Electrocardiografo IVY BIOMEDICAL 7800 (Manual)

Model 7600/7800 OPERATION MANUAL
Cardiac Trigger Monitor
Model 7800 shown
© 2019 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 3232-00-16
Part No. 2718-55-16
Rev.16 EN
TABLE OF CONTENTS
TABLE OF CONTENTS
1.0 USER RESPONSIBILITY .......................................................................................................................... 1
2.0 MANUAL REVISION HISTORY .............................................................................................................. 2
3.0 WARRANTY ................................................................................................................................................ 3
4.0 INTRODUCTION ........................................................................................................................................ 4
5.0 SAFETY ........................................................................................................................................................ 5

5.1 Essential Performance ................................................................................................................... 5
5.2 Electrical ......................................................................................................................................... 5
5.3 Explosion ......................................................................................................................................... 6
5.4 Patient Connections ........................................................................................................................ 6
5.5 MRI.................................................................................................................................................. 7
5.6 Pacemakers ..................................................................................................................................... 7
5.7 Electrosurgery Protection .............................................................................................................. 7
5.8 Defibrillation Protection ................................................................................................................ 8
5.9 Signal Amplitude ............................................................................................................................ 8
5.10 EMC ................................................................................................................................................ 8
5.11 Accessories ...................................................................................................................................... 8
5.12 Guidance and Manufacturer’s Declaration-Electromagnetic Emissions .................................. 9
5.13 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity ................................ 10
5.14 Description of Symbols Used ....................................................................................................... 12
6.0 MONITOR DESCRIPTION ...................................................................................................................... 13

6.1 Intended Use ................................................................................................................................. 14
6.2 Patient Population ........................................................................................................................ 14
6.3 Contraindications ......................................................................................................................... 14
6.4 Classification (in accordance with ANSI/AAMI ES60601-1).................................................... 14
6.5 Controls and Indicators ............................................................................................................... 15
6.6 Display ........................................................................................................................................... 16
6.7 Alarm Messages ............................................................................................................................ 16
6.8 Programmable Touch Keys ......................................................................................................... 16
6.9 Menu Structure............................................................................................................................. 17
6.10 Rear Panel ..................................................................................................................................... 18
6.11 Fuse Ratings .................................................................................................................................. 18
6.12 Rear Panel Description ................................................................................................................ 19
7.0 MONITOR SETUP .................................................................................................................................... 20

7.1 Monitor Installation ..................................................................................................................... 20
7.2 To Set Up the Instrument for Operation .................................................................................... 20
7.3 Setting the Date and Time ........................................................................................................... 21
7.4 Setting the QRS and Alarm Volume ........................................................................................... 21
7.5 Setting the Alarm Limits.............................................................................................................. 21
7.6 Setting the Trace Speed ............................................................................................................... 21
7.7 Default Settings ............................................................................................................................. 22
8.0 SYNCHRONIZED OUTPUT (TRIGGER) .............................................................................................. 23

8.1 The Synch Pulse ............................................................................................................................ 23
8.2 Trigger Mark ................................................................................................................................ 23
8.3 Polarity Lock (P-Lock) ................................................................................................................ 23
Model 7600/7800 Operation Manual i

TABLE OF CONTENTS
9.0 ECG MONITORING ................................................................................................................................. 24

9.1 Safety Considerations................................................................................................................... 24
9.2 Patient Connections ...................................................................................................................... 25
9.3 ECG Electrodes ............................................................................................................................ 26
9.4 Impedance Measurement (Model 7800 Only) ............................................................................ 27
9.5 ECG Waveform Amplitude (Size)............................................................................................... 28
9.6 ECG Notch Filter.......................................................................................................................... 28
9.7 Lead Selection ............................................................................................................................... 29
9.8 Low Signal Message ..................................................................................................................... 30
9.9 Pacemaker ..................................................................................................................................... 30
9.10 Alarm Limits ................................................................................................................................. 31
10.0 SYSTEM INTERLOCK OPERATION ................................................................................................. 32

10.1 X-Ray Status Messages (Model 7800 Only)................................................................................ 32
11.0 ECG DATA STORAGE AND TRANSFER ........................................................................................... 33

11.1 ECG Data Transfer Using the USB Port (Model 7800 Only) ................................................... 33
11.2 USB Port........................................................................................................................................ 33
12.0 RECORDER OPERATION ................................................................................................................... 34

12.1 Changing Paper ............................................................................................................................ 34
12.2 Recorder Modes............................................................................................................................ 35
12.3 Recorder Speed ............................................................................................................................. 36
12.4 Sample Printouts .......................................................................................................................... 36
13.0 ALARM MESSAGES .............................................................................................................................. 37

13.1 Reminder Signals .......................................................................................................................... 37
13.2 Patient Alarms .............................................................................................................................. 37
13.3 Technical Alarms.......................................................................................................................... 38
13.4 Informatory Messages .................................................................................................................. 38
14.0 MONITOR TESTING.............................................................................................................................. 39

14.1 Internal Test.................................................................................................................................. 39
14.2 ECG Simulator ............................................................................................................................. 39
15.0 TROUBLESHOOTING ........................................................................................................................... 41
16.0 MAINTENANCE AND CLEANING ...................................................................................................... 42

16.1 The Monitor .................................................................................................................................. 42
16.2 Patient Cables ............................................................................................................................... 42
16.3 Preventive Maintenance............................................................................................................... 42
17.0 ACCESSORIES ........................................................................................................................................ 43
18.0 DISPOSAL ................................................................................................................................................ 44

18.1 WEEE Directive 2012/19/EU ....................................................................................................... 44
18.2 RoHS Directive 2011/65/EU......................................................................................................... 44
18.3 Standard of the Electronics Industry of the People’s Republic of China SJ/T11363-2006 .... 44
19.0 SPECIFICATIONS .................................................................................................................................. 45
ii Model 7600/7800 Operation Manual

USER RESPONSIBILITY
1.0 USER RESPONSIBILITY
This product will perform in conformity with the description contained in this Operation Manual and accompanying
labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions
provided. This product must be checked periodically. A defective 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, 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.
The product must not be altered without the prior written approval of Ivy Biomedical Systems, Inc.’s Quality
Assurance Department. The user of this Product shall have the sole responsibility for any malfunction which results
from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Ivy Biomedical
Systems, Inc.
CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
Ivy Biomedical Systems, Inc.

11 Business Park Drive
Branford, Connecticut 06405 USA
(203) 481-4183  (800) 247-4614  FAX (203) 481-8734
www.ivybiomedical.com e-mail: [email protected]
Multi-language translations of this Operation Manual may be found on the Ivy Biomedical
website: www.ivybiomedical.com.
Model 7600/7800 Operation Manual 1

MANUAL REVISION HISTORY
2.0 MANUAL REVISION HISTORY
Revision Date Description

00 August 11, 2011 Initial Release of Model 7600 Operation Manual
01 March 13, 2012 Changed title to Model 7600/7800 Operation Manual.
Added model 7800 description, specifications etc. to
Operation Manual.
02 May 7, 2012 Revised Operation Manual to comply with IEC 60601-1 3rd
edition.
03 June 4, 2012 Added Patient Population and Contraindications statements
to Monitor Description section of the Operation Manual.
04 June 5, 2012 Revised Power/Standby symbol and added IPX1 statement.
05 September 28, 2012 Added warning statement regarding reducing the
possibility of a tripping hazard to the Monitor Setup section
of the Operation Manual.
06 January 31, 2013 Increased Operating Environment and Storage
Environment Temperature Range.
07 November 20, 2013 Updated China RoHS table and Warning and Caution
symbols.
08 December 9, 2013 Corrected typographical errors in sections 7.3 and 7.4.
09 March 9, 2015 Updated EMC Guidance and Manufacturer’s Declaration
on pages 8, 9 and 10. Added EAC symbol to User
Responsibility section on page 1. Updated all references to
WEEE Directive to 2012/19/EU. Revised all references to
fuse rating and type to T .5A, 250V.
10 September 2, 2015 Revised all references to fuse rating and type to T 0.5AL,
250V.
11 June 8, 2016 Revised sections 6.10 and 6.12.
12 March 1, 2017 Revised section 19.0 to include additional regulatory
standards.
13 March 15, 2017 Revised section 5.0 as per new requirements for IEC
60601-1-2:2014.
14 June 15, 2018 Revised section 19.0 to include additional regulatory
standards.
15 February 19, 2019 Revised section 19.0 to update regulatory standards.
16 October 14, 2019 Revised section 5.6.
_____________________________________________________________________________
2 Model 7600/7800 Operation Manual
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.
All accessories such as patient cables and lead wires, supplied 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 90 days from date of original shipment.
If an examination by Ivy Biomedical Systems, Inc. discloses such product(s) or component part(s) to have been
defective, then Ivy’s obligation is limited at Ivy’s option, to repair or replacement.
When a product or products need to be returned to the manufacturer for repair or examination, contact service
personnel at Ivy Biomedical Systems to obtain a Return Material Authorization number (RMA #) and the correct
packing instructions:
Service / Tech Support:

Telephone: (203) 481-4183 or (800) 247-4614
Fax: (203) 481-8734
E-mail: [email protected]
All products being returned for warranty repair shall be shipped prepaid to:
Ivy Biomedical Systems, Inc

Attn: Service Department
Branford, CT 06405 USA
Ivy will send the shipment of the repaired or replacement product to customer at Ivy’s expense.

