LifeWatch VSPS Vital Signs Patch User Manual

LifeWatch LTD. Vital Signs Patch

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VSPS User Manual

User Manual

1 Dear LifeWatch Technologies Ltd. device owner: Thank you for selecting the LifeWatch Technologies Ltd. Vital Signs Patch (VSP) device, CG-1101XX (models CG-1101U, CG-1101B, CG-1101UC). Please read this user guide before you start using your new device. The guide contains important information about your device as well as clear instructions about how to use it. If you have any questions about the new Vital Signs Patch, please contact: Customer Service at:

3 Declaration of Conformity The VSP System consists of a disposable patch, a reusable processing unit and a Smartphone based application. The VSP System is classified as internally powered equipment with type BF applied parts.  The device is suitable for continuous operation.  The Patch (CG-1101XX) is classified as type IP54 equipment affords protection against dust and splashing water. The VSP System is classified by the MDD as a Class IIa (Pulse oximeter; ECG; Heart Rate; Body Temperature)The VSP System is compliant with IEC 60601-1:2005IEC 60601-1-2:2007; however this does not preclude the possibility of electronic interference from other equipment where the device will need to be activated at a distance from the source(s) of interference. LifeWatch Technologies’ Quality System (QS) certified to ISO-9001:2008, ISO 13485:2003 CE 93/42 MDD and Canadian QS Requirements WARNING No modification of this equipment is allowed Refer servicing to qualified personnel only. DANGER Equipment not suitable for use in the presence of anesthetic mixture with air or with Oxygen or Nitrous Oxide. Federal Law (USA) restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device. disposable patch, a reusable processing unit and a Smartphone based application. internally powered equipment with equipment which dust and splashing water. Class IIa device Body Temperature) :2005 and however this does not preclude the possibility of electronic interference from other equipment where the device will need to be activated at a distance from the source(s) of (QS) is 9001:2008, ISO 13485:2003 Requirements Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide. Federal Law (USA) restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use

4 Graphic Symbols on VSP System Label Description Warning Precaution Notes; indicates important general information for using the system successfully. Refer to instruction manual/ bookletNOTE: On ME EQUIPMENT "Follow instructions for use.” XXXX Manufacturer and date of manufacture Type BF Applied Part Indicates the temperature limits for storage of thedevice. WEEE Directive for disposal of Electrical and Electronic Equipment Symbol for no SPO2 alarms Warning Under no circumstances should you interpret your heart rate, temperature, saturation or respiration vital signs or accelerometer data nor take any actions of a medical nature based on your understanding UNLESS you are a medical professional.indicates important general information for Refer to instruction manual/ booklet NOTE: On ME EQUIPMENT "Follow instructions anufacture for storage of the WEEE Directive for disposal of Electrical and heart rate, body vital signs or accelerometer nor take any actions of a medical nature based on your understanding UNLESS you are a medical professional.

5 Intended Use The Vital Signs Patch system is intended to be used by patients for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration, body temperature and blood saturation, when prescribed by a physician or other qualified healthcare professional. The VSP includes pacemaker detection to show pulses of pacemaker on the screen and can therefore be used by users with a pacemaker. Readings obtained using the non-standard 3-lead vital sign monitoring should not be compared with readings obtained using the standard 12-lead vital signs via standard electrode placement. Contraindications  The Vital Signs Patch (VSP) is not intended for use by persons with any type of defibrillator, external or internal (ICD); the VSP must be detached from the patient before using a defibrillator on the patient.  The VSP is not intended for the treatment or alleviation of disease  The VSP is not to be used in a magnetic resonance imaging (MRI) environment; the VSP unit must be removed from the patient’s skin before he/she undergoes MRI analysis.  The VSP is not a “life-saving” or therapeutic device; the VSP supplies vital signs data to a doctor or technician for the purpose of diagnosis by such (or other qualified) personnel  The VSP is not intended for use for patients who have undergone surgery on the chest and who still have a fresh incision on the chest  The VSP is not intended for use on patients with any skin damage on the area where the VSP is placed (such as burns, irritation, infections, wounds, etc.)

6 Contraindications regarding ECG/Heart Rate Due to the possible seriousness of the abnormal heart rhythms that can be associated with the following conditions, persons with these conditions should consult with their physician before using the VSP:  Coronary heart disease  Valvular heart disease  Heart transplant Heart failure

7 General conditions for use of the VSP Before using the VSP, check that you comply with the following conditions:  You understand the principles of operation described in this manual.  You speak and understand English or have access to a fluent English speaker who can explain how to use the device.  You can attach the VSP to your body or have access to someone who can attach the VSP to your body.  You can operate the Gateway application software or have access to someone who can operate the Gateway application software.  You can operate simple push-buttons. Precautions:  Use the device only for the purposes described in these instructions for use.  User Manual Warning: To prevent fire, do not expose the unit unnecessarily to moisture, nor to or excessive heat. Refer servicing to qualified personnel only  Do not use this device if it is not working properly, or if it has suffered any damage.

