OF8-TM8BTM8B Dual ECG Transmitter

1 TM8B DUAL ECG TRANSMITTER FCC ID: OF8-TM8B Tested To Comply With FCC Standards LIFE SENSING INSTRUMENT COMPANY, Inc. 329 WEST LINCOLN STREET TULLAHOMA, TENNESSEE 37388 (931- 455-9016) declares that the device manufactured as TeleMaster, model no. TM8B does conform to the regulations as outlined in Title 47 of the US code of federal regulations, Part 15 covering Class B personal computers and peripherals, and Part 95, subpart H covering Wireless Medical Telemetry Service (WMTS). Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to Parts 15 and 95 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 or television communications. However, there is no guarantee that the 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 of the interfered device. Increase the separation between the equipment and interfered device. • Connect the equipment to a different outlet on a circuit other than the one the interfered device is connected to. • Consult the dealer or an experienced radio/TV technician for help. CAUTION: Changes or modifications not expressly approved by the manufacturer can void the user’s authority to operate the equipment. It is the responsibility of the equipment user to maintain compliance with the FCC rules. To ensure compliance, use only those cables and/or accessories prescribed by the manufacturer. IMPORTANT: To comply with the FCC RF exposure requirements, users should avoid grasping the transmitter for any extended period of time while the device is in operation. 2 TM8B DUAL ECG TRANSMITTER OPERATING INSTRUCTIONS IMPORTANT - Operation of a TM8B requires prior coordination with the ASHE frequency coordination designator. For further guidance visit the ASHE website at: www.wmtssearch.com The TM8B Dual ECG Transmitter is a frequency synthesized transmitter operating in the UHF (608 - 614Mhz) range. The transmitter utilizes 5 independent patient lead wires with snap electrode adapters for disposable electrodes. The ECG viewed from ECG1 is dependent upon the placement of the White (-) and the Red (+) electrodes. The ECG viewed from ECG2 is dependent upon the placement of the Black (-) and Brown (+) electrodes. Both ECG leads are transmitted all the time. The Green lead serves as a reference to all four ECG leads, which minimizes common mode interference. Should an electrode become detached, a Lead Fault message will be displayed at the central station. The central station will switch to the other lead. A switch on the transmitter permits remote activation of the central station recorder. The TM8B transmitter uses 2 each 1.5 volt “AAA” batteries. Average battery life is 2 to 3 days. When the batteries reach an unsafe operating level, a Low Bat message will be displayed at the central station. Approximately 1 hour battery life is left when the Low Bat message is first displayed. The TM8B transmitter utilizes 5 electrodes to provide Lead II and a Modified Chest Lead (MCL) for review at the central station. For optimum monitoring the electrodes should be placed in the following locations: 3 TM8B DUAL ECG TRANSMITTER WHITE: ECG1 negative electrode. RIGHT CLAVICLE OR RIGHT STERNAL BORDER. RED: ECG1 positive electrode. LOWER LEFT RIB CAGE. BLACK: ECG2 negative electrode. LEFT CLAVICLE OR LEFT STERNAL BORDER. BROWN: ECG2 positive electrode. PLACE ON ANY OF 6 V-LEAD POSITIONS. GREEN: Reference electrode. LOWER RIGHT RIB CAGE. If only one lead of ECG is required remove the brown and black lead wires from the transmitter. Refer to the section on MULTI-VIEW WAVEFORMS in the central station operating manual to disable lead fault on second channel. WARNING! ONLY USE THE SAFETY LEAD WIRES SUPPLIED WITH THE TRANSMITTER. 4 TM8B DUAL ECG TRANSMITTER Attaching the Transmitter to the Patient Gently abrade the electrode sites with an alcohol prep pad until slight redness is observed. Dry the site before applying the electrodes. Attach the electrodes to the lead wires. Insert the batteries in the transmitter as follows: Hold the transmitter in one hand. Using the other hand thumb and index finger, grasp the battery cap and turn counter clockwise until the cap can be removed. Insert both batteries with the positive ends up. See the battery direction indicator on the battery cap. Repeat the above instructions for the battery cap, but rotate the cap clockwise. CAUTION MAKE SURE THE BATTERIES ARE INSTALLED CORRECTLY. IF THE BATTERIES ARE INSTALLED INCORRECTLY, THE TRANSMITTER WILL NOT FUNCTION. MAKE SURE THAT THE BATTERY CAP IS TIGHT. IF THE CAP IS NOT PROPERLY TIGHTENED, THE TRANSMITTER MAY BE INTERMITTENT AND THE WATER PROOFING SEAL MAY LEAK, CAUSING DAMAGE TO THE TRANSMITTER. Attach the electrodes to the patient on the prepared sites. Apply pressure to the outer edges of the electrode, not the center. Applying pressure to the center may cause the electrode conductive jelly to ooze out resulting in a loose electrode. REMOTE RECORD FUNCTION If it is desirable to start the recorder from the transmitter, press and hold the Remote Record control for approximately 2 seconds. This will generate a 20-second ECG recording at the central station.

