TelePatch. User Manual

Transcription

1 TelePatch Cardiac Monitor PM750 User Manual INSTRUCTIONS FOR USE TelePatch is intended for use as prescribed by a physician who wants to follow cardiac activity. TelePatch is not intended for diagnostic use. A physician must review and interpret ECG findings recorded during procedure. USER MANUAL - UTM D January 06, 2017

2 Table of Contents GETTING STARTED AND INTRODUCTION... 5 Notices, Cautions, and Copyrights... 5 TelePatch Cardiac Monitor User Kit... 6 Contact Us... 9 ABOUT TELEPATCH CARDIAC MONITOR PM INDICATIONS FOR USE... 9 OVERVIEW SAFETY SPECIFICATIONS AND COMPLIANCE Contraindication Safety Classification Modifications Defibrillation System Safety COMPLIANCE Safety Classification Radio Frequency Regulatory Compliance BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION TELEPATCH SYSTEM OVERVIEW TelePatch Pendant Description TelePatch Smartphone Description Accessories to the TelePatch System TelePatch Charger Cord Connecting Charger Cord: Smartphone TelePatch Battery Charger Connecting Charger Cord: Battery Charger TelePatch Electrode Patch STANDARD PROCEDURE SET-UP Patient Preparation USER MANUAL - UTM D 01/06/2017 1

3 Step 1 - Identify Electrode Patch Site Step 2 - Prepare the Skin Step 3 - Electrode Patch Application Step 4 - Turn on Pendant and Connect Step 5 - Starting the Smartphone Step 6 - Procedure Set Up Step 7 - Procedure Settings Pacemaker Settings Protocol Setting Set Up Start Over Step 8 - Initial Procedure Screens Recording Symptoms: Standard TelePatch Procedure Manual Diary Entry Audio Diary Entry PROCEDURE SET-UP: Cable Cradle with Patient Cable Step 1 - Identify Electrode Sites Step 2 - Prepare the Skin Step 3 - Snap on Electrodes and Set Up Cable Cradle Step 4 - Start Pendant Step 5 - Starting the Smartphone Step 6 - Procedure Set Up Step 7 - Procedure Settings Step 8 - Initial Procedure Screens Recording Symptoms: Cable Cradle Procedure PROCEDURE SET-UP: Fingertip Electrodes Step 1 - Start Pendant Step 2 - Starting the Smartphone Step 3 - Procedure Set Up Step 4 - Procedure Settings Step 5 - Initial Procedure Screens USER MANUAL - UTM D 01/06/2017 2

4 Recording Symptoms: Fingertip Electrode Procedure COMMON QUESTIONS How Do I Wear TelePatch System: Electrode Patch and Pendant? How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? Can I Shower? Tip For During Shower Tip For After Shower Stress Loops EMERGENCY AND SUPPORT NUMBERS Call PROCEDURE INFORMATION AND CAUTIONS TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH TELEPATCH SYSTEM WHEN USING CABLE CRADLE SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE SMARTPHONE / HANDSET BATTERY CHARGER PENDANT PRECAUTIONS ADVERSE REACTIONS MAINTENANCE Cleaning the TelePatch System VISUAL AND AUDIBLE INDICATORS Normal Performance Indicators Error Indicators TROUBLESHOOTING Setup Details and Troubleshooting Overview TelePatch System Hookup Testing Information Quality Hookup Tests Overview The Setup/Normal Setting Pacemakers Lead Position Test USER MANUAL - UTM D 01/06/2017 3

5 Skin Prep Results Error Displays Voltage Errors after Several Attempts Lead Position Tests Lead Test Error High/Low Voltage Notifications LOW VOLTAGE IN CHANNEL A LOW VOLTAGE IN CHANNEL B HIGH VOLTAGE IN CHANNEL A HIGH VOLTAGE IN CHANNEL B SAMPLE SCREEN WARNINGS Screen Warnings Unable to find Pendant Pendant is Turned Off Procedure Has Ended Start Procedure Exceptions Selecting a Pendant SAFE BATTERY USE AND DISPOSAL Safely Loading the Pendant Battery Battery Maintenance Disposal of Rechargeable Lithium Ion Batteries EXPLANATION OF MARKINGS EXPECTED LIFE PENDANT SPECIFICATIONS Guidance and Manufacturer s Declaration - Electromagnetic Emissions Recommended separation distances between portable and mobile RF communications equipment and the PM USER MANUAL - UTM D 01/06/2017 4

6 GETTING STARTED AND INTRODUCTION Notices, Cautions, and Copyrights CAUTION: FEDERAL LAW RESTRICTS TELEPATCH CARDIAC MONITOR PM750 FOR SALE BY, OR ON THE ORDER OF, A LICENSED MEDICAL PRACTITIONER. THE DATA OBTAINED FROM THE PENDANT IS FOR THE REVIEW BY A PHYSICIAN. IT IS RECOMMENDED THAT A PHYSICIAN OVERREAD THE RESULTS. THIS TELEPATCH CARDIAC MONITOR PM750 IS NOT INTENDED FOR USE BY USERS WHO ARE UNABLE TO ACTIVATE THE SYMPTOM BUTTON WHEN THEY ARE EXPERIENCING A SYMPTOM. USERS SHOULD BE SUPERVISED IF UNABLE TO ACTIVATE THE SYMPTOM BUTTON ON THEIR OWN. is a product of Medicomp, Inc. Medicomp, Inc. is the manufacturer and provider of TelePatch products and services. TelePatch is a trademark of Medicomp, Inc Medicomp, Inc. All rights reserved. COPYRIGHT MEDICOMP, INC ALL RIGHTS RESERVED. NO PART OF THIS PUBLICATION MAY BE REPRODUCED OR DISTRIBUTED IN ANY FORM OR BY MEANS WITHOUT PRIOR WRITTEN PERMISSION FROM MEDICOMP, INC. USER MANUAL - UTM D 01/06/2017 5

7 TelePatch Cardiac Monitor User Kit The standard TelePatch Cardiac Monitor PM750 kit comes with: 1. TelePatch Pendant 2. Electrode Patch with Cradle 3. Rechargeable Batteries 4. TelePatch Smartphone 5. Battery Charger 6. Charger Cord for both Smartphone and Battery Charger 7. Electrode Prep Pad 8. Quick Start Patient Guide 9. Survey Invitation 10. Return Envelope with Pre-paid Shipping Label TelePatch Cardiac Monitor Kit USER MANUAL - UTM D 01/06/2017 6

8 TELEPATCH KIT CONTENTS Item Quantity Picture TelePatch Pendant 1 Electrode Patch with Cradle* 1-4 *Kit will have one or the other patch style, single or double is based on procedure prescribed by physician Rechargeable Battery 2 TelePatch Smartphone* 1 *Holter procedures do not require a Smartphone USER MANUAL - UTM D 01/06/2017 7

9 Battery Charger 1 Charger Cord for Smartphone and Battery Charger 1 Quick Start Patient Guide 1 Electrode Prep Pad 1 Survey Invitation 1 Return Envelope with Pre-paid Shipping Label 1 Legal Booklet 1 PICTURE TO BE ADDED These items are not standard in TelePatch Kit. By physician request only Cable Cradle 1 Cable 3-lead or 5-lead 1 Electrodes (3-5 per pouch) 1-4 Breakaway Lanyard 1 USER MANUAL - UTM D 01/06/2017 8

10 Contact Us Contact Medicomp, Inc. for any issues concerning the TelePatch product such as: General questions about our product Product safety Safe disposal of component parts Return of product Contact information Medicomp, Inc. 600 Atlantis Rd. Melbourne, FL, Website: Telephone: HEART ( ) Fax: ABOUT TELEPATCH CARDIAC MONITOR PM750 INDICATIONS FOR USE The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. USER MANUAL - UTM D 01/06/2017 9

11 The TelePatch Cardiac Monitor System OVERVIEW Users of the TelePatch System should be able to activate the Symptom button unassisted or be supervised and assisted. The TelePatch System can be worn by users weighing less than 10kg. TelePatch is intended for use as prescribed by a physician who wants to follow cardiac activity. A physician must review and interpret ECG findings recorded during procedure. The TelePatch System is not intended for diagnostic use. SAFETY SPECIFICATIONS AND COMPLIANCE Contraindication There are no potential adverse effects of the TelePatch Cardiac Monitor, PM750 on health. Safety Classification In accordance with IEC Third Edition Am 1: 2012: This equipment is designed to be operated with one 3.7V 440mAh 1.62Wh lithium ion battery, and under no circumstances shall power be supplied in any other manner. Type BF equipment. Rated for Continuous Operation. Ordinary Equipment. Enclosed equipment. The device is protected to IP55 as required by the standard. This equipment shall not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide, or flammable cleaning agents. Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but not directly to the heart. The equipment requires no adjustment. Operating and Storage Humidity: 10% to 95%, non-condensing Operating Temperature: 0 C to 45 C (32 F to 284 F). Storage Temperature: -15 C to 60 C (5 F to 140 F). TelePatch System Shipment: Temperature limitation for shipment: -15 C to 60 C (5 F to 140 F). Atmospheric Pressure: Operating: 700 hpa to 1060 hpa; Storage/Transport: Not Applicable to TelePatch System The equipment contains no user-serviceable parts. It shall be serviced only by Medicomp, Inc. Unauthorized repairs of the equipment will void the warranty. Modifications For continued safety, equipment should not be modified in any manner and must be used only as indicated. Defibrillation The external parts of the equipment may provide a source of the defibrillation voltage if it is not removed from the patient during defibrillation. Due to the small size of the unit and patient connectors, the cable or connector may break down and cause the defibrillation voltage to be shunted and make it less effective for the patient. The unit and cable MUST be removed prior to defibrillation. System Safety Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC or clause 16 of the 3Ed. of IEC , respectively). Anybody connecting additional equipment to medical electrical equipment configures a USER MANUAL - UTM D 01/06/

