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Summary of Contents for Ivy Biomedical Systems 3000T
- Page 1 Toshiba Model 3000 OPERATION MANUAL With options T-A or T-B Designed exclusively to operate with Toshiba Medical Systems CT Scanners Cardiac Trigger Monitor © 2010 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 2718-55-16 Part No. 2718-52-16...
- Page 3 IVY Biomedical Systems, Inc. recommends that a telephone call or written request for service advice be made to IVY Biomedical Systems, Inc. Service Department. This product or any of its parts should not be repaired other than in accordance with instructions provided by IVY Biomedical Systems, Inc. trained personnel.
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- Page 5 Models: 3000 (T Option) We, Ivy Biomedical Systems, Inc., hereby declare that the devices mentioned above comply with the Swedish National Board of Health and Welfare Regulation and guidelines on medical devices LVFS 2003:11 (M) 28 October 1994 – transposing European Medical Devices Directive 93/42/EEC.
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Page 7: Table Of Contents
Intended Use ................................. 9 Classification ................................. 9 Control and Indicators ............................9 Basic Keys ..............................9 Programmable Keys ..........................10 Menu Structure Model 3000T-A ......................11 Menu Structure Model 3000T-B ......................12 Display ..............................13 Alarm Messages ............................. 14 Rear Panel .............................. 14 Fuse Ratings ............................ - Page 8 ECG Notch Filter ..............................24 Alarm Limits ............................... 25 Pacemaker ................................25 ECG DATA STORAGE AND TRANSFER (Model 3000T-B only) .............. 26 ECG and Impedance Data Transfer using the USB Port ................26 USB Port ................................26 RECORDER OPERATION ..........................27 Changing Paper ..............................
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Page 9: Warranty
WARRANTY WARRANTY All products manufactured by Ivy Biomedical Systems, Inc. under normal use, are warranted to be free from defects in material and workmanship and to operate within published specifications, for a period of 13 months from date of original shipment. - Page 10 WARRANTY This page is intentionally left blank. Model 3000T Operation Manual...
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Page 11: Introduction
INTRODUCTION This manual is to provide information on the correct use of the Model 3000T Cardiac Trigger monitor. It is up to the user to ensure that any applicable regulations regarding the installation and operation of the monitor are observed. -
Page 12: Safety
300 μA. Explosion DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environment or nitrous oxide. Model 3000T Operation Manual... -
Page 13: Patient Connections
If an alarm condition occurs while the alarms are set to off, neither visual nor audio alarms will be present. The Model 3000T should not be used within the magnetic field during Magnetic Resonance Imaging. Pacemakers Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. - Page 14 WARNING: The Model 3000T should not be used adjacent to or stacked with other equipment, however if adjacent or stacked use is necessary, the Model 3000T should be observed to verify normal operation in the configuration in which it will used.
- Page 15 Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 3000T monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 3000T should insure that they are used in such an environment.
- Page 16 To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 3000T is used exceeds the applicable RF compliance level above, the Model 3000T should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 3000T.
