Instructions for Use - Preventice

Instructions for Use

CONFIDENTIAL AND PROPRIETARY

The information contained in this document is confidential and proprietary to Preventice Technologies, Inc. This document may not be disclosed, copied, or distributed in any form to any third party without written permission of Preventice Technologies, Inc.

Copyright © Preventice Technologies, Inc. January 2021 All rights reserved. LA1054-A LL-60090-A

BodyGuardian One – Instructions for Use

Table of Contents

Equipment ............................................................................................................................................................................... 1 About BodyGuardian One .................................................................................................................................................. 1 BodyGuardian One menu options .................................................................................................................................. 2 Getting started ...................................................................................................................................................................... 3

1 Prepare your skin ................................................................................................................................................................ 3 2 Attach electrodes to lead wires ..................................................................................................................................... 4 3 Attach to your chest .......................................................................................................................................................... 4 4 Route lead wires under and around clothing ........................................................................................................... 6 5 Power on the monitor ........................................................................................................................................................ 6 6 Plug lead set into monitor ............................................................................................................................................... 8 7 Take an initial ECG recording ......................................................................................................................................... 9

Daily usage ........................................................................................................................................................................... 10 1 Recording your symptoms ............................................................................................................................................ 10 2 Charging the BodyGuardian One .................................................................................................................................. 11 3 Replacing the electrodes ................................................................................................................................................ 12 4 Showering, bathing, swimming .................................................................................................................................... 14 5 MRI .......................................................................................................................................................................................... 14 6 Air travel ............................................................................................................................................................................... 14 7 Touchscreen dimming ..................................................................................................................................................... 14

Maintenance and Service ................................................................................................................................................. 14 1 Cleaning ................................................................................................................................................................................ 14 2 Service .................................................................................................................................................................................... 15 3 Troubleshooting ................................................................................................................................................................. 15 4 Battery storage ................................................................................................................................................................... 15

Indications for Use .............................................................................................................................................................. 16 Contraindications ................................................................................................................................................................ 16 Precautions ........................................................................................................................................................................... 16 Appendix A: Symbols ........................................................................................................................................................ 17 Appendix B: Technical Specifications .......................................................................................................................... 18 Appendix C: Wireless Compliance ................................................................................................................................ 19 Appendix D: Arrhythmia Detection Performance .................................................................................................... 21 Appendix E: Handling Instructions for Lithium-Ion Battery ................................................................................. 22

BodyGuardian One – Instructions for Use 1

Equipment

monitor

monitor (back)

monitor batteries (2)

battery charger

ECG lead wires

standard ECG electrodes

About BodyGuardian One The BodyGuardian One is a portable, battery powered, wireless cardiac monitor which may be worn to record ECG data for up to 30 consecutive days.

The BodyGuardian One captures patient activated and auto-triggered cardiac events, such as Bradycardia, Tachycardia, and Atrial Fibrillation, that are identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering data to Preventice.

Important

• BodyGuardian One does not summon physicians nor emergency assistance and does not replace direct communication with your health care provider. If you are experiencing a medical emergency, dial emergency assistance (911 US)

• If you have questions or encounter problems while you are using BodyGuardian One, contact your health care provider.

• For a complete list of indications, contraindications, and precautions, see page 16.


BodyGuardian One menu options BodyGuardian One provides additional menu options that can assist you while you are operating the device.

To access the menu options:

1. Unplug the ECG cable from the device to pause monitoring. The Insert ECG lead cable screen is displayed.

2. Using the touchscreen, press on the MENU icon. 3. Press the menu option that you want to enable or view.

Label Description INFO Press the INFO icon to display the following:

• Device serial number • Software version number • SIM card ID • IMEI ID • Firmware version number

FLIGHT MODE Press the FLIGHT MODE icon to disable network connectivity and prevent the device from sending data to or receiving data from the Preventice servers. The device will still be recording ECG/heart rate data. The icon is highlighted when the option is enabled. Press the icon again to disable the option.

SOUND ON/OFF

Press the SOUND ON/OFF icon to toggle on and off the sound from the device (this includes audible chime alerts).

Note: Unplugging the ECG cable pauses monitoring.


ALERT ON/OFF

Press the ALERT ON/OFF icon to toggle on and off the visual and auditory alerts that result from leads being disconnected for longer than 10 seconds.

MONITORING Press the MONITORING icon to return to the Insert ECG lead cable screen with the selections enabled.

