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.
GETTING STARTED AND INTRODUCTION ....................5 Notices, Cautions, and Copyrights ......................5 TelePatch Cardiac Monitor User Kit ......................6 Contact Us ..............................9 ABOUT TELEPATCH CARDIAC MONITOR PM750 ..................9 INDICATIONS FOR USE ..........................9 OVERVIEW ............................... 10 SAFETY SPECIFICATIONS AND COMPLIANCE ..................... 10 Contraindication .............................
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Set Up ..............................38 Start Over ............................38 Step 8 - Initial Procedure Screens ......................39 Recording Symptoms: Standard TelePatch Procedure ................41 Manual Diary Entry ..........................42 Audio Diary Entry ..........................44 PROCEDURE SET-UP: Cable Cradle with Patient Cable ................44 Step 1 - Identify Electrode Sites ......................
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COMMON QUESTIONS ..........................50 How Do I Wear TelePatch System: Electrode Patch and Pendant? ............50 How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? ........51 Can I Shower? ............................51 Tip For During Shower ..........................51 Tip For After Shower ..........................
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EXPECTED LIFE ............................71 PENDANT SPECIFICATIONS......................... 72 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ..........73 Recommended separation distances between portable and mobile RF communications equipment and the PM750 ..............................75 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
Have a question or need assistance? Call Medicomp Patient Support: 800-234-3278 ext. 2370 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.
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*Kit will have one or the other patch style, single or double is based with Cradle* 1 - 4 on procedure prescribed by physician Rechargeable Battery TelePatch Smartphone* *Holter procedures do not require a Smartphone TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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Electrode Prep Pad Survey Invitation Return Envelope with Pre-paid Shipping Label Legal Booklet PICTURE TO BE ADDED These items are not standard in TelePatch Kit. By physician request only Cable Cradle Cable 3-lead or 5-lead Electrodes (3-5 per pouch) 1- 4 Breakaway Lanyard TelePatch™...
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.
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.
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.
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.
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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.
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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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Have a question or need assistance? Call Medicomp Patient Support: 800-234-3278 ext. 2370 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.
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.
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Call Medicomp Patient Support: 800-234-3278 ext. 2370 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.
Have a question or need assistance? Call Medicomp Patient Support: 800-234-3278 ext. 2370 THE RECHARGEABLE BATTERY PROVIDED WITH THE TELEPATCH SYSTEM IS NOT TO BE DISCARDED IN HOUSEHOLD WASTE. IF A BATTERY GETS DAMAGED CONTACT MEDICOMP, INC.: 877-996-5553 TelePatch Pendant...
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...
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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.
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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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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 ...
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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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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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.
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.
● 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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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● 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.
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.
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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.
Smartphone. Wait for the Medicomp main screen to appear on the screen before continuing with standard procedure setup. Tap “Start Procedure.” TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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:...
Users should check with child's Pediatrician to verify heart rate. The Pediatric protocol sets Normal Sinus Rhythm at 80-150bpm. To select a setting from protocol: To apply 'Protocol' as a setting: Tap “Standard” Tap desired Protocol Press “Accept Settings” TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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: •...
For example, the normal heart rate in Standard protocol is 60-100 bpm. Pediatric Protocol: this range is 80-150 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.
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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.
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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
(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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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Have a question or need assistance? Call Medicomp Patient Support: 800-234-3278 ext. 2370 Symptom Menu Location Menu Activity Menu Select Diary Options Screen – Options chosen TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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, two- channel ambulatory monitoring. By convention in the symptom recording reports, V5 is Channel A and the modified Lead I is Channel B.
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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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). TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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● 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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
● 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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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 TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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.
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.
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.
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 ...
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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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.
Beep 5 times in unison with for 0.5 seconds every second lit LEDs New Holter procedure Green blinks twice and blue None power- blinks once repetitively up – running cradle and lead- TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
The TelePatch Quality Hookup tests evaluate cable connections, skin preparation, and signal- voltage 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.
2370 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”...
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.
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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.
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.
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. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
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: ●...
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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.
● 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.
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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 Item is recyclable. Battery Users should properly dispose of components through TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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.
IEC 61000-3-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The PM750 is intended for use in the electromagnetic environment specified below. The customer or user of the PM750 should assure that it is used in such an environment. TelePatch™ Cardiac Monitor PM750...
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30 A/m (Both 50Hz, 60Hz) field IEC 61000-4-8 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. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The PM750 is intended for use in the electromagnetic environment specified below.
Recommended separation distances between portable and mobile RF communications equipment and the PM750 The PM750 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of PM750 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PM750 as recommended below, according to the maximum output power of the communications equipment.
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NOTE: 1 - At 80 MHZ and 800 MHZ, the separation distance for the higher frequency range applies. NOTE: 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. TelePatch™ Cardiac Monitor PM750 USER MANUAL - UTM0000701-04D 01/06/2017...
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