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Ivy Biomedical Systems 7810 Operation Manual

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Model 7810
OPERATION MANUAL
Cardiac and Respiratory
Synchronization Monitor
© 2023 IVY Biomedical Systems Inc. All Rights Reserved.
REF: 3541-00-16 Rev.06 EN

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Summary of Contents for Ivy Biomedical Systems 7810

  • Page 1 Model 7810 OPERATION MANUAL Cardiac and Respiratory Synchronization Monitor © 2023 IVY Biomedical Systems Inc. All Rights Reserved. REF: 3541-00-16 Rev.06 EN...

  • Page 3: Table Of Contents

    7.4 Setting the QRS and Alarm Volume ................... 25 7.5 Setting the Alarm Limits......................25 7.6 Setting the Monitor Mode ......................25 7.7 Setting the Trace Speed ....................... 25 7.8 Default Settings ..........................26 7.9 Customer Settings......................... 27 Model 7810 Operation Manual...
  • Page 4 13.2 Recorder Modes ..........................47 13.3 Recorder Speed ..........................48 13.4 Sample Printouts .......................... 48 14.0 ALARM MESSAGES ..........................49 14.1 Reminder Signals .......................... 49 14.2 Patient Alarms ..........................49 14.3 Technical Alarms .......................... 50 14.4 Informatory Messages ........................50 Model 7810 Operation Manual...
  • Page 5 19.1 WEEE Directive 2012/19/EU ....................... 58 19.2 RoHS Directive 2011/65/EU ......................58 19.3 Standard of the Electronics Industry of the People’s Republic of China SJ/T11363-2006 ..58 20.0 SPECIFICATIONS ..........................59 21.0 REGULATORY COMPLIANCE ......................64 Model 7810 Operation Manual...
  • Page 6 TABLE OF CONTENTS This page is intentionally left blank. Model 7810 Operation Manual...

  • Page 7: 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 8: Manual Revision History

    2.0 MANUAL REVISION HISTORY Revision Date Description November 16, 2016 Initial release of the Model 7810 Operation Manual. March 1, 2017 Revised section 20.0 to include additional regulatory standards. February 19, 2019 Revised section 5.0 as per new requirements for IEC 60601-1-2:2014.

  • Page 9: 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 10: Introduction

    Fax: +1 203.481.8734 E-mail: sales@ivybiomedical.com This manual explains how to set up and use the Model 7810. Important safety information is located throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE YOU OPERATE THE MONITOR. Model 7810 Operation Manual...

  • Page 11: Safety

    (UPS). WARNING: Do not place the monitor in any position that may cause it to fall on the patient. Do not lift the monitor by the power supply cord or ECG trunk cable. Model 7810 Operation Manual...
  • Page 12 Not intended for detecting a breath rate alarm or apnea events. WARNING: To ensure proper monitor ventilation, do not use the monitor without the bottom cover feet or the optional bottom cover mounting plate. WARNING: Do not modify this equipment without authorization of the manufacturer. Model 7810 Operation Manual...

  • Page 13: Explosion

    WARNING: MR-unsafe! Do not expose the Model 7810 to a magnetic resonance (MR) environment. The Model 7810 may present a risk of projectile injury due to the presence of ferromagnetic materials which can be attracted by the MR magnet core.

  • Page 14: Pacemakers

    WARNING: The Model 7810 should not be used adjacent to or stacked with other equipment. However, if adjacent or stacked use is necessary, the Model 7810 should be observed to verify normal operation in the configuration in which it will be used.

  • Page 15: Accessories

    Guidance and manufacturer’s declaration – Electromagnetic emissions The Model 7810 monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 7810 should ensure that it is used in such an environment. Emissions test...

  • Page 16: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 7810 monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 7810 should ensure that it is used in such an environment. Immunity test...
  • Page 17 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 7810 is used exceeds the applicable RF compliance level above, the Model 7810 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 7810.

