cl Pre ud l i es min Ti ar nm y an ) Mini Mitter Company, Inc. Bend, OR USA (in VitalSense ® Integrated Physiological Monitoring System Instruction Manual Version 1.1 This document is Mini Mitter Part Number 910-0500-XX © 2003-2004 Mini Mitter Company, Inc. VitalSense ® is a registered trademark of Mini Mitter Company, Inc. Medic Mode™ is a trademark of the Mini Mitter Company, Inc.
MINI MITTER COMPANY, INC. WARRANTY POLICY 1. WARRANTY: Mini Mitter warrants that upon delivery the goods sold hereunder will be free of defects in materials and workmanship, and such goods will substantially conform to the specifications furnished by the Seller, and to any drawings or specifications furnished to the Buyer by Mini Mitter if approved by Mini Mitter. a) Commencement of Warranty – The warranty period begins on the date of delivery.
Table of Contents Technical Support v Notices to Practitioners and Subjects vi System Introduction 1-1 Monitor Operation/Sensor Activation 2-1 VitalSense Application Program 3-1 Maintenance 4-1 VitalSense XHR Heart Rate Sensor 5-1 Appendices Frequently Asked Questions A-1 Universal Coordinated Time B-1 Medic Mode™ C-1 Specification D-1 Index iii
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Thank You! .....for purchasing Mini Mitter products. If you need assistance with your VitalSense Physiological Monitoring System, remember Mini Mitter support continues after the purchase. If you have any problems or questions, please call our Technical Support staff of technicians, engineers, and scientists. We are available by telephone, fax, e-mail, or website. Contacting Mini Mitter Technical Support Mailing and Shipping Address Mini Mitter Company, Inc.
Safety Labels and Terminology DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION (with safety alert symbol) indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
Notices to Practitioners and Subjects Electromagnetic Interference (EMI) Advisories Introduction The VitalSense Integrated Physiological Monitoring System uses wireless telemetry to send data over a distance. By nature, wireless devices use an “open” channel which is shared by other wireless devices which may be interfered with, or may interfere with the VitalSense system. Consequently, the customer is advised to carefully consider the environment in which the VitalSense system will be used.
EMI Avoidance The VitalSense system is intended as a short range wireless device. The maximum distance at which the capsule sensor can be used is 1 m, and the maximum distance at which the patch can be used is 2 m. If transmissions appear to be lost, bring the monitor closer to the sensors. Move the system away from any devices you suspect may be emitting electrical radiation. The VitalSense system is intended to be an ambulatory system worn on the body, with the monitor placed at or near the waist.
Radio Frequency Environments Table 1.2 summarizes the general electromagnetic environments and lists the environments in which the system has been verified to operate. For additional information, contact Mini Mitter Company, Inc. Operation within environments other than those verified may cause loss of data. Mini Mitter Company, Inc. is not responsible for customer operation of the system within environments other than those verified. Table 1.
Medical Telemetry Systems VitalSense has been designed in accordance with the FDA advisory, “FDA Public Health Advisory: Risk of Electromagnetic Interference with Medical Telemetry Systems,” July 10, 2000; and in accordance with FDA Guidance Document, “Wireless Medical Telemetry Risks and Recommendations.” In regard to those advisories: • The VitalSense system does not operate in the TV or PLMRS bands at 174-216 MHz and 450-470 MHz. • VitalSense does not operate within the frequency bands 26.96-27.
Precautions Prior to Using the VitalSense System Restrictions Federal law restricts the VitalSense Physiological Monitoring System products for sale to or on the order of a health care practitioner licensed by the law of the State in which he/she practices to use or order the use of this device. Emissions This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
Travel by Commercial Aircraft Following activation, VitalSense sensors are radio transmitters. The Dermal Patch sensor has a range up to 2 meters, and the Capsule Sensor has a range up to 1 meter. The VitalSense Monitor can be a source of radio interference. They should not be used on commercial aircraft without the expressed permission of the governing aircraft security agency in countries of travel and the airline carrier.