12 medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department WARNINGS USE THE TELEPATCH SYSTEM ONLY WITH THE LEADS, ELECTRODES, AND ACCESSORIES RECOMMENDED BY MEDICOMP. USE OF OTHER ACCESSORIES MAY ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE OR MAY RESULT IN STRONGER ELECTROMAGNETIC EMISSIONS OR REDUCE THE ELECTROMAGNETIC IMMUNITY OF TELEPATCH CARDIAC MONITOR PM750 CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH. USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP WHILE THAT DEVICE IS TURNED ON. THE OPERATION OF THESE PENDANTS INTERFERES WITH THE TELEPATCH S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE DEVICES SHOULD BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH. DO NOT USE THE TELEPATCH IN COMBINATION WITH EXTERNAL CARDIAC DEFIBRILLATORS OR HIGH FREQUENCY SURGICAL EQUIPMENT. PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THIS PENDANT SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE TELEPATCH CARDIAC MONITOR BATTERY COMPARTMENT. LEAD FAILURES ARE DETECTED BY A 10 MV PEAK, 50% DUTY CYCLE RECTANGULAR PULSE, WHICH IS APPLIED TO EACH PATIENT ELECTRODE CONNECTION THROUGH A 4.9MOHM RESISTOR AT A RATE OF 15 HZ WITH RESPECT TO THE SYSTEM GROUND. THIS IS A PRESCRIBED MEDICAL DEVICE, NOT A TOY, INFANTS AND CHILDREN MUST BE SUPERVISED. WARNING: CHOKING HAZARD ADULT SUPERVISION REQUIRED IN THE EVENT OF A DAMAGED PENDANT, DISCONTINUE USE AND CALL MEDICOMP PATIENT SUPPORT: EXT. 2370, FOR RETURN AND REPLACEMENT. COMPLIANCE Safety Classification In accordance with IEC Third Edition Am 1:2012 : Conformance to Standards non-clinical testing demonstrated conformance to voluntary safety IEC and to IEC Class B Medicomp, Inc. s Quality System conforms to 21 CFR 820 and ISO 13485:2003 Radio Frequency Regulatory Compliance Conformance to Standards Non-clinical testing demonstrated conformance to voluntary safety IEC and to IEC Class B Medicomp, Inc. s Quality System conforms to 21 CFR 820 and ISO 13485:2003 This Pendant contains transmitter module FCC ID: Model Name: TAS FCC ID: 2AGDTPM750 IC account number/ic company number: PM750 CAN ICES-3 (B)/NMB-3(B) This Pendant complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This Pendant may not cause harmful interference, and (2) this Pendant must accept any interference received, including interference that may cause undesired operation. Part 15 Clause Note: This equipment has been tested and found to comply with the limits for a Class B digital Pendant, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. USER MANUAL - UTM D 01/06/

13 Consult the dealer or an experienced radio/tv technician for help. Part 15 Clause Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment This Pendant complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this Pendant may not cause interference, and (2) this Pendant must accept any interference, including interference that may cause undesired operation of the Pendant. Le présent appareil est conforme aux CNR d'industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.» Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformément à la réglementation d'industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité nécessaire à l'établissement d'une communication satisfaisante. BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION Below is a detailed description of TelePatch Icons and Screen Indicators. USER GUIDE DESCRIPTIONS FOR SCREEN INDICATORS AND ICONS ARE FOR USE WITH THE TELEPATCH SMARTPHONE APPLICATION ONLY AND NOT FOR NORMAL CELLULAR PHONE USAGE. The Smartphone POWER Button TELEPATCH APPLICABLE BUTTONS This is the Smartphone POWER button. It is located on the top, RIGHT side of the Smartphone. Front View Side View USER MANUAL - UTM D 01/06/

14 The Pendant POWER Button This is the Pendant POWER button. It is located on the FACE of the Pendant. The Pendant Symptom Button This is the Pendant Symptom button. It is located in the center of the FACE of the Pendant. Users push the Symptom* button to manually initiate the recording of symptoms that they may be experiencing. (*Symptom capture can also be initiated on the Smartphone) The Smartphone Needs Charging Indicator Smartphone will have red flashing LED at top of Smartphone when battery is low. This LED will stop flashing when plugged into the Charger Cord and Smartphone is charging. The Smartphone Charged Light Indicator There is no light indicator showing Smartphone is charging or full charged. Smartphone battery percentage will read 100%. TELEPATCH APPLICABLE TOUCH KEYS - Smartphone Start Procedure Initiates procedure for the TelePatch system. Symptom Button Press when experiencing a symptom. FREQUENT SCREEN ICONS AND INDICATORS Cell Network Strength Icon USER MANUAL - UTM D 01/06/

15 3G Connectivity Icon Bluetooth Connectivity Icon The Smartphone Battery Strength Indicator This is the Smartphone Battery Strength Indicator in percentages. This is located in the lower left corner of the Smartphone screen once Bluetooth communication has been set up. In this example, the Smartphone battery strength is 100 percent. Pendant Battery Strength Indicator This is the Pendant Battery Strength Indicator in percentages. This is located in the lower right corner of the Smartphone screen once Bluetooth communication has been set up. In this example, the Pendant battery strength is 40 percent. The Bluetooth Communication Indicator This is the Bluetooth communication Indicator. Once Procedure Setup has been completed and communication with the Pendant has been established, ' BT' will appear in the bottom left side of the Smartphone screen. TELEPATCH SYSTEM OVERVIEW USER MANUAL - UTM D 01/06/

16 Below is a graphical overview of the TelePatch System. Detailed description of icons, buttons, and screen indicators are in previous section. KEY DESCRIPTIONS PROVIDED BELOW ARE FOR USE WITH THE TELEPATCH APPLICATION ONLY. KEY DESCRIPTIONS ARE NOT INTENDED FOR NORMAL CELLULAR PHONE USAGE. Front of TelePatch Pendant Back of TelePatch Pendant Front of TelePatch Smartphone Back of TelePatch Smartphone PENDANT AND SMARTPHONE PICTURED ARE NOT ACTUAL SIZE. USER MANUAL - UTM D 01/06/

17 TELEPATCH CARDIAC MONITOR DESCRIPTION TelePatch Pendant Description Below is an overview of the TelePatch Pendant, which is part of the TelePatch Cardiac Monitor System. The TelePatch Pendant is very light-weight. It is a light gray, pager-sized ECG data collecting Pendant. The Pendant SYMPTOM Button The TelePatch Pendant has a Symptom* button which is located in the center of the face of the Pendant. (*Symptoms can also be initiated on the Smartphone screen). The Symptom button has two raised bars so it can be distinguished from power button by touch. The Pendant POWER Button The Pendant POWER button is located on the face of the Pendant, below the Symptom button. USER MANUAL - UTM D 01/06/

18 Fingertip Electrode Accessory The fingertip electrode is built into the TelePatch pendant. Fingertip electrodes are used when the patient cannot tolerate wearing the Electrode Patch or individual electrode patches. Fingertip electrode procedures should be performed only after consulting your physician. Detailed directions about fingertip electrode procedures begin on page 49. TelePatch Battery Bottom and top views of the TelePatch lithium ion battery TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the battery well of the back of the TelePatch Pendant. USER MANUAL - UTM D 01/06/

19 THE RECHARGEABLE BATTERY PROVIDED WITH THE TELEPATCH SYSTEM IS NOT TO BE DISCARDED IN HOUSEHOLD WASTE. IF A BATTERY GETS DAMAGED CONTACT MEDICOMP, INC.: TelePatch Pendant Battery Well Battery properly inserted in Battery Well Detailed directions to change and charge the battery properly are found on page 25 or page 68. IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE PENDANT BELOW THE SYMPTOM BUTTON. TelePatch Smartphone Description Below is an overview of the Smartphone, which is part of TelePatch System. TelePatch the USER MANUAL - UTM D 01/06/

20 Accessories to the TelePatch System TelePatch Charger Cord The TelePatch Charger Cord is compliant for use with the Smartphone and the Battery Charger. Both are components of the TelePatch System. The Charger Cord is a two piece device: MicroUSB Cable AC Power Supply MicroUSB Cable SKN6430A / S AC Power Supply SPN5504A / S004ASU USER MANUAL - UTM D 01/06/

