored  Change the monitoring settings  View ECG data recorded by the Vpatch System The Vpatch System devices MUST be re-assigned and re-configured every time they are used by a new patient, or each time there is a new monitoring period. Failure to reconfigure a monitor may result in ECG data not reaching the Vpatch website. NOTE: Please contact your distributor to obtain login details for the Vpatch website. Your distributor will also ensure that the correct devices are added to your facility. This is necessary for assigning a device to a patient in support of successful monitoring. NOTE TO DISTRIBUTORS: When adding new devices to a customer’s inventory, you must enter the Vpod serial number correctly, to enable the clinician or HCP to assign the device to a patient. 6.7 Device Operation 6.7.1 Switching the Vpod on and off The Vpod device is switched on when the batteries are inserted and the case is closed using the release clips. Once the case is opened using the release clips, the Vpod is switched off. To insert the Vpod batteries: 1. Open the Vpod device using the release clips (labelled ‘B’ in Figure 14 below). Note: The Left Release Clip can be opened by using the fingers only while the Right Release Clip needs a tool to be unlocked (See Figure 3 and 4 below). 2. Place both coin cell batteries into the case, positive side upwards (i.e. the smooth side with writing, ‘+’ symbol will be etched on this side). 3. Close the Vpod case by securing the release clips. 4. The Vpod will beep once* to indicate ‘Power On’. Ensure older batteries are not used with new batteries in the device. Only new batteries should be inserted into the device when replacing used batteries. For information on battery disposal please refer to Section 10.0, Page 17. * If the Vpod memory is full, two beeps will be heard approximately 30 seconds after the ‘Power On’ beep during Vpod start-up, otherwise only the ‘Power On’ beep will be heard. If three beeps are repeatedly heard immediately after switching on, please see the Section 14.0 Troubleshooting Guide. 7

During monitoring, the Vpod should only be switched off during the following; when batteries are being replaced, once monitoring has concluded or if the person intends not to wear the Vpod for several hours. NOTE: Healthcare professionals and patient must be familiar with the correct procedure for inserting and replacing Vpod batteries. Left Release Tool Clip Right Release Clip Figure 3: Using the tool to unlock the Right Release Clip. Figure 4: The tip of the tool is used to unlock the Right Release Clip. 6.7.2 Device Start-up After the configuration settings have been selected the devices are now ready to be set up. A Vpod must be paired with a Vcell before the system is used to allow the patient’s ECG data to be sent to the Vpatch website. Before commencing a new monitoring period or using the devices on a new patient, it is important to pair the Vpod and Vcell, even if the devices have been paired previously. Pairing clears any stored events from the device memory and restores the Vpatch System’s to the default settings, i.e. the system records up to 20 seconds pre-event and 30 seconds post-event ECG data when the Event Button is pressed or when one of nine arrhythmias are detected (See Section 2.0 for a list of arrhythmias). Figure 14 indicates V Patch device labelling. 8

A F B E C D Figure 14: Device Labelling A Event Button/Pairing Button B Release Clips C Charging Port D On/Off Button E LED F Pairing Button 9