Sanitizing VitalSense Components The VitalSense monitor may be sanitized with a soft cloth moistened with a non-alcohol based antibacterial cleaner. The Capsule Sensor and Dermal Patch Sensor are single-use disposable devices. They are supplied ready-for-use as long as they remain in their original factory packaging. For VitalSense Monitor maintenance cleaning, see “Cleaning” on page 4-6. Do not autoclave the VitalSense monitor or the associated sensors. They will be destroyed in the process.
Precautions Prior to Using the VitalSense Monitor Safety ♥ This device is classified as having Type CF protection against electrical shocks during the sensor activation procedure. NOTE: For additional advisories with respect to the VitalSense Monitor, see “Precautions Prior to Using the VitalSense System” on page -xi, and “EMI Effects on VitalSense System” on page -vii.
Precautions Prior to Using the Dermal Patch Sensor Read before administering Dermal Patch Sensor! Description • Supplied one Dermal Patch Sensor per package • Patch is biocompatible, colored plastic • Temperature Sensing Range: -20 °C to 60 °C • Reception Range: maximum of 2 meters • Battery life following activation: maximum of 240 hours (10 days) Indications An indication is a sign or circumstance that indicates proper treatment.
Cautions The following cautions indicate conditions that may result in minor or moderate injury to the subject. • The Dermal Patch Sensor should be administered only by a health care practitioner. • Following activation, the Dermal Patch Sensor can be affixed to nearly any flat, hairless area on the body. Placement, however, is limited to the size of the patch. It cannot be trimmed or altered, and should not be bent or crushed.
Precautions Prior to Using the Capsule Sensor Read before administering capsule! Limitations of Capsule Sensor The VitalSense ingestible capsule thermometer is a Class II Medical Device according to 21 CFR 882.1845 and is classified as a Surface Contacting Device according to ISO 10993-1. The capsule is intended to be used in contact with the mucosal membrane (alimentary tract) only.
If suspected, a contrasted X-ray series should be considered prior to ingestion. Warnings A warning indicates a condition that may endanger the subject or patient. • DO NOT attempt an MRI (magnetic resonance imaging) if a Capsule Sensor has been ingested. Wait until the device is passed from the digestive system. Affix an MRI Warning wrist band (supplied) to the subject with instructions to wear it until the Capsule Sensor has been passed.
Adverse Reactions • May cause choking. Should be taken with water. • In rare instances, may become lodged in the intestines.
Precautions Prior to Using VS-XHR Heart Rate Sensor Read before administering VS-XHR Heart Rate Sensor! Description VS-XHR is a cardiac monitor sensor, used to detect, measure, and transmit Heart Rate and Respiration Rate values to the VitalSense Integrated Physiological Monitoring System (VS-IPMS). VS-XHR attaches directly to the chest surface using standard disposable ECG (EKG) electrodes. VS-XHR is powered from its own internal rechargeable lithium coin cell; there is no external power source.
Contraindications A contraindication is any circumstance that indicates a form of treatment may be inappropriate. • The VS-XHR Sensor is contraindicated for the detection of Heart Rate due to bigeminal arrhythmias or systoleic arrhythmias. • The VS-XHR Sensor is contraindicated for use in conjunction with pacemakers, electrosurgical equipment, and defibrillators. • VS-XHR Sensor is contraindicated for use in measuring ST segment shifts.
Defibrillation Defibrillator use may interfere with or damage this device. Do not rely on this device to measure heart rate or respiration rate during defibrillator use. Remove VS-XHR prior to defibrillator use. Cautions The following cautions indicate conditions that may result in minor or moderate injury to the subject. Infant Use VitalSense-XHR Heart Rate Sensor is not intended for use on infants weighing less than 10 kg. ST Segment Shifts This equipment is not designed to measure ST segment shifts.
Precautions Prior to Using the Multicharger Read before charging VS-XHR Heart Rate Sensor! Description The purpose of the Multicharger is to charge multiple VS-XHR Heart Rate Sensors. An AC to DC converter is provided which powers the device. Up to three VS-XHR Sensors can be mounted on the Multicharger, providing a full charge within 11 hours (typical).