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Page 17: Description Of Warning Labels
Output signal. _______ Input signal. Stand By (STBY) Alternate Current (AC) Protective earth (ground) Input/Output signal WEEE Compliance Manufacturer Caution - Electric shock hazard. Do not remove covers or panels. Refer service to qualified service personnel. Model 3000T Operation Manual... -
Page 18: Monitor Description
The Model 3000T-B has a USB drive that allows the operator to store and retrieve ECG data on a USB memory stick device. The Model 3000T-B also has special hardware and software that allows for the measurement of ECG electrode impedance, prior to, and after the CT scan. -
Page 19: Intended Use
Intended Use The Ivy Biomedical Model 3000T Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. -
Page 20: Programmable Keys
Displayed above each programmable key is either a menu item or a function. Pressing a programmable key will display other menu levels or activate an appropriate function. Menu functions are described in the Menu Structure section of this manual. Model 3000T Operation Manual... -
Page 21: Menu Structure Model 3000T-A
MONITOR DESCRIPTION Menu Structure – Model 3000T-A Model 3000T Operation Manual... -
Page 22: Menu Structure Model 3000T-B
MONITOR DESCRIPTION Menu Structure – Model 3000T-B Model 3000T Operation Manual... -
Page 23: Display
ECG: Trace is displayed across the screen moving from left to right. XRAY ON/OFF (available only in model 3000T-B*): Indicates that the CT-Scanner X-Ray is “ON” or the CT Scanner X-Ray is “OFF”. The XRAY On/Off indicator is located in the upper right hand corner of the display. -
Page 24: Alarm Messages
The date of manufacture is encoded in the first 4 digits of the serial number using the YYMM format. LINE VOLTAGE SELECTOR: Switch to select the input voltage range of the device (100 to 230V~, 47 to 63 Hz.). Model 3000T Operation Manual... -
Page 25: Fuse Ratings
The fuses are located behind the cover of the power entry module. To replace the fuses, unplug the ac power cord. Remove the power entry module cover and replace the fuse(s) only with same type and rating T.5A, 250V (Metric 5x20mm). Model 3000T Operation Manual... -
Page 26: Monitor Setup
9. Press [NEXT] to move to the MINUTE setting. Use the keys to increase or decrease the minute setting. When all date, clock and audio settings are correct, select [EXIT] to enter the settings into the monitor’s memory. Model 3000T Operation Manual... -
Page 27: Trace Speed
Some settings (see list below) are stored in non-volatile memory which means that the monitor powers up with the same options that were in effect when power was last turned off. Setting Options Speed 25mm/sec 50mm/sec Recorder Direct Timed Delay Alarm Vol. High P-Lock Enabled Disabled Model 3000T Operation Manual... -
Page 28: Synchronized Output (Trigger)
T rigger S p ot T rigger Ma rk *The model 3000T that is available in Japan may be set to generate a trigger pulse of 50ms (width) and 0-5V (amplitude) instead of the standard trigger pulse of 100ms and 0-5V. -
Page 29: Ecg Monitoring
Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance. Model 3000T Operation Manual... -
Page 30: Patient Connections
Use only high quality silver/silver-chloride short term monitoring ECG electrodes such as Ivy part number: 590342. Use only high quality silver/silver-chloride ECG Electrodes or equivalent. For best ECG performance, use ECG Electrodes supplied by Ivy Biomedical Systems (see Accessories). Use the following procedure for ECG monitoring: 1. -
Page 31: Ecg Electrodes
Re-measure skin impedance after 1-2 minutes of repositioning electrodes on the patient skin. The Model 3000T can also be set up to take two measurements after the LEAD OFF alarm disappears. The measurements will occur at 30 and 60 seconds intervals after the LEAD OFF alarm is inactive. For information on how to activate this feature contact Ivy biomedical Systems Inc at (203) 481-4183. -
Page 32: Ecg Waveform Amplitude (Size)
ECG MONITORING Cardiac Trigger Monitor 3000T Cardia c Trigger Monitor 3150 PA T IENT ID 858745 11:40 XRAY ON IMPEDANCE I-FILT XRAY OFF I-FILT 60 - 160 10k 12k 2 0 MM/MV REC: DIRE CT 20 MM/MV STBY REC: DIRECT... -
Page 33: Lead Selection
ECG MONITORING Cardiac Trigger Monitor 3000T Cardia c Trigger Monitor 3150 PA T IENT ID 858745 11:40 XRAY ON IMPEDANCE I-FILT XRAY OFF I-FILT 60 - 160 10k 12k 2 0 MM/MV REC: DIRE CT 20 MM/MV STBY REC: DIRECT... -
Page 34: Low Signal Message