LANGUAGE Press the LANGUAGE icon to open a screen where you can select the language to use in operator mode. You can select English or Spanish. The selection enables a green check mark. Press the MONITORING icon to operate the device in the language you selected.

Getting started

1 Prepare your skin 1. If hair is present, remove the hair where you will place the ECG electrodes.

2. Thoroughly clean the area with soap and water. Dry the area completely.

3. Do not apply lotions, oils or perfumes.


2 Attach electrodes to lead wires Complete the following steps to attach the electrodes:

1. Snap one ECG electrode into each of the five colored leads.

3 Attach to your chest

1. Remove the adhesive backing from each of the electrodes, then attach them to your chest:

2. Attach the LA - BLACK lead.

Remove the adhesive backing from the

electrode. Attach aligned with the left side of the neck, two to three inches below the left collarbone.

3. Attach the LL - RED lead.

Apply electrodes only to intact, clean skin. Do not apply over open wounds, lesions, infected, or inflamed areas. If you have skin allergies or hypersensitivities to adhesives, consult your doctor to select the appropriate option.



electrode. Attach below the black lead, under the breast to the outer ribcage.

4. Attach the RA - WHITE lead.


electrode. Attach aligned with the right side of the neck, two to three inches below the right collarbone.

5. Attach the RL - GREEN lead.


electrode. Attach below the white lead, under the breast to the outer ribcage.

6. Attach the V1 - BROWN lead.



electrode. Attach to the center of the chest, slightly to the right of the sternum.

4 Route lead wires under and around clothing Run the lead wires from the electrodes neatly under your clothing to your belt area, where you will clip the monitor.

5 Power on the monitor 1. Slide the battery cover off the back of the monitor.

All five leads must remain securely attached to the chest during the prescribed monitoring period. If any one of the leads becomes detached from an electrode worn on the chest, the device will notify the wearer by displaying the message: CHECK ELECTRODES.


2. Insert one of the batteries at an angle so that the battery contacts enter the compartment first.

3. Drop the cover (as pictured) back onto the monitor, then slide it into place.

4. After the battery is installed, wait 2-3 minutes for the Insert ECG Lead Cable screen. If that screen does not appear, do not insert the cable; call Preventice for assistance.


6 Plug lead set into monitor 1. Plug the connector on the lead set cable into the monitor.

The monitor will alert you with a beep when the lead set is securely plugged into the monitor.

2. On the touchscreen, a spinning circle displays. Do not touch the screen.

3. After several seconds, the MONITORING message appears on the screen. You are now monitoring.


4. If you see the following screen, press the red RECORD button on the monitor. This will display the MONITORING screen. You are now monitoring.

7 Take an initial ECG recording At least 1 minute after the MONITORING screen displays, you must take an initial ECG recording. This will start your monitoring service.

1. Wait at least 1 minute after you first see the MONITORING screen, then press/hold the red RECORD button for 3 seconds.

2. On the touchscreen, tap NONE/ACCIDENTAL. Then tap SUBMIT. 3. On the touchscreen, tap RESTING. Then tap SUBMIT.

If the screen changes back to ACTIVATION PENDING after starting monitoring, contact Preventice at 888.500.3522 (press 1, 1, 4).


Daily usage

1 Recording your symptoms If you feel symptoms related to why the monitor was prescribed, such as dizziness, chest pain or shortness of breath, you can manually record these events. The BodyGuardian One will also be automatically recording and transmitting asymptomatic cardiac events as they occur without requiring you to press the Record button or interface with the monitor.

1. Do one of the following to record an event: • Press the Record button. • Press the MONITORING bar on the touchscreen.

The BodyGuardian One displays the Select Symptom(s) screen and prompts you to select the symptoms you are feeling.

2. Use the touchscreen to highlight the symptoms and press SUBMIT. Multiple symptoms can be selected. The Select Activity Level screen will appear after you submit your symptom.


3. Use the touchscreen to highlight the activity (for example, Exercising), and press SUBMIT.

4. Repeat steps 1 - 3 to record additional events.

2 Charging the BodyGuardian One The BodyGuardian One is powered by an externally rechargeable lithium-ion battery. Each device is supplied with two batteries and one battery charger. We recommend charging one battery while the other is being used in the monitor. Several factors, including the cellular network coverage quality and the amount of data being transmitted can impact battery life.