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.
The Model 7600/7800 is ME EQUIPMENT (Medical Electrical Equipment) that is intended to monitor patients
under medical supervision. The Model 7600/7800 monitor must be operated by trained and qualified medical
personnel only.
Using This Manual
We recommend that you read this manual before operating the equipment. This manual is written to include all
options. If your monitor does not include all options, menu selections and display data for those options will not
appear on your monitor.
Use the Monitor Description section for general descriptions of controls and displays. For details on the use of each
option, refer to the section of the manual dealing with the appropriate option.
Boldface type is used in text to refer to the labeling on user controls. Brackets [ ] surround menu selections used
with the programmable touch keys.
Manufacturer’s Responsibility
The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the
equipment only if:
• Assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the
manufacturer
• The electrical installation complies with all applicable regulations
• The equipment is used in accordance with the instructions in this manual
Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures
relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury.
Ivy Biomedical Systems, Inc.

Branford, Connecticut 06405
(203) 481-4183 or (800) 247-4614
Fax (203) 481-8734
E-mail: [email protected]
This manual explains how to set up and use the Model 7600/7800. Important safety information is located
throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE
YOU OPERATE THE MONITOR.

SAFETY
5.0 SAFETY
5.1 Essential Performance
List of Essential Performance functions (defined in the IEC 60601-1 Test Report):
• To monitor and display the patient’s heart rate accurately (within limits of 60601-2-27).
• To monitor and display the patient’s ECG waveform accurately (within limits of 60601-2-27).
• To produce an R-Wave gating output pulse to provide proper, accurate, reliable triggering.
• To produce an alarm signal when operator intervention is required.
5.2 Electrical
This product is intended to be operated from a mains power source of 100-120V~ or 200-230V~, 50/60 Hz and a
maximum ac power consumption of 45VA.
WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth. Connect the monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor
plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a
qualified electrician must install one in accordance with the governing electric code.
WARNING: Do not under any circumstances remove grounding conductor from the power plug.
WARNING: The power cable supplied with this equipment provides for this protection. Do not attempt to
defeat this protection by modifying the cable or by using ungrounded adapters or extension cables. The power cord
and plug must be intact and undamaged. To disconnect the equipment from the mains power; unplug the power
cord.
WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer.
WARNING: If there is any doubt about the integrity of the protective ground conductor arrangement, do not
operate the monitor until the ac power source protective conductor is fully functional.
WARNING: For power interruptions exceeding 30 seconds, the monitor must be turned on manually by
pressing the Power On/Standby switch. When monitor power is restored, the monitor will return to manufacturer's
DEFAULT settings. (An option is available which will allow monitor to use the last used or STORED settings.)
WARNING: To avoid unacceptable RISK caused by power interruptions, connect the monitor to an
appropriate medical-grade uninterruptable power source (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 patient cable.
WARNING: Carefully route monitor cables (patient cables, power cords, etc.) to reduce the possibility of a
tripping hazard.

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.
WARNING: Disconnect the monitor from its power source when serviced. Refer service to trained and
qualified service personnel.
WARNING: All replaceable parts should be replaced by trained and qualified service personnel.
WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses.
Replace fuse only with same rating and type: T 0.5AL, 250V.
WARNING: Do not clean monitor while it is plugged into a power source.
WARNING: If unit is accidentally wet, immediately disconnect the monitor from its power source.
Discontinue use until dry and then test unit for proper operation before reuse on a patient.
WARNING: This unit uses a common isolation path for the ECG leads and Electrodes. Do not allow the
ECG leads and/or Electrodes to come in contact with other conductive parts including earth ground. Do not connect
any non-isolated accessories to the ECG input when connected to a patient, as this may compromise the safety of the
unit. When attached to other devices, ensure that the total chassis leakage currents of all units do not exceed 300
μA.
WARNING: The synchronized output pulse is not designed to synchronize a defibrillator discharge or a
cardioversion procedure.
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.
5.3 Explosion
WARNING: 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.
5.4 Patient Connections
WARNING: Carefully route patient cables to reduce the possibility of patient entanglement or strangulation.

SAFETY
Patient connections are electrically isolated. For all connections use isolated probes. Don’t let patient connections
contact other conductive parts, including earth ground. See instructions for patient connections in this manual.
Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative
leakage current that can be caused by other equipment used on the patient at the same time as this monitor.
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
lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an
unreasonable risk of adverse health consequences or death.
Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. To
minimize this problem, ensure proper electrode placement and cable arrangement.
If an alarm condition occurs while the alarms are set to off, neither visual nor audio alarms will be present.
5.5 MRI
WARNING: MR-unsafe! Do not expose the Model 7600 and Model 7800 to a magnetic resonance (MR)
environment. The Model 7600 and Model 7800 may present a risk of projectile injury due to the presence of
ferromagnetic materials which can be attracted by the MR magnet core.
WARNING: Thermal injury and burns may occur due to the metal components of the device which can heat
during MR scanning.
WARNING: The device may generate artifacts in the MR image.
WARNING: The device may not function properly due to the strong magnetic and radiofrequency fields
generated by the MR scanner.
5.6 Pacemakers
WARNING – PACEMAKER PATIENTS: Rate meters might continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely on rate meter ALARM SIGNALS. Keep
pacemaker PATIENTS under close surveillance. See the SPECIFICATIONS section in this manual for disclosure of
the pacemaker pulse rejection capabilities of this instrument. AV sequential and dual chamber pacemaker pulse
rejection have not been evaluated; do not rely on pacemaker rejection with patients with dual chamber pacemakers.
5.7 Electrosurgery Protection
This equipment has been tested in accordance with EN 60601-2-27.
This equipment is protected against electrosurgery potentials. To avoid the potential of electrosurgery burns at
monitoring sites, ensure proper connection of the electrosurgery return circuit as described by the manufacturer’s
instructions. If improperly connected, some electrosurgery units might allow energy to return through the ECG
electrodes. This equipment returns to normal operation in less than 10 seconds.

SAFETY
5.8 Defibrillation Protection

This equipment is protected up to 360 J defibrillator discharge. The monitor is internally protected to limit current
through the electrodes to prevent injury to the patient and damage to the equipment as long as the defibrillator is
used in conformance with the manufacturer’s instructions. Use only Ivy specified accessories (see Accessories).
5.9 Signal Amplitude
WARNING: The minimum patient physiological “R-wave” signal amplitude is 0.5 mV.
The use of the Model 7600/7800, below the above amplitude value, may cause inaccurate results.
5.10 EMC
This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2:2014 for
use in hospital and small clinic.
CAUTION: Medical Equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the Operation Manual.
CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING: This device has not been tested for use in the presence of various potential EMC/EMI sources
such as diathermy, radio frequency identification (RFID), electromagnetic security systems (e.g. metal detectors),
etc. Caution should be used if operating this device in the presence of such devices.
WARNING: The Model 7600/7800 should not be used adjacent to or stacked with other equipment.
However, if adjacent or stacked use is necessary, the Model 7600/7800 should be observed to verify normal
operation in the configuration in which it will used.
5.11 Accessories
WARNING: The use of accessories other than those specified in the Accessories Section of this manual may
result in increased emissions or decreased immunity of the equipment.