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SECTION 1 VITALSENSE SYSTEM INTRODUCTION CHAPTER 1 This is an instruction manual for the operation and maintenance of the VitalSense Integrated Physiological Monitoring System.
A Standard Mode VitalSense Monitor can monitor up to ten sensors. In order to do this, each sensor must be activated by the monitor that will be recording that specific sensor. During activation, each sensor and the monitor are synchronized. In optional Medic Mode™, an unlimited number of sensors may be operationally verified and the temperature recorded with a time stamp.
Tracking Tracking is a term used in this manual which refers to the synchronization of the VitalSense Monitor and the sensors. In order to preserve battery power of the VitalSense Monitor and conserve the power of the sensors, the sensors are designed to transmit according to a pre-determined schedule. Both the sensor and the monitor which activated it have this schedule. As a result, the monitor only “listens” for a specific sensor for a short period during the expected transmission time.
1-4 Introduction
SECTION 2 VITALSENSE MONITOR OPERATION CHAPTER 2 VitalSense Monitor - Description The VitalSense Monitor is a splash-resistant, battery-operated receiver and logger. It activates the sensor via an optical beam, receives data from the sensor by radio, records data in a non-volatile memory, and facilitates transferring the data to a computer via a cable.
Front Panel Controls VitalSense controls are sealed, splash-resistant, and provide tactile feedback. Power On/Off Turns the monitor on and off. Data and settings are preserved when the power is turned off. Backlight Light is activated for approximately 10 seconds when this button is pressed. If subsequent buttons are pressed, the backlight will remain on. Marker Button Inserts a time mark into the recorded data. Data Views Toggles between the Sensor List and the Data Graph chosen from the Sensor List.
Other features • RS-232 Port - Accepts RS-232 serial cable to facilitate transfer of data. • Battery compartment - Access to lithium power source. • Activation Port - Activates sensor during activation procedure.
Monitor Setup for Data Collection Before data collection can begin, the monitor must be set up, or configured. All configuring can be done from the monitor front panel, and some configuration functions can be done from the host PC. This section will cover monitor front panel operations.
Precautions Prior to Activating the Dermal Patch Sensor Read before activating patch sensor! Become familiar with the section “ Notices to Practitioners and Subjects ” on page -vii. It contains important information you need to know prior to activating the sensors. The VitalSense Dermal Patch Sensor is a wireless, miniaturized, externally activated, temperature monitoring device that is attached to the skin with a pressure sensitive adhesive (PSA) and a protective layer.
Precautions Prior to Activating the Capsule Sensor Read before activating capsule! Become familiar with the section “ Notices to Practitioners and Subjects ” on page -vii. It contains important information you need to know prior to activating the sensors. Comparative Size Jelly bean Capsule Sensor • DO NOT remove the Capsule Sensor from the package until it is to be activated. • Activate the Capsule Sensor prior to swallowing. It cannot be activated once swallowed.
Activating Sensors Using the VitalSense Monitor 1 The process of sensor activation begins by first turning on the monitor. Press the Power button (see 1 below) and hold for approximately ½second. 2 Next, press Activate Sensor (see 2 below). Initiating the activation sequence 1 2 Activation 3 Follow the directions on the display. Place the sensor lens against the Activation Port. Press Activate Sensor again.
4 During the activation prompts (below), do not remove the sensor from the Activation Port. Placement for activation 5 If other sensors are activated, you may receive the following message. Waiting for transmission gap 6 You will be informed when the sensor has been successfully activated. Remove the sensor from the activation port. Activation Complete Successful activation As shown above, you are asked if you want an optional sensor identification, or label.
7 Use the arrow buttons to choose either OK or Cancel, and press Enter. 8 If you choose to label the sensor, use the arrow buttons to choose the appropriate identifier for the sensor, and press Enter. In the illustrations below, the Right Leg (r_leg) is the label assigned to sensor 1204. Sensor Labeling Activate Sensor > (activated) > OK > Identifier 9 Sensor activation is complete. For additional sensors, repeat the procedure. Up to 10 sensors may be placed on-line per monitor.