21 Details pertaining to pertinent electrical specifications are provided below. MicroUSB cable Connector type Micro-USB AC Power Supply INPUT V~ 50/60Hz 0.2A OUTPUT 5.1V=850mA The TelePatch Charger Cord will replenish battery power when the Smartphone power or Pendant Battery is depleted. When the Smartphone is turned on, the Smartphone battery indicator lets users know when the battery life of the Smartphone and the Pendants Lithium Ion Battery are depleting. Icons are displayed on the screen of the Smartphone. For optimal performance from the Smartphone, it is recommended to plug the charger cord into the Smartphone overnight until the Smartphone is fully charged. Instructions on charging the Smartphone are on page 22 of this User Manual. TelePatch Pendant Batteries will need to charge every seven (7) days on average. There are two (2) lithium ion batteries in the TelePatch Kit, so the procedure will not be interrupted. Instructions about how to charge the Pendant Battery can be found in the charging the Batteries section of this User Manual. How to attach USB Cable to AC Power Supply block: Should the Charger Cord come apart or if the Charger Cord is in two pieces (the MicroUSB cable and the Power Supply) when the TelePatch Kit is received, insert the USB connector into the port on the power supply. Keep the two pieces connected for the duration of the procedure. USER MANUAL - UTM D 01/06/

22 SMARTPHONE AND BATTERY CHARGER ARE POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED IN TO SMARTPHONE OR BATTERY CHARGER AND THEN A WALL OUTLET. CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED. Connecting Charger Cord: Smartphone The port for the Charger Cord is located on the left side of the smartphone near the bottom Charger properly inserted Correct direction of charger head Incorrect direction of charger head USER MANUAL - UTM D 01/06/

23 Connecting the Charger Cord to the Smartphone: Take the end of the Charger Cord and insert it into the lower left side of the Smartphone as displayed in the graphic. The side of the Charger Cord plug-in with the indented circle is the correct way to insert in the Charger Cord into the Smartphone. WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE POWER OUTLET AND THE SMARTPHONE. MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH. SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED IN TO BOTH SMARTPHONE AND WALL OUTLET. CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED. UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING SMARTPHONE IN POCKET OR PURSE/BRIEFCASE. DO NOT WEAR THE SMARTPHONE WHILE THE CHARGER IS ATTACHED TO THE SMARTPHONE. TelePatch Battery Charger USER MANUAL - UTM D 01/06/

24 Battery Charger Top Battery Charger - Bottom TelePatch rechargeable batteries have an approximate seven (7) day life before needing to be recharged. The TelePatch Kit has two (2) batteries, a Battery Charger and a Charger Cable (also used to charge the Smartphone). TelePatch Pendant batteries need to be changed when the Pendant indicates the battery is low on power: the orange LED will blink continuously on the face of the Pendant, and the Pendant will chirp every 4 minutes. The battery level can also be seen on the Smartphone screen. Using the Charger Cord with the TelePatch Battery Charger The TelePatch Battery Charger will replenish battery power when lithium ion battery power is depleted. The same Charger Cord used to charge the Smartphone is used to power the Battery Charger. For optimal performance from the Battery Charger, it is recommended to plug the Charger Cord into the Battery Charger and a wall outlet until the battery is fully charged. The indicator light on the flat end of the charger, next to the Charger Cord outlet, is flashing orange while charging, and steady green when fully charged. The Battery Charger will stop charging the battery once fully charged. Connecting Charger Cord: Battery Charger Place the Battery Charger on a flat, dry surface, near a wall outlet Plug Charger Cord into the corresponding outlet on the Battery Charger Plug the Charger Cord into the wall outlet USER MANUAL - UTM D 01/06/

25 Charger Cord properly inserted into Battery Charger Correct direction of Charger Cord head Incorrect direction of Charger Cord head Charging a Battery in the Battery Charger THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. TO ENSURE SAFE CHARGING AND MAXIMUM PERFORMANCE OVER THE LIFE OF THE PRODUCT ALWAYS USE THE MEDICOMP PROVIDED CHARGER. DO NOT ATTEMPT TO CHARGE THE BATTERY ON ANOTHER MANUFACTURER S CHARGER. Place a Battery from the TelePatch Kit into the Battery Charger, with the Medicomp label facing up and the two small tabs into the notches Slide the latch at the back of the Battery to the left, securing the battery in place. The Battery is locked in place when the latch is below the BLUE lock icon USER MANUAL - UTM D 01/06/

26 Battery IS NOT locked in the charger Battery IS correctly locked into charger A light at the end of the Battery Charger, next to the Charger Cord, will turn green when the battery is fully charged. Flashing Orange Light: Battery is charging Green Light: Battery is charged MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH. BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED IN TO BOTH BATTERY CHARGER AND WALL OUTLET. USER MANUAL - UTM D 01/06/

27 CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED. THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN T USED. TO ENSURE OPTIMAL PERFORMANCE AND LIFETIME OF THE BATTERY PACK, PLEASE FULLY CHARGE THE BATTERY AT LEAST ONCE EVERY 6 MONTHS REGARDLESS OF USE. IT IS FURTHER RECOMMENDED THAT IF THE BATTERY HASN T BEEN CHARGED MORE RECENTLY THAN A MONTH AGO THAT IT BE FULLY CHARGED PRIOR TO THE START OF A PATIENT PROCEDURE. DO NOT STORE BATTERIES IN THE BATTERY CHARGER. TelePatch Electrode Patch Single Channel Electrode Patch with Cradle Dual Channel Electrode Patch with Cradle The TelePatch Pendant slides into the cradle on the Electrode Patch. Placing Pendant into Electrode Patch cradle Slide Pendant into cradle with lock facing down into cradle. USER MANUAL - UTM D 01/06/

28 The Pendant is correctly placed when it clicks into cradle Single Channel Electrode Patch Dual Channel Electrode Patch Single Channel Electrode Patch supports modified lead II with reference right leg drive. Dual Channel Electrode Patch supports Channel A modified lead II, Channel B modified III and a reference electrode. THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE. MAKE SURE TO REMOVE THE TELEPATCH PENDANT FROM THE CRADLE BEFORE DISCARDING THE ELECTRODE PATCH. THE PENDANT IS TO BE INSERTED IN CRADLE OF FRESH ELECTRODE PATCH TO CONTINUE PROCEDURE. USER MANUAL - UTM D 01/06/

29 Description of Patch and Patch Packaging Electrode Patch Description Medical sensor electrode, Foam, 1.5 teardrop shape, wet gel Gel Gel Sponge Substrate Foam Conductive Ink Insulator Release Liner Connector Wet Gel 7% KCL Polyurethane (reticulated foam) Polyester printed with black ink polyethylene foam with acrylic adhesive Ag/AgCl Blue UV Dielectic Polystyrene (HIPS) with silicone release 5 Pin Housing Packaging Pouch Material Dimensions 25# Paper/7.2#LOPE/.0003 Foil/14# LDPE (minimum) 7 x11 Pouch Contents Printed Circuit Sensor STANDARD PROCEDURE SET-UP TelePatch Electrode Patch Procedure USER MANUAL - UTM D 01/06/

30 Patient Preparation This section contains step-by-step instructions that describe how to prepare patient for a TelePatch Cardiac Monitor procedure with the Electrode Patch. Follow the skin preparation sequence as closely as possible. This will greatly enhance the ECG signal quality and optimize analysis. Patch Placement for the TelePatch Procedure Step 1 - Identify Electrode Patch Site Refer to the figure below for proper patch placement: Dual Channel and Single Channel Electrode Patch Placement Step 2 - Prepare the Skin Because the Electrode Patch will be worn for up to seven (7) days, proper skin preparation is important for the procedure. Good skin preparation means better ECG signal traces that, in turn, are easier for the doctor to review and evaluate. In order to obtain the best ECG recording, the following procedure is recommended for initial hookup: 1. Whenever possible, be in an upright sitting position. This may be useful if any setup problems occur that concern the signal voltage. 2. Following the placement diagram, select sites that are flat. Avoid skin folds or creases, irritated skin or scar tissue, and highly muscular areas. 3. If necessary, shave an area at the patch site slightly larger than the size of the Electrode Patch. 4. If powder, lotion, sun block, etc. has been applied to the chest or if skin is excessively oily, wash site with plain soap and water. Do not use a soap that contains lotion or oil. USER MANUAL - UTM D 01/06/

31 5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and prepare skin for initial application. The above skin prep procedure is only required at the beginning of the procedure, during Smartphone initialization. Users will not be required to perform this type of preparation each time they apply a new Electrode Patch. It is best for users to have freshly showered with plain soap each time they apply new Electrode Patches (about every 7 days). If patch has connectivity issues the skin can be lightly abraded each electrode site with a rough wash cloth, or an abrasive pad. Step 3 - Electrode Patch Application Applying TelePatch Patch Prepare skin, as shown in Step 2. When ready to position Electrode Patch on skin, remove backing from Electrode Patch, apply to chest, using placement in the illustration. This can be done before inserting Pendant in the cradle or after. Press Electrode Patch firmly onto skin with fingers once correctly positioned on the left side of chest (Below collarbone). Once it is firmly adhered to skin peel remaining white tabs on the patch so the whole surface of the patch is adhered to skin. THE MEDICOMP ECG ELECTRODE PATCH IS SINGLE USE, NON-STERILE, AND DISPOSABLE AND IS TO BE USED ON INTACT (UNINJURED) SKIN. USER MANUAL - UTM D 01/06/

