Related Manuals for Ivy Biomedical Systems 7600
Summary of Contents for Ivy Biomedical Systems 7600
- Page 1 Model 7600/7800 OPERATION MANUAL Cardiac Trigger Monitor Model 7800 shown © 2017 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 3232-00-16 Rev.12 EN Part No. 2718-55-16...
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Page 2: Table Of Contents
7.5 Setting the Alarm Limits......................20 7.6 Setting the Trace Speed ....................... 20 7.7 Default Settings ..........................21 8.0 SYNCHRONIZED OUTPUT (TRIGGER) ....................22 8.1 The Synch Pulse ..........................22 8.2 Trigger Mark ..........................22 8.3 Polarity Lock (P-Lock) ........................ 22 Model 7600/7800 Operation Manual... - Page 3 17.0 ACCESSORIES ............................42 18.0 DISPOSAL ..............................43 18.1 WEEE Directive 2012/19/EU ....................... 43 18.2 RoHS Directive 2011/65/EU ......................43 18.3 Standard of the Electronics Industry of the People’s Republic of China SJ/T11363-2006 ..43 19.0 SPECIFICATIONS ..........................44 Model 7600/7800 Operation Manual...
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Page 4: User Responsibility
Ivy Biomedical Systems, Inc. recommends that a telephone call or written request for service advice be made to Ivy Biomedical Systems, Inc.’s 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.’s trained personnel. -
Page 5: Manual Revision History
MANUAL REVISION HISTORY 2.0 MANUAL REVISION HISTORY Revision Date Description August 11, 2011 Initial Release of Model 7600 Operation Manual March 13, 2012 Changed title to Model 7600/7800 Operation Manual. Added model 7800 description, specifications etc. to Operation Manual. May 7, 2012 Revised Operation Manual to comply with IEC 60601-1 3 edition. -
Page 6: Warranty
WARRANTY 3.0 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: Introduction
INTRODUCTION 4.0 INTRODUCTION This manual provides information on the correct use of the Model 7600/7800 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 8: Safety
WARNING: Do not position the monitor in a way that would cause difficulty to the operator to disconnect it from the power source. WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to trained and qualified service personnel. Model 7600/7800 Operation Manual... -
Page 9: Explosion
To ensure that the leakage current protection remains within the specifications, use only the patient cables specified in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected Model 7600/7800 Operation Manual... -
Page 10: Mri
If an alarm condition occurs while the alarms are set to off, neither visual nor audio alarms will be present. 5.4 MRI The Model 7600/7800 should not be used within the magnetic field during Magnetic Resonance Imaging. 5.5 Pacemakers WARNING – PACEMAKER PATIENTS: Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. -
Page 11: Accessories
Guidance and manufacturer’s declaration – Electromagnetic emissions The Model 7600/7800 monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 7600/7800 should ensure that it is used in such an environment. - Page 12 Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 7600/7800 monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 7600/7800 should ensure that it is used in such an environment.
- Page 13 RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 7600/7800 is used exceeds the applicable RF compliance level above, the Model 7600/7800 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 7600/7800.
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Page 14: Description Of Symbols Used
Input Signal Earth (Ground) Input / Output Signal Power On/Standby Manufacturer Date of Manufacture Alarm Mute ∼ WEEE Compliant Alternating Current Electric shock hazard: Do not remove covers or panels. Refer service to qualified service personnel. Model 7600/7800 Operation Manual... -
Page 15: Monitor Description
MONITOR DESCRIPTION 6.0 MONITOR DESCRIPTION The Model 7600/7800 is an easy-to-use Cardiac Trigger Monitor that features a bright color touch screen LCD display. The Model 7600/7800 displays two simultaneous ECG vectors and the patient’s heart rate. The Trigger ECG vector (top ECG waveform) can be selected from Leads I, II III or Auto. The Second ECG vector (bottom ECG waveform) can be selected from Leads I, II or III. -
Page 16: Intended Use
Degree of safety of application in the presence of a Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen flammable anesthetic mixture or nitrous oxide: Mode of operation: Continuous Model 7600/7800 Operation Manual... -
Page 17: Controls And Indicators
Dual, Simultaneous XRAY Status ECG Waveforms with (Model 7800 Only) Lead Selection 6-Pin ECG Patient Cable Connector Power On/Standby Switch (Basic Key) Model 7800 shown Mains Power Programmable Alarm Mute Switch LED Indicator Touch Keys (Basic Key) Model 7600/7800 Operation Manual... -
Page 18: Display
WARNING: The monitor powers on with audible alarms paused for 30 seconds. Other configuration options are available upon request. 6.8 Programmable Touch Keys Pressing a programmable touch key will display other menu levels or activate an appropriate function. Menu functions are described in the Menu Structure. Model 7600/7800 Operation Manual... -
Page 19: Menu Structure
Recorder Mode: Direct, Timed, Delay TEST OFF Mode: Adult, Ped/Neo ECG MENU MAIN Size: 5, 10, 20, 40mm/mV MENU Filter: On, Off Model 7800 Only Selections: P-Lock: On, Off Measure Impedance Pacer Detect: On, Off USB Menu Model 7600/7800 Operation Manual... -
Page 20: Rear Panel
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 rating and type: T 0.5AL, 250V. Model 7600/7800 Operation Manual... -
Page 21: Rear Panel Description