The healthcare professional responsible for issuing, assigning or fitting a V Patch System must read and understand the contents in Table 1 “System Setup”, be familiar with the device operation and expert in the listed contents of section 14.0 “Troubleshooting Guide” PRIOR to using the device. Function Indication To configure the device, please refer to Section 6.4.2, before use. The length of the monitoring period is chosen during the previous system configuration. Switch on the Vcell by pressing ‘D’: ‘E’ will turn orange and then green while 1 beep is heard. To pair the devices, press and hold ‘F’ on the Vcell until the pairing mode indication is seen: 1 beep and ‘E’ is green when ‘F’ is pressed initially Enter Pairing Mode on the Vcell by ‘E’ flashes green to indicate that it is in pairing mode and is searching for pressing and holding ‘F’: Vpod. ‘E’ can now be released. Once ‘E’ begins to flash green, the user has 60 seconds to complete the pairing process by switching on the Vpod and placing it in pairing mode. If pairing is not completed within 60 seconds the devices will timeout and return to normal operation. If pairing is still required, the healthcare professional must switch the devices off and then on again and repeat the sequence. Insert the coin cell batteries into the 1 beep or 3 beeps (See Section 6.7.1, Page 7) Vpod and close the case using ‘B’: 1 beep (depending on previous configuration) when ‘A’ is pressed initially Repeated fast beeping while searching for Vcell Press and hold ‘A’ on Vpod: Long beep when successfully paired with Vcell ‘E’ on Vcell is stops flashing when successfully paired with Vpod 1 long beep is heard from the Vpod and ‘E’ stops flashing on the Vcell to indicate that it has successfully paired and that the system has been reset to the default settings (30 seconds of ECG data recorded when an arrhythmia is detected or when Event Button is pressed). The Vcell will connect to the network to retrieve configuration settings. Please note the solid orange LED described below to confirm that the device has connected successfully. While the device is searching for a ‘E’ is flashing orange Network connection When a successful connection has ‘E’ is solid orange been established If the Vcell is unable to connect to the ‘E’ will stop flashing orange network The Vcell will then ensure it is in range with the Vpod (whether there is a successful connection to the network or not). The Vcell will then send any new configuration settings available to the Vpod. The LED sequence may vary at this stage; however the system has successfully received the new settings when 3 beeps are heard from the Vpod. ‘E’ will be orange for a short time while data is transferred Sending configuration settings 3 beeps will be heard from the Vpod Devices in range ‘E’ will remain solid green ‘E’ will become solid green again when the system is ready for use. This indicates that the paired Vpod and Vcell are within range of each other. The Vpod can now be connected to the Biosensor Array that is applied to the patient. When the devices are out of range, ‘E’ will not be lit, but will flash green approximately every 10 seconds as it searches for the Vpod it was previously paired with. To switch off the Vcell, press and hold ‘D’. Vcell switching off ‘E’ is solid orange while 1 beep is heard Table 1: System Setup 10

6.8 To Begin Monitoring  Once the devices have been set up and connected to the patient via the Biosensor Array, the Event Button ‘A’ should be pressed to send an initial ECG trace to the server. This will allow a predefined amount of data to be recorded and sent to the Vcell. One beep will be heard from the Vpod when the event button is pressed.  The ECG file will be present on the website within a few minutes providing there is a constant and uninterrupted cellular network signal. It is highly recommended that the ECG file is viewed before the patient leaves the healthcare professionals workplace. This verifies that the system is configured correctly. 6.9 Frequently Used Functions During the Monitoring Period NOTE: If the Vpod becomes disconnected from the Biosensor Array during the monitoring period, it should be reconnected as soon as possible. NOTE: There are no frequently used functions available to the patient during the monitoring period that they cannot safely use. 6.8.1 Pressing the Event Button If the patient feels unwell during monitoring they must press the Event Button, ‘A’. One beep will be heard from the Vpod. The Vpod will queue up to ten events if it is already recording data. Two beeps will be heard from the Vpod every 5 minutes or when ‘A’ is pressed on the 5th occasion, and thereafter. If events are queued on the Vpod, ensure that the Vcell is in range and in line of sight. If events remain queued, please refer to Section 14.0 “Troubleshooting Guide”. This recorded data is sent to the central receiving station for analysis by the patient’s clinician. 6.9.2 Out of Range Indicators During use, the LED on the Vcell will be green to indicate that the Vpod and Vcell are within range of each other. Should the Vpod and Vcell be out of range, the green LED will flash approximately every 10 seconds until the devices are back in range again. 6.9.3 Low Battery Alarms Low battery alarms may sound during the monitoring period: Vpod: Single beep sounding every 5 seconds. The patient should replace the batteries if the battery alarm sounds. (See Section 6.5.1). This alarm may be silenced by pressing and holding ‘A’ until a long beep is heard. The low battery alarm can only be silenced 5 times before the batteries must be changed. Vcell: Single beep sounding every 5 seconds. This alarm can be silenced by pressing and holding ‘F’ or connecting the device to the charger provided. The Vcell should be connected to the charger as soon as possible. If the battery level of the Vpod is no longer sufficient to record and transmit events, a critical low battery alarm will sound. Batteries MUST be replaced at this point. The critical low battery alarm on the Vpod is described below: Vpod: Single beep sounding every 2 seconds. The wireless link between Vpod and Vcell is now shut down and the Vcell will appear to be out of range (‘E’ will flash green once every 10 seconds). The patient should replace the batteries as soon as possible. (See Section 6.5.1, Page 12). 11