Replace the rechargeable battery in the monitor every 24 hours or when the low battery indicator alerts you. The monitor will alert you with a beep and visual indicator when the battery is low.

Use only IEC 62133 certified lithium-ion batteries supplied by Preventice with the BodyGuardian One. It takes approximately 4 hours to charge the BodyGuardian One battery.

Always unplug the lead set cable from the BodyGuardian One monitor prior to exchanging the battery to prevent any potential loss of data.


To charge the BodyGuardian One monitor battery:

1. Place the rechargeable lithium-ion battery face down into the charger.

2. Plug the charger into the wall outlet (110 or 220V). 3. Once the battery is properly inserted, the charger displays either a solid blue light

indicating the attached battery is fully charged (or no battery is attached to the charger), a solid pink light indicating it is charging, or a solid red light if there was an error in charging the battery, as shown in the following graphics:

Charged Battery Charging Charge Error

3 Replacing the electrodes We recommend changing the electrodes every three days or when they no longer adhere to your skin.

Notes:

• It is recommended to replace all electrodes at once • Replace each electrode one at a time • Never reuse electrodes


1. Unplug the ECG lead set cable connection from the BodyGuardian One to disconnect the lead wires and pause monitoring.

2. Unsnap the lead from the old electrode, and then snap the lead to a new electrode. 3. Remove the adhesive backing from the new electrode. 4. Attach the new electrode an inch away from the old electrode. Make sure the

electrodes are attached within the following placement zone:

5. Peel the old electrodes off the skin. Use soap and water to reduce irritation and to remove any residue. Dispose of the electrodes.

6. Plug the ECG lead set cable into the monitor to resume monitoring.

Note: Always unplug the cable before changing out electrodes to prevent ECG data loss

All five leads must remain securely attached to chest during the prescribed monitoring period; this ensures that the device will trigger events properly.


4 Showering, bathing, swimming BodyGuardian One is NOT waterproof. Keep the monitor away from water. Remove the monitor and the lead set wires when you bathe, swim or perform other similar activities, then re-attach lead wires afterwards. You do not need to remove the ECG electrodes.

5 MRI BodyGuardian One cannot be worn while undergoing an MRI. Remove the monitor, lead wires, and ECG electrodes when preparing for an MRI.

6 Air travel The monitor cannot be worn while traveling on an aircraft. This monitor does not operate outside the United States. Contact Patient Services if you plan to travel outside the United States.

7 Touchscreen dimming Even when the BodyGuardian One is collecting data, the monitor turns off the touchscreen to conserve battery. This is normal. The monitor is still performing its monitoring functions. It has simply turned off the touchscreen display. To activate the touchscreen, briefly press and release the Record button on the monitor.

Maintenance and Service

1 Cleaning To clean BodyGuardian One monitor:

1. Remove the battery from the monitor. DO NOT TRY TO CLEAN BATTERY. 2. Dampen a soft cloth with a mild detergent and water mixture. An example of a mild

detergent is an alcohol-free hand soap or sodium hypochlorite (bleach) solution 10% in water.

3. Clean the monitor and ECG lead cables 4. Remove any remaining adhesives from the ECG lead cables with an adhesive tape

remover solution or swab of mild detergent. Avoid kinking the ECG lead cables. Store cables suspended if possible.

If leads are detached for 10 seconds, the monitor will send an audible and vibration alert. Notification will repeat every 2 minutes until leads are reattached.


2 Service If there is a problem with BodyGuardian One monitor or accessories, first review Troubleshooting section for a solution. If you need further help, include monitor’s serial number and a problem description in an email message to Preventice Customer Support at: 888.500.3522 (press 1, 1, 4).

3 Troubleshooting Symptom Solution No power Check battery power and recharge.

Install new or fully charged battery.

Low battery Recharge battery. Install new or fully charged battery.

Battery charge does NOT last the number of hours expected

Ensure a new battery is used.

Noise artifacts on ECG signal Ensure all electrodes are securely attached and that electrodes used are of quality recommended. Ensure ECG lead cable is inserted completely into monitor.

4 Battery storage First remove lithium-Ion (li-Ion) battery from BodyGuardian One monitor and then store monitor and battery at room temperature in a dry area.

If a battery is damaged or no longer holds its charge, recycle it.

Cover the battery terminals (+ and -) with an insulation tape or place the batteries that you want to recycle into a box or bag, take them to a collection point.