Administration Both the Capsule Sensor and the Dermal Patch contain ferromagnetic materials incompatible with MRI (magnetic resonance imaging) and should not be worn nor ingested if an MRI is planned. Any subject ingesting or affixing the above sensors is to wear an MRI Warning wrist band (supplied with each sensor) as long as the sensors are in place. Dermal Patch Sensor 1 Remove excess hair from the area in which the sensor will be mounted. 2 Prepare the skin by cleaning with an alcohol-moistened wipe.
Sensor Does Not Activate Failure to activate immediately If the sensor does not activate within a few seconds, it may be waiting for a transmission from a previously activated sensor. Hold the sensor in place. Once the transmission has been received, the monitor will activate the new sensor. NOTE: As more sensors are brought on-line, the monitor may need to wait for longer periods. Activation delay notice Failure to activate If a sensor fails to activate, you will be prompted.
Duplicate sensor The sensor will not activate if the identification number of the sensor is identical to one already in the monitor schedule. Duplicate sensor notice NOTE: This error is very unlikely. Very few sensors will ever share the same identification. In the unlikely event this happens, use another sensor.
VitalSense Monitor Details of Operation - Display The Data Graph displays a variety of operational characteristics. 1-Display-type icon 5-Low battery 6-Logging is on indicator 2-Missed transmission 3-Sensor label 4-Start time 10-Sensor Temperature 7-Temperature/time curve 11-Sensor Units 9-Max/Min temp 8-Graph length (X) 1 Display-type - Activation, Menu, or Data View. 2 Asterisk - one or more of the last transmissions was missed. If reacquired, it will disappear.
Icon Definitions • Activation display • Menu display • Data View display • Low battery indicator • Logging enabled NOTE: If the VitalSense Monitor display should inexplicably go blank, momentarily press any button. High discharges of ESD can cause the display to shut down. See “ Electrostatic Discharge Effects on Monitor ” on page -x.
VitalSense Monitor Details of Operation - Menus The Main Menu is a gateway to several sub-menus. Sensor Options Sensor Activate Sensor Options Main > Sensor Options > Activate Sensor The process described above is identical to the function of the Activate Sensor button on the front panel of the monitor. See “ Activating Sensors Using the VitalSense Monitor ” on page 2-7.
Sensor Remove Sensor Options The Remove Sensor function deletes a sensor from the sensor schedule. However, data from that sensor, if logged, will be preserved. Once a sensor has been removed from tracking, the tracking cannot be reestablished for that sensor. 1 Select Remove Sensor from the Sensor Option list. Main > Sensor Options > Remove Sensor 2 From the sensor schedule, use the arrow buttons to select the sensor that is to be removed. Press Enter.
4 The selected sensor is removed from the sensor schedule.
Sensor Logging ON/OFF Options This function toggles the VitalSense Monitor logging selection ON or OFF. If turned off, the VitalSense Monitor will continue to communicate with the sensors, but the data memory will not log the data until logging is toggled back to ON. 1 Use the arrow buttons to select between ON and OFF. 2 Press Enter. Main > Sensor Options > Logging On/Off Sensor Sensor Units Options Temperatures can be displayed in Celsius or Fahrenheit.
Graph Options Graph Options Length (X) This function sets the length (in hours) of the X-axis displayed in the Data Views graph. Up to 48 hours of data can be displayed. The following choices are available. Use the arrow buttons to make the selection, and press Enter. • 1.
Adjusting the Time/Date When setting the clock, use the arrow buttons to navigate through the menus and increment and decrement the highlighted choices. Press Enter to make your selection. There are two methods by which the clock should be set. Method A 1 Check (or uncheck) Daylight Saving Time Auto-set. 2 Set the UTC Offset. 3 Set the local time. If the previous three steps are followed, the UTC clock will be set automatically. Method B 1 Set the UTC time. 2 Set the UTC offset.
2 If you have sensors on-line, you will receive an advisory that the time and date cannot be changed. Sensor on-line advisory 3 Use the up and down arrow buttons to select either OK or Cancel, and press Enter. 4 The following menu is the Time/Date entry display. To make changes, use the arrows to navigate to the desired location, and press Enter. Again, use the arrow buttons to make your selection. Time/Date menu Setting the Time and Date This procedure will set the monitor to Local or UTC time.
