Invivo Corporation VISION TelePak TELEMETRY TRANSMITTER OPERATIONS MANUAL Model Number 20701
TABLE OF CONTENTS Paragraph Number Page Number Equipment Classification .............................................................................................................. i Precautions .................................................................................................................................... ii User Responsibility ........................................................................................................................v Accessories .........................
Precautions General Federal law in the USA or Canada restricts this device to sale by, or on, the order of a physician. The Alkaline AA batteries powering the VISION TelePak are consumable components and must be replaced regularly to ensure proper operation. Dispose used batteries properly, according to local regulations. Use only high-quality, 1.5V size AA Alkaline batteries in the VISION TelePak. Use of other batteries may shorten battery life.
Precautions SpO2 Use only NONINTM SpO2 sensors specified for VISION TelePak. Incorrect sensor application or use may cause tissue damage or improper operation of the transmitter. Follow directions for use provided. Incident light, poor perfusion, and other factors may affect SpO2 performance and accuracy. Inaccurate measurements or loss of pulse signal may be caused by: • Incorrect sensor application or use. • Significant levels of dysfunctional hemoglobins (HbCO or MetHb).
USER RESPONSIBILITY This product must be checked periodically for proper operation. A defective or questionable product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should such repair or replacement become necessary, Invivo recommends that a telephone call or written request for service be made to the factory or nearest service center.
Accessories VISION TelePak Telemetry Transmitter Item Description Part Number VISION TelePak Shielded 5-Leadwire Set..................................................................................E2910-50 VISION TelePak XPod SpO2 Patient Cable................................................................................E2910-51 VISION TelePak 8000A Clip Finger Sensor (for use with E2910-51) ......................................E2910-52 VISION TelePak IPod SpO2 Cable/Sensor (complete) ..................
SECTION 1 VISION TelePak TELEMETRY TRANSMITTER 1.0 VISION TelePakTM TELEMETRY TRANSMITTER. 1.1 Introduction. The VISION TelePakTM telemetry transmitter is intended only as an adjunct to patient assessment. It cannot replace skilled nursing care and proper surveillance. Carefully read this operator’s manual, all directions for use of the VISION TelePak, Invivo monitors and monitor accessories, and all precautionary information before attempting clinical use of the VISION TelePak.
1.2.1 Control Keys. The VISION TelePak has three control keys that provide the operator with a method for changing the displayed waveform, activating the nurse call system, making a remote printout and navigation through the operational menu’s. Control Key Description Waveform Control Key. The Waveform key provides the ability to select the displayed waveform. There are up to five (5) waveforms available: ECG Leads I, II, III and V, and (if available) SpO2.
(e) (2) To the left of the waveform there is a single vertical line that is equivalent to 1 mV in height. This line indicates the relative size of the waveform. (f) There is no user control of waveform sizing. The size bar adjusts automatically as required. If the waveform peaks are above the display the system will size down and if no waveform appears in the upper 1/3 of the display then the system will size up. (g) There is no size bar during SpO2 waveform display.
(1) Available BIO Configuration settings are: Channel ID, Language, LCD Intensity, SpO2 Avg., SpO2 Mode, Nurse Call Timeout, Remote Record Enable, 3- or 5-Lead Selection and 3-Lead Default. (a) SELECT CHANL. This selects the channel ID for connection to the Vision Central Station or bedside monitor. (b) LANGUAGE. The only language supported at this time is English. (c) LCD BIAS. This value will adjust the LCD contrast setting with an available range of 0 - 31. The default is 15. (d) NURSE.
1.2.5 SpO2 Operation. The NONIN SpO2 module is automatically detected when plugged in with the display screen reconfiguring for the SpO2 data. a. SpO2 Modes of Operation. There are two (2) modes of operation available: Continuous and Interval. (1) Continuous Mode of Operation. This mode provides continuous SpO2 readings and waveform data. If no valid readings are obtained, the values are set to “---” to indicate that they are invalid. (2) Interval Mode of Operation.
1.8 Cleaning. The following guidelines provide information on cleaning the VISION TelePak: a. For cleaning, use only a lint-free, nonabrasive cloth which has been slightly dampened with mild detergent, a glass cleaner, or a non-alcoholic based solvent. b. Avoid harsh cleaning solutions such as isopropyl alcohol or other solvents that might harm plastic surfaces. Avoid anti-bacterial cleaning solutions, especially those containing Phenol. c. Do not immerse unit or any components in liquid. d.
APPENDIX A SPECIFICATIONS GENERAL Patient Safety Designed to meet the requirements of CSA, UL 2601 and IEC 601-1. Transmitter complies with radio frequency exposure limits specified in FCC sections 1.1307 and 2.1093. Water resistant. Defibrillator protection up to 5 KV. Power Requirements Operating Voltage 3 V. Battery Type Two (2) 1.5V AA batteries, alkaline. Battery Operation Time 36 hours with continuous SpO2, minimum. 72 hours with ECG only, minimum.
ECG CHANNEL ECG Amplifier Over voltage Protection Protected against defibrillator and electro surgery potentials. Standard Lead Configurations I, II or III and V. Differential Input Impedance 20 Meg. Common Mode Rejection Ratio >80 dB. Electrode Offset Potential +/- 300 mV. Baseline Recover from defibrillation <3 seconds. Alarms Set at the Remote Monitor. PULSE OXIMETER SpO2 port standard for NONIN external SpO2 sensor module.
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