8 Table of Contents 1 Glossary ................................................................................ 10 2 VSP System Introduction ................................................... 11 2.1 GENERAL DESCRIPTION ................................................. 11 2.2 THE VSP KIT ................................................................ 12 3 Physical Features ................................................................ 13 3.1 PARTS ......................................................................... 13 3.2 PATCH ......................................................................... 13 3.3 BRAIN ........................................................................ 14 3.4 GATEWAY APPLICATION ................................................. 15 3.5 GATEWAY RECHARGING PROCEDURE ............................. 17 4 Using the VSP System ........................................................ 18 4.1 GENERAL ..................................................................... 18 4.2 PATCH ......................................................................... 18 4.2.1 Preparing the Skin .............................................. 18 4.2.2 Placing the Upper 3-lead Patch .......................... 19 4.2.3 Placing the Lower 3-lead Patch .......................... 20 4.3 INSTALLING THE BRAIN .................................................. 21 4.4 REMOVING THE VSP ..................................................... 22 5 Using the Gateway Application ......................................... 23 5.1 STARTING THE APPLICATION .......................................... 23 5.2 VSP SCREEN ............................................................... 23 5.3 GATEWAY APPLICATION FUNCTIONS ............................... 23 5.3.1 Displaying the Main Screen ................................ 24 5.3.2 Displaying Sensor Data ...................................... 24 5.3.3 Displaying HW/SW Version on the About Screen25

9 5.3.4 Displaying Alerts ................................................. 25 5.3.5 Creating Manual Events ..................................... 26 6 Heart Rate Calculation Method .......................................... 28 6.1 INTRODUCTION.............................................................. 28 6.2 METHOD OF CALCULATION ............................................. 28 7 Maintenance ......................................................................... 29 7.1 CONDITIONS OF USE ..................................................... 29 7.2 CARING FOR YOUR VSP ................................................ 29 7.3 CLEANING .................................................................... 30 7.4 ENVIRONMENT .............................................................. 30 8 Troubleshooting .................................................................. 31 9 Specifications ....................................................................... 32 9.1 VSP BRAIN SPECIFICATIONS ......................................... 32 9.2 VSP PATCH SPECIFICATIONS......................................... 35 9.3 TRANSMISSION SPECIFICATIONS ..................................... 36 Appendix A Warnings and Precautions ................................... 37 END USER LICENSE AGREEMENT - SOFTWARE LICENSE AGREEMENT ............................................................................... 47 NOTICE POLICY AND MEDICAL WASTE DISCLAIMER ........ 50

VSP System User Guide 10 1 GLOSSARY BRAIN Main Processing Unit, vital sign data communication device that collects the body vital signs and sends these signs to the gateway device. The BRAIN can receive settings updates from the Gateway ECG Electrocardiogram; a representation of the heart's electrical activity recorded from electrodes on the body surface Gateway device Device for receiving vital signs from the BRAIN and transmitting them on to the monitoring center; the gateway can receive settings updates from the monitoring center Heart Rate The number of heartbeats per unit of time, usually per minute. Monitoring Center Monitoring Center equipped with hardware and software that receives, analyzes and stores vital signs signals received from the VSP system, and can generate reports for the medical staff Respiration Rate The number of movements of the chest wall per unit of time, indicative of inhalation and exhalation RF A range of radio frequencies used for wireless transmission Saturation Blood’s oxygen saturation level measured in percentage Temperature The patient’s body temperature recorded from a thermistor on the body surface VSP Vital Signs Patch system CG-1101XX Internal Part Number indicating the type of Vital Signs Patch (CG-1101C, CG-1101B or CG-1101UC)

VSP System User Guide 11 2 VSP SYSTEM INTRODUCTION 2.1 General Description The VSP system is a medical device that allows recording of heart rate, ECG (up to 3 Lead), body temperature, oxygen blood saturation and respiration; the VSP also enables transmission of vital sign recordings to a Monitoring Center, thereby allowing your physician or other medical personnel to monitor your health condition anywhere, any time. Figure 1 - Vital Sign Patch System

VSP System User Guide 12 2.2 The VSP Kit 1. 3-lead Disposable Patch for upper placement 2. 3-lead Disposable Patch for lower placement 3. Brain 4. Gateway device 5. Gateway Charger 6. Quick User Guide (not shown) Figure 2 - VSP Kit Components

VSP System User Guide 13 3 PHYSICAL FEATURES 3.1 Parts The VSP system includes the following components:  Disposable Patch (CG-1101XX)  Brain  Gateway application 3.2 Patch The Patch is a disposable unit that is attached to the body and contains the following sensors:  ECG sensor  Temperature sensor  Blood oxygen saturation sensor  Respiration sensor Figure 3 - Patch Components (general) Cradle BRAIN Sensors

VSP System User Guide 14 3.3 BRAIN The BRAIN is a non-disposable part, containing an RF transmitter and a receiver for communicating with the Gateway. The BRAIN connects to the Patch via a dedicated cradle located on the Patch. The BRAIN includes a processor unit, and receives power and vital signs data from the Patch. In addition, the Brain has an accelerometer for sensing when a patient falls. The BRAIN has a centrally placed event button for recording and subsequent transmission of manual events. Events can also be triggered manually via an icon on the Gateway application. A LED rim around the button blinks to indicate the status of the VSP system - a green light indicates that the VSP system is working properly, while a red light indicates a problem (refer to the troubleshooting section for details of possible problems). Figure 4 - Brain Components

VSP System User Guide 15 3.4 Gateway Application The Gateway application runs on a smartphone using the Android operating system, RF capabilities (Nordic), and a proprietary application. Figure 5 - Gateway Application