32 PRODUCT SHELF LIFE IN INTACT, ORIGINALLY SEALED PACKAGING IS 12 MONTHS. ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP PROCEDURE INITATION ERRORS FROM OCCURRING. CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH. Wearing TelePatch The Electrode Patch should stay in position about seven (7) days on average. The cradle on Electrode Patch holds the Pendant. Leave the Electrode Patch in place until it no longer remains adhered or as ordered by physician. The Electrode Patch with the TelePatch Pendant in the cradle can be worn in shower during procedure, pat dry with a towel once shower is complete. Do not go swimming while wearing Electrode Patch or Pendant during procedure. The Electrode Patch should be disposed of when changed for a fresh Electrode Patch or at the completion of the procedure. For additional patches for your procedure contact Medicomp Patient Care: DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR SUBMERGED IN WATER DURING PROCEDURE. THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH. THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE. USER MANUAL - UTM D 01/06/

33 Step 4 - Turn on Pendant and Connect Insert a Battery into the Pendant Remove the Pendant from the TelePatch Kit. Hold the Pendant face down in hand or place on a flat surface. There is a well where the Battery will be inserted. Insert the Battery into the opening, with the Medicomp label facing up and the two small tabs into the notches, as pictured. Slide the latch at the back of the Battery to the left, securing the Battery in place Battery is NOT secure in Pendant unlocked Battery IS secure in Pendant - Locked Turn the Pendant over, slide the Pendant into the Electrode Patch Cradle with the lock facing down into the cradle. The Pendant is correctly placed when it clicks into the Electrode Patch Cradle. USER MANUAL - UTM D 01/06/

34 Turn the Pendant on: Press and hold the power button on the face of the Pendant until the Pendant green LED flashes. For a Holter procedure (24 hour to 96 hour) o Press the Symptom button three (3) times For all other procedures (7 day to 30 day) o The Pendant will initiate on its own. o If Pendant does not turn on its own, press Power button to turn on pendant During the TelePatch Procedure: Wear and Electrode Patch and TelePatch Pendant all day and all night. A physician will determine the duration of the TelePatch procedure. The Electrode Patch will stay in position for seven (7) days, on average. The Pendant should always be in the Electrode Patch Cradle. TelePatch Pendant and Electrode Patch can be worn in the shower and during exercise. All regular activities can be enjoyed during a TelePatch procedure. TURN THE PENDANT ON BEFORE TAPPING START PROCEDURE ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT. PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS USER MANUAL - UTM D 01/06/

35 IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE ON/OFF BUTTON IS LOCATED ON THE FACE OF THE PENDANT. THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH. IMPORTANT NOTE: If setting up a 24 hour 96 hour Holter procedure, the procedure set-up is complete at this point. The Smartphone is not used with Holter procedures. Step 5 - Starting the Smartphone Before using the Smartphone: Charge the Smartphone until it is fully powered. If it is not fully charged (low) a red LED will flash in the upper left corner of the face of the Smartphone. Take the Smartphone and turn it on by pressing and holding the POWER button which is located in the upper right side of the Smartphone. Wait for the Medicomp main screen to appear on the screen before continuing with standard procedure setup. Tap Start Procedure. USER MANUAL - UTM D 01/06/

36 Medicomp TelePatch Smartphone Main Screen Step 6 - Procedure Set Up After identifying Electrode Patch site, preparing the skin, applying the Electrode Patch and, turning on the Pendant, turning on the Smartphone, the patient is now ready for 'Procedure Setup' with the TelePatch System. The steps are described below. After following the instructions on the patient preparation screen, which may have already been completed, the next step is to select the correct settings before starting a procedure. Tap OK Medicomp TelePatch Smartphone Patient Preparation Screen USER MANUAL - UTM D 01/06/

37 Step 7 - Procedure Settings After following the instructions on the patient preparation screen, the next step is to select the correct settings before starting a procedure. Follow the instructions below on how to select the necessary procedure settings from the TelePatch System. The Procedure Setup screen will display the default settings, which are: Patient has Pacemaker = No Protocol = Standard Setup = Normal Medicomp TelePatch Smartphone Procedure Set Up Screen Choose Accept Settings or change settings from this screen. To accept default settings: Tap Accept Settings OR to change settings: Tap the setting to be changed Pacemaker Settings The following describes the steps and screens when 'Pacemaker' is selected as a setting. To select a setting for pacemakers: Tap No Tap option desired. If the patient desires to change more settings, then repeat the steps above for Protocol USER MANUAL - UTM D 01/06/

38 and Setup. After all the correct settings have been chosen. Tap Accept Settings If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the Smartphone displays a screen of QRS during the procedure setup. Then it will display the settings. Please select Yes to accept this step. After all the correct settings have been chosen. Tap Accept Settings Pacemaker Setup Screens For additional standard procedure setup instructions, go to patient preparation. Protocol Setting 'Protocol' has three (3) sub-options. More information pertaining to those options is provided below. Standard - Standard is the default for adult users. Atrial Fib - Use Atrial Fib for users who have permanent Atrial Fibrillation. Pediatric - Use Pediatric for users under 16 years of age. Users should check with child's Pediatrician to verify heart rate. The Pediatric protocol sets Normal Sinus Rhythm at bpm. To select a setting from protocol: To apply 'Protocol' as a setting: Tap Standard Tap desired Protocol Press Accept Settings USER MANUAL - UTM D 01/06/

39 For additional standard procedure setup instructions, go to PATIENT PREPARATION. THE TELEPATCH SYSTEM CAN BE USED FOR INFANTS WEIGHING LESS THAN 10KG. TEST SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE SUPERVISION AND GUIDANCE OF A MEDICOMP CARDIAC MONITORING CENTER (CMC) TECHNICIAN. CALL THE CMC FOR GUIDANCE IN TEST MODE. Set Up All TelePatch systems will be shipped in Normal mode. There is therefore, no need to instruct users on how to select the Normal mode. The following instructions describe the steps and screens for selecting Test mode. To apply the Test mode: Tap Normal Tap Test on drop down menu If there are additional settings changes desired, repeat the steps above for Pacemaker and Protocol. After all the correct settings have been chosen, Tap Accept Settings An example of a test result screen for the Skin Prep is provided below. Skin Prep Test Result For additional standard procedure setup instructions, go to PATIENT PREPARATION. If a mistake is made during the procedure setup process, the set up can Start Over. START OVER WILL ERASE ALL PREVIOUS SETTING SELECTIONS IN ORDER TO START THE ENTIRE PROCEDURE SETTINGS PROCESS FROM THE VERY BEGINNING. Start Over Tap Start Over button This will erase all previous setting selections in order to start the entire procedure settings USER MANUAL - UTM D 01/06/

40 process over from the very beginning. Protocol: The protocol is an integral part of the auto capture capability. It may be defined as a set of guidelines that the ECG analysis algorithm uses in identifying clinically-significant events. For example, the normal heart rate in Standard protocol is bpm. Pediatric Protocol: this range is bpm. Therefore, the TelePatch System would not trigger to generate recordings for heart-rate events of 140 bpm if the protocol had been set to Pediatric, but would trigger if it had been set to Standard. For additional standard procedure setup instructions, go to PATIENT PREPARATION. Step 8 - Initial Procedure Screens After applying and accepting the procedure settings, the procedure will initialize. Medicomp TelePatch Smartphone Scanning for TelePatch Pendant The TelePatch system will first collect ECG data, then the ECG Data will appear on the screen for a short time, then the screen Medicomp TelePatch Smartphone Initializing Procedure Medicomp TelePatch Smartphone ECG Baseline Reading USER MANUAL - UTM D 01/06/

41 will display Monitoring. 'Monitoring' will be displayed the majority of the time during a procedure. The Medicomp TelePatch Smartphone Monitoring Screen The TelePatch procedure is now running. IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT. DEPENDING ON THE SETTINGS, AND THE PATIENT PREPARATION, SOME INTERMITTENT CONFIRMATION AND/OR ERROR SCREENS MAY APPEAR DURING THE INITIALIZATION. PLEASE PERIODICALLY CHECK THE PENDANT AND/OR SMARTPHONE TO ENSURE THEY ARE BOTH IN MONITORING MODE. THIS MEANS THE PENDANT IS BLINKING BLUE LED LIGHTS, AND THE SMARTPHONE DISPLAY STATES MONITORING. THE TELEPATCH SYSTEM IS DESIGNED TO OPERATE IN ENVIRONMENTS THAT MAY EXPERIENCE TRANSIENT ELECTRICAL EVENTS LIKE ELECTROSTATIC DISCHARGE (ESD). TELEPATCH IS DESIGNED TO BE RESISTANT TO SUCH EVENTS AND WILL TYPICALLY CONTINUE TO OPERATE NORMALLY. A SEVERE ESD EVENT MAY CAUSE THE DEVICE TO SHUT DOWN IN ORDER TO PROTECT THE MEMORY. IF A SHUTDOWN OCCURS, MANUALLY POWER THE DEVICE ON USING THE POWER BUTTON ON THE FRONT OF THE DEVICE. ONCE POWERED ON, TELEPATCH SHALL RESUME NORMAL OPERATION WITH NO LOSS OF FUNCTIONALITY OR INFORMATION. USER MANUAL - UTM D 01/06/