• Use of the accessory in the PATIENT VICINITY • Evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard Model 7600/7800 Operation Manual... -
Page 22: Monitor Setup
7.0 MONITOR SETUP 7.1 Monitor Installation CAUTION: Underwriters Laboratory (UL) has not tested/approved the Model 7600/7800 with Roll Stand (Ivy P/N: 590441) as a system. Assemble the Roll Stand (Ivy P/N: 590441) by following the GCX Light Duty Roll Stand Assembly Instructions (DU-RS-0025-02). -
Page 23: Setting The Date And Time
Press the [DISPLAY MENU] touch key in the main menu. Press the [SPEED] touch key to select the trace speed. Selections are 25 and 50 mm/s. CAUTION: The [SPEED] touch key also changes the speed of the recorder. Model 7600/7800 Operation Manual... -
Page 24: Default Settings
On or Off (Configuration Dependent) Pacer Detection On or Off (Configuration Dependent) Default/Stored settings may be customized (password required) by a Responsible Organization. For information on how to activate this feature, contact Ivy Biomedical Systems at (203) 481-4183. Model 7600/7800 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 7600/7800 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
CAUTION: The Model 7600/7800 is compatible with HF electrosurgical devices. When used with HF electrosurgical devices, applied parts of the equipment are provided with protection against burning of the patient. -
Page 27: Patient Connections
Systems (see Accessories). Other cables might not produce reliable results. 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: Prepare each electrode site and apply the electrodes. -
Page 28: Ecg Electrodes
Nuprep gel (Ivy P/N: 590291). Alternatively, it may be necessary to remove cream or powder from the patient’s skin using warm soapy water. Model 7600/7800 Operation Manual... -
Page 29: Impedance Measurement (Model 7800 Only)
• For proper skin preparation follow the instructions indicated on the ECG electrode packaging. • Re-measure skin impedance after 1-2 minutes of repositioning electrodes on the patient’s skin. Measure Impedance Touch Key Impedance Values in kΩ Model 7600/7800 Operation Manual... -
Page 30: Ecg Waveform Amplitude (Size)
The FILTER sets the frequency response of the displayed waveform as follows: Filtered: 1.5 to 40 Hz or 3.0 to 25 Hz (Configuration Dependent) Unfiltered: 0.67 to 100 Hz Press [MAIN MENU] to return to the main menu. Model 7600/7800 Operation Manual... -
Page 31: Lead Selection
9.7 Lead Selection The Model 7600/7800 includes an AUTO lead select feature (Trigger lead only). When selected, this feature will determine which lead (I, II or III) provides the best quality ECG signal and thus a more reliable cardiac trigger. -
Page 32: Low Signal Message
PATIENTS under close surveillance. See the SPECIFICATIONS section in this manual for disclosure of the pacemaker pulse rejection capabilities of this instrument. AV sequential pacemaker pulse rejection has not been evaluated; do not rely on pacemaker rejection with patients with dual chamber pacemakers. Model 7600/7800 Operation Manual... -
Page 33: Alarm Limits
Each time you press a key, the corresponding limit changes by 5 BPM. The current HR limits are shown in the upper portion of the display directly under the heart rate reading. Press [MAIN MENU] to return to the main menu. Alarm Type Default Limit Heart Rate Low Heart Rate High Model 7600/7800 Operation Manual... -
Page 34: System Interlock Operation
XRAY ON: The CT Scanner X-Ray is active or “ON”. The Model 7800 will store ECG data during this time. XRAY OFF: The CT Scanner X-Ray is “OFF”. XRAY DISCONNECT: The Model 7800 and the CT scanner are NOT interfaced correctly. STORING DATA: ECG data is being stored. X-RAY Status STORING DATA Model 7600/7800 Operation Manual... -
Page 35: Ecg Data Storage And Transfer
USB type memory drive (memory stick) with a minimum capacity of 1GB. The connection of any other type of USB device to this port could result in damage to the monitor. WARNING: The USB memory device used with this port MUST NOT BE POWERED FROM AN EXTERNAL SOURCE. USB Port Model 7600/7800 Operation Manual... -
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 7600/7800 Operation Manual... -
Page 37: Recorder Modes
Delay mode automatically prints 30 or 40 seconds of ECG waveform after the occurrence of an alarm condition 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 7600/7800 Operation Manual... -
Page 38: Recorder Speed
Press the [SPEED] touch key in the [DISPLAY MENU] select the recorder speed. Selections are 25, and 50 mm/s. NOTE: The [SPEED] touch key also changes the speed of the ECG trace. 12.4 Sample Printouts DIRECT Mode: XRAY Mode (Model 7800 Only): Model 7600/7800 Operation Manual... -
Page 39: Alarm Messages
HR HIGH The high heart rate alarm limit has been exceeded for three seconds. HR LOW The low heart rate alarm limit has been exceeded for three seconds. ASYSTOLE The interval between heartbeats has exceeded six seconds. Model 7600/7800 Operation Manual... -
Page 40: Technical Alarms
Check Electrode Message (Model 7800 Only) The “CHECK ELECTRODE” message will be displayed in yellow should any electrode impedance value be over 50kΩ. The appropriate lead(s) will flash the value in red indicating that the value is outside the recommended range. Model 7600/7800 Operation Manual... -
Page 41: Monitor Testing
1) LEAD OFF message disappears, and 2) Monitor starts counting QRS. 14.2 ECG Simulator The Model 7600/7800 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 Unplug the patient cable. Check that the LEAD OFF message is displayed and the audio alarm is present. CAUTION: The above simulator test should be performed each time prior to monitoring a patient. If the above indications are not present, contact qualified service personnel. Model 7600/7800 Operation Manual...
