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 ..............................................................................................
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.
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 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.
.0 System Operation 6.1 Device Preparation and Charging 6.2 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.
6.5 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.
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.
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. Tool Left Release Clip Right Release Clip Figure 3: Using the tool to unlock the Right Release Clip.
A F B E C D Figure 14: Device Labelling A B C D E F Event Button/Pairing Button Release Clips Charging Port On/Off Button LED 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.
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.
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.
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.
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 Test level Immunity test Electrostatic discharge (ESD) ±6 kV contact IEC 61000-4-2 ±8 kV air Compliance level Electromagnetic environment - guidance ±6 kV contact Floors should be wood, concrete or ceramic tile.
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.
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.
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.
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.
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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 Setup 1 flash Setup complete 1 sec VCELL BUZZER VPOD BUZZER Single 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.
13.0 Indicator Guide The following indicators can occur at any time during normal use.
Warning Indicators The following indicators can occur at any time during normal use. These indicators require a corrective action to rectify the issue.
14.0 Troubleshooting Guide Problem Possible Solution One beep heard every 5 seconds from the Vpod This is the low battery alarm. To silence the alarm, press and hold ‘A’ until a long beep is heard. Insert new batteries into the Vpod as soon as possible. One beep heard every 2 seconds from the Vpod This is the critical low battery alarm. The Vpod has shut down communications with the Vcell, which will therefore show the “Out of Range” indication (See Section 13, Page 21).
Problem Possible Solution Three beeps heard from the Vpod when the Event Button is pressed The Vpod has not been configured to record ECG data when ‘A’ is pressed. See Section 6.4 for information on configuration. Three beeps repeatedly heard from the Vpod when it is switched on This is a system error. The Vpod must be switched off and on. If the error persists, please contact your distributor. Alternating green and orange LEDs and one beep every second on the Vcell This is a system error.
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.
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 19.0 0805 Authorized Representative in the European Community Medical Manufacturers Europe Co Ltd. St.