SAFETY
5.12 Guidance and Manufacturer’s Declaration-Electromagnetic Emissions

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.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The Model 7600/7800 uses RF energy only for its
CISPR 11 Radiated Class B internal function. Therefore, their RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions Class B The Model 7600/7800 is suitable for use in all
CISPR 11 Conducted establishments other than domestic and those
Harmonic emissions Class A directly connected to the public low-voltage power
IEC 61000-3-2 supply network that supplies buildings used for
Voltage fluctuations/ Class A domestic purposes.
flicker emissions
IEC 61000-3-3

SAFETY
5.13 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity
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.
Immunity test IEC 60601 test Compliance level Electromagnetic environment
level – guidance
Electrostatic ±8 kV contact ±9 kV contact Floors should be wood,
discharge (ESD) concrete, or ceramic tile. If
IEC 61000-4-2 ±15 kV air ±15 kV air floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast ±2 kV for power ±3 kV for power Mains power quality should be
Transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 hospital environment.
±1 kV for ±1.5 kV for
input/output lines input/output lines
100 kHz repetition 100 kHz repetition

frequency frequency
Surge ±1 kV differential ±1.5 kV differential Mains power quality should be

IEC 61000-4-5 mode mode that of a typical commercial or
hospital environment.
±2 kV common ±3 kV common
mode mode
Voltage dips, short 0 % U T: 0.5 cycle 0 % U T: 0.5 cycle Mains power quality should be
interruptions, and at 0, 45, 90, 135, at 0, 45, 90, 135, that of a typical commercial or
voltage variations 180, 225, 270 and 180, 225, 270 and hospital environment. If the
on power supply 315 degrees. 315 degrees. user of the Model 7600/7800
input lines requires continued operation
IEC61000-4-11 0 % U T : 1 cycle and 0 % U T : 1 cycle and during power mains
70% U T ; 25/30 70% U T ; 25/30 interruptions, it is
cycles. cycles. recommended that the Model
7600/7800 be powered from an
Single phase: at 0 Single phase: at 0 uninterruptible power supply.
degrees degrees
0 % U T ; 250/300 0 % U T ; 250/300
cycles. cycles.
Power frequency 30 A/m 30 A/m Power frequency magnetic

(50/60 Hz) fields should be at levels
magnetic field 50 Hz or 60 Hz 50 Hz and 60 Hz characteristic of a typical
IEC 61000-4-8 location in a typical commercial
or hospital environment.

SAFETY
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.
Immunity test IEC 60601 test Compliance level Electromagnetic environment – guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the Model 7600/7800, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF IEC 3 Vrms 5 Vrms d = 1.2 p

61000-4-6
150 kHz to 80 MHz 150 kHz to 80 MHz
d = 1.2 p 80 MHz to 800 MHz
6 Vrms in ISM 6 Vrms in ISM
bands between 0.15 bands between 0.15
MHz and 80 MHz MHz and 80 MHz d = 2.3 p 800 MHz to 2.7 GHz
80% AM @ 2 Hz 80% AM @ 2 Hz Where p is the maximum output power rating

of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Radiated RF IEC 3 V/m 10 V/m
61000-4-3, Field strengths from fixed RF transmitters, as
including Clause 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz determined by an electromagnetic site survey
a
8.10, Table 9, for , should be less than the compliance level in
proximity to 80% AM @ 2 Hz 80% AM @ 2 Hz each frequency range b
wireless devices.
Including Clause Including Clause Interference may occur in the vicinity of the
8.10, Table 9, for 8.10, Table 9, for equipment marked with the following symbol:
proximity to proximity to
wireless devices wireless devices
NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an 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.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

SAFETY
5.14 Description of Symbols Used
Consult instructions for use Warning
Type CF Applied Part, Caution

Defibrillator proof
Equipotential ground connector RoHS Compliant
Fuse type / rating Output Signal
MR Unsafe 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.

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. In addition, high and low heart rate alarm limits can be
adjusted to bracket the patient’s heart rate so that a violation of these limits produces an audible and visual
indication of the violation. The Model 7600/7800 color display includes dual ECG traces, large heart rate numbers
and alphanumeric characters for other data, alarm messages, menus and user information.
• The Model 7600/7800 monitor is intended primarily for use on patients in applications requiring precision
R-wave synchronization such as timed imaging studies.
• 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.
• The Model 7600/7800 has an electrically isolated RS-232 micro-D connector that provides two-way
communications between the monitor and the external console for the transfer of ECG data.
• The Model 7600/7800 is available with different options; not all options are included in all monitors. An
optional integral recorder is available. Set up of recorder functions is made through the monitor touch screen
menus.
• The Model 7600/7800 is suitable for use in presence of electrosurgery.
• The Model 7600/7800 is not intended for use with any other physiological monitoring unit.
• The Model 7600/7800 is restricted to use on one patient at a time.
Model 7800 Only:
• The Model 7800 has special hardware and software that allows for the measurement of skin to electrode
impedance.
• The Model 7800 provides two Ethernet channels from a single RJ45 connector. The first channel provides
two way communications between the monitor and the CT console for the transfer of ECG data, trigger
timing data and the receipt of patient identification information. The second channel provides ECG data to
the CT Gantry display. These functions will only operate when the Model 7800 is electrically connected to
a CT console and CT gantry capable of displaying ECG data.
• The Model 7800 has a USB drive that allows the operator to store and retrieve ECG data on a USB
memory stick device.
• The Model 7800 has an Auxiliary 9-pin D-subminiature connector that provides a customized interface for
specific installations.

MONITOR DESCRIPTION
6.1 Intended Use

The Ivy Biomedical Model 7000 Series Cardiac Trigger Monitors are simple-to-use instruments for monitoring ECG
and Heart Rate. They are designed for use in the ICU, CCU and operating room conditions. They can sound an
alarm when HR falls outside of preset limits. They provide an output pulse, synchronized to the R-wave for use in
applications requiring precision R-wave synchronization.
6.2 Patient Population
The Model 7000 Series Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse
detection on adult, geriatric, pediatric and neonatal patients. R-Wave synchronization is typically used for gating
nuclear scanners, CT scanners, or other imaging devices.
6.3 Contraindications
The Model 7000 Series is limited to use by trained and qualified medical professionals. This device is not intended
for use as life support equipment or for performing cardiac diagnostics. The product is not intended for use in home
care monitoring or for use in an MRI environment.
6.4 Classification (in accordance with ANSI/AAMI ES60601-1)
Protection against electric shock: Class 1.
Degree of protection against electric shock: Type CF applied part. Defibrillator proof: ECG
Degree of protection against harmful ingress of water: Ordinary Equipment IPX1 per IEC-60529
Methods of Maintenance and Cleaning: See Maintenance and Cleaning section of this manual
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

MONITOR DESCRIPTION
6.5 Controls and Indicators
Basic Keys
When the monitor is plugged into an ac power source, the Power On/Standby switch, when
pressed, provides power to the monitor’s electronic circuits. Press this key again to disconnect
power from the monitor’s electronic circuits.
WARNING: To disconnect the monitor from mains power, unplug the ac power cord.
The Alarm Mute switch disables the audible alarms. Press this key again to return the alarms to
normal function.
Heart Rate (BPM)
Measure Impedance
Touch Key
(Model 7800 Only)
4-Lead ECG Simulator
Impedance RA, RL, LL, LA
Readings in kΩ
(Model 7800 Only)
XRAY Status Dual, Simultaneous

(Model 7800 Only) ECG Waveforms with
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)

MONITOR DESCRIPTION
6.6 Display
HEART RATE: Displayed in large numerals in beats per minute (BPM) on the upper part of the screen.
ECG: Dual simultaneous ECG waveforms are displayed across the screen moving from left to right. The trigger
ECG trace is displayed on the top and the second ECG trace is displayed on the bottom.
SETUP: Selections are made through the touch screen menus. Lead selects are displayed to the right of their
respective traces. Filter ON/OFF is displayed on the upper right hand corner of the display. Alarm limits are
displayed directly under the heart rate.
Impedance Measurement (Model 7800 Only): Displays the measured value of the impedance between the
patient’s skin and each individual ECG electrode (RA, LA, LL, RL). Impedance measurements are located at the
upper left hand corner of the display.
XRAY Status (Model 7800 Only): Displays the status of the CT Scanner X-ray. The XRAY status message is
located in the upper left hand corner of the display. Displayed messages are either: XRAY OFF, XRAY ON, or
XRAY DISCONNECT.
6.7 Alarm Messages
ALARM MUTE: A REMINDER SIGNAL indicating that the audible alarms have been turned
off.
Note: ALARM MUTE is equivalent to AUDIO OFF.
The following alarm indications are displayed in reverse video. Alarm indications appear on the center of the screen
and flash once per second.
LEAD OFF: A TECHNICAL ALARM indicating that a lead has become detached. The
LEAD OFF alarm message will appear within 1 second of detection.
CHECK LEAD: A TECHNICAL ALARM indicating that an imbalance between leads has been
detected. The CHECK LEAD alarm message will appear within 1 second of
detection.
HR HIGH: A PATIENT ALARM indicating that the high heart rate limit has been exceeded
for three seconds.
HR LOW: A PATIENT ALARM indicating that the low heart rate limit has been exceeded
for three seconds.
ASYSTOLE: A PATIENT ALARM indicating that the interval between heartbeats has
exceeded six seconds.
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.