42 Best Practices for using the Smartphone and the Pendant Keep the Smartphone charged and turned on Keep Smartphone within 10 of the Pendant during procedure Review how to record a SYMPTOM, make a Diary Entry Review how to charge the Smartphone daily Review how to change and charge the Pendant battery Recording Symptoms: Standard TelePatch Procedure When a Symptom is felt, or at other times as directed by your physician: Press the SYMPTOM button on the Pendant or on the Smartphone, to record heart s activity. The SYMPTOM button on the Pendant has two raised bars so it can be easily located. Press SYMPTOM on TelePatch Pendant OR Press SYMPTOM on Smartphone The TelePatch Smartphone will display Recording in Progress for 60 seconds The TelePatch Smartphone will light up with a message to make a Diary Entry USER MANUAL - UTM D 01/06/

43 How to Make a Diary Entry: It is important the prescribing physician to know when a symptom is felt and activity at the time the SYMPTOM button was pressed. While Recording in Progress is displayed on the Smartphone, Diary options will be displayed Manual Diary Entry Tap Manual Below the word Symptom Tap No symptom selected Choose a symptom from the list Tap Save Below the word Location Tap No location selected Choose a location from the list Tap Save Below the word Activity Tap No activity selected Choose an activity from the list Tap Save From the Select Diary Options screen (showing options picked) Tap Save The Monitoring display will return* *The screen may return to Recording in Progress, Smartphone screen will return to Monitoring as soon as recording period is complete. USER MANUAL - UTM D 01/06/

44 Symptom Menu Location Menu Activity Menu Select Diary Options Screen Options chosen USER MANUAL - UTM D 01/06/

45 Audio Diary Entry Tap Audio Cleary state the symptom, location where symptom occurred, and activity during symptom Tap Done The Monitoring display will return* *The screen may return to Recording in Progress, Smartphone screen will return to Monitoring as soon as recording period is complete. PROCEDURE SET-UP: Cable Cradle with Patient Cable If wearing TelePatch Cradle and Pendant with individual electrodes, start preparation here Patient Preparation This section contains step-by-step instructions that describe how to prepare TelePatch System and skin for a TelePatch Cable Cradle with Cable procedure - (requires individual chest electrode patch application). Please follow the skin preparation sequence as closely as possible. This will greatly enhance the ECG signal quality and optimize analysis. Electrode Placement for the TelePatch Procedure Step 1 - Identify Electrode Sites Leads V5/MCL5 and a modified Lead I are used with the TelePatch Cable Cradle procedure, twochannel ambulatory monitoring. By convention in the symptom recording reports, V5 is Channel A and the modified Lead I is Channel B. Refer to the figure below for proper electrode placement: USER MANUAL - UTM D 01/06/

46 3-Lead Wire Hook-Up 5-Lead Wire Hook-Up A- WHITE A- WHITE A+ / B+ RED A+ RED B- BLACK B- BLACK B+ BROWN G GREEN For women with large breasts, the following electrode positions are recommended: Red in the left axillary line Black in the right axillary line This lead placement may eliminate potential skin prep problems and minimizes occurrences of artifact. Step 2 - Prepare the Skin Individual electrodes may be worn for a few. In order to obtain the best ECG recording, the following procedure is recommended for initial patient hookup: 1. Whenever possible, be in an upright sitting position. This may be useful if any setup problems occur that concern the signal voltage. 2. Following the lead placement diagram, select sites that are flat and bony. Avoid skin folds or creases, irritated skin or scar tissue, and highly muscular areas. 3. If necessary, shave an area at each electrode site slightly larger than the size of the electrode. USER MANUAL - UTM D 01/06/

47 4. If powder, lotion, sun block, etc. has been applied to the chest, or if skin is excessively oily, wash each site with plain soap and water. Do not use a soap that contains lotion or oil. 5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and prepare skin for initial application. The above skin prep procedure is only required at the beginning of the procedure, during Smartphone initialization. Users will not be required to perform this type of preparation each time they re-locate electrodes. It is best for users to have freshly showered with plain soap each time they apply new electrodes. When the Pendant is reconnected to the patient cable, the unit performs a less restrictive setup. If electrodes have connectivity issues the skin can be lightly abraded each electrode site with a rough wash cloth, or an abrasive pad ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP PROCEDURE INITATION ERRORS FROM OCCURRING. CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH. Step 3 - Snap on Electrodes and Set Up Cable Cradle Locate the Cable Cradle, one battery, lead wires, envelope of electrodes and lanyard (optional). USER MANUAL - UTM D 01/06/

48 Snap the wires onto the electrodes while they are still attached to the plastic backing. One by one, peel each electrode from the backing and apply it to the chest. Position the electrodes at the appropriate color-coded sites. If wearing cable cradle on lanyard, clip lanyard onto the loop at the top of cradle. Cable Cradle may also be carried in pocket, be careful Cable remains connected to Cable Cradle Hold flat plug at the end of electrodes cable and connect cable to the base of cradle into the corresponding outlet. Place the lanyard over head to wear the cradle with cable attached LANYARD IS NOT TO BE WORN WHILE SLEEPING. USER MANUAL - UTM D 01/06/

49 CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS. PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY CABLE CRADLE WITH PENDANT IN POCKET. THE BREAKAWAY LANYARD IS TO BE DISPOSED OF AS HOUSEHOLD WASTE FOLLOWING THE PROCEDURE. WARNING: CHOKING HAZARD ADULT SUPERVISION REQUIRED IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE LOADING BATTERIES, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE RIGHT SIDE OF THE PENDANT. Step 4 - Start Pendant Follow directions for starting Pendant on page 32 Step 5 - Starting the Smartphone Follow directions for starting Smartphone on page 35 Step 6 - Procedure Set Up Follow directions for initiating procedure on page 35 Step 7 - Procedure Settings Follow directions for initial procedure set up on page 36 Step 8 - Initial Procedure Screens Follow directions for completing procedure set up on page 39 Recording Symptoms: Cable Cradle Procedure Follow directions for Recording a Symptom on page 41 Procedure while wearing the Cable Cradle Wear the Cable Cradle and Pendant all day and all night - except when showering USER MANUAL - UTM D 01/06/

50 The Cable Cradle can be worn on the included break-away lanyard or can be kept in pocket (make sure Cable stays firmly attached). The Cable Cradle and Pendant should go into a pocket of a nightshirt while sleeping Do not wear the lanyard at night while sleeping The physician will tell you the duration of your procedure The Pendant should always be in the Cable Cradle, the Cable should remain plugged into the Cable Cradle Enjoy all of your regular activities like exercise or gardening, while wearing the Pendant, Cable Cradle and Cable DO NOT shower with the Cable Cradle and Cable Turn off the Pendant by pressing the Power Button Unsnap the cable heads from the electrodes Leave Cable Cradle, Cable, Pendant (and lanyard) outside the shower Electrodes may be worn in the shower - fresh electrodes may need to be applied following the shower After showered and dry, place lanyard with Cable Cradle and Pendant back on, re-attach electrodes, turn on Pendant PROCEDURE SET-UP: Fingertip Electrodes If using Fingertip Electrodes for procedure, start preparation here. Step 1 - Start Pendant Follow directions for starting Pendant on page 32 Step 2 - Starting the Smartphone Follow directions for starting Smartphone on page 35 Step 3 - Procedure Set Up Follow directions for initiating procedure on page 35 Step 4 - Procedure Settings Follow directions for initial procedure set up on page 36 Step 5 - Initial Procedure Screens Follow directions for completing procedure set up on page 39 Recording Symptoms: Fingertip Electrode Procedure When experiencing a symptom, or at other times as directed by physician, Remove the Pendant from pocket or cable cradle Press the SYMPTOM button on the Pendant or on the Smartphone USER MANUAL - UTM D 01/06/

51 Place index fingers firmly on the Fingertip Electrodes (the silver-gray corners) on the top edge of the Pendant for 30 seconds. Smartphone will display Recording in Progress, keep fingers on the Fingertip Electrode corners until the Smartphone screen message says Recording Complete The Smartphone will light up and a message will remind user to make a Diary Entry. See page 42 for instructions on making a Dairy entry Procedure while using and Pendant and Fingertip Electrodes Carry the Pendant all day and have it nearby at night. Charge Smartphone daily. The physician will determine the duration of the procedure. Enjoy all regular activities like exercise or gardening, during procedure. COMMON QUESTIONS How Do I Wear TelePatch System: Electrode Patch and Pendant? The TelePatch Pendant is securely held in the Electrode Patch cradle, and won t interfere with day to day activities. Make sure the Symptom button (on the Pendant or Smartphone) is easily accessible. USER MANUAL - UTM D 01/06/