  • Page 18: Symbols Glossary

    Defibrillator-proof To identify a defibrillator type CF Applied proof type CF applied part IEC 60417 reference 5336 Part complying with IEC 60601-1 Quantity Indicates the quantity. Model 7810 Operation Manual...
  • Page 19 To identify the control whereby a bell may be Alarm Mute switched off or to indicate ISO 7000 reference 5576 the operating status of the bell Model 7810 Operation Manual...
  • Page 20 IEC 62570 reference 7.3.3 other persons within the MR environment Indicates compliance with WEEE Compliant the Waste from Electrical WEEE Directive 2012/19/EU and Electronic Equipment Directive Dangerous Voltage To indicate hazards arising IEC 60417 reference 5036 from dangerous voltage Model 7810 Operation Manual...
  • Page 21 ISO 7000 reference 0632 limits at which the item shall be stored, transported or used. To indicate the acceptable Humidity upper and lower limits of ISO 7000 reference 2620 Limitation relative humidity for transport and storage. Model 7810 Operation Manual...
  • Page 22 Product was not intended Do not autoclave to be sterilized in a steam sterilizer (autoclave) To indicate the entity Importer importing the medical ISO 7000 reference 3725 device into the locale Model 7810 Operation Manual...

  • Page 23: Monitor Description

    Data exchanged includes monitor command and control, patient case identifiers, parameter waveform data, and trigger timing. • The Model 7810 has a USB drive that allows the operator to store and retrieve parameter data onto a USB memory stick device. •...

  • Page 24: Intended Use

    MONITOR DESCRIPTION 6.1 Intended Use The Ivy Biomedical Model 7810 is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.

  • Page 25: Controls And Indicators

    Readings in kΩ 4-Lead ECG Simulator RA, RL, LL, LA ECG Waveform Respiration Connector Respiration Waveform 6-Pin ECG Trunk Cable Connector Power On/Standby Switch (Basic Key) Mains Power Alarm Mute Switch LED Indicator Programmable (Basic Key) Touch Keys Model 7810 Operation Manual...

  • Page 26: 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 7810 Operation Manual...

  • Page 27: Menu Structure

    MONITOR DESCRIPTION 6.9 Menu Structure Model 7810 Operation Manual...

  • Page 28: 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 7810 Operation Manual...

  • Page 29: Rear Panel Description

    ETHERNET: This is a two-channel Ethernet output that provides an Ethernet protocol (10Base-T, IEEE 802.3) from a single RJ45 connector. The first channel connects the Model 7810 and the CT scanner console to share data and control options. A second Ethernet channel from the same connector provides ECG data to the CT gantry display.

  • Page 30: Monitor Setup

    7.0 MONITOR SETUP 7.1 Monitor Installation CAUTION: Underwriters Laboratory (UL) has not tested/approved the Model 7810 with Roll Stand (Ivy REF: 590441) as a system. Assemble the Roll Stand (Ivy REF: 590441) by following the GCX Light Duty Roll Stand Assembly Instructions (DU-RS-0025-02).

  • Page 31: 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 7810 Operation Manual...

  • Page 32: Default Settings

    PACER DET RESP GAIN MEDIUM RESP MENU Resp Sens MEDIUM RESP TRIGGER INHALE STORE DATA START HR LOW HR HIGH OPTIONS MENU QRS VOL ALARM VOL MEDIUM REC MODE DIRECT TEST MENU INTERNAL TEST SIM RATE Model 7810 Operation Manual...

  • Page 33: Customer Settings

    MONITOR SETUP 7.9 Customer Settings Customer settings may be customized (password required) by a Responsible Organization. For information on how to activate these features, contact Ivy Biomedical Systems at +1 203.481.4183. Menu Setting Selections ALARMS 30 Sec, Mute or No Mute...

  • Page 34: Ecg Monitoring

    CAUTION: The Model 7810 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 35: Patient Connections

    To ensure compliance with safety and performance specifications, use the ECG trunk cables and leads supplied by Ivy Biomedical 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).

  • Page 36: Ecg Electrodes

    Ivy ECG Electrodes (Ivy REF: 590494): • 10% Potassium Chloride (KCl) wet gel • Low AC Impedance • Radiotranslucent • Latex free Model 7810 Operation Manual...

  • Page 37: Impedance Measurement

    ECG MONITORING 8.4 Impedance Measurement The Model 7810 has unique hardware and software which allows the measurement and identification of the impedance value between the patient’s skin and each individual ECG electrode (RA, LA, LL and RL). The purpose of the impedance measurement is to verify proper skin preparation and proper ECG electrode application and to assure a good ECG signal and therefore a reliable trigger pulse.

  • Page 38: Ecg Waveform Amplitude (Gain)

    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 7810 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 39 ECG MONITORING ECG MENU: ECG Menu PACER DET ECG GAIN P-LOCK Touch Key Touch Key Touch Key DISPLAY MENU: ECG Filter Status Display Menu FILTER TRACE 2 TRIG TRACE Touch Key Touch Key Touch Key Model 7810 Operation Manual...