TrensCenter Central Station Cardiac Monitor Operator’s Manual Page 1 TABLE OF CONTENTS SUBJECT PAGE Preface 2 Safety Summary 3 Arrhythmia Monitoring 4 Dual Lead Transmitter 5 Attaching Transmitter to Patient 7 Alarm Indications, Operator Alerts 8 Alarm and Alert Matrix 10 Patient Name, Room, ID Entry 11 Changing Patient Display Color 12 Alarm Limit Settings 13 ECG Size Adjustment, Low QRS Alert 19 Relearn of ECG Rhythm 20 FILTER and MONITOR 21 Back-Up Transmitter 22 Discharging a Patient 23 Report Generation 24 Pacemaker Patients 25 Remote Record 26 Alarm Volume Control 26 Setting Charting Intervals 27 Date and Time Setting 28 Automatic Recording, All Record 29 Long and Short Record 30 Manual Recording (STORE EVENT ) 31 Silencing Alarms 32 System Status 33 Store All 35 View Events, List Events 35 Delete a Stored Event 37 Multi-View, Multi Lead Telemetry 38 Full Disclosure 39 View Trends 41 Cleaning the Display 42 Loading Paper and Recordings 43 Faxing Documents CARDIAC REHAB 44 Revision 3.016R Date July 2002 TrensCenter Central Station Cardiac Monitor Operator’s Manual Page 2 PREFACE This manual describes the operation and use of the TrensCenter Telemetry System. It is intended for use by clinicians trained in the use of clinical monitoring systems familiar with the associated terms and procedures. The system is intended to be used in any area of the hospital where cardiac monitoring is required. The system is intended to be used in accordance with accepted hospital and clinical protocols and the instructions contained in this manual. Use of the system with other than supplied accessories or parts may result in inaccurate patient information or damage to the monitor. The manual contains detailed descriptions of all controls and indicators. Each control of the system is depicted in this manual by the use of hand symbols: When a specific control function is described, a hand symbol will point to the location of that control key or button. When multiple control functions are described on a single display, the hand symbols will be numbered in the order that they are referenced in the text. Example: Å - Ü. Those controls appearing on a keyboard or keypad are referred to as keys. Additionally, Button Controls are as shown below: NOTE statements are for general information applicable to the current subject and appear in bold italic type style. Note statements appear as shown below: NOTES Note Information. CAUTION statements in the manual identify conditions or operations that could result in damage to the system or other property. Caution statements appear in UPPERCASE as shown below: CAUTION CAUTION INFORMATION. WARNING statements in the manual identify conditions or operations that could result in personal injury. Warning statements appear in UPPERCASE BOLD type style as shown below: WARNING! WARNING INFORMATION. TrensCenter Central Station Cardiac Monitor Operator’s Manual Page 3 SAFETY SUMMARY 1) Do Not autoclave the patient transmitters. 2) Frequent electrical and visual checks should be made on electrode wires. Broken or frayed electrode wires or loose fittings may cause interference or loss of signal. Particular attention should be paid to the point where the electrode wire enters the snap fittings since flexure will eventually cause breakage of strands at this point. 3) Do Not operate this product in the presence of flammable anesthetics. Explosion may result. 4) If the system is connected to accessory equipment, leakage current requirements must be maintained. 5) To insure patient safety, use only software, accessories and parts recommended by the manufacturer. 6) A product that has been dropped or severely abused should be checked by qualified service personnel to verify proper operation. 7) Component replacement or adjustment must be made by qualified service personnel only. 8) Patient transmitters have limited range. Ensure that patients remain within the area covered by the antenna system. 9) The system is intended as a complement to, not a substitute for, patient observation by trained health care personnel. Do not rely entirely on the alarm, arrhythmia or paging structure of the system. 10) WARNING PACEMAKER PATIENTS. Heart Rate Counts on patients with pacemakers may be erratic. Follow the instructions contained in the Paced Patients section of this manual. Keep pacemaker patients under close observation. 11) Do not place any item on top of the receiver enclosure that would obstruct air flow since heat may build up and cause damage to receivers. 12) Do not allow objects to rest on keyboard since erroneous data may be entered into patient chart and certain keys may cause adverse operations. TrensCenter Central Station Cardiac Monitor Operator’s Manual Page 4 ARRHYTHMIA MONITORING Monitoring systems are aids to the nursing staff and are not intended to replace the vigilance of the staff to react to a displayed waveform on the monitor and take the appropriate action for the patient’s well being even though the monitor has not alarmed. Qualified and trained monitoring technicians working in concert with arrhythmia detection systems produce the best results in detecting and alerting the nursing staff to patients’ problems. No arrhythmia detection algorithm is currently available from any supplier that can guarantee 100% accuracy. There is no method in use to simulate the infinite number of variations in patient waveforms. No arrhythmia system can, without some human intervention both at the monitor and the patient, detect and identify every type of morphology change that may occur in the total patient population. The arrhythmia algorithm contained in the central station has been in use since the 1960’s in many clinical environments. The algorithm has been tested against the AHA, MIT, and Beth Israel data bases and was found to be well over 90% accurate. This is well within the government standards. The algorithm looks at five parameters of each and every ECG complex to decide if it is…