52 How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? You can wear the Cable Cradle on the breakaway Lanyard, or keep it in your pocket. Make sure the cable stays plugged into the Cable Cradle at all times. When wearing Cable Cradle avoid areas where the buttons might accidentally be pressed. At bedtime place Cable Cradle next to you where its location is the most comfortable. Do not wear the Lanyard when sleeping. Can I Shower? When wearing the TelePatch Pendant with the Electrode Patch you can shower with the Pendant and patch on. When done in the shower gently pat (not rub) the face of the patch and the Pendant dry. You can remove the Pendant from the patch cradle if you would like to dry behind the Pendant, then reinsert in the cradle immediately. When wearing the Cable Cradle with cable DONOT wear the Cable Cradle or cable in the shower. 1. Disconnect the cable from the Pendant and set the unit aside. 2. Unsnap the wires from electrodes. A diagram in the Patient Guide will help you to replace them correctly when re-connecting. Remove electrodes if skin is very irritated or if it has been 72 hours or more (per electrode manufacturer's directive) since the last electrode change. If you don't need to remove the electrodes, just make sure that water does not fall directly on them. Tip For During Shower The Electrode Patch and Pendant are water resistant. They will withstand brief periods in contact with water such as when showering. You can and should wear the Electrode Patch and Pendant while showering but do not submerge or soak the devices in water. If it is time to remove the electrodes, try removing them during your shower after they have become thoroughly soaked with water. This will make removal easier. Tip For After Shower Please make sure to dry both the pendant and the plastic on the patch that holds the pendant after getting wet. If you are replacing Electrode Patch or single electrodes: After showering, determine where electrode will be placed (refer to the diagram in the Patient Guide for placement) and dry your skin well in those areas. USER MANUAL - UTM D 01/06/

53 If wearing the Cable Cradle with individual electrodes: Snap the wires onto the electrodes. Now, carefully remove the back plastic cover from each electrode in turn and press the electrodes to your skin so that complete contact is made with the adhesive backing. Plug the cable into the Cable Cradle if it has been unplugged. Make sure the Pendant is turned on. The Smartphone will resume receiving data from the Pendant. Stress Loops Stress Loops are only applicable to the TelePatch Cable Cradle procedure. Stress loops are recommended. Two examples of stress loops are shown below. Lead Wire Stress Loops This is a good way to secure lead wires to prevent pulling, thus minimizing noise interference during the procedure. Wear the Cable Cradle with the lanyard or keep the Cable Cradle in a pocket. EMERGENCY AND SUPPORT NUMBERS Call 911 Below are instructions on how to call 911 from the Smartphone. From the 'Monitoring' screen Tap Call Option Tap Call 911 Tap YES Hang up the call with the End Key USER MANUAL - UTM D 01/06/

54 PROCEDURE INFORMATION AND CAUTIONS TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP PROCEDURE INITIATION ERRORS FROM OCCURRING. UNLESS OTHERWISE INSTRUCTED, WEAR THE TELEPATCH CONTINUOUSLY DURING NORMAL DAILY ACTIVITIES. TURN THE PENDANT ON BEFORE TAPPING START PROCEDURE ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON. HEAVY EXERCISE OR OTHER ACTIVITIES THAT EXPOSE THE TELEPATCH TO MOISTURE CAN AFFECT PATCH ADHESION DURATION. IF A PATCH SELF- REMOVES DUE TO EXERCISE OR ACTIVITY, CLEAN THE AREA AS NOTED IN THE PATIENT GUIDE AND APPLY A NEW PATCH. THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH ELECTRODE PATCH, NOT DISCARDED WITH REMOVED ELECTRODE PATCH. THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE. ONLY THE ELECTRODE PATCH SHOULD BE DISCARDED AFTER USE. RETURN TELEPATCH PENDANT AND ALL COMPONENTS IN KIT PROVIDED, TO MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE. SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH THE TELEPATCH PENDANT IS WATER RESISTANT. YOU CAN SHOWER WITH THE TELEPATCH PENDANT AND ELECTRODE PATCH INTACT. TELEPATCH PENDANT AND ELECTRODE PATCH ARE NOT WATERPROOF, MEANING THE PENDANT COULD CEASE TO FUNCTION IF FULLY SUBMERGED IN WATER FOR A PERIOD OF TIME. AVOID SWIMMING AND FULL SUBMERSION INTO WATER, WHILE WEARING TELEPATCH. USER MANUAL - UTM D 01/06/

55 REMOVE TELEPATCH PENDANT BEFORE SWIMMING. THE PATCH WILL NOT REMAIN INTACT ON THE SKIN IF SUBMERGED IN WATER FOR AN EXTENDED PERIOD OF TIME. DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR SUBMERGED IN WATER DURING PROCEDURE. TELEPATCH SYSTEM WHEN USING CABLE CRADLE ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP PROCEDURE INITIATION ERRORS FROM OCCURRING. TURN THE PENDANT ON BEFORE TAPPING START PROCEDURE ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON. IF WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL ELECTRODES IT IS RECOMMENDED TO PLACE THE PENDANT IN A POCKET DURING EXERCISE OR OTHER ACTIVITIES. IF INDIVIDUAL ELECTRODES SELF-REMOVE DURING ACTIVITY, CLEAN THE AREAS AND APPLY NEW ELECTRODES. AVOID FULL IMMERSION INTO WATER (POOLS, HOT TUBS, OPEN WATER SWIMMING). BREAKAWAY LANYARD IS NOT TO BE WORN WHILE SLEEPING. CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS. PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY CABLE CRADLE WITH PENDANT IN POCKET. THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER. THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE. THE INDIVIDUAL ELECTRODES SHOULD BE DISCARDED AFTER USE. THE BREAKAWAY LANYARD SHOULD BE DISCARDED AFTER USE. RETURN TELEPATCH PENDANT, AND ALL COMPONENTS IN KIT PROVIDED, TO MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE. SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER. WHEN WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL ELECTRODES: BEFORE TAKING A SHOWER OR BATH, UNSNAP THE LEAD WIRES FROM THE ELECTRODES (THAT ARE ATTACHED TO CHEST) REMOVE THE CABLES, CABLE CRADLE AND LANYARD BEFORE ENTERING SHOWER.. USER MANUAL - UTM D 01/06/

56 WATER WILL NOT AFFECT THE INDIVIDUAL ELECTRODES; DO NOT REMOVE THEM BEFORE SHOWERING IF THEY ARE STILL FIRMLY ATTACHED TO THE SKIN. IF AN INDIVIDUAL ELECTRODE SELF-REMOVES IN SHOWER, PREPARE THE AREAS AND APPLY NEW ELECTRODES. IF SHOWERING WITH ELECTRODES, GENTLY PAT THEM DRY WITH A TOWEL BEFORE RECONNECTING THE LEAD WIRES TO THE ELECTRODES IF SWIMMING, REMOVE CABLE, CABLE CRADLE AND PENDANT BEFORE SUBMERGING INTO WATER. USER MAY LEAVE ELECTRODES ON IF THEY ARE STILL FIRMLY ATTACHED TO THE SKIN. SMARTPHONE / HANDSET TURN THE PENDANT ON BEFORE TAPPING START PROCEDURE ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH. CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED. SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED INTO BOTH SMARTPHONE AND WALL OUTLET. WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE POWER OUTLET AND THE SMARTPHONE. UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING SMARTPHONE IN POCKET OR PURSE/BRIEFCASE. DO NOT WEAR THE SMARTPHONE WHILE THE CHARGER IS ATTACHED TO THE SMARTPHONE. BATTERY CHARGER BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED INTO BATTERY CHARGER AND THEN A WALL OUTLET. MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH. CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED. BATTERY CHARGER LIGHT WILL BE FLASHING AMBER OR ORANGE WHILE BATTERY IS CHARGING. BATTERY CHARGER LIGHT WILL BE GREEN WHEN BATTERY IS FULLY CHARGED. BATTERY CHARGER LIGHT MAY FLASH RED WHEN BATTERY IS NOT INSTALLED IN CHARGER PROPERLY. USER MANUAL - UTM D 01/06/

57 IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG, VERIFY CHARGER CORD IS PLUGGED INTO BATTERY CHARGER AND WALL PROPERLY. IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG, VERIFY BATTERY IS PLACED IN CHARGER PROPERLY. WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE POWER OUTLET AND THE BATTERY CHARGER. PENDANT PRECAUTIONS CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. This Pendant should not be used adjacent to or stacked with other equipment in accordance with the directions described in the Practice Reference Manual. NOTE: EUT (PM750 Pendant) shuts down between +/-8 and 15kV Air Discharge. It is recommended that you restart the device (wait 30 seconds after power down) upon occurrence of this event. WARNING: When using lead wires, they should not contact other conductive equipment or electric ground, including earth. Lead failures are detected by a 10 mv peak, 50% duty cycle rectangular pulse, which is applied to each patient electrode connection through a 4.9Mohm resistor at a rate of 15 Hz with respect to the system ground. This is a prescribed medical Pendant, not a toy; keep away from small children. In the event of a damaged Pendant, discontinue use and call Medicomp Patient Support: ext. 2370, for return and replacement. ADVERSE REACTIONS In the event of irritation worse than minor itching, to the Electrode Patch or individual electrodes, consult your physician. Users may also contact Medicomp to discuss alternative, Physicians must request change of procedure to Medicomp. Medicomp cannot authorize change of patient procedure. Signs of significant irritation where the electrode patch is in contact with the skin. Any other unanticipated reaction to the adhesive or the electrode gel. USER MANUAL - UTM D 01/06/