VSP System User Guide 16 Gateway Placement For optimal system performance, the recommended distances between the Gateway and Patch should be as follows: – Within 20 inches (50 cm) for normal operation – Within 10 feet (3 meters) during Gateway charging – Within 30 feet (10 meters) maximum distance

VSP System User Guide 17 3.5 Gateway Recharging Procedure Charge the Gateway whenever possible during the day. In addition, charge the Gateway every night (regardless of battery level icon), making sure that the VSP is within 10 feet (3 meters) of the Gateway. The Gateway battery level icon ( ) indicates when charging is needed. When charging is complete, the battery level icon will indicate full charging ( ). Battery full Battery partially drained Battery very low Battery charging To Charge the Gateway 1. Plug the Gateway charger power cord into the power socket on the Gateway. 2. Plug the supplied Gateway charger unit into a standard wall outlet. 3. When finished, disconnect the Gateway charger from the wall outlet and then from the Gateway.

VSP System User Guide 18 4 USING THE VSP SYSTEM 4.1 General A certified clinician is responsible for dispensing the VSP to the patient. A trained and certified technician is responsible for maintaining and cleaning the reusable parts of the VSP System. 4.2 Patch Before attaching the Patch you must prepare the skin. 4.2.1 Preparing the Skin Skin Preparation 1. Wash the skin on the upper part of your chest using warm water and gentle soap if the Patch is placed in the top location. Figure 6 - Skin Hair-removal Region 2. Wash the skin on the lower part of your chest using warm water and gentle soap, if the Patch is placed in the bottom location. 3. Remove excess hair from the areas by carefully clipping with scissors. Avoid shaving in order to minimize irritation. 4. Make sure that your skin is clean and fully dry before proceeding. 5. Do not apply the patch to skin that is broken or irritated. 6. Contact LifeWatch if you have any questions concerning the use of the device.

VSP System User Guide19 Note There are physiological conditions that may affect the gateway from detecting the electrode connection certain period of time. Even though the sensorbe in good contact with the body, the alert continue to appear. Some examples that can cause delayed electrode recognition are very dry skin or immediately after attaching the electrodes. If the condition does not resolve, contact LifeWatch.4.2.2 Placing the Upper 3-lead Patch To place the patch 1. Peel off the plastic liner covering the adhesive from the back of the Patch contact pad. 2. Dispose of the plastic liner. 3. Place the Patch on the skin vertically aligned with the the chest. Figure 7 – Upper Patch Placement VSP System User Guide There are physiological conditions that may affect the gateway from detecting the electrode connection for a sensors seem to alert message will that can cause are very dry skin or contact after attaching the electrodes. If the condition does not resolve, contact LifeWatch. Peel off the plastic liner covering the adhesive from the back of the with the mid-point of

VSP System User Guide 20 4.2.3 Placing the Lower 3-lead Patch To place the patch 1. Peel off the plastic liner that covers the adhesive from the back of the Patch contact pad. 2. Dispose of the plastic liner. 3. Place the Patch on the skin vertically aligned with the mid-point of the left half of the chest, approximately 5 cm (2 inches) below the left breast. 4. Place the upper electrode of the Patch approximately 5 cm (2 inches) above the right of the sternum. In order to collect vital sign data the Patch must be placed on an area of the body containing veins. If the breast prevents the Patch from being placed in the correct location, lift the breast slightly. Figure 8 – Lower Patch Placement

VSP System User Guide 21 4.3 Installing the Brain To install the Brain 1. Position the Brain in the cradle with the groove facing upwards and the button facing outwards. 2. Push gently until the tab on the cradle locks into the groove on the Brain. If the brain is correctly installed it will start to receive signals from the sensors in the Patch (Brain/patch ON, removal of Brain OFF). Figure 9 - Placing Brain into Cradle Ensure that the Brain is positioned properly with the correct side up before pushing it into place. Precaution: Using excessive force when putting the Brain in the cradle can cause the pins to bend, preventing the Brain from being installed or removed.

VSP System User Guide22 4.4 Removing the VSP To remove the patch  Peel the Patch contact pads from the skin. If you experience difficulty in removing the Patch contact pads, water to weaken the adhesive. Do not use the VSP if you have a history of experiencing irritation to electrode adhesives. To remove the Brain 1. Lift the tab (Item 3 in Figure 9) holding the Brain in the cradle.2. Place finger in the groove (Item 1 in Figure 9) on the Brain. 3. Gently pull the top of the Brain away from the cradle.4. Remove the Brain from the cradle, remove the battery from the patch and place in the envelope to return to LifeWatch WARNING The Patch is for single use only. Dispose of the Patch after use in a place designated as for disposal of biomedical waste. WARNING Dispose of the battery in a battery disposal that meets WEEE requirements. Note Returning the Patch to LifeWatch Services ensures proper disposal. VSP System User Guide removing the Patch contact pads, use of experiencing irritation to in the cradle. the top of the away from the cradle. , remove the battery from the and place in the envelope to return to LifeWatch. in a place designated as for that meets WEEE ervices ensures proper disposal.