MONITOR DESCRIPTION
6.9 Menu Structure

MEASURE
IMPEDANCE
MAIN MENU:
DISPLAY ECG OPTIONS FREEZE PRINT

MENU MENU MENU DIRECT
TRIGGER SIZE Date/Time QRS VOL

AUTO 10 MM/MV OFF
NEXT
ALARM
SECOND FILTER
VOL
LEAD I ON ↑ MEDIUM
SPEED P-LOCK ↓ REC MODE CLEAR

25 MM/SEC ON DIRECT MEMORY
Alarm
Limits
TEST PACER DET MODE COPY TO
MENU ON LOW ADULT USB DRIVE
MAIN MAIN ↑ MAIN MAIN

MENU MENU MENU MENU
↓
HIGH
SIM RATE ↑ USB

OFF MENU
↓
FINE TUNE
↓
KEY SELECTIONS
FINE TUNE
DISPLAY MENU OPTIONS MENU
↑
Trigger: Lead I – II – III – AUTO QRS Volume: Off, Low, High
Second: Lead I – II – III Alarm Volume: Low, Medium, High
INTERNAL Speed: 25mm/s and 50mm/s Recorder Mode: Direct, Timed, Delay
TEST OFF Mode: Adult, Ped/Neo
ECG MENU
Size: 5, 10, 20, 40mm/mV
MAIN
Filter: On, Off Model 7800 Only Selections:
MENU P-Lock: On, Off Measure Impedance
Pacer Detect: On, Off USB Menu

MONITOR DESCRIPTION
6.10 Rear Panel
4-Lead ECG Simulator 9-Pin micro-D

RA, RL, LL, LA RS-232
BNC Connector ¼” Stereo Jack

SYNCHRONIZED ECG OUTPUT
OUTPUT
9-pin D-subminiature
RJ45 Connector
AUXILIARY
ETHERNET
(Model 7800 Only)
(Model 7800 Only)
Serial Number
Label
PEQ Ground
Fuses
(Behind Panel)
Power Entry Module
Mains Power Input Model 7800 shown
6.11 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 rating and type: T 0.5AL, 250V.

MONITOR DESCRIPTION
6.12 Rear Panel Description
The following are located on the rear panel.
MAINS POWER INPUT: A receptacle for a standard ac power cord.
CAUTION: When the monitor is connected to another piece of equipment, always make sure that each piece
of connected equipment has its own separate ground connection.
Do not attempt to connect cables to these connectors without contacting your Biomedical Engineering Department.
This is to ensure the connection complies with leakage current requirements of one of the following applicable
standards: ANSI/AAMI ES60601-1:2005, CAN/CSA-C22.2 No.60601-1:08, and CE-MDD 93/42/EEC. The
maximum non-destructive voltage that may be applied to these connectors is 5V.
SYNCHRONIZED OUTPUT: A BNC type connector with a pulse output synchronized with the peak of the R-wave.
The synch pulse amplitude is factory configurable: 0 to +5V, +5V to 0V, -10V to +10V, or +10V to -10V. Available
synch pulse widths: 1ms, 50ms, 100ms and 150ms.
PEQ GROUND: Potential Equalization - A ground connection that can be used to ensure that no potential differences
can develop between this equipment and other electrical equipment.
FUSE: Replace only with the same type and rating of fuse as indicated on the fuse rating label: T 0.5AL, 250V.
ECG OUTPUT: This is a ¼ inch stereo jack with an ECG analog waveform output on the tip, synchronized pulse
output on the ring, and common on the sleeve. Limit to 100Hz bandwidth.
RS-232: An electrically isolated RS-232 micro-D connector for device communication. The RS-232 connector
provides 6V and -6Vwith a maximum current of 20mA.
AUXILIARY (Model 7800 only): A 9-pin D-subminiature connector that provides a customized interface for
specific installations. The auxiliary output provides +5V and -12V with a maximum current of 12mA.
ETHERNET (Model 7800 Only): 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 7800 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.
SERIAL NUMBER LABEL: The serial number label indicates the model and a unique serial number for the
monitor.
WARNING: The use of ACCESSORY equipment not complying with the equivalent safety requirements of
this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice of
accessories shall include:
• 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

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.
1. Assemble the Roll Stand (Ivy P/N: 590441) by following the GCX Light Duty Roll Stand Assembly
Instructions (DU-RS-0025-02).
2. Align the monitor and its adapter plate with the roll stand mounting adapter (Fig.1).
Fig. 1 Fig. 2
3. Pull down the safety pin and slide the monitor onto the roll stand mounting adapter (Fig. 2). Release the
safety pin and make sure the safety pin is engaged in the monitor’s adapter plate. (The adapter plate has a
hole to allow the safety pin to secure the monitor.)
4. Tighten the two nylon screws in the roll stand mounting adapter by turning them clockwise.
7.2 To Set Up the Instrument for Operation

1. Plug in the supplied detachable hospital grade power cord into the monitor. Plug the other end into an ac
power source (100-120V~ or 200-230V~).
CAUTION: Grounding reliability can only be achieved when the equipment is connected to an equivalent
receptacle marked “Hospital Grade”.
2. Press the Power On/Standby switch at the left side of the front panel to turn power on.
3. Connect the patient cable to the ECG connector on the side panel.
WARNING: Carefully route monitor cables (patient cables, power cords, etc.) to reduce the possibility of a
tripping hazard.

MONITOR SETUP
7.3 Setting the Date and Time
Use the following procedure to set the date and time. The time is indicated in the upper right hand corner of the
display.
1. Press the [OPTIONS MENU] touch key in the main menu.

2. Press the and touch keys under DATE/TIME to select the MONTH.
3. Press [NEXT -- >] to move to the DAY setting. Use the and touch keys to increase or decrease the day
setting.
4. Press [NEXT -- >] to move to the YEAR setting. Use the and touch keys to increase or decrease the year
setting.
5. Press [NEXT - - >] to move to the HOUR setting. Use the and touch keys to increase or decrease the
hour setting.
6. Press [NEXT -- >] to move to the MINUTE setting. Use the and keys to increase or decrease the minute
setting.
7.4 Setting the QRS and Alarm Volume

Use the following procedure to set the QRS and Alarm volume.

2. Press the [QRS VOL] touch key to select QRS Volume. Selections are OFF, LOW, or HIGH.
3. Press the [ALARM VOL] touch key to select Alarm Volume. Selections are: LOW, MEDIUM, or HIGH.
When all date, clock and audio settings are correct, press [MAIN MENU] to return to the main monitoring screen.
7.5 Setting the Alarm Limits

2. Press the HR LOW and touch keys under ALARM LIMITS to select HR LOW limits. Selections are
from 10 BPM to 245 BPM in 5 BPM increments.
3. Press the HR HIGH and touch keys under ALARM LIMITS to select HR HIGH limits. Selections are
from 15 BPM to 250 BPM in 5 BPM increments.
7.6 Setting the Trace Speed

1. Press the [DISPLAY MENU] touch key in the main menu.
2. 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.

MONITOR SETUP
7.7 Default Settings

To reset the monitor to the default settings, turn the monitor off by pressing the Power On/Standby switch; then
turn the monitor back on by again pressing the Power On/Standby switch.
Setting Initial Default

Language Setting English (Configuration Dependent)
ECG Size 10mm/mV
Trigger Lead II or Auto (Configuration Dependent)
Second Lead I
Filter ON
Impedance Threshold 50kΩ (Configuration Dependent)
Heart Rate Low Limit 30
Heart Rate High Limit 120
Trace Speed 25mm/sec
Recorder Direct
QRS Volume Off
Alarm Volume Medium
Internal Test Off
Simulator Rate Off
Alarms 30 Seconds or Off (Configuration Dependent)
Trigger Polarity Positive or Negative (Configuration Dependent)
P-Lock 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.