Do NOT immerse monitor in water or any other cleaning solution. Do NOT use alcohol or acetone to clean ECG lead cables. Alcohol or acetone can cause cables to stiffen and cables insulating plastic to crack.


Indications for Use BodyGuardian One is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.

Contraindications BodyGuardian One is NOT intended for use under the following conditions:

• Patients with potentially life-threatening arrhythmias who require inpatient monitoring. • Patients who the attending physician believes should be hospitalized. • Infants weighing less than 22 lbs (10 kg).

Precautions • Use only ECG lead cables provided by Preventice with BodyGuardian One. • Disconnect ECG lead cable before using a defibrillator. • When viewing ECG data, the presence of pacemaker signals in the ECG trace should

NOT be considered true representations of the actual pacemaker stimulus amplitude. Caution: No computerized information is completely reliable, and physicians should review all ECG results.

• To avoid unintended battery discharge, remove battery from BodyGuardian One when it will NOT be used for an extended period of time. See Appendix E: Handling Instructions for Lithium-Ion Battery.

• To receive the best recording results, stay away from heavy electrical equipment or other sources of electromagnetic interference. Equipment such as electric blankets and heating pads are included in this group.

• Do NOT expose BodyGuardian One or battery to water or excessive moisture. • Do NOT expose BodyGuardian One or battery to extreme temperatures beyond the

limits shown in Appendix B: Technical Specifications.


Appendix A: Symbols

Symbol Description

Consult Instructions For Use.

Manufacturer

RxOnly Prescription Only

Type CF Applied Part

Serial Number

Catalog Number

IPX0 Non-protected against fluid ingress


Appendix B: Technical Specifications Characteristics Test Conditions Min. Typical Max. Unit

Physical Length 101 mm Width 66 mm Thickness 13 mm Weight With battery 90 gm Functional ECG Channels Cable selectable 2 2 3 n/a Accelerometer Sampling Rate

±2g/±4g/±8g Dynamically selectable Variable

1.56

8

30 12

800 14

Hz Bits Resolution

Memory Recording Time 30 days Data Retention microSDHC flash

media 10 years

Wireless Communication Technology 4G LTE

Cellular Bands LTE FDD 4, 13 Operating Frequencies 777

1710 787

1745 MHz

Output Power 1720.0 – 1745.0 MHz 0.380 W 1712.5 – 1752.5 MHz 0.257

782.0 – 782.0 MHz 0.129 779.5 – 784.5 MHz 0.101

Electrical CMRR 90 105 dB AC Range ±6 mV DC Range ±300 mV Input Impedance >10 MOhm Frequency Response 0.05 to 40 Hz Recovery Time 1.33 sec ADC Resolution 12 12 16 Bits ADC Sample Rate 125 250 1000 Hz Battery Type Replicable, externally

re-chargeable Li-Ion 3.7 V

Life From full charge 72 hours Storage Temperature < 30 days -20 50 C (shipped condition) < 30 days -20 35 C Relative Humidity 45 85 % Environmental Operating Temperature 0 40 C Storage Temperature -25 70 C Relative Humidity Non-condensing 23 C 10 93 % Atmospheric Pressure 700 1060 hPa

Preventice Technologies reserves all rights to improve, change and modify the products and the contents of the Instructions for Use without prior notice.


Appendix C: Wireless Compliance FCC ID: 2ACA9-10002V

FCC Regulations Compliance Statement

The Federal Communications Commission (FCC) has adopted a safety standard for human exposure to Radio Frequency (RF) electromagnetic energy emitted by FCC-certified equipment. This wireless electro-cardiovascular monitor has been evaluated under FCC Bulletin OET 65C (01-01) and found to be compliant to the requirements of uncontrolled environmental limits as set forth in CFR 47 Sections 2.1091, 2.1093 addressing RF Exposure from radio frequency devices when operated in accordance with the operation guidelines described in this manual. Proper operation of this radio device according to the instruction in this publication will result in user exposure substantially below the FCC recommended limits.

The BodyGuardian One contains a radio transmitter and receiver. It is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. Government. These limits are part of the comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on standards that were developed by independent scientific organizations through periodic and thorough evaluation of scientific studies. The standards include a substantial safety margin designed to assure the safety of all persons, regardless of age and health.

The exposure standard for wireless mobile devices employs a unit of measurement known as the Specific Absorption rate, or SAR. The SAR limit set by the FCC is 1.6W/Kg. Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands. Although the SAR is determined at the highest certified power level in all tested frequency bands. Although the SAR is determined at the highest certified power level, the actual SAR level of the device while operating can be well below the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless base station antenna, the lower the power output.