VSP System User Guide 23 5 USING THE GATEWAY APPLICATION 5.1 Starting the Application To start the Gateway application  Activate the device running the application. The application is automatically launched and the Main Screen is displayed. The maximum unblocked distance between the Brain and the Gateway is 10 meters (30 ft.); walls and other obstructions will reduce this distance. Do not exceed this distance under any circumstances as this will prevent data transfer from the Brain. 5.2 VSP Screen The VSP screen displays signal, connectivity, time, available battery power and the Gateway application functions and screens. 5.3 Gateway Application Functions The Gateway application has the following functions:  Displaying the main screen  Displaying sensor data  Displaying HW/SW version on the About screen  Displaying alerts  Creating manual events  Displaying questionnaires

VSP System User Guide 24 5.3.1 Displaying the Main Screen To display the main screen  Activate the device that contains the application. The main screen is displayed. Figure 10 – Main screen 5.3.2 Displaying Sensor Data To display data on the signal viewer 1. Select one of the vital sign signal viewers from the Main Screen. 2. Enter the password. The raw signal data is displayed. Figure 11 – ECG Respiration

VSP System User Guide 25 5.3.3 Displaying HW/SW Version on the About Screen To display hardware/software information on the screen  On the left bottom, press the Menu button. Then, click About. The About screen is displayed with the hardware, software and Gateway application versions. 5.3.4 Displaying Alerts An error initiates one of two types of alerts – one for the Brain and one for the Gateway. 5.3.4.1 Brain Error Alerts A Brain error triggers the following alerts:  LED rim light flashes red  VSP system initiates sporadic beeping (1 sec beep)  Gateway screen displays the error 5.3.4.2 Gateway Error Alerts A Gateway error triggers the following alerts:  VSP brain initiates sporadic beeping  Gateway screen displays the error An alert will continue as long as the error exists. Any errors occurring during an initial alert will be indicated as well.  Once an error has been corrected, the alert stops and the Main Screen is displayed.

VSP System User Guide 26 5.3.5 Creating Manual Events There are two methods for creating a manual event:  Pushing the Manual Event button on the Brain.  Tapping the Manual Event button in the Gateway application. When a manual event is created, the following occurs: 1. The Gateway application notifies the Monitoring Center that a manual event was created. 2. A questionnaire appears in the Gateway application asking the patient to identify the symptom(s) being experienced by the patient.

VSP System User Guide 27 Figure 12 - Gateway Questionnaire 5.3.5.1 Responding to the Gateway Questionnaire To respond to the Gateway questionnaire 1. Tap to check the relevant symptom(s) from the predefined list. 2. Click Send. The questionnaire is closed, and the data is sent. If the questionnaire is not completed in the allotted time, the responses are sent to the Monitoring Center. If the patient does not respond to the questionnaire after the allotted time, the blank questionnaire is sent to the Monitoring Center.

VSP System User Guide 28 6 HEART RATE CALCULATION METHOD 6.1 Introduction This section describes the heart rate (HR) calculation within the LifeWatch V. HR is defined as the number of heart beats during a GIVEN TIME INTERVAL (usually one minute). It is reported by the algorithm each time a QRS complex is detected. 6.2 Method of Calculation The momentary HR is the inverse of the time lasting between two consecutive heart beats. As the momentary HR fluctuates due to inaccuracies in detecting the exact R wave timing eight momentary HR values are averaged to generate the displayed HR. Therefore the reported HR is the mean of the last momentary HR values WHICH CORRESPOND TO THE DETECTED R COMPLEXES FOR THE LAST 8 SECONDS. OCCASIONS IN WHICH THE HR IS NOT REPORTED: If during a specific QRS complex the signal is considered as too low to be considered accurate or is considered as noise, the displayed HR will be 0. 7 PAUSE CALCULATION Pause is considered a lack of Ventricular activity for more than 3 seconds. In order to detect a pause one of two conditions needs to be detected: 1. Lack of QRS detection for more than 3 seconds 2. A flat signal (P complexes can occur) for slightly less than 3 seconds. Once one of the above conditions is detected a pause event is called.

VSP System User Guide 29 8 MAINTENANCE 8.1 Conditions of Use Your VSP conforms to international regulations insofar as it is used under normal conditions and in accordance with the instructions below. 8.2 Caring for your VSP  Do not open or attempt to repair your VSP yourself. Only authorized service personnel may repair the product.  Do not bend the Brain, which can damage the circuitry.  Do not use extreme force when pressing the button on the Brain.  Do not submerge the Brain in water.

VSP System User Guide 30 8.3 Cleaning The clinician should clean the Brain with a wet towel and 99% isopropyl alcohol after use between patients. 8.4 Environment  Keep the VSP away from extreme heat. Do not leave it on the dashboard of a car or near a heater. Do not leave it in any place that is extremely damp or dusty.  Do not store the VSP in a place where it will be continuously exposed to moisture, steam or perspiration, etc. Extended exposure to moisture may cause malfunction. The battery and electronics of the VSP are covered by the European Directive 2012/19/EC (WEEE) or by other local/national environmental regulations. All electrical and electronic products should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities. You can also dispose of the Patch by returning it to LifeWatch as per their instructions. Correct disposal of the Patch will help prevent potential negative consequences for the environment and human health.