  • Page 40: Trace Selection

    8.8 Trace Selection The Model 7810 includes an AUTO lead select feature (Trigger trace 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 41: 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 OPTIONS MENU: Model 7810 Operation Manual...

  • Page 42: Respiratory Acquisition And Gating

    The Pneumatic Respiratory Pillow provides continuous non-invasive detection of the respiratory cycle to the Model 7810 circuits on adult, geriatric, and pediatric patients in the CT environment during CT scans, for the purpose of providing a respiration trigger.

  • Page 43: The Respiratory Waveform

    Select [TRIG TRACE RESP]. The respiratory waveform will be displayed on the top trace. Breath Rate in Br/Min. Breath Indicator Respiratory Waveform (yellow) Trigger time displayed in red ECG Waveform (green) Display Menu TRACE 2 TRIG TRACE Touch Key Touch Key Model 7810 Operation Manual...

  • Page 44: Respiration Gain (Size)

    Press the [ECG/RESP MENU] touch key from the main menu. Press the [RESP MENU] touch key. Press the [RESP THRESH] touch key. Selections are 10%, 20%, 30%, 40%, 50%. Press [MAIN MENU] to return to the main menu. Model 7810 Operation Manual...

  • Page 45: Respiratory Data Storage

    Press the [STORE DATA START] to initiate respiratory data storage. Press [STORE DATA STOP] to stop respiratory data storage. RESP MENU STORE DATA STORE DATA Touch Key RESP SENS RESP TRIGGER Touch Key Touch Key Touch Key Model 7810 Operation Manual...

  • Page 46: Synchronized Outputs (Trigger)

    Select lead with the highest amplitude, typically Lead II or select AUTO. • The proper placement of the ECG electrodes. The ECG electrodes may need to be repositioned. • The ECG electrodes still have moist conductive gel. Model 7810 Operation Manual...

  • Page 47: Quiet Time

    To turn QUIET TIME ON / OFF: Press the [ECG/RESP MENU] touch key in the main menu. Press the [TRIGGER MODE] touch key. Selections are ECG/RESP or QUIET TIME. QUIET TIME Indicator ECG/RESP MENU TRIGGER MODE Touch Key Model 7810 Operation Manual...

  • Page 48: The Respiratory Synch Pulse

    The Synchronized trigger output is always active. Tick marks indicate the detected peak of inhalation (inspiration) and at the peak of exhalation (expiration). The portion of the respiratory waveform corresponding to the timing of the synch pulse is highlighted in red. Model 7810 Operation Manual...

  • Page 49: System Interlock Operation

    11.0 SYSTEM INTERLOCK OPERATION 11.1 X-RAY Status Messages (Future Feature) When the Model 7810 is interfaced via the rear panel AUXILIARY connector to a CT scanner, the monitor can store ECG data and transfer this data to a USB Memory Stick.

  • Page 50: Data Storage And Transfer

    Press the [ECG/RESP MENU] touch key from the main menu. Press the [RESP MENU] touch key. Press the third programmable touch key [STORE DATA START] to initiate respiratory data storage. Press [STORE DATA STOP] to stop respiratory data storage. Model 7810 Operation Manual...

  • Page 51: Data Transfer Via The Usb Port

    ECG data from the monitor memory or press MAIN MENU to return to the main menu. CAUTION: The Model 7810 USB port is used only for the transfer of internal data to an external media using a standard 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.

  • Page 52: 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 7810 Operation Manual...

  • Page 53: 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 7810 Operation Manual...

  • Page 54: 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. 13.4 Sample Printouts DIRECT Mode: XRAY Mode Model 7810 Operation Manual...

  • Page 55: 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 7810 Operation Manual...

  • Page 56: Technical Alarms

    Check Electrode Message 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 7810 Operation Manual...

  • Page 57: Monitor Testing

    1) LEAD OFF message disappears, and 2) Monitor starts counting QRS. 15.2 ECG Simulator The Model 7810 has an integrated ECG simulator that is used to verify the integrity of the ECG trunk cable, lead wires and electronic circuits involved in the processing of the ECG signal.

  • Page 58: Testing For Visual And Audio Alarms

    Respiration trace is displayed in yellow. Respiration trigger is displayed in red. CAUTION: The above tests should be performed each time prior to monitoring a patient. If the above indications are not present, contact qualified service personnel. Model 7810 Operation Manual...