58 MAINTENANCE Cleaning the TelePatch System The TelePatch pendant may need to be cleaned if for any reason it becomes exposed to biological materials, like body fluids or matter. The user should clean the TelePatch Monitoring System in order to maintain optimal use and functionality. Use a tissue, lightly moistened with alcohol or a hospital-grade cleanser such as Sporicidin (Do not saturate) - wipe off debris, dirt or other matter that may gather on either the Smartphone or Pendant of the TelePatch System. If the Pendant has been dropped in a basin water (i.e.: sink or toilet) and will not power back on, contact Customer Support for a replacement. VISUAL AND AUDIBLE INDICATORS Normal Performance Indicators Pendant Action Visual Indicator Audible Indicator Pendant power up Pendant ready to start procedure Green, blue, and orange lit simultaneously for 1.5 seconds. Green LED blinks fast Beep High-Low-High for 0.5 second per frequency while LEDs are lit. None Procedure initiated: Press Symptom button 3 times (Holter Only) Green LED solid for 1.5 seconds Beep High-Low-High for 0.5 second duration for each beep Procedure initiated not in cradle: Press Symptom button 3 times (Holter procedure only) Procedure in progress: not in cradle Orange and blue blinks fast in unison 3 LED sections: continuous flashing Beep 4 times in unison with LEDs None Pendant removed from 3 LED sections: continuous None USER MANUAL - UTM D 01/06/

59 Cradle Pendant placed in cradle with procedure running BT OFF/Holter Symptom Button Press on cables or patch: Record Symptom Symptom Recording Complete on Cables or Patch Finger Tip Electrodes Start of Recording Finger Tip Electrodes during Recording period Finger Tip Electrode Recording complete Pendant communicating with Smartphone Holter procedure end Pendant power down flashing Green LED: every 4 seconds Green LED lit for 1 second Recording Complete message will be seen on screen of smartphone Green LED 3 flashes 0.5 second each then Green LED lit for 1 second Green LED flashes during 32 second recording period Green LED lit for 1 second Blue LED: every 4 seconds Green and blue blink alternately at 2Hz All three LEDs simultaneously every 1.5 seconds Beep for 2 seconds before entering this mode for the first time Beep for 1 second None Beep 3 times in unison with LED flashes then Beep for 1 second None Beep for 1 second None None Beep 3 times in unison with lit LEDS. Error Indicators Pendant Action Visual Indicator Audible Indicator Pendant configuration wrong New Holter procedure powerup running cradle and lead- Blink all three LEDs 5 times for 0.5 seconds every second Green blinks twice and blue blinks once repetitively Beep 5 times in unison with lit LEDs None USER MANUAL - UTM D 01/06/

60 on/lead-off tests. New Holter procedure power-up, low main battery error detected. RECORD button pressed, Pendant not in cradle RECORD button pressed while Pendant creating a recording Early low main battery warning Late low main battery warning Orange LED blinks fast 3 slow Green flashes, then Green LED flashing fast Green LED Flash Orange LED blink 1 per second Orange LED blink 3 times per second None 3 beeps then none Long beep Beep 1 second duration every 4 minutes Beep 1 second duration every 30 seconds TROUBLESHOOTING Setup Details and Troubleshooting Overview This section helps resolve any problems that may be encountered while you are setting up the TelePatch. Reduce the likelihood of seeing errors by making sure fresh Electrode Patch or fresh individual electrodes are used, as appropriate, the cable is in good condition and securely connected to the Cable Cradle, and care has been taken to perform the recommended skin preparation. Some problems are unavoidable due to a patient's particular heart condition or the unexpected failure of a component. However, these cases are infrequently encountered. When the TelePatch is connected begins its startup sequence, it assesses the quality of the ECG signal. The TelePatch system will signal if there is a problem with the connections or if the signal voltage is too high or too low for ideal auto-capturing. Messages on the Smartphone's display will direct any necessary corrections. Information is also provided in this section to assist with the setup procedure of any replacement or exchanged TelePatch system component (e.g. Smartphone or Pendant). USER MANUAL - UTM D 01/06/

61 Replaced components of the TelePatch will follow a slightly different setup procedure to the standard method. TelePatch System Hookup Testing Information Quality Hookup Tests Overview The TelePatch Quality Hookup tests evaluate cable connections, skin preparation, and signalvoltage conditions. This is a test that is performed automatically by the TelePatch System, with no indication to, or participation from, the user or patient until specifically directed by specific commands on the Smartphone. The Quality Hookup test starts once either: 1. The patient has the electrode patch in place on the chest with the pendant secured in the electrode patch cradle and the Smartphone is turned on to initiate the patient s procedure. OR 2. The patient has the individual electrodes in place with the cable attached to both the electrodes and the cable cradle, and the Smartphone is turned on to initiate the patient s procedure. The TelePatch System (Pendant and Smartphone) determines whether there is a problem and the problem will be displayed on the Smartphone. The option that is used to define how the wireless system handles these conditions is called the 'Setup' option. The Setup/Normal Setting All TelePatch systems are shipped in the 'Setup/Normal' mode. 'TEST' SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE SUPERVISION AND GUIDANCE OF MEDICOMP PATIENT SUPPORT. THE PATIENT SHOULD CALL MEDICOMP FOR GUIDANCE IN THE 'TEST' MODE. During the Quality Hookup Tests, the Smartphone may display the following screens before the procedure begins: Pacemakers USER MANUAL - UTM D 01/06/

62 If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the Smartphone displays a screen to confirm the QRS prior to beginning the procedure. Lead Position Test If no QRS is found, the following screen may be displayed before the procedure begins. If this screen is displayed, the patient is to follow the guidance of a Cardiac Monitoring Center technician, or Patient Support technician. Skin Prep Results The results of the skin prep test may be displayed before the procedure begins. Go to PATIENT PREPARATION for additional steps. For additional troubleshooting instructions, call Medicomp Patient Support: ext Error Displays During procedure hookup, the TelePatch tests for flex circuit or cable breakage, and checks that its minimal requirements for skin prep and signal voltage are met. These tests could last only a few minutes or may take longer, depending on what the TelePatch detects. The Smartphone's objective is to make sure that it receives a good signal. This ensures optimal auto-capturing and good report results. IMPORTANT POINTS With very few exceptions, only errors seen with 'Lead Position Test' require that electrodes be re-located on the patient's chest. Most of the time, errors seen with Lead Test Error and Testing Skin Prep require reprepping or equipment changes. Each time you make a change to correct a problem, you will need to tap 'Retry' for the TelePatch to continue testing. USER MANUAL - UTM D 01/06/

63 USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP WHILE THAT DEVICE IS TURNED ON. THE OPERATION OF THESE PENDANTS INTERFERES WITH THE TELEPATCH S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE DEVICES SHOULD BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH. Go to PATIENT PREPARATION for additional steps. For additional troubleshooting instructions, call Medicomp Patient Support: ext Voltage Errors after Several Attempts For Cable Cradle Procedures If inadequate signal voltage (can be either low or high) in one channel while the other one is acceptable, place the electrodes in a parallel, or side-by-side lead arrangement. Identify the channel that has the acceptable voltage and place the electrodes of the problem channel side-by-side with it. For example: Channel A good, Channel B bad - place Black electrode next to White. Configuration will be: Black and white electrodes on the right upper chest, and red electrode underneath the left breast. Channel B good, Channel A bad - place White next to Black. Configuration will be: black and white electrodes on the right lower chest. Go to PATIENT PREPARATION for additional steps. For additional troubleshooting instructions, go to TROUBLESHOOTING OVERVIEW Lead Position Tests Lead Test Error When a Lead Test Error occurs, the Smartphone displays a message similar to: THE WHITE ELECTRODE HAS A CONNECTION PROBLEM. White = White electrode site (A-) USER MANUAL - UTM D 01/06/

64 Red = Red electrode site (A+/B+) Black = Black electrode site (B-) Lead errors occur when the lead wire connected to the Cable Cradle detects a very high resistance that may be caused by one or more of the following conditions: Very high resistance values Expiration of Electrodes Cables disconnected Very high resistance values May indicate a problem with the cable. Try changing the cable first, if one is available, otherwise move on to the next step. If not done so already, thoroughly wash the electrode site with PLAIN (no lotion or oil) soap and water. Apply a small amount (about the size of the tip of a cotton swab) of Skin Prep gel to a paper towel and firmly rub it into the skin at the gel cup site. Wipe off the excess gel. If no Skin Prep is available, this can also be done with a rough, wet, washcloth. Always apply a new electrode to the site. In difficult cases, light abrasion with a scrub pad may also be required; this may occur with users who have very oily skin. Press down on the center snap of the electrode and Tap 'Retry' on the Smartphone. If the TelePatch Pendant and Smartphone proceed through to 'Lead Position Test', then after all tests are completed and the Smartphone is actively 'Monitoring,' change the electrode, this time making sure that it is in good contact with the skin. Expiration Date of Electrodes Check the expiration date on the electrodes. Inspect the electrode(s) in question to verify moist gel cups. If the gel is dry, you will need to replace the electrode. Cables (lead wires) not connected If the electrode cables are disconnected, this error message will also appear. Go to PATIENT PREPARATION for additional steps. For additional troubleshooting instructions, call Medicomp Patient Support: ext USER MANUAL - UTM D 01/06/