The battery level of the Vcell can be checked by pressing ‘F’ once at any time during use.  One beep and a green LED will indicate that there is sufficient battery level power in the Vcell.  One beep and an orange LED will indicate that the battery level is low and the Vcell requires charging. 6.9.4 Restarting the Vpod and Vcell Should the Vpod or Vcell be switched off (intentionally or unintentionally), the user is not required to re-pair the devices as outlined in Table 1. The Vpod and Vcell retains the most recent device pairing information. It is important that the user avoids switching devices off unnecessarily during any monitoring period. To restart the devices: Vpod: Ensure fresh batteries are inserted and that the Vpod case is closed correctly (See Section 6.5.1). The sounding of one beep indicates correct operation. If two beeps are sounded within 30 seconds, the Vpod memory is full. ECG data will send to the Vcell when both devices are in range again. If three beeps are repeated after switching on, please see Section 14.0 “Troubleshooting Guide” Vcell: If the Vcell has sufficient charge, it should be switched on again by pressing ‘D’. Otherwise connect the device to the charger provided and press ‘D’ if required. 6.10 Viewing the Patient’s ECG Data To view the patient’s ECG file: 1. Log on to the Vpatch website using a user name and password.) 2. Refer to Section 6.4.2 for more information on selecting the correct patient. 3. Click on the patient’s first or last name in order to see the Patient Dashboard. 4. From the files listed in the “Recent Measurements” the clinician can view any of the most recent ECG measurements sent to the Vpatch website. 5. Clicking on the “Overview” link will bring the clinician to the full list of events sent to the website, with each monitoring period in a separate section. 7.0 Transmission of Data If any events are recorded in an area of limited cellular network signal, the system is equipped to ensure that no data is lost if communications are restored before the devices are re-paired. Up to 10 events may be stored on the Vcell device at any one time. The cellular communications also support global roaming functionality, permitting the user to move between countries without losing any of the benefits of the Vpatch System. 12

8.0 Specifications Size and Weight:  Vpod: External dimensions: 59mm x 48mm x 18mm Weight: 34grams  Vcell: External dimensions: 86mm x 61mm x 20mm Weight: 78grams IP Rating:  Vpod: IP22  Vcell: IP21 FCC ID:  Vpod: 2ARNZ-1001  3G Vcell: 2ARNZ-1002. The Vpod requires 2 x CR3032 Lithium coin cell batteries. Care must be taken to insert the batteries correctly, with the positive side facing upwards. (See Section 6.5.1) NOTE: The batteries MUST be removed from the Vpod when not in use. Power Sources: Battery Voltage Device Battery Type (V) Vpod 3.0 Coin Cell: Non-Rechargeable Vcell 3.7 Li-Ion: Rechargeable Table 2 CR3032 Coin Cell Battery: (Specifications) Nominal Voltage (V) 3 Nominal Capacity (mAh) 500 Continuous Standard Load (mA) 0.2 Operating Temperature (C) -30 to +60 Table 3 Mascot Type 2240 Li-Ion Battery Charger (Containing 1.3 mm x 3.8 mm power connector): Input Voltage Output Voltage Current (Max) Operating Temperature (VAC) (V) (A) (°C) 90-264 4.2 1.3 -25 ~ +40 Table 4 LED Indicators on Mascot Type 2240 Li-Ion Battery Charger Red LED Green LED Vcell is not fully charged Vcell is fully charged Table 5 NOTE: Do not use any other mains adapter with the charger as it may result in damage to the Vcell unit or affect system operation. Expected Service Life The Li-Ion battery in the Vcell is rated last for at least 300 charging cycles. At maximum use, assuming a charging cycle of every 5 days, this should provide an expected service life of the Vpatch System of 5 years. 13