The filter sets the frequency response of the displayed waveform as follows: Filtered: 3.0 to 25 Hz Unfiltered: 0.2 to 100 Hz Cardiac Trigger Monitor 3000T Cardia c Trigger Monitor 3150 PA T IENT ID 858745 11:40 XRAY ON... -
Page 35: Alarm Limits
The message “PACER DETECT DISABLED” will appear if the pacer detection circuit is not active. WARNING: Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on heart rate alarms. Keep pacemaker patients under close surveillance. Model 3000T Operation Manual... -
Page 36: Ecg Data Storage And Transfer (Model 3000T-B Only)
ECG and Impedance Data Transfer using the USB Port The Model 3000T-B has a USB port that allows the user to connect a USB memory stick and retrieve up to 100 ECG events and measured impedance values stored in the monitor. -
Page 37: Recorder Operation
Align the paper with the pinch roller on the door. Print Head Pinch Roller Pinch Roller Hold the paper against the pinch roller and close the door. Model 3000T Operation Manual... -
Page 38: Recorder Modes
Delay mode plots 30 or 40 seconds of ECG waveform after the occurrence of an alarm condition or if print button is pushed depending on the speed selected: 15 seconds before and 15 seconds after at 50mm/s 20 seconds before and 20 seconds after at 25mm/s Model 3000T Operation Manual... -
Page 39: Recorder Speed
Use the following procedure to change the recorder speed. Press the [SPEED] key in the main menu to select the trace speed. Selections are 25, and 50 mm/s. NOTE: The [SPEED] key also changes the speed of the ECG trace. Example Printout Direct Mode Model 3000T Operation Manual... -
Page 40: Alarm Messages
The message “PACER DETECT DISABLED” will appear if the pacer detection circuit is disabled through the ECG menu. Check Electrode Message (Model 3000T-B only) The “CHECK ELECTRODE” message will flash in yellow should any electrode impedance value be over 50kΩ. -
Page 41: Monitor Testing
>0.5 V, a inoperable condition is indicated by flashing LEAD OFF indicator on the display. ECG Simulator The Model 3000T has an integrated ECG simulator that is used to verify the integrity of the patient cable, lead wires and electronic circuits involved in the processing of the ECG signal. -
Page 42: Troubleshooting
ECG size is optimal (select Lead II) ECG waveform has enough amplitude (Select Lead II). Erratic ECG waveform. Heart Rate is Electrodes placement (see ECG section for proper not counting. placement diagram). ECG electrodes have enough conductive gel. Model 3000T Operation Manual... -
Page 43: Maintenance And Cleaning
The LEAD OFF message is displayed when the patient cable is connected, but the patient leads are not connected. Connecting the patient leads together should make the message disappear. The BNC Interconnect cable is clean and intact. NOTE: There are no user serviceable items contained in the Model 3000T. Model 3000T Operation Manual... -
Page 44: Accessories
WEEE Directive 2002/96/EC.- Do not dispose of WEEE products in general waste. At the end of life of product contact IVY Biomedical Systems, Inc. customer service for return instructions. See Addendum 1 for a table of hazardous substances and their concentrations. -
Page 45: Specifications
300 V peak Sensitivity: Heart Rate Averaging: Exponential averaging calculated once a second with a maximum response time of 8 seconds. Response Time: ≤ 8 seconds (typically 2-3 sec) Rejects T waves R wave Tall T Wave Rejection: Model 3000T Operation Manual... - Page 46 Delay - Records 20 seconds before and 20 seconds after an alarm Paper Speeds: 25 and 50 mm/s Resolution: Vertical - 200 dots/in. Horizontal - 600 dots/in. at 25 mm/s 400 dots/in. at >25 mm/s Frequency Response: >100 Hz at 50 mm/s Data Rate: 400 samples/s/trace Model 3000T Operation Manual...
- Page 47 Consumption: 35 VA Regulatory Unit meets or exceeds the specifications for the AAMI Cardiac Monitor Standard EC-13, UL2601-1, CAN/CSA C22.2 No 601.1-M90, CDN MDR (CMDCAS), IEC 60601-2-25, IEC 60601-2-27, MDD.93/42/EEC, CE 0143, ISO 13485, and FDA/CGMP. Model 3000T Operation Manual...
- Page 48 ADDENDUM 1 Table of hazardous substances’ name and concentration Hazardous substances’ name Assembly (Pb) (Hg) (Cd) (PBB) (PBDE) Component name Number Main assembly 2700-00-01 Front assembly 2699-01-01 Rear Panel assembly 2697-00-01 Model Option 2738-05-15 Recorder Option 2739-01-15 ECG Simulator Option 2772-00-15 Accessory Option 2740-32-15...
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