2 Use the arrows to navigate to the hour as shown below. (The selection will default to the hour when the Time/Date menu is selected.) Press Enter. Use the arrow buttons to increment and decrement the selection. Press Enter to input the selection. Hours selected 3 Use the arrows to navigate to the minutes. Press Enter. Use the arrow buttons to increment and decrement the selection. Press Enter to make your selection. Minutes selected 4 Repeat this procedure to change the seconds.
5 This procedure is also used to change the date, beginning with the year. Year selected Daylight Saving Time Auto-Set VitalSense will automatically compensate for the change of Daylight Saving Time to Standard Time and back again based on the monitor’s time and date settings. However, this feature can be turned off. NOTE: Automatic Daylight Saving Time should be used only in the United States, and in those regions observing DST. 1 Use the arrow buttons to navigate to DST:, and press Enter.
Setting the UTC Offset The UTC (Universal Coordinated Time) Offset sets the differential between Local Time and the UTC time, not including Daylight Saving time. The DST setting may contribute an additional 1-hour offset based on the date, if enabled. For more information on UTC, see “ A note on UTC ” on page 2-4, and for detailed information see the appendix entitled “ Universal Coordinated Time ” on page B-1.
Setup Monitor Setup Monitor LCD Contrast If necessary, the contrast of the LCD can be adjusted. 1 Use the arrow buttons to change the contrast. 2 Press Enter.
Setup Monitor RS-232 Interface It may become necessary to change the RS-232 configuration. The default configuration is: 57.6 kilobaud, Flow Control: Off. Main > Setup Monitor > RS-232 Interface The combinations available are listed in the table below: Baud Rate 2400, 4800, 9600, 19.2 k, 38.4 k, 57.6 k, 115.2 k Flow Control ON, OFF Reporting ON, OFF NOTE: It is recommended that if you are unfamiliar with these terms, you leave the settings to the default values.
Setup Monitor Erase Data Memory Prior to initiating a new session, the data memory should be erased to provide maximum storage capacity. 1 Use the arrow buttons to access Erase Data Memory. Main > Setup Monitor > Erase Data Memory 2 Use the arrow buttons to select OK. Memory erasure will take up to 30 seconds. The monitor front panel functions will be locked out until the memory is cleared.
3 You will be prompted when the memory is clear.
Setup Monitor Reset to Defaults This procedure will return the VitalSense Monitor to the factory configuration. 1 Press the Power button on the monitor front panel. The following Main menu will appear. Main Menu 2 Using the arrow buttons, highlight Setup Monitor, and press Enter. Main > Setup Monitor 3 Using the arrow buttons, highlight Reset to Defaults, and press Enter.
4 A prompt will appear. Use the arrow buttons, select OK, and press Enter. Advisory prompt The monitor has now reset to the factory default settings.
Lockout Mode Lockout Activate Lockout Mode enables the practitioner to lock the front panel functions to discourage unauthorized tampering of the settings, or to prevent accidental activation of front panel buttons while the monitor is in the carrying pouch. 1 Use the arrow buttons to select Lockout Mode. 2 Use the arrow buttons to select OK, and press Return to activate. Main > Lockout Mode Lockout deactivate To deactivate Lockout Mode, press and hold the up arrow, and press Cancel.
Data Views Pressing the Data Views button on the VitalSense Monitor front panel will toggle two means by which to view the sensor data: Sensor List and Data Graph. 1 On the monitor front panel, press the Data Views button. A list of sensors will be displayed along with the temperature and time stamp. (Use the up and down arrows to view sensors which may not be visible on the display.
Out-of-Range Conditions With respect to periodic hygiene, change of clothing, decontamination, and other related tasks, it may be necessary to remove the VitalSense Monitor from the working range of the sensors for short periods of time. The VitalSense Monitor may be removed from sensor range for up to 30 minutes. Beyond 30 minutes, VitalSense may have difficulty resynchronizing with sensor transmissions, and a significant loss of data may occur.
2-34 Monitor Operation and Sensor Activation