Guidance and manufacturer’s declaration – electromagnetic immunity The Wireless ECG Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless ECG Monitor should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic Immunity test Test level level environment - guidance ±6 kV contact Floors should be wood, Electrostatic discharge ±6 kV contact concrete or ceramic tile. If floors (ESD) are covered with synthetic ±8 kV air material, the relative humidity IEC 61000-4-2 ±8 kV air should be at least 30%. Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting Guidance and manufacturer’s declaration – electromagnetic immunity The Wireless ECG Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless ECG Monitor should assure that it is used in such an environment Radiated RF 3 V/m [E1]V/m d = [1.17]√P…80MHz to 800 MHz IEC 61000-4-3 80 MHz to 2.5 GHz d = [2.33]√P…800 MHz to 2.5GHz 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 metres (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in b 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. 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 a considered. If the measured field strength in the location in which the Wireless ECG Monitor is used exceeds the applicable RF compliance level above, the Vpatch System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Wireless ECG Monitor. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting 14

Recommended separation distances between portable and mobile RF communication equipment and the Wireless ECG Monitor The Wireless ECG Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Wireless ECG Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Wireless ECG Monitor as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 80 MHz to 800 MHz 800 MHz to 2.5GHz W d = [1.17]√P d = [2.33]√P 0.01 0.12 0.23 0.1 0.37 0.75 1 1.17 2.33 10 3.70 7.36 100 11.70 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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. Recommended separation distances between portable and mobile RF communications equipment and the equipment and system – for equipment and systems that are not life supporting 8.1 EMC Compliance This product is compliant with the electromagnetic compatibility requirements of IEC60601-1- 2. Guidance and Manufacturer's Declaration – Electromagnetic Emissions The Vpatch System is intended for use in the electromagnetic environment specified below. The customer or the user of the Vpatch System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 GROUP 1 The Vpatch System 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 11 Class B The Vpatch System is suitable for use in all establishments other than domestic and those Harmonic emissions Class A directly connected to the public low-voltage IEC 61000-3-2 power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3 15

8.2 FCC Compliance The Vpod device and Vcell device comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. NOTE: This equipment (Vpod device and Vcell device) 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. Caution: Changes or modifications (not expressly approved by the party responsible for compliance) could void the user's authority to operate the equipment. 16

9.0 Storage and Transport Conditions The Vpatch System electronics must be stored between the temperatures of -20 °C and 40 °C (-4 °F and 104 °F) and at 30% relative humidity. The electronics must be protected from water and other liquids at all times. Temperature Limitation Handle with care Temperature Relative Humidity Air Pressure Transport -10 to +60°C 10 to 90%** 700 to 1013 hPa Storage -20 to +40°C 10 to 85%** 700 to 1013 hPa Operation 0 to +40°C 20 to 80%** 800 to 1013 hPa **Wet bulb limit of 7°C 9.1 Maintenance Vpatch System Should be kept clean and periodically checked to ensure the integrity of the case, hinges, contact points and battery contact points. Power leads and battery charger should also be visually inspected for signs of wear and damage. The system is to be cleaned before and after use on each patient. The device may be cleaned using an alcoholic or non-alcoholic wipe and dried with a lint-free cloth. It is recommended that that the device is kept in the supplied case while not in use and the rechargeable battery charged periodically. The following guidelines should be adhered to.  Care should be taken to ensure that the Vpod and Vcell devices do not come into contact with water or any other liquids.  There are no user serviceable parts. 17

10.0 Disposal The information below is sourced from a recommended battery manufacturer’s guideline material: When disposing batteries, insulate the (+) and (-) terminals of batteries with insulating tape, etc. (see Figure 15). When disposed of improperly, lithium batteries may short, causing them to become hot, burst or ignite. Figure 15 The Vpod and Vcell are electronic devices and must be returned to the distributor for disposal. Do not heat or dispose of any part of the Vpatch System in fire. The devices may burst or release toxic materials. Do not disassemble, apply excessive pressure or deform any part of the Vpatch System. NOTE: Electronics and battery disposal must be in accordance with local and state regulations 18

