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Related Manuals for Ivy Biomedical Systems 3150-B
Summary of Contents for Ivy Biomedical Systems 3150-B
- Page 1 Model 3150-B OPERATION MANUAL Designed exclusively to operate with GE Healthcare CT Scanners GE Part Number: 5304770 Cardiac Trigger Monitor © 2014 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 2718-55-16 Part No. 2718-24-16...
- Page 2 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 4: Table Of Contents
Patient Connections ............................20 ECG Electrodes ..............................21 Impedance Measurement ..........................21 ECG Waveform Amplitude (Size) ........................22 Lead Selection ..............................23 Low Signal Message ............................24 ECG Notch Filter ..............................24 Alarm Limits ............................... 25 Pacemaker ................................25 Model 3150-B Operation Manual... - Page 5 MONITOR TESTING ............................33 ECG Simulator ..............................33 TROUBLESHOOTING ............................. 34 MAINTENANCE AND CLEANING ....................... 35 Monitor ................................35 Patient Cables ..............................35 Preventive Maintenance ............................. 35 ACCESSORIES ..............................36 ECG ..................................36 Disposal ................................36 SPECIFICATIONS ............................37 Model 3150-B Operation Manual...
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Page 6: 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 7 WARRANTY This page is intentionally left blank. Model 3150-B Operation Manual...
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Page 8: Introduction
INTRODUCTION INTRODUCTION This manual is to provide information on the correct use of the Model 3150-B 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 9: 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 3150-B Operation Manual... -
Page 10: Patient Connections
If an alarm condition occurs while the alarms are set to off, neither visual nor audio alarms will be present. The Model 3150-B 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 11 Guidance and manufacturer’s declaration – Electromagnetic emissions The Model 3150-B monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 3150-B should insure that they are used in such an environment.
- Page 12 Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 3150-B monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 3150-B should insure that they are used in such an environment.
- Page 13 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 3150-B is used exceeds the applicable RF compliance level above, the Model 3150-B 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 3150-B.
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Page 14: 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 3150-B Operation Manual... -
Page 15: Monitor Description
CT console. The Model 3150-B has a USB drive that allows the operator to store and retrieve ECG data on a USB memory stick device. The Model 3150-B also has special hardware and software that allows for the measurement of ECG electrode impedance, prior to, during and after the CT scan. -
Page 16: Classification
Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen Equipment not suitable for use in the presence of a or nitrous oxide: flammable anesthetic mixture Mode of operation: Continuous Model 3150-B Operation Manual... -
Page 17: Control And Indicators
(Basic Key) 60 - 160 10k 12k 2 0 MM/MV REC: DIRE CT 20 MM/MV STBY Recorder REC: DIRECT 18-JUL-2002 P ACER DET ECT 11:40 ECG Patient DIS ABLE D Cable Connector Alarm Pause Programmable Keys Model 3150-B Operation Manual... -
Page 18: 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 3150-B Operation Manual... -
Page 19: Menu Structure
MONITOR DESCRIPTION Menu Structure – Model 3150-B T EST MEAS URE SET UP PRINT FREEZE MODE IMPED ANCE VOL/CLOCK LIMIT S EXIT REC MODE US B DRIVE LEAD REC MODE SIM RAT E NEXT DIRECT OPT IONS QRS VOL FINE... -
Page 20: Display
System Interlock: Large symbols in the upper right hand corner of the display provide the operator with a visual indication of the status of the connection between the Model 3150-B and the CT Scanner. XRAY On/Off: 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 21: Alarm Messages
AUXILIARY: A digital interface for device communication. This auxiliary output provides 5V and -8Vwith a maximum current of 20mA. ETHERNET: This output provides an Ethernet protocol (10Base-T, IEEE 802.3) to allow the Model 3150-B and the CT scanner console to share data and control options. -
Page 22: 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 3150-B Operation Manual... -
Page 23: 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 3150-B Operation Manual... -
Page 24: 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 X-Ray HR-Var Alarm Vol. High P-Lock Enabled Disabled Model 3150-B Operation Manual... -
Page 25: Synchronized Output (Trigger)
S wave causing double triggering. The polarity control algorithm (P-Lock) reduces the number of false triggers when tall T waves or deep S waves occur. The P-Lock algorithm allows the Model 3150-B to detect and trigger only at the peak of the R wave, rejecting most of the tall T waves and deep S waves that might have caused false triggers. -