VSP System User Guide 31 9 TROUBLESHOOTING Problem Possible Cause(s) Solution VSP system displays failure or an inaccurate reading. Patch has become loose or detached. Electrodes not clean; skin is oily or with excessive hair. Make sure Patch is correctly placed or detach and reattach. Restart Gateway. Clean electrodes, clean or shave skin. Contact LifeWatch customer service. Data is not being transmitted to the smartphone. Disconnected RF channel between Brain and Gateway. 1) Verify the smartphone is set for communication and the VSP system is listed as a paired device. 2) Move the Brain closer to the Gateway (Gateway has a range of 10 meters). 3) Replace Patch. 4) Contact LifeWatch customer service. No display when Gateway is activated. The battery is very low or depleted. Connect the Gateway to charger to charge the battery. Hardware error. Hardware not functional. Contact LifeWatch customer service. If you are experiencing a critical error not included in this table, restart any running applications and then disconnect and reconnect the Brain. If the critical error is not resolved, contact LifeWatch Customer Service.

VSP System User Guide 32 10 SPECIFICATIONS 10.1 VSP Brain Specifications Parameter Min Max Typical Units Input Operating DC voltage 2 3.3 V Average Current consumption 10 mA Without SPO2 7.5 mA Peak Current Consumption 50 mA Manual event triggering N/A N/A Yes None Environmental and Operating conditions Operating temperature 10 (50) 45 (113) N/A °C (°F) Environmental Operation humidity 10% 95% Environmental atmospheric pressure 70 106 kPA Transport & storage temperature -20 (-4) 65 (149) N/A °C (°F) Transport & storage humidity 10% 85% Transport & storage atmospheric pressure 50 106 kPA Dimensions Dimensions (max.) N/A N/A 59 x 47 x 9 (2.32 x 1.85 x 0.35) mm (inch) Net Weight 23 (0.811) gr. (oz.)

VSP System User Guide 33 Parameter Min Max Typical Units ECG ECG Input Impedance 10 MΩ ECG Input dynamic range N/A +/- 5 N/A mV ECG ADC sample Rate 250 250 250 Hz ECG DC offset correction 0 +/-300 mV ECG HPF Cutoff Frequency N/A N/A 131 Hz ECG System noise 0 30 μV Respiration Respiration Impedance 500 2000 N/A Mohm Respiration ∆ Impedance 0.2 3 N/A Mohm Respiration Sampling Rate 25 /sec Temperature Temperature Range 35 (95) 42 (107.6) N/A °C (°F) Temperature Accuracy 0.3 (0.54) °C (°F) Accelerometer Accelerometer Acceleration Range 0.1 6.0 N/A G Accelerometer Sampling Rate 50 /sec Accelerometer resolution 12bit A2D

VSP System User Guide 34 Parameter Min Max Typical Units SPO2 specification Saturation LED Current 5 30 mA Saturation Measurement Resolution 16bit A2D Saturation Noise (in darkness) 2bit A2D Saturation Sampling Rate 13 /msec SPO2 parameters Oxygen saturation range: 70 to 100 % Pulse rate range: 18 to 300 pulses per minute Data averaging and update period 3 seconds; data is sent every 0.5 seconds Measurement wavelengths: Red 660 nanometers Infrared 910 nanometers Alarm indication The device does not have the capability to detect an SpO2 or pulse rate physiological alarm condition Pulse rate Accuracy 3 % ± 1 digits SPO2 Accuracy Root Mean Square (RMS) error: 3.5% Note: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall within ±Arms of the value measured by a co-oximeter.

VSP System User Guide 35 10.2 VSP Patch Specifications VSP Patch specifications are listed below: Parameter Min Max Typical Units Dimensions (max.) Upper N/A N/A 195 x 115 (7.7 x 4.5) mm (inches) Lower N/A N/A 192 x 110 (7.6 x 4.3) mm (inches) Battery type lithium/ manganese dioxide Battery voltage 3.0 V Battery capacity 1500 mAh Battery dimensions 5.5x35x35 mm Battery life 4 7 Use dependent Days (dependent upon mode) Net Weight 50 (1.76) g (oz.)

VSP System User Guide 36 10.3 Transmission Specifications Parameter Typical Units Operating Frequency 2.4GHz MHz Output power 0 dBm Crystal frequency 16 MHz Frequency deviation @ 250kbps ±160 kHz Frequency deviation @ 1Mbps ±160 kHz Frequency deviation @ 2Mbps ±320 kHz Air Data rate kbps Non-overlapping channel spacing @ 250kbps/1Mbps 1 MHz Non-overlapping channel spacing @ 2Mbps 2 MHz

VSP System User Guide 37 APPENDIX A WARNINGS AND PRECAUTIONS Declaration of RoHS Compliance The VSP was designed by LifeWatch Technologies Ltd. to comply with Directive 2011/65 /EC of the European Parliament - RoHS (Restriction of Hazardous Substances) - with respect to use of the following substances in the device:  Lead (Pb)  Mercury (Hg)  Cadmium (Cd)  Hexavalent Chromium (Cr (VI))  Polybrominated biphenyls (PBBs)  Polybrominated diphenyl ethers (PBDEs)

VSP System User Guide 38 Warnings The VSP is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring. Due to the risk of ignition or fire, the VSP is not intended for use in a hyperbaric chamber, within an oxygen tent or in the presence of flammable anesthetics / medical gases. To prevent an allergic reaction, do not use the VSP or accessories if you have a known allergy to nickel, silver or other metals. The VSP is not defibrillation-proof. Exposure to defibrillation may damage the VSP, or the VSP may interfere with the operation of the defibrillator. The user of the VSP should not take any actions of a medical or clinical nature based on his/her understanding or interpretation of monitoring without consulting a healthcare professional. The VSP System should not be used to monitor chest pain and it cannot predict or diagnose a heart attack (myocardial infarction). Do not operate the VSP in combination with the following medical electronic devices as this may cause a malfunction of this device: Electronic life support systems such as an artificial heart/lung.