11.0 Explanation of Symbols Used on Vpatch System Documentation The symbols used in the documentation for the Vpatch System are summarised in the following table: Symbol Description Symbol Description Symbol Description Symbol Description Temperature Manufacturer CE Mark Serial Number limitation 0805 Consult Equipment should not be Use-by date Handle with care Instructions disposed of with normal for Use waste stream Do not get wet Date of Catalogue Number manufacture Non-ionizing Defibrillator Proof Type BF: The Vpod device is a type Batch code electromagnetic BF device and has a high level of protection against radio defibrillation energy as per EN 60601-1. Table 6 11.1 Vpatch System Model/Serial Numbers The Vpatch System model/serial numbers are in the format shown below. Vkit model number FG06120 contains: 1 x Vpod 1 x Vcell 1 x Mascot battery charger type 2240 1 x Carry case The first three digits of the model/serial number are the model number and indicate the device type (Vpod or Vcell). The last six digits are the serial number. Vpod devices will have the model/serial numbers: 101-XXXXXX 001XXXXX Vcell devices will have the model/serial numbers: 201-XXXXXX Representing models with 2G SIM cards 301-XXXXXX Representing models with 3G SIM cards The device labels include a Global Trade Item Number (GTIN) that provides an additional form of model identification. 19

12.0 Start-Up Guide The following indicators and actions are required to start and configure the Vpatch System. Press ‘D’ to switch on Vcell and wait for green LED and 1 beep.  START UP VCELL LED VCELL BUZZER VPOD BUZZER Setup 1 flash Single Setup complete 1 sec beep  If PAIRING is not required, switch on the Vpod immediately and skip to NETWORK. To PAIR devices, press and hold ‘F’ on the Vcell until ‘E’ begins to flash. Then switch on the Vpod and press and hold ‘A’ until 1 long beep is heard. This indicates successful pairing.  PAIRING VCELL LED VCELL BUZZER VPOD BUZZER Fast Fast While searching flashing beeping Successful Long Successful pairing pairing beep Vcell moves on to next Single Default Settings reset stage (see next table) beep  The Vcell will then immediately connect to the Network. This LED sequence may vary slightly.  NETWORK VCELL LED VCELL BUZZER VPOD BUZZER Slow While searching flashing Successful For duration connection of action  The Vcell will then check that it is in range with the Vpod.  RANGE VCELL LED VCELL BUZZER VPOD BUZZER In Range  The Vcell will check for configuration settings and transfer them to the Vpod.  CONFIGURATION VCELL LED VCELL BUZZER VPOD BUZZER Sending configuration Three data beeps  The green LED on the Vcell will light up, indicating that the devices are in range. The system is now ready for use. 20

13.0 Indicator Guide The following indicators can occur at any time during normal use. Vpod/Vcell Range RANGE VCELL LED VCELL BUZZER VPOD BUZZER In Range 1 flash Out of Range every 10 seconds ECG Data Transfer (from Vpod to Vcell) If Vpod is in range of Vcell  ECG Data Transfer VCELL LED VCELL BUZZER VPOD BUZZER Vpod to Vcell ECG Flashing for Transfer duration ECG Data Transfer (from Vcell to Internet) If ECG Data is on Vcell  ECG Data Transfer VCELL LED VCELL BUZZER VPOD BUZZER While searching Slow flashing N/A N/A Successful Fast flashing connection and data for duration of N/A N/A transfer transfer Vcell Network Checks Every 4 hours the Vcell will connect to the Internet to check for new configuration settings. The clinician/patient is not required to take any action.  NETWORK VCELL LED VCELL BUZZER VPOD BUZZER While searching Slow flashing N/A N/A Successful For duration N/A N/A connection of action 21