Before a device model is available for sale to the public, it must be tested and certified to the FCC that it does not exceed the limit established by the government-adopted requirement for safe exposure. The tests are performed in positions and locations (for example, worn on the body) as required by the FCC for each model.

This device has been tested and meets FCC RF exposure guidelines when worn in a holster or belt clip over belt or waistband of an outer garment with 15mm minimum separation distance from the body.

The highest reported SAR value for this body-worn device is: 1.44 W/kg.

The FCC has granted an Equipment Authorization for this wireless electro-cardiovascular monitor with all reported SAR levels evaluated as in compliance with the FCC RF exposure guidelines. SAR information on this device is on file with the FCC and can be found under the


“Display Grant” section of: http://transition.fcc.gov/oet/ea/fccid/ after searching on FCC ID: 2ACA9-10002.

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.

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 receiving antenna. • Increase separation between equipment and receiver. • Connect 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.

Third-party belt-clips, holsters, and similar accessories used with this monitor 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.

The Grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the user’s authority to operate the equipment.

Canadian Regulations Compliance Statement IC ID: 11948A-10002

BodyGuardian One complied with the Canadian RSS – 102 Issue 4: 2010 and IEC 62209-2: 2010 requirements. This device complies with RSS 210 of Industry Canada. This Class B device meets all the requirements of the Canadian interference-causing equipment regulations.

This device complies with Industry Canada license exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

http://transition.fcc.gov/oet/ea/fccid/


Appendix D: Arrhythmia Detection Performance The BodyGuardian One incorporates a real-time embedded arrhythmia detection algorithm. The processing steps include signal bandpass and morphological filtering, estimation of the motion artifact, analysis of the slope, width and amplitude of the signal, decision making logic to determine location and length of the QRS complexes, atrial activity analysis and template matching for AF detection.

Algorithm performance testing was done according to the ANSI/AAMI EC57 standard. The MIT-BIH, AHA, and NST databases were used to verify performance of the algorithm. The algorithm performance testing summary is provided in the tables below:

QRS Detection Performance

Database QRS Sensitivity QRS Positive Predictivity MIT-BIH 99.77% 99.81% AHA 99.72% 99.82% NST 96.59% 79.86%

AF Detection Performance

Database AF Sensitivity AF Specificity MIT-BIH AF 93.43% 96.88%


Appendix E: Handling Instructions for Lithium-Ion Battery Improper use of the battery may cause heat, fire, explosion, damage or capacity deterioration of the battery. Please read and follow these battery manufacturers’ general handling instructions before using lithium-Ion batteries and battery charger supplied with BodyGuardian One monitor.

Danger

• Do NOT dip or wet the battery in water, seawater, or other liquid. Otherwise the battery may be shorted, which may generate heat or cause damage.

• Do NOT use or leave the battery near a heat source as fire or heater. • Do NOT heat the battery. Otherwise the electrolyte may boil, and resin parts may melt,

causing leakage, explosion or fire. • The battery has a predetermined polarity. If the battery will not connect well to the

charger or equipment, do NOT try to connect the battery forcefully. Check the polarity first. If the battery is connected in reverse, it will be charged in reverse and may cause leakage, heat generation, explosion or fire due to an abnormal chemical reaction.

• Do NOT connect the battery in reverse relation to the positive (+) and negative (-) terminals in the charger or equipment. If the battery is connected in reverse, it will be charged in reverse, discharge excessive current and may cause heat generation, explosion or fire due to an abnormal chemical reaction.

• Do NOT let the battery terminals (+ and -) come into contact with a wire or any metal (like a metal necklace or a hairpin) with which it is carried or stored. In such a case, the battery will be shorted and discharge excessive current, which may result in heat generation, explosion or fire.

• Do NOT apply any heavy impact to the battery, throw or drop it. Otherwise the battery may be shorted and result in heat generation, explosion or fire.

• Do NOT drive a nail into, hammer or stamp on the battery. Otherwise the battery may be shorted and result in heat generation, explosion or fire.

When using battery:

Danger

• Do NOT solder the battery directly. Heat applied during soldering may melt resin parts such as separator or gasket, and result in leakage, heat generation, explosion or fire.

• Do NOT disassemble or alter the battery. Otherwise the battery may be shorted and result in heat generation or fire.