  • Page 59: Troubleshooting

    ✓ Adjust elastic strap. CAUTION: The ECG trunk cable and lead wires are considered consumable items that periodically need to be replaced. To prevent disruptions with monitoring the patient, it is recommended that a spare set is always available. Model 7810 Operation Manual...

  • Page 60: Maintenance And Cleaning

    CAUTION: If the respiratory pillow, hose or elastic strap has been contaminated with blood or other bodily fluids, it should be discarded. Wipe the respiratory pillow, hose and elastic strap with a cleaning solution (mild detergent or dilute bleach solution (1-2%). Rinse with water and dry. Model 7810 Operation Manual...

  • Page 61: Disinfecting The Reusable Respiratory Pillow, Hose And Elastic Strap

    Rinse well with water and dry. 17.5 Preventive Maintenance The Ivy Model 7810 Cardiac and Respiratory Synchronization Monitor does not require any preventive maintenance. There are no serviceable items contained in the Model 7810.

  • Page 62: Accessories

    ECG LEAD WIRES, 4-LEAD SET, RT CARBON, IEC, 30 IN 590442 ECG LEAD WIRES, 4-LEAD SET, RT CARBON, AHA, 36 IN 590452 ECG LEAD WIRES, 4-LEAD SET, RT CARBON, IEC, 36 IN AHA Colors: White, Green, Red, Black IEC Colors: Red, Black, Green, Yellow Model 7810 Operation Manual...

  • Page 63: Ecg Electrodes And Skin Prep

    POWER CORD, 2.5 M, HOSPITAL GRADE, 10A 250V~, AUSTRALIA 610046 POWER CORD, 2.5 M, HOSPITAL GRADE, 10A 250V~, CHINA To order accessories please contact customer service: • Tel: +1 800.247.4614 • Tel: +1 203.481.4183 • Fax: +1 203.481.8734 • E-mail: sales@ivybiomedical.com Model 7810 Operation Manual...

  • Page 64: Disposal

    Ivy Biomedical Systems, Inc.’s Customer Service for return instructions. 19.2 RoHS Directive 2011/65/EU The Model 7810 and its accessories are in compliance with the RoHS Directive 2011/65/EU. 19.3 Standard of the Electronics Industry of the People’s Republic of China...

  • Page 65: Specifications

    ≤50kΩ: ±3% ±1kΩ; >50kΩ: ±10% ±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: 590494) Model 7810 Operation Manual...
  • Page 66 Sensitivity: Heart Rate Averaging: Exponential averaging calculated once a second with a maximum response time of 8 seconds. Response Time – Model 7810: – Change from 80 to 120 BPM: 2 seconds – Change from 80 to 40 BPM: 2 seconds...
  • Page 67 Default IP address: 10.44.22.21 Channels: Standard Temperature: 32 to 158°F (0 to 70°C) Size: 1.574 x 1.929 in (40mm x 49mm) Mechanical Size: Height: 8.72in. (22.14cm) Width: 9.25in. (23.50cm) Depth: 6.10in. (15.49cm) Weight: 5.6 lbs (2.54kg) Model 7810 Operation Manual...
  • Page 68 5 years at a temperature of 25 Note: The dedicated real time clock lithium battery is embedded in the SNAPHAT package (not a bare battery) and therefore is considered “contained in equipment”. Model 7810 Operation Manual...
  • Page 69 Resp Waveform Output -12V Supply NDNCT (cable status indication) Low (0V) =disconnected; High (+5V)=connected Ground (Shield) ECG Trigger Pulse Output X-Ray On/Off Input Low (0V) = X-Ray ON; High (+5V)= X-Ray OFF +5V Supply ECG Waveform Output (x1000) Model 7810 Operation Manual...

  • Page 70: Regulatory Compliance

    RoHS 2011/65/EU - Restriction of Hazardous Substances • WEEE 2012/19/EU – Directive of the European Parliament and of the Council on Waste Electrical and Electronic Equipment. • FDA/CGMP – FDA Current Good Manufacturing Practice Regulations. • MDSAP –Medical Device Single Audit Program. Model 7810 Operation Manual...
  • Page 71 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 Parliament and Council on medical devices 2017/745 Medical Devices Regulation when it’s used in accordance with the instructions provided in the Operation and Service Manuals.