Warning Indicators The following indicators can occur at any time during normal use. These indicators require a corrective action to rectify the issue. Low Battery LOW BATTERY VCELL LED VCELL BUZZER VPOD BUZZER Beep every Vpod Low Battery N/A N/A N/A N/A 5 sec Beep every Vcell Low Battery N/A N/A 5 sec N/A N/A Flash Vpod Critically Low Beep every every N/A N/A Battery 2 sec 10 sec  Connect Vcell to charger or Replace Vpod batteries Vpod Memory Full MEMORY FULL VCELL LED VCELL BUZZER VPOD BUZZER Double beep Ten events stored every 5 min or N/A N/A N/A N/A on Vpod when Event Button pressed  Ensure Vpod is in range of Vcell Vcell Memory Full MEMORY FULL VCELL LED VCELL BUZZER VPOD BUZZER Ten events stored Double flash Double beep on Vcell every 5 min every 5 min  Move to an area of cellular network coverage. Vpod System Error SYSTEM ERROR VCELL LED VCELL BUZZER VPOD BUZZER Repeated System error N/A N/A N/A N/A triple beep on Start Up  Switch Vpod off and on again. If error persists contact you distributor. Vcell System Error SYSTEM ERROR VCELL LED VCELL BUZZER VPOD BUZZER Alternating green and One beep System error every sec N/A N/A orange LEDs  Switch Vcell off and on again. If error persists contact you distributor. For further information on warning indications, please see the Troubleshooting Guide (Table 7). 22

14.0 Troubleshooting Guide Problem Possible Solution One beep heard every 5 This is the low battery alarm. To silence the alarm, press and hold ‘A’ until a seconds from the Vpod long beep is heard. Insert new batteries into the Vpod as soon as possible. This is the critical low battery alarm. The Vpod has shut down communications One beep heard every 2 with the Vcell, which will therefore show the “Out of Range” indication (See seconds from the Vpod Section 13, Page 21). Insert new batteries into the Vpod as soon as possible. This is the low battery alarm. To silence the alarm, press and hold ‘F’ or One beep heard every 5 connect the device to the charger provided. The Vcell must be connected to the seconds from the Vcell charger as soon as possible. Connect the Vcell to the charger provided. If the LED on the charger is red the Vcell requires charging. If the LED on the charger is green you may need to disconnect the charger from the mains while it is still connected to the Vcell, Vcell will not switch on reconnect and try again. The Vcell should be charged for 3hrs (minimum). If the device does not switch on after charging, ‘D’ should be pressed and held for approximately 15 seconds. Release ‘D’ and switch the Vcell on as normal. The Vcell will then switch on. This results in a full reset of the Vcell. Press and hold ‘D’ for approximately 15 seconds. Release ‘D’ and switch the Vcell on as normal. The Vcell will then switch on. This is a full reset of the Vcell. Vcell will not switch off Any ECG data stored on the device can still be transmitted to the Vpatch website. Switch the Vpod off and on again. If there is still no beep heard on start up, No beep heard from place new batteries in the Vpod (See Section 6.5) and retry. If there is no Vpod when switched on audible tone after new batteries have been inserted, please contact your distributor. Pairing beeps may be heard from the Vpod up to 10 seconds after initially No pairing beeps heard pressing and holding the pairing button. If no pairing beeps or LED indications from Vpod / are heard or seen after this time, ensure that enough digital pressure is No flashing green LED consistently placed on the device buttons. from Vcell / Switch both devices off and on again and re-try. Devices will not pair Insert new batteries into the Vpod and re-try. Switch the Vpod off and on again. If there is still no beep heard when the Event No beep heard from the Button is pressed, place new batteries in the Vpod (See Section 6.5) and retry. Vpod when Event If there is no tone after new batteries have been inserted, please contact your Button is pressed distributor. Two beeps heard from the Vpod every 5 The Vpod has ten events stored in its memory and is now full. Ensure the Vpod minutes and when the and Vcell are within range and are in direct line of sight of each other. Event Button is pressed Two beeps and two The Vcell has ten events stored in its memory and is now full. Ensure the user orange LED flashes is in an area of good cellular network. Press ‘F’ on the Vcell twice, ensuring a from Vcell every 5 beep is heard with each press to allow the Vcell to attempt a network minutes connection. Additionally, the Vcell will do this every 4 hours itself. Table 7 (continued on following page) 23