VSP System User Guide 39 Precautions The VSP System generates, uses, and can radiate radio frequency energy and, if not used in accordance with the instruction manual, may cause harmful interference to radio communications. The VSP System employs cellular technology. The location of the VSP System and the associated environment, including cellular phone coverage in the particular area, may cause transmission interruption or delay. Do not open or attempt to repair the device. Only authorized service personnel may repair the system components. To avoid damage to the system, the system and accessories should be kept away from extreme heat, including placement of the VSP on the dashboard of a car or near a heater. The system should not be subjected to severe impact or bending force. Exposure to these types of stresses can damage the system components. Do not use or store the VSP in a location where liquids such as water, juice, coffee can splash on it. The VSP is intended to be used in conjunction with a monitoring service that reviews the transmissions and provides information to the physician for his/her final diagnostic interpretation. The VSP is not intended for use as an emergency medical response system and should not be used by patients at risk for serious or life-threatening cardiac arrhythmias. If you are experiencing symptoms that are not consistent with any of your monitoring, you should consult your healthcare provider, doctor or other appropriate medical professional.

VSP System User Guide40 If you are taking medications you should consult your healthcare professional concerning the possible effect of the medications on the monitoring. Note: Modifications not expressly approved by the manufacturer could void the user authority to operate the equipment. THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO OPERATE THE EQUIPMENT. VSP System User Guide If you are taking medications you should consult your healthcare professional concerning the possible effect of the Modifications not expressly approved by the manufacturer authority to operate the equipment. THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO

VSP System User Guide 41 IMPORTANT FCC Part 15 This device complies 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. FCC WARNING This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and the receiver. • Connect the equipment into an outlet different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. NOTE: THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO OPERATE THE EQUIPMENT.

VSP System User Guide 42 Gateway (Cellular Phone) Warnings Using Your Gateway near Other Electronic Devices Most modern electronic equipment is shielded from radio frequency (RF) signals. However, certain electronic equipment may not be shielded against the RF signals from your wireless phone. Consult the manufacturer to discuss alternatives. Implantable Medical Devices A minimum separation of six (6) inches (15 cm) should be maintained between a handheld wireless phone and an implantable medical device, such as a pacemaker, to avoid potential interference with the device. Persons who have such devices: • Should ALWAYS keep the phone more than six (6) inches (15 cm) from their implantable medical device when the phone is turned ON; • Should not carry the phone in a breast pocket; • Should use the ear opposite the implantable medical device to minimize the potential for interference; • Should turn the phone OFF immediately if there is any reason to suspect that interference is taking place. • Should read and follow the directions from the manufacturer of your implantable medical device. If you have any questions about using your wireless phone with such a device, consult your health care provider. Hearing Aid Compatibility with Mobile Phones FCC Hearing-Aid Compatibility (HAC) Regulations for Wireless Devices

VSP System User Guide 43 On July 10, 2003, the U.S. Federal Communications Commission (FCC) Report and Order in WT Docket 01-309 modified the exception of wireless phones under the Hearing Aid Compatibility Act of 1988 (HAC Act) to require digital wireless phones be compatible with hearing-aids. The intent of the HAC Act is to ensure reasonable access to telecommunications services for persons with hearing disabilities. While some wireless phones are used near some hearing devices (hearing aids and cochlear implants), users may detect a buzzing, humming, or whining noise. Some hearing devices are more immune than others to this interference noise, and phones also vary in the amount of interference they generate. The wireless telephone industry has developed a rating system for wireless phones, to assist hearing device users find phones that may be compatible with their hearing devices. Not all phones have been rated. Phones that are rated have the rating on their box or a label located on the box. The ratings are not guarantees. Results will vary depending on the user’s hearing device and hearing loss. If your hearing device happens to be vulnerable to interference, you may not be able to use a rated phone successfully. Trying out the phone with your hearing device is the best way to evaluate it for your personal needs. M-Ratings: Phones rated M3 or M4 meet FCC requirements and are likely to generate less interference to hearing devices than phones that are not labeled. M4 is the better/higher of the two ratings. T-Ratings: Phones rated T3 or T4 meet FCC requirements and are likely to be more usable with a hearing aid’s telecoil than phones that are not rated. T4 is the better/higher of the two ratings. Hearing devices may also be rated. Your hearing device manufacturer or hearing health professional may help you find this rating. Higher ratings mean that the hearing device is relatively

VSP System User Guide 44 immune to interference noise. The hearing aid and wireless phone rating values are then added together. A sum of 5 is considered acceptable for normal use. A sum of 6 is considered for best use. In the above example, if a hearing aid meets the M2 level rating and the wireless phone meets the M3 level rating, the sum of the two values equal M5. This should provide the hearing aid user with “normal usage” while using their hearing aid with the particular wireless phone. “Normal usage” in this context is defined as a signal quality that is acceptable for normal operation. The M mark is intended to be synonymous with the U mark. The T mark is intended to be synonymous with the UT mark. The M and T marks are recommended by the Alliance for Telecommunications Industries Solutions (ATIS). The U and UT marks are referenced in Section 20.19 of the FCC Rules. The HAC rating and measurement procedure are described in the American National Standards Institute (ANSI) C63.19 standard. Some digital wireless phones may interfere with some hearing aids. In the event of such interference, you may wish to consult your hearing aid manufacturer to discuss alternatives.