• Do NOT use or leave the battery near fire, heaters, inside an automobile in hot weather or under strong sunshine. Such conditions or high temperature may damage the separator, and the battery may be shorted and result in heat generation, explosion or fire.

• When charging the battery, do NOT use any battery charger NOT specified by the manufacturer. Always follow the charge conditions specified by the manufacturer. If the battery is charged under other conditions (a high temperature, a high voltage/current


or an altered charger) NOT specified by the manufacturer, the battery may cause heat generation, explosion or fire due to abnormal chemical reactions.

• Do NOT connect the battery directly to an electric outlet or cigarette lighter socket in a car. Applying a high voltage may generate an excessive current and cause an electric shock. In such a case, the battery may leak electrolyte, overheat, explode or cause fire.

Warnings

• Do NOT put the battery in a microwave oven or a pressure cooker. Sudden heat may damage the seal of the battery and may cause heat generation, explosion or fire.

• Do NOT use the battery together with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. In such a case, over-discharge during use or overcharge during charging may occur and abnormal chemical reactions may cause heat generation, explosion or fire from the battery.

• If you notice any unusual odor, heat, discoloration, deformation or any other characteristic apart from what you are used to while using, charging or storing the battery, then take it out of the equipment or charger, and avoid using it. Using it in such state may result in heat generation, explosion or fire.

Caution

• If battery leaks and its electrolyte comes into contact with skin or clothes, wash contact area well with tap water or other clean water right away. Otherwise skin may break out in a rash.

• When the battery is expected not to be used for a long time, take the battery out of the equipment or device and store it in a less humid area.

• After long periods of storage without being used, the battery should be charged before it is used. Charge the battery every 6 months to the level specified by the manufacturer.

• Do NOT leave the battery pack connected to the charger. It may cause the degradation of battery performance, such as a shortening of battery life.

• Do NOT use battery in a place where the static electricity (more than the limit of the manufacturer’s guarantee) occurs. Otherwise, the protecting device in the battery might be damaged and cause heat generation, explosion, or fire.

• Do not use or leave the battery at very high temperature (for example, in strong direct sunlight or in a vehicle in extremely hot weather). Otherwise, it can overheat or fire or its performance will be degenerated, and its service life will be decreased.

• Do not transport or store the battery together with metal objects such as necklaces and hairpins.

• Do NOT use battery in other than the following conditions:

Discharge: -20° C to +60° C Store (less than 30 days): -20° C to +50° C Store (less than 90 days): -20° C to +35° C


When charging battery:

Danger

• Do NOT use any battery charger NOT specified by Preventice. Follow the charge conditions specified by Preventice. If the battery is charged under other conditions (a high temperature, a high voltage or current, or an altered charger) NOT specified by Preventice the battery may cause heat generation, explosion, or fire with abnormal chemical reactions. Do NOT charge the battery over the specified time described in the instructions. Charge battery at between 0° C (32° F) to 45° C (113° F).

• Do NOT connect the battery directly to an electrical outlet or cigarette heater socket in a car. Applying a high voltage may generate an excessive current and cause an electric shock. In such a case, the battery may leak electrolyte, overheat, explode or cause fire.

• Do NOT charge the battery near fire or in a car under the blazing sun. Such a high temperature may cause damage of the protecting device in the battery, which may result in heat generation, explosion, or fire.

• Discontinue charging after specified charging time even if the charge is NOT complete. Otherwise, the battery might cause heat generation, explosion, or fire.

When discharging battery:

Danger

• Do NOT use or leave battery in a place near fire, heaters, or high temperature sources. Such a high temperature may cause heat generation, explosion, or fire.

• Do NOT use battery with any equipment other than specified. Any such practice may expose some types of equipment to an abnormal current, which may result in heat generation, explosion, or fire.

Caution

• Do NOT use battery in other than the following conditions:

Discharge: -20° C to +60° C Store (less than 30 days): -20° C to +50° C Store (less than 90 days): -20° C to +35° C

MONITOR RhythMedix 5000 Atrium Way Suite #1 Mt Laurel Township, NJ 08054 USA

DISTRIBUTOR / ASSEMBLER

Preventice Technologies, Inc. 2900 37th Street NW Building 003 Rochester, MN 55901 USA

For manufacturer comments or concerns: 866-712-6678 507-218-3437

Documents

Instructions for Use - Preventice