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Page 43: Troubleshooting
ECG waveform has enough amplitude (Select Lead II or Erratic ECG waveform. Heart Rate is AUTO). not counting. Electrodes placement (see ECG section for proper placement diagram). ECG electrodes have enough conductive gel. Measured Impedance < 50kΩ. Model 7600/7800 Operation Manual... -
Page 44: Maintenance And Cleaning
Wipe the cables using a cloth dampened with water. Never submerge the cables in any liquid or allow liquids to enter the electrical connections. 16.3 Preventive Maintenance The Model 7600/7800 cardiac trigger monitor does not require any preventive maintenance. There are no serviceable items contained in the Model 7600/7800. Check before connecting the monitor to a new patient that: •... -
Page 45: Accessories
Roll stand with 3” Plunger Plate 3302-00-15 Roll stand mounting kit for 7000 series monitors To order accessories please contact customer service: • Tel: (800) 247-4614 • Tel: (203) 481-4183 • Fax: (203) 481-8734 • E-mail: sales@ivybiomedical.com Model 7600/7800 Operation Manual... -
Page 46: Disposal
Ivy Biomedical Systems, Inc.’s Customer Service for return instructions. 18.2 RoHS Directive 2011/65/EU The Model 7600/7800 and its accessories are in compliance with the RoHS Directive 2011/65/EU. 18.3 Standard of the Electronics Industry of the People’s Republic of China... -
Page 47: Specifications
±3% ±1kΩ Measurement Accuracy: Measurement Leads: RA, LA, LL, RL Measurement Mode: Manual Measurement Time: < 4 seconds; ECG recovery < 8 seconds Minimum Recommended <50kΩ Electrode Impedance: Recommended Electrode: 10% Chloride sponge type (Ivy P/N: 590436) Model 7600/7800 Operation Manual... - Page 48 Sensitivity: Heart Rate Averaging: Exponential averaging calculated once a second with a maximum response time of 8 seconds. Response Time – Model 7600: – Change from 80 to 120 BPM: 8 seconds – Change from 80 to 40 BPM: 8 seconds Response Time –...
- Page 49 SPECIFICATIONS Display - Model 7600 Type: Active Matrix TFT Color Touch Screen LCD (640x480) Trace: Dual simultaneous ECG traces with “freeze” function. Screen Size: 13.25cm x 9.94cm, 16.5cm (6.5in) diagonal Sweep Speed: 25, 50 mm/s Display - Model 7800 Type:...
- Page 50 -100 meters to +14,000 meters Power Requirements Voltage Input: 100-120V~; 200-230V~ Line Frequency: 50/60 Hz Fuse Rating and Type: T 0.5AL, 250V Maximum ac Power Consumption: 45 VA Power Recovery: Automatic, if power is restored within 30 seconds Model 7600/7800 Operation Manual...
- Page 51 CAN/CSA C22.2 No. 601.1-M90:2005 • CDN MDR (CMDCAS) • CAN/CSA-C22.2 No. 60601-1:2008 • CAN/CSA-C22.2 No. 60601-1:2014 • CAN/CSA-C22.2 No. 60601-1-2:2016 • MDD 93/42/EEC • CE 0413 • ISO 13485:2003 • RoHS 2011/65/EU • WEEE 2012/19/EU • FDA/CGMP Model 7600/7800 Operation Manual...
- Page 52 IEC 60601-2-27 (2011), IEC 60601-1-6:2010 (Third Edition) + A1:2013, IEC 60601-1- 8: 2006 (Second Edition) + Am.1: 2012 Ivy Biomedical Systems, Inc. has declared that this product conforms with the European Council Directive 93/42/EEC Medical Device Directive when it’s used in accordance with the instructions provided in the Operation and Service Manuals.
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