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Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 1 of 2 EXTERNAL PHOTOGRAPHS Figure 1: Overview - Front Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 2 of 2 Figure 2: Overview - Back

Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 1 of 1 LABEL LOCATION Figure 1: Label location

FCCID: OF8-TM8B

Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 1 of 4 INTERNAL PHOTOGRAPHS Figure 1: Inside cover Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 2 of 4 Figure 2: PCB and RF boards assembled, top view Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 3 of 4 Figure 3: PCB and RF board assembly with RF board removed Intertek Testing Services Life Sensing Instrument Company Model: TM8B FCCID: OF8-TM8B Page 4 of 4 Figure 4: PCB rear view

EMC Report for Life Sensing Instrument Company on the TM8B FCCID: OF8-TM8B Page 1 of 19 TEST REPORT Report Number: 0232047W.doc Project Number: 3032147 August 20, 2002 Evaluation of the Dual Lead Telemetry Transmitter Model Number: TM8B to FCC Part 95, Subpart H Class For Life Sensing Instrument Company Test Performed by: Test Authorized by: Intertek Testing Services 1950 Evergreen Blvd, Suite 100 Duluth, GA 30096 Life Sensing Instrument Company 329 West Lincoln Street Tullahoma, TN 37388 Prepared by: Date: Shawn McGuinness Reviewed by: Date: David Schramm All services undertaken are subject to the following general policy: Reports are submitted for exclusive use of the client to whom they are addressed. Their significance is subject to the adequacy and representative character of the samples and to the comprehensiveness of the tests, examinations or surveys made. This report shall not be reproduced except in full, without written consent of Intertek Testing Services NA Inc. This report must not be used to claim product endorsement by A2LA, NIST nor any other agency of the U.S. Government. Intertek Testing Services EMC Report for Life Sensing Instrument Company on the TM8B FCCID: OF8-TM8B Page 2 of 19 TABLE OF CONTENTS 1 JOB DESCRIPTION .......................................................................................................................... 3 1.1 CLIENT INFORMATION................................................................................................................... 3 1.2 TEST PLAN REFERENCE: ................................................................................................................ 3 1.3 EQUIPMENT UNDER TEST (EUT) .................................................................................................. 3 1.3.1 Test Summary........................................................................................................................ 4 1.3.2 Brief Description................................................................................................................... 4 1.3.3 System Support Equipment.................................................................................................... 4 1.3.4 Cables associated with EUT ................................................................................................. 4 1.3.5 System Block Diagram .......................................................................................................... 5 1.3.6 Justification........................................................................................................................... 6 1.3.7 EUT exercising...................................................................................................................... 6 1.3.8 Mode(s) of operation............................................................................................................. 6 1.4 MODIFICATIONS REQUIRED FOR COMPLIANCE.............................................................................. 6 2 TEST ENVIRONMENT .................................................................................................................... 7 2.1 TEST FACILITY.............................................................................................................................. 7 2.2 TEST EQUIPMENT.......................................................................................................................... 7 2.3 EXAMPLE FIELD STRENGTH CALCULATION................................................................................. 8 2.4 MEASUREMENT UNCERTAINTY..................................................................................................... 9 3 RADIATED EMISSIONS ................................................................................................................ 10 3.1 TEST DESCRIPTION...................................................................................................................... 10 3.2 TEST PROCEDURE........................................................................................................................ 10 3.3 TEST RESULTS............................................................................................................................. 11 3.4 TEST CONFIGURATION PHOTOGRAPH......................................................................................... 12 4 OCCUPIED BANDWIDTH.............................................................................................................14 4.1 TEST DESCRIPTION...................................................................................................................... 14 4.2 TEST PROCEDURE........................................................................................................................ 14 4.3 TEST RESULTS............................................................................................................................. 14 5 SPURIOUS EMISSIONS AT ANTENNA TERMINAL ............................................................... 15 5.1 TEST PROCEDURE........................................................................................................................ 15 6 FREQUENCY STABILITY.............................................................................................................16 6.1 TEST DESCRIPTION...................................................................................................................... 16 6.2 TEST PROCEDURE........................................................................................................................ 16 6.2.1 Frequency stability vs. temperature .................................................................................... 16 6.2.2 Frequency stability vs. voltage............................................................................................ 16 6.3 TEST RESULTS.................................................................................................…

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