Problem Possible Solution Three beeps heard from The Vpod has not been configured to record ECG data when ‘A’ is pressed. the Vpod when the See Section 6.4 for information on configuration. Event Button is pressed Three beeps repeatedly This is a system error. The Vpod must be switched off and on. If the error heard from the Vpod persists, please contact your distributor. when it is switched on Alternating green and orange LEDs and one This is a system error. The Vcell must be switched off and on. If the error beep every second on persists, please contact your distributor. the Vcell Ensure that the recommended skin prep and removal of excessive body hair were followed and attended to if not. Ensure the magnetic studs on the Vpod and Biosensor Array are clean and Poor quality ECG signal free of all debris. from one or more leads Ensure the Vpod is securely connected to the Biosensor Array via each of the magnetic studs. Ensure the Biosensor Array has been applied correctly, as outlined in Section 6.3, Page 4. Ensure the correct Vpod Serial Number is assigned to the correct patient and that the monitoring period has not ended (See Section 6.4). Events cannot be If the Vpatch System is an area of limited or zero cellular network coverage, viewed on Vpatch ECG data sent from the Vpod to the Vcell cannot be transmitted to the Vpatch System website website. The Vcell can store up to ten events in its memory. Once the system returns to an area of cellular network coverage any stored events will be transmitted to the Vpatch website. If the Vpatch System is being set up in an area of limited or zero cellular The Vcell does not network coverage. Move to an area of cellular network coverage and re-try. connect to network You can initiate the Vcell to attempt to connect to the network by pressing ‘F’ during set-up twice, ensuring that a beep is heard with each button press. If the Vcell consistently fails to connect to the network, please contact your distributor. Table 7 (Continued) 24

15.0 Standards The Vpatch System has been designed and tested to conform to the essential requirements and provisions of European Council Medical Devices Directive 93/42/EEC Annex II (excluding Section 4) for a Class IIa device, (under Annex IX Rule 10 – non-invasive active device), obtaining the European CE Mark. The device has been designed to conform to the following International Standards: IEC 60601-1 : ISO 14971:2012 BS EN 980:2008 2005/AMD1:2012/COR1:2014 IEC 60601-1-2 :2014 EN 1041 : 2008 BS PD IEC TR 60878:2003 IEC 60601-1-6 : 2010+AMD1: 2013 ANSI/AAMI EC57:2012 EC38 : 1998 IEC 60601-1-11:2015 BS EN 60529: 1992 AAMI EC 12:2000 (R2015) ISO 15223-1:2016 EN 60950-1 : 2001 plus amendments ISO 13485 2016 A11:2004 Table 8 16.0 Warranty Medical Manufacturers products are warranted to be free from manufacturing and material defects for a period of 1 year from the date of shipment by the manufacturer to the distributor or directly to the health care professional workplace. Excluded from this warranty are the CR3032 Lithium Coin Cell Batteries and the Mascot Battery Charger. Any repairs made to the product that are not covered by the warranty shall be billed to the customer. For service or technical support contact your distributor. 25

17.0 Distributor Details Vpatch Cardio Pty Ltd. 1221 Toorak Road, Camberwell, Victoria, Australia 3124 w: www.vpatchcardio.com e: info@vpatchcardio.com 18.0 Manufacturer Details Manufactured by: Medical Manufacturers Unit 131, 45 Gilby Road, Mt. Waverley, Victoria, Australia 3149 0805 19.0 Authorized Representative in the European Community  Medical Manufacturers Europe Co Ltd. St. Marys House Netherhampton, Salisbury Wiltshire, SP2 8PU United Kingdom Tel: +44 7831 429 245 26


Document Created: 2019-01-16 12:30:26
Document Modified: 2019-01-16 12:30:26
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