VSP System User Guide 45 Other Medical Devices If you use any other personal medical device, consult the manufacturer of your device to determine if it is adequately shielded from external RF energy. Your physician may be able to assist you in obtaining this information. Switch your phone off in health care facilities when any regulations posted in these areas instruct you to do so. Hospitals or health care facilities may be using equipment that could be sensitive to external RF energy. Children Using Wireless Phones The scientific evidence does not show a danger to users of wireless phones, including children and teenagers. If you want to take steps to lower exposure to radio frequency energy (RF), the measures described above would apply to children and teenagers using wireless phones. Reducing the time of wireless phone use and increasing the distance between the user and the RF source will reduce RF exposure. Some groups sponsored by other national governments have advised that children be discouraged from using wireless phones at all. For example, the government in the United Kingdom distributed leaflets containing such a recommendation in December 2000. They noted that no evidence exists that using a wireless phone causes Brain tumors or other ill effects. Their recommendation to limit wireless phone use by children was strictly precautionary; it was not based on scientific evidence that any health hazard exists. Body-worn Operation To comply with RF exposure requirements, a minimum separation distance of 0.50 inch (1.5 cm) must be maintained between the user’s body and the handset, including the antenna. Third-party belt-clips, holsters, and similar accessories used by this device should not contain any metallic components. Body-worn accessories that do not meet these requirements may not comply with RF exposure requirements and should be avoided.

VSP System User Guide 46 Use only the supplied or an approved antenna. Unauthorized antennas, modifications, or attachments could impair call quality, damage the phone, or result in violation of regulations. Do not use the phone with a damaged antenna. If a damaged antenna comes into contact with the skin, a minor burn may result. Please contact your local dealer for replacement antenna.

VSP System User Guide 47 END USER LICENSE AGREEMENT - SOFTWARE LICENSE AGREEMENT Single Use License PLEASE READ CAREFULLY BEFORE USING THE DEVICE AND SOFTWARE: This License Agreement (“License”) for a certain LifeWatch Technologies Ltd. (“Lifewatch”) product is a legal agreement between you (either an individual or an entity) and Lifewatch, its affiliates, third party suppliers and licensors for all the relevant software (which includes hardware and components provided by suppliers and licensors to Lifewatch) bundled with the LifeWatch product purchased by you, and as such may be updated from time to time (the “Software”). BY ACTIVATING AND/OR USING THIS VITAL SIGNS PATCH SYSTEM (HEREINAFTER, THE “DEVICE”) AND THE SOFTWARE, YOU CONFIRM THAT YOU HAVE READ, UNDERSTOOD AND AGREE TO BE BOUND BY THE TERMS OF THIS LICENSE AGREEMENT. If, prior to indicating your acceptance by activating, using, downloading or installing this Device and/or the Software, you decline, for any reason, any of the terms of this License, you have no right to use the Device or the Software and you should: (i) promptly return the Software to LifeWatch or, if downloaded by you, delete it; or (ii) if you have purchased the Device on which the Software is pre-installed by or on behalf of Lifewatch, promptly return the Device and the accompanying Software and items (including Documentation and packaging) to LifeWatch or the LifeWatch authorized distributor from whom you purchased the Device. 1. Grant of License. LifeWatch hereby grants to you a non-exclusive restricted license to use the Software but only in conjunction with the Device in which the Software is originally embedded and only in accordance with the accompanying documentation (“Documentation”). 2. License Restrictions. (a) Except to the extent otherwise expressly and unambiguously authorized by LifeWatch or, with respect to any restriction which is explicitly prohibited by applicable law, you shall NOT otherwise: (i) permit other individuals to use the Software; (ii) modify, translate, reverse engineer, decompile, disassemble or create derivative works based upon the Device, the Software or Documentation; (iii) make any copies of the Software or Documentation; (iv) rent, lease, transfer, sublicense or otherwise transfer rights to the Software or Documentation; (v) remove any proprietary notices or labels on the Device, Software or Documentation; or (vi) add, integrate or combine any other software with the Software. ANY SUCH FORBIDDEN USE SHALL IMMEDIATELY TERMINATE YOUR LICENSE TO THE SOFTWARE.