SYNCHRONIZED OUTPUT
8.0 SYNCHRONIZED OUTPUT

(Trigger)
8.1 The Synch Pulse
The ECG Synchronized Output produces a trigger pulse starting at the peak of each R-wave, which is available on
the SYNCHRONIZED OUTPUT BNC connector and on the ECG OUTPUT (ring on the ¼” stereo jack)
connector on the rear panel of the monitor. Connect the Synchronized Output from the monitor to the device being
synchronized.
The following shows the timing of the trigger pulse compared to the ECG waveform.
5V
0V
TR-Wave
rigger-Spot
Peak 100 m s
Trigger Mark
Trigger Mark
8.2 Trigger Mark
The Synchronized trigger output is always active. A portion of the ECG waveform corresponding to the timing of
the synch pulse is highlighted in red.
If the trigger function appears to be erratic verify the following:

• 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.
8.3 Polarity Lock (P-LOCK)
With some patients’ ECGs the shape of a tall T wave or deep S wave sometimes matches the criteria used to detect
the R wave. When this situation occurs the monitor correctly detects the R wave and then falsely detects the T wave
or 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.
To turn P-Lock ON / OFF follow the next steps:
1. Press the [ECG MENU] touch key in the main menu.

2. Press the [P-LOCK] touch key to select P-LOCK. Selections are ON and OFF.

ECG MONITORING
9.0 ECG MONITORING

Dual simultaneous ECG waveforms move across the display from left to right. The top waveform (Trigger) is used
for cardiac triggering. The bottom trace (Second) is used for display only. Lead selections are displayed to the right
of their respective waveforms. The heart rate and heart rate alarm limits are displayed on the upper part of the
screen. Alarm indications appear on the center of the screen and flash once per second. Also, a heart symbol flashes
each time a heartbeat is detected.
9.1 Safety Considerations
WARNING: This monitor is supplied with protected lead wires. Do not use cables and leads with
unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an
unreasonable risk of adverse health consequences or death.
CAUTION: ECG Electrodes are intended for single-use only. Do not attempt to reuse.
CAUTION: ECG Patient connections are electrically isolated Type CF For ECG connections use
insulated probes. Don’t let patient connections contact other conductive parts, including earth. See instructions for
patient connections in this manual.
CAUTION: Leakage current is limited internally by this monitor to less than 10 μA. However, always
consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as
this monitor.
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.
To avoid the potential of electrosurgery burns at ECG monitoring sites, ensure proper connection of the
electrosurgery return circuit as described by manufacturer’s instructions. If improperly connected, some
electrosurgery units might allow energy to return through the electrodes.
CAUTION: Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart
rate alarms. To minimize this problem, ensure proper electrode placement and cable arrangement.

ECG MONITORING
9.2 Patient Connections

To ensure compliance with safety and performance specifications, use the patient cables 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).
Use the following procedure for ECG monitoring:
1. Prepare each electrode site and apply the electrodes.
2. Connect a 4-lead patient cable to the monitor's ECG input.
3. Connect the leads to the patient cable.
4. Attach the leads to the electrodes as shown below.
Color code comparison table for patient leads:
Lead Type US (AHA) Color Code EU (IEC) Color Code

RA – Right Arm White Red
RL – Right Leg Green Black
LL – Left Leg Red Green
LA – Left Arm Black Yellow
Recommended Lead Placement:
5. Use the procedures described in the following sections for alarm limit settings, lead selection, amplitude
adjustment and enabling or disabling the filter.

ECG MONITORING
9.3 ECG Electrodes
ECG electrodes vary in both construction and quality among the different manufacturers. However, typically there
are two main groups: long term monitoring electrodes and short term monitoring electrodes. Ivy recommends the
use of short term monitoring electrodes which stabilize faster due to their higher chloride content. For the best
performance, Ivy recommends the Ivy ECG Electrodes (Ivy P/N: 590436).
Prior to applying the ECG electrodes to the patient’s skin, Ivy recommends preparing the electrode location by
rubbing the skin with a dry gauze pad or a skin prep gel such as 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.

ECG MONITORING
9.4 Impedance Measurement (Model 7800 Only)
The Model 7800 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. Ivy recommends that the
impedance value of each ECG connection be less than 50,000Ω (50kΩ). The use of the wrong type of ECG
electrodes, improper application or poor skin preparation can increase the electrode impedance value, causing an
imbalance between the leads which can allow noise to be induced into the ECG signal which can cause inaccurate
trigger pulses.
• The impedance value of each ECG electrode can be measured by pressing the Measure Impedance touch
key on the screen. Note: ECG is not monitored during impedance measurements. ECG recovers within 8
seconds after pressing the Measure Impedance touch key.
• The impedance value is displayed in the top left hand portion of the display.
• Impedance values of less than 50kΩ are displayed in blue.
• 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.
• If the measurements are in red, remove the ECG electrodes and clean the skin with a gauze pad or a skin
prep gel such as Nuprep gel (Ivy P/N: 590291) before re-applying a fresh ECG electrode.
• 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

ECG MONITORING
9.5 ECG Waveform Amplitude (Size)

Use the following procedure to adjust the amplitude (size) of the displayed ECG waveforms.
1. Press the [ECG MENU] touch key from the main menu. The following menu appears.
2. Press the first programmable touch key [SIZE] to adjust the ECG waveform amplitude. Selections are: 5, 10,
20, and 40mm/mV.
3. Press [MAIN MENU] to return to the main menu.
ECG Notch Filter

Status
ECG SIZE ECG NOTCH FILTER

Touch Key Touch Key
9.6 ECG Notch Filter
Use the following procedure to activate the ECG Notch Filter:
1. Press the [ECG MENU] touch key from the main menu. The above menu appears.
2. Press the second programmable touch key [FILTER] to change the ECG NOTCH FILTER selection. Select
between FILTER ON and FILTER OFF. The FILTER status indicator is shown in the upper right hand portion
of the display. The FILTER sets the frequency response of the displayed waveform as follows:
a. Filtered: 1.5 to 40 Hz or 3.0 to 25 Hz (Configuration Dependent)

b. Unfiltered: 0.67 to 100 Hz

ECG MONITORING
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.
Use the following procedure to change the lead selection of the Trigger ECG vector (top ECG waveform) and the
Second ECG vector (bottom ECG waveform).
1. Press the [DISPLAY MENU] touch key from the main menu. The following menu appears.
Trigger Lead Selection
Second Lead Selection
TRIGGER LEAD SELECT SECOND LEAD SELECT

Touch Key Touch Key
2. Press the first programmable touch key [TRIGGER] to select the desired ECG lead for the top ECG
waveform. Selections are: Lead I, Lead II, Lead III, and AUTO. The selected lead will appear to the right
of the top ECG waveform.
3. Press the second programmable touch key [SECOND] to select the desired ECG lead. Selections are:
Lead I, Lead II, and Lead III. The selected lead will appear to the right of the bottom ECG waveform.

ECG MONITORING
9.8 Low Signal Message
If the amplitude of the ECG signal is between 300µV and 500µV (3-5mm of amplitude at size 10mm/mV) for a
period of eight seconds a LOW SIGNAL message will be displayed in yellow.
If the trigger function appears to be erratic while the message is displayed, verify the following:
• Select the TRIGGER lead with the highest amplitude, typically Lead II or AUTO.
• The proper placement of the ECG electrodes. The ECG electrodes may need to be repositioned.
• The ECG electrodes still have moist conductive gel.
9.9 Pacemaker
Use the following procedure to activate or deactivate the pacemaker detection function:
1. Press the [ECG MENU] touch key from the main menu.
2. Press the [PACER DET] touch key to toggle between pacer detection ON and OFF.
• When a pacemaker has been detected, a P will start flashing in the heart symbol.
• The message PACER DETECT OFF will appear in red if the pacer detection circuit is not active.
WARNING – PACEMAKER PATIENTS: Rate meters might continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely on rate meter ALARM SIGNALS. Keep
pacemaker 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.