Page 26: 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 3150-B Operation Manual... -
Page 27: 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 28: Ecg Electrodes
Re-measure skin impedance after 1-2 minutes of repositioning electrodes on the patient skin. The Model 3150-B 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 your local GE Healthcare Field Engineer or contact Ivy biomedical Systems Inc at (203) 481-4183 Ext. -
Page 29: Ecg Waveform Amplitude (Size)
10k 12k 2 0 MM/MV REC: DIRE CT 20 MM/MV STBY REC: DIRECT 18-JUL-2002 P ACER DET ECT 11:40 DIS ABLE D “ECG” Soft key 2. Press the first programmable key [ECG] once to select ECG. Model 3150-B Operation Manual... -
Page 30: Lead Selection
3. Select [LEAD] to change the lead selection. The current lead selection is shown above the alarm limits in the upper left portion of the display. Available lead selections are Lead I, Lead II, or Lead III. 4. Press [EXIT] to return to the main menu. Model 3150-B Operation Manual... -
Page 31: Low Signal Message
XRAY OFF I-FILT 60 - 160 10k 12k 2 0 MM/MV REC: DIRE CT 20 MM/MV STBY REC: DIRECT 18-JUL-2002 P ACER DET ECT 11:40 DIS ABLE D 4. Press [EXIT] to return to the main menu. Model 3150-B Operation Manual... -
Page 32: 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 3150-B Operation Manual... -
Page 33: System Interlock Operation
SYSTEM INTERLOCK OPERATION System Interlock Messages When the Model 3150-B is interfaced via the rear auxiliary connector to a CT Scanner, the monitor can store ECG data and transfer this data to a USB Memory Stick . The system interlock feature is designed to indicate to the system operator: 1. -
Page 34: Patient Identification Number
When the Model 3150-B is connected to the CT console and the Ethernet mode is selected, the alphanumeric Patient ID is entered on the CT console, and transmitted to the Model 3150-B monitor. The first 12 characters of the Patient ID are shown at the top of the display above the heart rate. The same Patient ID is also stored for transmission back to the CT console if a subsequent Data Recall operation is performed. -
Page 35: Ecg Data Storage And Transfer
ECG and Impedance Data Transfer using the USB Port The Model 3150-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 data stored in the monitor. -
Page 36: Recorder Operation
Pull some paper from the roll. Make sure the sensitive (shiny) side of the paper faces the print head. The shiny side of the paper normally faces inside the roll. Align the paper with the pinch roller on the door. Print Head Pinch Roller Hold the paper against the pinch roller and close the door. Model 3150-B Operation Manual... -
Page 37: Recorder Modes
Use the following procedure to select the printing mode to be used. Selections are DIRECT, TIMED, DELAY, HR- VAR, and X-RAY. The print mode is indicated in the left center of the display. Press the [SETUP] key from the main menu. . Press the programmable key [REC MODE] to select the printing mode. Model 3150-B Operation Manual... -
Page 38: 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 X-Ray Mode Model 3150-B Operation Manual... -
Page 39: Alarm Messages
Check Electrode Message The “CHECK ELECTRODE” message will flash in yellow should any electrode impedance value be over 50k . The appropriate lead(s) will flash the value in red indicating that the value is outside the recommended range. Model 3150-B Operation Manual... -
Page 40: Monitor Testing
>0.5 V, a inoperable condition is indicated by flashing LEAD OFF indicator on the display. ECG Simulator The Model 3150-B 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 41: Troubleshooting
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. Auxiliary port is connected System Interlock symbol does not show connection Model 3150-B Operation Manual... -
Page 42: 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 3150-B. Model 3150-B Operation Manual... -
Page 43: 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 44: Specifications
1 BPM Sensitivity: 300 V peak Heart Rate Averaging: Exponential averaging calculated once a second with a maximum response time of 8 seconds. Response Time: 8 seconds Tall T Wave Rejection: Rejects T waves R wave Model 3150-B Operation Manual... - Page 45 10.44.22.21 Data Rates: 300bps to 115.2Kbps Standard Temperature: 32 to 158°F (0 to 70°C) Size: 1.574 x 1.929 in (40mm x 49mm) Mechanical Size: Height: 6.70in. (17.2cm) Width: 9.25in. (33.5cm) Depth: 9.21in. (23.4cm) Weight: 6.5lbs (2.9kg) Model 3150-B Operation Manual...
- Page 46 Consumption: 45 VA Regulatory Unit meets or exceeds the specifications for the AAMI Cardiac Monitor Standard EC-13, UL60601-1, 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 13485:1996, and FDA/CGMP. Model 3150-B Operation Manual...
- Page 47 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 2738-12-15 Recorder Option 2739-01-15 ECG Simulator Option 2772-00-15 Accessory Option 2740-31-15...
- Page 48 ADDENDUM 2 Model 3100-B / 3150-B Installation Instructions 1. Remove the new monitor from the shipping carton. 2. Line up the new monitor and its adapter plate with the mounting plate on the roll stand. Pull down the safety pin and slide the monitor on the adapter plate. Release the safety pin and make sure safety pin is engaged in the adapter plate (The adapter plate has a hole to allow the safety pin to secure the monitor).
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