VSP System User Guide 48 (b) You agree that you shall only use the ce, Software and Documentation in a manner that complies with all applicable laws in the jurisdictions in which you use the Device, Software and Documentation, including, but not limited to, applicable restrictions concerning relevant copyright and other intellectual property rights and/or the export controlling regulations. (c) You shall only use the Software and Documentation for your private, non-commercial use. You shall not use the Software in any way to provide, or as part of, any commercial service or application. You shall not use the Device or the Software in an attempt to, or in conjunction with, any device, program or service designed to circumvent technological measures employed to control access to, or the rights in, a content file or other work protected by the copyright laws of any jurisdiction. 3. Title. Title, ownership, and intellectual property rights in and to the Software, the Device, and Documentation shall remain vested in LifeWatch (including all its relevant suppliers/licensors). The Software is protected by the copyright laws, including those of the United States, the EU and international copyright treaties. 4. Transfer. You may not rent, lease, lend, sell, redistribute, or sublicense the Software. You may, however, make a one-time permanent transfer of all of your license rights to the Software to another party in connection with the transfer of ownership of your Device, provided that: (a) the transfer must include your Device and all of the Software, including all its component parts, original media, printed materials and this License; (b) you do not retain any copies of the Software, full or partial, including copies stored on a computer or other storage device; and (c) the party receiving the Device and the Software reads and agrees to accept the terms and conditions of this License. 5. Consent to Use of Data. (a) LifeWatch is committed to keeping your personal information private, safe and discrete. LifeWatch will never share, sell, rent, or trade any of your personally identifiable information with third parties for their promotional commercial purposes, without your consent. (b) The developers of the Device and the Software have conscientiously and carefully tried to present the Device and the Software in conformance with the standards of professional practice and internationally accepted medical standards that prevailed at the time of the manufacture of the Device and the publication of the Software; however, such standards and practices in medicine may change as new data become available and due to advances in technology, and you or any medical professional with access to the Device or the Software should consult a variety of professional sources as appropriate in the medical profession. In addition, with respect to prescription medication, you are advised to check the product information sheet accompanying each drug to verify conditions of use and

VSP System User Guide 49 identify any changes in dosage schedule or contraindications, particularly if the agent to be administered is new, infrequently used, or has a narrow therapeutic range. The Device and the Software are no substitute for individual patient assessment based upon examination of each patient by a professional healthcare provider and consideration of laboratory data and other factors unique to the patient. The Device and the Software may be used as tools to help you understand diagnostic and treatment decisions, bearing in mind that individual and unique circumstance may lead you or your healthcare provider to reach decisions not presented in the Software. (c) Physicians and other healthcare professionals who use the Device and the Software should exercise independent clinical judgment as to the information they provide, and not rely on the Device, the Software or information derived therefrom as a conclusive source for diagnosis or as a replacement for independent examinations. Individuals with any type of medical condition are specifically cautioned to seek professional medical advice before beginning any sort of health treatment. For medical concerns, users should always consult their physician or other qualified healthcare professional. 9. Disclaimer of Warranties. (a) To the maximum extent permitted by applicable law, the Device, the Software and any services are provided "as is" and "as available", with all faults and without warranty of any kind, and LifeWatch hereby disclaim all warranties and conditions with respect to the Device, the Software and services, either express, implied or statutory, including, but not limited to, the implied warranties and/or conditions of merchantability, satisfactory quality, fitness for a particular purpose, accuracy, and non-infringement of third party rights. 10. Limitation of Liability. To the extent not prohibited by applicable law, in no event shall LifeWatch be liable for personal injury, or any incidental, special, indirect or consequential damages whatsoever, including, without limitation, damages for loss of profits, corruption or loss of data, failure to transmit or receive any data, business interruption or any other commercial damages or losses, arising out of or related to your use or inability to use the Device, the Software and services or any third party software or applications in conjunction with the Device, the Software or services, however caused, regardless of the theory of liability (contract, tort or otherwise) and even if LifeWatch has been advised of the possibility of such damages. Some jurisdictions do not allow the limitation of liability for personal injury, or of incidental or consequential damages, so this limitation may not apply to you. In no event shall LifeWatch’s total liability to you for all damages (other than as may be required by applicable law in cases involving personal injury) exceed the amount actually paid by you for the Software

VSP System User Guide 50 and the Device. The foregoing limitations will apply even if the above stated remedy fails to achieve its essential purpose. 11. Controlling Law and Severability. This License will be governed by and construed in accordance with the laws of the state of New York, excluding its conflict of law principles. This License shall not be governed by the United Nations Convention on Contracts for the International Sale of Goods, the application of which is expressly excluded. If for any reason a court of competent jurisdiction finds any provision, or portion thereof, to be unenforceable, the remainder of this License shall continue in full force and effect. 12. Complete Agreement; Governing Language. This License constitutes the entire agreement between you and LifeWatch relating to the Device, the Software and supersedes all prior or contemporaneous understandings regarding such subject matter. No amendment to or modification of this License will be binding unless in writing and signed by Lifewatch. Any translation of this License is done for local requirements and in the event of a dispute between the English and any non-English versions, the English version of this License shall govern, to the extent not prohibited by local law in your jurisdiction. 13. Contacting Us. If you have any questions regarding this License or the use of the Software or the Device, please contact us NOTICE POLICY AND MEDICAL WASTE DISCLAIMER BY USING THE DEVICE, SOFTWARE, WEBSITE AND/OR WEBSITE SERVICES YOU HEREBY AGREE TO BE BOUND BY THE FOLLOWING NOTICE POLICY AND MEDICAL WASTE DISCLAIMER. IF YOU DO NOT AGREE WITH THE NOTICE POLICY AND/OR MEDICAL WASTE DISCLAIMER, YOU SHOULD DISCONTINUE USE OF THE DEVICE, SOFTWARE, AND/OR OTHER SERVICES. MEDICAL WASTE DISCLAIMER In no event shall LifeWatch be liable for personal injury, or any incidental, special, indirect or consequential damages whatsoever that result from the disposal of any medical waste. UG-00077 rev01 2013-03

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