ECG MONITORING
9.10 Alarm Limits
1. Press the [OPTIONS MENU] touch key from the main menu. The menu shown below appears.
2. Use the programmable up/down arrow touch keys to set the high and low heart rate limits.
 Increases HR LOW limit

HR LOW
 Decreases HR LOW limit
 Increases HR HIGH limit

HR HIGH
 Decreases HR HIGH limit
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.
Alarm Type Default Limit

Heart Rate Low 30
Heart Rate High 120

SYSTEM INTERLOCK OPERATION
10.0 SYSTEM INTERLOCK OPERATION
10.1 X-RAY Status Messages (Model 7800 Only)
When the Model 7800 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.
There are three X-RAY status messages:
1. XRAY ON: The CT Scanner X-Ray is active or “ON”. The Model 7800 will store ECG data during this
time.
2. XRAY OFF: The CT Scanner X-Ray is “OFF”.
3. XRAY DISCONNECT: The Model 7800 and the CT scanner are NOT interfaced correctly.
4. STORING DATA: ECG data is being stored.
X-RAY Status
STORING DATA

ECG DATA STORAGE AND TRANSFER
11.0 ECG DATA STORAGE AND TRANSFER
11.1 ECG Data Transfer Using the USB Port (Model 7800 Only)
The Model 7800 has a USB port that allows the user to connect a USB memory stick and retrieve up to 200 ECG
events and measured impedance data stored in the monitor.
ECG data is stored in the monitor’s memory when the X-RAY signal from the CT scanner becomes active. The
ECG data storage stops 10 seconds after the X-RAY signal becomes inactive.
ECG Data Stored (1 event):
10 seconds prior to X-ray, during X-Ray, and 10 seconds after X-Ray
The ECG data can be downloaded to a memory stick device (1GB minimum) by following these steps:
1. Plug a USB memory stick into the USB port on the side of the monitor.
2. From the [OPTIONS MENU], press the [USB MENU] touch key.
3. Press [COPY TO USB DRIVE] touch key.
4. When all the data has been downloaded on to the memory stick, press [CLEAR MEMORY] to delete the
ECG data from the monitor memory or press MAIN MENU to return to the main menu.
11.2 USB Port
CAUTION: The Model 7800 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.
WARNING: The USB memory device used with this port MUST NOT BE POWERED FROM AN
EXTERNAL SOURCE.
USB Port

RECORDER OPERATION
12.0 RECORDER OPERATION
12.1 Changing Paper

Replace the roll of thermal paper as follows. (Recorder paper is Ivy P/N: 590035)
1. Press the paper eject button to open the door at the front of the recorder.
Press Here
If the door does not open completely, pull it toward you until it is completely open.
2. Reach in and remove the spent paper core by pulling it gently toward you.
3. Place a new paper roll between the two round tabs of the paper holder.
4. 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.
5. Align the paper with the pinch roller on the door.
Print
Head
Pinch
Roller
6. Hold the paper against the pinch roller and close the door.

RECORDER OPERATION
12.2 Recorder Modes

Use the following procedure to select the recorder mode to be used. Selections are DIRECT, TIMED, DELAY, and
XRAY.
1. Press the [OPTIONS MENU] touch key from the main menu. .
2. Press the third programmable touch key [REC MODE] to select the recorder mode.
Recorder Mode Selection
All Recorder Modes - To print, press the [PRINT] key in the main menu. Press [PRINT] again to stop
printing.
Direct - To print in DIRECT recorder mode, press the [PRINT] key in the main menu. Press [PRINT]
again to stop printing.
The plot contains parameter settings and the time/date.
The speed of the plot and vertical resolution are the same as the display. The plot is labeled with the speed
of the plot in mm/s, the recorder mode and the parameters.
Timed - TIMED mode starts by pressing PRINT and prints for 30 seconds.
Delay - 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

RECORDER OPERATION
XRAY (Model 7800 Only) - Xray mode automatically prints 20 seconds of ECG waveform after the
occurrence of an X-ray:
10 seconds before and 10 seconds after the occurrence of an X-ray
12.3 Recorder Speed

Use the following procedure to change the 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):

ALARM MESSAGES
13.0 ALARM MESSAGES
13.1 Reminder Signals
WARNING: The monitor powers on with audible alarms paused for 30 seconds.
Note: Other options are available upon request.
The following messages are REMINDER SIGNALS that appear in the upper left hand corner of the monitor’s
display. Reminder messages are displayed in white letters on a red background.
PAUSE: Indicates time (seconds) before audible alarms are enabled.

ALARM MUTE: Audible alarms have been disabled.
Note: ALARM MUTE is equivalent to AUDIO OFF.
The Alarm Mute key allows the user to toggle between pausing audible alarms for 120 seconds and enabling
audible alarms:
1. To pause audible alarms for 120 seconds, momentarily press the key once.
Note: The PAUSE alarm message will appear in the upper left hand corner of the display.
2. To re-enable audible alarms, momentarily press the key once.
The Alarm Mute key also allows the user to disable audible alarms:
1. To disable audible alarms, press and hold the key for three seconds.
Note: The ALARM MUTE reminder signal will appear in the upper left hand corner of the display.
2. To re-enable audible alarms, momentarily press the key once.
WARNING: All alarms are considered HIGH PRIORITY and require immediate attention.
13.2 Patient Alarms

The following messages are PATIENT ALARMS that appear directly below the heart rate on the monitor’s display.
White letters on a red background flash at a rate of once every second with an audio alarm tone.
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.

ALARM MESSAGES
13.3 Technical Alarms

The following messages are TECHNICAL ALARMS that appear directly below the heart rate on the monitor’s
display. White letters on a red back ground flash at a rate of once every second with an audio alarm tone.
LEAD OFF: A lead has become detached. The LEAD OFF alarm message will appear within 1 second
of detection.
CHECK LEAD: An imbalance between leads has been detected. The CHECK LEAD alarm message will
appear within 1 second of detection.
SYSTEM ERROR: A monitor malfunction has been detected. Contact qualified service personnel.
13.4 Informatory Messages

Low Signal Message
If the amplitude of the ECG signal is between 300µV and 500µV (3mm to 5mm at size 10mm/mv) for a period of
eight seconds, a “LOW SIGNAL” message will be displayed in yellow below the ECG waveform (see ECG
monitoring section).
Pacer Detect Message

The “PACER DETECT OFF” message will appear in red if the pacer detection circuit is turned OFF through the
ECG menu.
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.

MONITOR TESTING
14.0 MONITOR TESTING
CAUTION: Under normal operation, no internal adjustment or calibration is required. Safety tests should be
done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local
or governmental regulations. In the event that service is necessary, refer to the Service Manual for this equipment.
14.1 Internal Test

Turn on the monitor by pressing the front panel Power On/Standby key. Listen for three audio beeps. Press the
DISPLAY MENU touch key from the main menu. Next, press the TEST MENU touch key. Press INTERNAL
TEST touch key. Selections are OFF and ON. When turned ON, the INTERNAL TEST function generates a 1mV
pulse at 70 BPM, causing a waveform and a 70 BPM indication on the display and a signal at the rear panel stereo
jack and BNC connector. The INTERNAL TEST verifies the internal functions of the monitor. You should do this
each time you begin monitoring a patient. If the following indications are not present, contact qualified service
personnel.
To test for visual and audio alarms:
If the alarms are paused or muted, press the key to turn alarms on. Unplug the patient cable. Check that the
LEAD OFF message is displayed and the audio alarm is on. With INTERNAL TEST ON, check for the following:
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.
Turn on the monitor by pressing the front panel Power On/Standby key. Listen for three audio beeps. Plug in the
patient cable. Attach the four lead wires to the simulator terminals that are located on the right side panel of the
monitor. The terminals have four color-coded labels for easy identification. The simulator generates an ECG
waveform and heart rate range between 10-250 BPM (user selectable).
ECG Simulator Operation
To turn the simulator on and set the heart rate, follow the procedure below:
1. Press the DISPLAY MENU touch key from the main menu. Next, press the [TEST MENU] touch key.
2. Press the SIM RATE touch key to turn the simulator on and toggle through the heart rate options.
3. Press the keys ↑FINE TUNE↓ to change the heart rate in increments of one.
4. Check that the displayed heart rate is equivalent to the selected Simulator Rate. Check that two ECG traces
are displayed.
NOTE: When the simulator is on, the SIMULATOR ON message is displayed in yellow on the screen.