65 High/Low Voltage Notifications LOW VOLTAGE IN CHANNEL A (WHITE [A-]/RED [A+] ELECTRODE PAIR) Although the TelePatch System automatically adjusts the signal size (voltage) to ensure optimal analysis, some users may have cardiac anomalies that result in unacceptable signal voltage. The signal may be too large or too small. The following section describes each error that might occur. Sometimes, just having the patient lean back in a chair will increase the ECG voltage. The Smartphone's message for this error is: Low A, Move Red First, move the red electrode After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Red (A+/B+) electrode pictured. Don't try more than a few different locations. For additional troubleshooting instructions, call Medicomp Patient Support: ext LOW VOLTAGE IN CHANNEL B (BLACK [B-], RED [A+] ELECTRODE PAIR The Smartphone's message for a low voltage in Channel B is: Low B, Move Black First, move the black electrode Low Voltage in Channel B, Move Black After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode. Don't try more than a few different locations. For additional troubleshooting instructions, call Medicomp Patient Support: ext HIGH VOLTAGE IN CHANNEL A (RED [A+]/WHITE [A-] ELECTRODE PAIR) The Smartphone's message for this error is: High A, Move Red First, move the red electrode High Voltage in Channel A, Move Red After repositioning, USER MANUAL - UTM D 01/06/

66 Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Red (A+/B+) electrode. Don't try more than a few different locations. For additional troubleshooting instructions, call Medicomp Patient Support: ext HIGH VOLTAGE IN CHANNEL B (BLACK [B-]/RED [A+] ELECTRODE PAIR) The Smartphone's message for a high voltage in Channel B is: High B, Move Black First, move the black electrode High Voltage in Channel B, Move Black After repositioning, Press 'Retry' If the Smartphone continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode pictured. Don't try more than a few different locations. For additional troubleshooting instructions, call Medicomp Patient Support: ext SAMPLE SCREEN WARNINGS Screen Warnings There are a number of screen warnings that may appear on the Smartphone screen. Below is a sampling of some of the most common screen warnings. Unable to find Pendant At the very start of a new procedure, if the Smartphone IS turned on and the Pendant is NOT turned on, the following warning or alert will be displayed. Turn on the Pendant to proceed. While continuing a procedure, if the Pendant is NOT turned on when the Smartphone IS turned on, the following warning or alert will be displayed. Turn on the Pendant to proceed. USER MANUAL - UTM D 01/06/

67 Pendant is Turned Off If the Pendant is turned off while in the middle of monitoring, the following warning or alert will be displayed. Turn on the Pendant to proceed. Procedure Has Ended When the procedure ends, an alert will be displayed. Users should return the unit to the Medicomp address provided in the Patient Guide. Every TelePatch Kit has a postage paid return envelope. Include all components in the zippered kit and mail from any mailbox. For additional troubleshooting instructions, call Medicomp Patient Support: ext Start Procedure Exceptions Selecting a Pendant If more than one Pendant is identified after pressing 'Start Procedure,' the patient will be prompted to 'Select a Pendant to Use.' The instructions below provide detail steps to select a Pendant before starting a procedure. Select a Pendant to Use User chooses from the list of Pendants on the screen Select the Pendant with the unique serial number listed inside the well of the Pendant. Tap and highlight the Pendant serial number. Tap 'Select' SAFE BATTERY USE AND DISPOSAL The TelePatch Cardiac Monitor Pendant operates on a single, 3.7V lithium ion battery. USER MANUAL - UTM D 01/06/

68 Bottom and top views of the TelePatch Pendant Battery IF PENDANT S BACKUP BATTERY IS LOW, PATIENT SHOULD CALL MEDICOMP PATIENT SUPPORT: ext IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON. THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. TO ENSURE SAFE CHARGING AND MAXIMUM PERFORMANCE OVER THE LIFE OF THE PRODUCT ALWAYS USE THE MEDICOMP PROVIDED CHARGER. DO NOT ATTEMPT TO CHARGE THE BATTERY ON ANOTHER MANUFACTURER S CHARGER. THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN T USED. TO ENSURE OPTIMAL PERFORMANCE AND LIFETIME OF THE BATTERY PACK, PLEASE FULLY CHARGE THE BATTERY AT LEAST ONCE EVERY 6 MONTHS REGARDLESS OF USE. IT IS FURTHER RECOMMENDED THAT IF THE BATTERY HASN T BEEN CHARGED MORE RECENTLY THAN A MONTH AGO THAT IT BE FULLY CHARGED PRIOR TO THE START OF A PATIENT PROCEDURE. Safely Loading the Pendant Battery TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the battery well of the back of the TelePatch Pendant. To safely load the battery into the Pendant: Remove the Pendant and one battery from the zippered kit Insert battery into Pendant. Hold Pendant face down in hand or place on a flat surface. There is a well where battery will be inserted Insert battery into well of Pendant: with the Medicomp label facing up, and the two small tabs into notches in flat wall of the well USER MANUAL - UTM D 01/06/

69 Inserting battery into Pendant battery well Slide the latch at back of the battery to left, securing battery in place. Battery is locked in place when moveable latch is under blue lock icon on label Battery is unlocked (latch under RED icon) Battery Is locked (latch under BLUE icon) LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE TELEPATCH CARDIAC MONITOR BATTERY COMPARTMENT. Properly inserted TelePatch Battery IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE PENDANT BELOW THE SYMPTOM BUTTON. USER MANUAL - UTM D 01/06/

70 Battery Maintenance Remove the battery from the Pendant during storage or if the Pendant is not to be used for longer than two (2) weeks. Store in a cool, dry place, the best location is in the TelePatch Cardiac Monitor Kit supplied for your procedure. Disposal of Rechargeable Lithium Ion Batteries In accordance with federal laws and regional regulations: RETURN all batteries to Medicomp, Inc. The rechargeable battery provided with the TelePatch System is NOT to be discarded in household waste. If a battery gets damaged contact Medicomp, Inc.: EXPLANATION OF MARKINGS Equipment markings and caution labels are important for safe and reliable use; they must not be removed. The following symbols are used in this user manual, patch packaging, lithium ion battery or the Pendant label. They may also appear on an accessory or accessory packaging. Icon Description Pendant, Lanyard Operating instructions Pendant This symbol indicates type BF equipment classified in accordance with IEC Publication IEC Safety of medical electrical equipment. Type BF equipment: equipment with isolated patient connections, connections not defibrillation-proof. IP55 Pendant This symbol indicates Ingress protection- Solids: 5 Ingress of dust is not entirely prevented, but it must not enter in sufficient quantity to interfere with the satisfactory operation of the equipment; complete protection against contact. Liquids: 5 - Water projected by a nozzle (6.3mm) against enclosure from any direction shall have no harmful effects. USER MANUAL - UTM D 01/06/

71 Pendant This symbol informs the user that the respectively labeled component is not to be disposed of in the trash. Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling. Pendant. Lithium Ion Battery WEEE LOGO The WEEE logo on this product indicates that this product must not be disposed of with standard waste but rather recycled. Please contact Medicomp, Inc. for more information on proper component disposal. RoHS Compliance This product is in compliance with Directive 2002/95/ EC of the European Parliament and of the Council of 27 January 2003, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) and its amendments. Pendant Serial Number Patch Prescription Required Patch Caution, consult accompanying documents Patch Do not reuse. This is a single use item Patch Batch code of product Patch Use by date indicated Patch Catalog Number/Part Number Lithium Ion Battery Item is recyclable. Users should properly dispose of components through USER MANUAL - UTM D 01/06/

72 Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling. REACH Lithium Ion Battery Lithium Ion Battery Lithium Ion Battery EU regulation of chemicals and safe use: Registration, Evaluation, Authorization and Restriction of Chemical substances. Component substances are REACH approved. Item must not be disposed of to the normal household waste, but be separately collected and recycled. Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling. Do not incinerate Lithium Ion Battery Lead Wire packaging Shipping packaging Product is lead free. Component and Assembly Pb content shall be less than 0.1% by weight of the device (in accordance with IPC/EIA J-STD-006) and shall not be intentionally introduced. Lead wires comply with the Performance Standard for electrode lead wires Temperature limitation for shipment of system is -15 C to 60 C (5 F to 140 F). The TelePatch Pendant should NOT be treated as household waste. ONLY the Electrode Patch or individual electrodes should be discarded after use. Return TelePatch, Pendant, and all components in kit provided, to Medicomp, Inc., using the included postage paid envelope. EXPECTED LIFE TelePatch Pendant Unit is expected to provide at least 7 years of normal use. USER MANUAL - UTM D 01/06/