MONITOR TESTING
SIMULATOR ON
message
To test for visual and audio alarms:
If the alarms are paused or muted, press the key to turn alarms on.
1. Set the SIM RATE to OFF. Check that the ASYSTOLE alarm message is displayed and the audio alarm is
present.
2. 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.

TROUBLESHOOTING
15.0 TROUBLESHOOTING
Problem Verify that:

• Unit does not turn on.  Power cord is plugged into the monitor and the ac outlet.
 Fuses are not blown.
 The ON switch is pressed.
• Trigger pulse is not functional  ECG size is optimal (select Lead II or AUTO)
• Erratic ECG waveform. Heart Rate is  ECG waveform has enough amplitude (Select Lead II or
not counting. AUTO).
 Electrodes placement (see ECG section for proper
placement diagram).
 ECG electrodes have enough conductive gel.
 Measured Impedance < 50kΩ.

MAINTENANCE AND CLEANING
16.0 MAINTENANCE AND CLEANING
16.1 The Monitor
When necessary, clean the exterior surfaces of the monitor with a cloth or swab dampened with water. Do not allow
liquids to enter the interior of the instrument.
CAUTION:
• Do not autoclave, pressure sterilize, or gas sterilize the monitor.
• Do not soak or immerse in any liquid.
• Use cleaning solution sparingly. Excessive solution can flow into the monitor and cause damage to internal
components.
• Do not touch, press or rub the display and covers with abrasive cleaning compounds, instruments, brushes,
rough surface materials, or bring them into contact with anything that could scratch the display or the
covers.
• Do not use petroleum based or acetone solutions or other harsh solvents to clean the monitor.
16.2 Patient Cables
CAUTION: Do not autoclave the patient cables.
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:
• Patient Cables and Leads are clean and intact.

• The LEAD OFF message is displayed when the patient cable and/or the patient leads are not connected.
Connecting the patient cable and the patient leads to the side simulator will make the LEAD OFF message
disappear.

ACCESSORIES
17.0 ACCESSORIES
Ivy P/N Description
590432 Low Noise, Four Lead ECG Patient Cable, 10 ft. Long, Colors: White, Green, Red, Black
590433 Set of Four Shielded Lead Wires, 24 Inches Long, Colors: White, Green, Red, Black
590435 Set of Four Radiotranslucent Lead Wires, 30 Inches Long, Colors: White, Green, Red, Black
590442 Set of Four Radiotranslucent Lead Wires, 36 Inches Long, Colors: White, Green, Red, Black
590436 Radiotranslucent ECG electrodes- One Bag of 40 electrodes (10 pouches of 4 electrodes)
590436-CS Radiotranslucent ECG electrodes- One Case of 600 electrodes (15 bags of 40 electrodes)
590446 Low Noise, Four Lead ECG Patient Cable, 10 ft. Long, IEC Colors: Red, Black, Green, Yellow
590447 Set of Four Shielded Lead Wires, 24 Inches Long, IEC Colors: Red, Black, Green, Yellow
590451 Set of Four Radiotranslucent Lead Wires, 30 Inches Long, IEC Colors: Red, Black, Green, Yellow
590452 Set of Four Radiotranslucent Lead Wires, 36 Inches Long, IEC Colors: Red, Black, Green, Yellow
590291 Nuprep Gel
590035 Recorder paper, pack of 10 rolls
590368 Recorder paper, case of 100 rolls
590386 USB Memory Stick (1GB) with ECG Viewer Software
590441 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: [email protected]

DISPOSAL
18.0 DISPOSAL
18.1 WEEE Directive 2012/19/EU

Disposal of devices or consumables must be done in accordance with local, state, and federal laws and regulations.
WEEE Directive 2012/19/EU - Do not dispose of WEEE products in general waste. At the end of life of the product,
contact Ivy Biomedical Systems, Inc.’s Customer Service for return instructions.
18.2 RoHS2 Directive 2011/65/EU
The Model 7600/7800 and its accessories are in compliance with the RoHS2 Directive 2011/65/EU.
18.3 Standard of the Electronics Industry of the People’s Republic of China

SJ/T11363-2006
Table of toxic or hazardous substances and elements for the Model 7600/7800
Part Toxic or Hazardous Substances and Elements
Name
Pb Hg Cd Cr (VI) PBB PBDE
Model 7600/7800
X O O O O O
Final Assembly
Packing Assembly O O O O O O
Accessory Option O O O O O O
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is
below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for
this part is above the limit requirement in SJ/T11363-2006.
The data above represents best information available at the time of publication.
(EFUP) Environmentally Friendly Use Period - 50 Years

Some consumable or OEM items may have their own label with an EFUP value less than the system and may not be
identified in the table. This symbol indicates the product contains hazardous materials in excess of the limits
established by the Chinese standard SJ/T11363-2006. The number indicates the number of years the product can be
used in normal conditions before the hazardous materials may cause serious harm to the environment or health of
humans. This product must not be disposed of as unsorted municipal waste, and must be collected separately.

SPECIFICATIONS
19.0 SPECIFICATIONS
ECG
Lead Selection:
Trigger Lead: LI, LII, LIII, and AUTO - menu selectable.
Second Lead: LI, LII and LIII – menu selectable.
Patient Cable: 4-lead patient cable with 6-Pin AAMI standard connector.
Isolation: Isolated from ground related circuits by >4 kV rms, 5.5 kV peak
CMRR: ≥90 dB with patient cable and 51 kΩ/47 nF imbalance
Input Impedance: ≥20 MΩ at 10 Hz with patient cable
Frequency Response
LCD Display and Recorder: Filtered: 1.5 to 40 Hz
or
3.0 to 25 Hz (Configuration Dependent)
Unfiltered: 0.67 to 100 Hz
Frequency Response
ECG output: Unfiltered: 0.67 to 100 Hz
Input Bias Current: Each lead <100 nA dc maximum
Electrode Offset Potential: ±0.5 V DC
Lead Off sensing current: 56nA
Noise: <20 µV peak-to-peak, referred to the input with all leads connected
through a 51 kΩ/47 nF to ground
Defibrillator Protection: Protected against 360 J discharge and electrosurgery potentials

Recovery time < 5 seconds
Leakage Current: <10 µA at normal condition
Electrosurgical Interference
Protection: Standard. Recovery time < 5 seconds
Notch Filter: 50/60 Hz (automatic).
Electrode Impedance Measurement (Model 7800 Only)

Measurement Technique: 10 Hz ac signal < 10 uA rms
Measurement Range: 200kΩ per lead
Measurement Accuracy: ±3% ±1kΩ
Measurement Leads: RA, LA, LL, RL
Measurement Mode: Manual
Measurement Time: < 4 seconds; ECG recovery < 8 seconds
Minimum Recommended
Electrode Impedance: <50kΩ
Recommended Electrode: 10% Chloride sponge type (Ivy P/N: 590436)

SPECIFICATIONS
Cardiotach
Range: 10 to 350 BPM (Pediatric / Neonate)
10 to 300 BPM (Adult)
Accuracy: ±1% ±1 BPM
Resolution: 1 BPM
Sensitivity: 300 µV peak
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
Response Time – Model 7800:

Response to irregular rhythm: A1: 40 BPM, A2: 60 BPM, A3: 120 BPM, A4: 90 BPM
(According to IEC specification 60601-2-27, 201.7.9.2.9.101-b-4)
Tall T Wave Rejection: Rejects T waves ≤ 1.2 * R-wave
Pacer Pulse Rejection

Width: 0.1 to 2 ms at ±2 to ±700 mV
Overshoot: Between 4 and 100ms and not greater than 2mV.
Fast ECG Signals: 1.73 V/s
Detector Disabling: User selectable.
CAUTION: Pacemaker pulses are not present in any rear panel outputs.
Alarms
High Rate: 15 to 250 BPM in 5 BPM increments
Low Rate: 10 to 245 BPM in 5 BPM increments
Asystole: R to R interval >6 seconds
Lead Off: Detached lead
Check Lead: Imbalance between leads > 0.5V
Time to alarm for Tachycardia:
B1 and B2: < 10 seconds
Note: B1 Half Amplitude produces a LOW SIGNAL warning message
in < 5 seconds (Not an alarm)
(According to IEC specification 60601-2-27, 201.7.9.2.9.101-b-6)
Alarm Sound Pressure Level: 76 dBA (Alarm volume set to Low) to
88 dBA (Alarm volume set to High)
Alarm Tones: Conforms to IEC 60601-1-8:2006 Table 3, High Priority Alarms
Test Mode
Internal:
ECG 1 mV/100 ms referred to input @ 70 BPM
Simulator:
ECG waveform amplitude: 1mV
Simulator Range: 10 – 250 BPM.
Simulator Rate: In steps of 30, 60, 90, 120, 150, 180, 210 and 240 BPM.
Adjustable in increments of 1 BPM.

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: Active Matrix TFT Color Touch Screen LCD (640x480)
Trace: Dual simultaneous ECG traces with “freeze” function.
Screen Size: 17.09cm x 12.82cm, 21.36cm (8.4in) diagonal
Sweep Speed: 25, 50 mm/s
USB Port and Data Transfer (Model 7800 Only)

Type: USB Flash Drive (memory stick) minimum capacity of 1GB
ECG storage: 200 most recent events
Ethernet Module (Model 7800 Only)

Network Interface: RJ45 (10BASE-T)
Ethernet compatibility: Version 2.0/IEEE 802.3
Protocol: TCP/IP
Packet Rate: 250ms
ECG Data Rate: 240 samples/s
Default IP address: 10.44.22.21
Channels: 2
Standard Temperature: 32 to 158°F (0 to 70°C)
Size: 1.574 x 1.929 in (40mm x 49mm)
Mechanical – Model 7600

Size: Height: 7.49in. (19.02cm)
Width: 7.94in. (20.17cm)
Depth: 5.18in. (13.16cm)
Weight: 3.9 lbs (1.80kg)
Mechanical – Model 7800

Size: Height: 8.72in. (22.14cm)
Width: 9.25in. (23.50cm)
Depth: 6.10in. (15.49cm)
Weight: 5.6 lbs (2.54kg)
Recorder
Writing Method: Direct Thermal
Number of Traces: 2
Modes: Direct - Manual Recording
Timed - Print button initiates a 30 second recording
Delay - Records 20 seconds before and 20 seconds after the occurrence
of an alarm at 25mm/s. Records 15 seconds before and 15 seconds after
the occurrence of an alarm at 50mm/s.
XRAY (Model 7800 Only) – Records 10 seconds before and 10
seconds after the occurrence of an X-ray
Paper Speeds: 25 and 50 mm/s

SPECIFICATIONS
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: 500 samples
Synchronized Output (Trigger)

Test input signal at ECG leads: Conditions: ½ sine wave, 60ms width, 1mV amplitude, 1 pulse/second
Output Trigger Delay: < 2 ms
R to R Trigger Accuracy: ±75 µs typical @ 1 mV input
Pulse width: 1ms, 50ms, 100ms or 150ms (Configuration Dependent)
Pulse amplitude: 0V to +5V or -10V to +10V (Configuration Dependent)
Pulse amplitude polarity: Positive or Negative (Configuration Dependent)
Output Impedance: <100 Ω
Sensitivity and Threshold
Adjustment: Fully Automatic
Real Time Clock

Resolution: 1 minute
Display: 24 hours
Power Requirement: The real time clock keeps time whether the monitor has power or not.
The real time clock is powered by a dedicated lithium battery whose
life is a minimum 5 years at a temperature of 25oC
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”.
Operating Environment
Temperature Range: 5°C to 40°C
Relative Humidity: 0% to 90% non-condensing
Altitude: -100 meters to +3,600 meters
Atmospheric Pressure: 500-1060 mbar
Protection against ingress of fluids: IPX1 – Protection against vertically falling drops of water
Storage Environment
Temperature Range: -40°C to +70°C
Relative Humidity: 5% to 95%
Altitude: -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

SPECIFICATIONS
Regulatory
Unit meets or exceeds the specifications for:
• ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012

• IEC 60601-1 Edition 3.1 (2012)/EN 60601-1:2006 + A1:2013 + A12:2014
• IEC 60601-1-2 4th edition (2014)
• IEC 60601-1-6:2010 (Third Edition) + A1:2013; IEC 62366:2007 (First Edition) + A1:2014
• IEC 60601-1-8:2006 (Second Edition) + Am.1:2012
• IEC 60601-2-27 (2011)
• IEC 62304:2006
• CAN/CSA-C22.2 No. 60601-1:2014
• CAN/CSA-C22.2 No. 60601-1-2:2016
• MDD 93/42/EEC
• CE 0413
• ISO 13485:2016
• RoHS2 2011/65/EU
• WEEE 2012/19/EU
• FDA/CGMP
• MDSAP

SPECIFICATIONS
Medical Equipment
With respect to electric-shock, fire and
mechanical hazards only in accordance with
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA C22.2 No. 60601-1(2014),

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.
Eurasian Conformity (EAC): This product passed all conformity assessment (approval) procedures that correspond to the requirements of
applicable technical regulations of the Customs Union.

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Model 7600/7800 OPERATION MANUAL

Cardiac Trigger Monitor

Model 7800 shown

2.0 MANUAL REVISION HISTORY .............................................................................................................. 2

3.0 WARRANTY ................................................................................................................................................ 3

4.0 INTRODUCTION ........................................................................................................................................ 4

5.0 SAFETY ........................................................................................................................................................ 5

6.0 MONITOR DESCRIPTION ...................................................................................................................... 13

7.0 MONITOR SETUP .................................................................................................................................... 20

8.0 SYNCHRONIZED OUTPUT (TRIGGER) .............................................................................................. 23

Model 7600/7800 Operation Manual i

9.0 ECG MONITORING ................................................................................................................................. 24

10.0 SYSTEM INTERLOCK OPERATION ................................................................................................. 32

11.0 ECG DATA STORAGE AND TRANSFER ........................................................................................... 33

12.0 RECORDER OPERATION ................................................................................................................... 34

13.0 ALARM MESSAGES .............................................................................................................................. 37

14.0 MONITOR TESTING.............................................................................................................................. 39

15.0 TROUBLESHOOTING ........................................................................................................................... 41

16.0 MAINTENANCE AND CLEANING ...................................................................................................... 42

17.0 ACCESSORIES ........................................................................................................................................ 43

18.0 DISPOSAL ................................................................................................................................................ 44

19.0 SPECIFICATIONS .................................................................................................................................. 45

ii Model 7600/7800 Operation Manual

1.0 USER RESPONSIBILITY

Ivy Biomedical Systems, Inc.

Model 7600/7800 Operation Manual 1

2.0 MANUAL REVISION HISTORY

Revision Date Description

Service / Tech Support:

Ivy Biomedical Systems, Inc

Model 7600/7800 Operation Manual 3

Using This Manual

• The electrical installation complies with all applicable regulations

• The equipment is used in accordance with the instructions in this manual

Ivy Biomedical Systems, Inc.

4 Model 7600/7800 Operation Manual

WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer.

Model 7600/7800 Operation Manual 5

WARNING: Do not clean monitor while it is plugged into a power source.

WARNING: Do not modify this equipment without authorization of the manufacturer.

5.4 Patient Connections

6 Model 7600/7800 Operation Manual

WARNING: The device may generate artifacts in the MR image.

5.7 Electrosurgery Protection

This equipment has been tested in accordance with EN 60601-2-27.

Model 7600/7800 Operation Manual 7

5.8 Defibrillation Protection

5.9 Signal Amplitude

8 Model 7600/7800 Operation Manual

5.12 Guidance and Manufacturer’s Declaration-Electromagnetic Emissions

Model 7600/7800 Operation Manual 9

5.13 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity

Guidance and manufacturer’s declaration – Electromagnetic immunity

100 kHz repetition 100 kHz repetition

Surge ±1 kV differential ±1.5 kV differential Mains power quality should be

Power frequency 30 A/m 30 A/m Power frequency magnetic

10 Model 7600/7800 Operation Manual

Guidance and manufacturer’s declaration – Electromagnetic immunity

Recommended separation distance