GE Medical Systems Responder 2000 User Manual
Operator’s Manual
2026116-001 Revision B
English
REVISION HISTORY
Part Number and Revision Date Comment
2026116-001 Revision A
2026116-001 Revision B November 2006 Minor changes: Update page 18 to
October 2006 Initial Release
identify “Rotary Selector knob” not
“button”.
TABLE OF CONTENTS
REVISION HISTORY.......................................................................................................................II
TABLE OF CONTENTS .................................................................................................................III
SECTION 1: INTRODUCTION ........................................................................................................9
OVERVIEW..................................................................................................................................9
RESPONDER
INDICATIONS
CONTRAINDICATIONS
CONTRAINDICATIONS FOR MANUAL DEFIBRILLATION THERAPY............................... 11
CONTRAINDICATIONS FOR SEMI-AUTOMATIC THERAPY.............................................11
CONTRAINDICATIONS FOR NONINVASIVE PACING THERAPY..................................... 11
SAFETY
DANGERS.............................................................................................................................12
WARNINGS...........................................................................................................................12
PRECAUTIONS.....................................................................................................................15
NOTES ..................................................................................................................................18
SYMBOL
SAFETY
OPERATOR
SECTION 2: GETTING STARTED................................................................................................23
2000 DESCRIPTION.......................................................................................... 10
FOR USE/INTENDED USE ...............................................................................11
FOR USE............................................................................................ 11
TERMS AND CONDITIONS .......................................................................................12
DESCRIPTIONS ........................................................................................................19
AND PERFORMANCE STANDARDS ........................................................................21
TRAINING REQUIREMENTS............................................................................... 22
OVERVIEW................................................................................................................................23
UNPACKING
AND INSPECTING .............................................................................................. 24
SETTING UP THE RESPONDER 2000.....................................................................................25
RECHARGEABLE BATTERY INSTALLATION AND REMOVAL ......................................... 25
TO INSTALL THE RECHARGEABLE BATTERY.............................................................25
TO REMOVE THE BATTERY........................................................................................... 26
TO CHECK THE BATTERY.............................................................................................. 26
USING THE BATTERY CHARGER ...................................................................................... 27
THE BATTERY CALIBRATION CYLE.............................................................................. 28
CALIBRATING BATTERY WHILE INSIDE THE RESPONDER 2000.............................. 28
CHARGING BATTERY WHILE INSIDE THE RESPONDER 2000 .................................. 28
CONNECTING PADDLES OR PADS ................................................................................... 29
STORING THE PADDLES .................................................................................................... 29
CONNECTING THE ECG LEADS ........................................................................................30
CONNECTING THE SPO
CABLE (OPTIONAL FEATURE)................................................ 30
2
INSTALLING PAPER INTO THE PRINTER .........................................................................31
POWERING THE RESPONDER 2000 .................................................................................32
RESPONDER
2000 FRONT AND BACK CONTROLS AND INDICATORS ..............................33
RESPONDER 2000 SIDE CONTROLS AND INDICATORS .....................................................33
RESPONDER
Z-BAR™
2000 SIDE CONTROLS AND INDICATORS .....................................................34
INDICATOR................................................................................................................35
Z-BAR FOR PADS AND PADDLES...................................................................................... 35
Z-BAR FOR SPOONS........................................................................................................... 35
BUTTONS.................................................................................................................................. 36
POWER BUTTON ................................................................................................................. 36
2026116-001 Revision B Responder™ 2000 Page iii
POWER ON ......................................................................................................................36
POWER OFF ....................................................................................................................36
CHARGE BUTTON ...............................................................................................................37
SHOCK BUTTON ..................................................................................................................37
MANUAL BUTTON................................................................................................................ 38
ROTARY
SELECTOR KNOB..................................................................................................... 39
SOFT KEYS ...............................................................................................................................39
STATUS LEDS...........................................................................................................................40
PADDLE
RS-232
CONTROLS................................................................................................................ 40
DATA TRANSFER CONNECTION...............................................................................40
GRAPHICS DISPLAY ................................................................................................................ 41
MONITOR SCREEN..............................................................................................................41
INFORMATION BAR .............................................................................................................41
MESSAGE AREA ..................................................................................................................41
CHANNEL 1 ..........................................................................................................................42
CHANNEL 2 ..........................................................................................................................42
INFORMATION AREAS ........................................................................................................ 43
ECG INFORMATION BOX................................................................................................43
SPO
INFORMATION (OPTIONAL) .................................................................................43
2
PACING INFORMATION (OPTIONAL) ............................................................................43
ON-SCREEN INDICATORS.................................................................................................. 44
BATTERY INDICATOR.....................................................................................................44
BATTERY WARNING MESSAGES..............................................................................44
HEART RATE ...................................................................................................................45
SECTION 3: USING THE RESPONDER 2000 .............................................................................47
OVERVIEW................................................................................................................................47
RESPONDER
2000 PREPARATION.........................................................................................48
PATIENT PREPARATION ......................................................................................................... 48
USING PADS ........................................................................................................................48
APPLYING PADS .............................................................................................................49
SPECIAL PAD PLACEMENT SITUATIONS ................................................................49
ANTERIOR-LATERAL PLACEMENT OF PADS FOR DEFIBRILLATION/SYNC
SHOCK (MOST COMMONLY USED)..........................................................................50
ANTERIOR-POSTERIOR PLACMENT OF PADS FOR NON-INVASIVE PACING AND
DEFIBRILLATION/SYNC SHOCK................................................................................ 51
CHANGING PADS ............................................................................................................52
PADS OFF NOTIFICATION.............................................................................................. 52
PADS SHORTED NOTIFICATION ...................................................................................52
USING
ECG ELECTRODES...................................................................................................... 53
APPLYING ECG MONITORING ELECTRODES.................................................................. 53
USING
EXTERNAL PADDLES ..................................................................................................55
INSERTING THE SPOON ELECTRODE...................................................................................58
DEFIBRILLATOR APPLICATION GUIDELINES .............................................................. 59
DEFIBRILLATION
MODES........................................................................................................ 60
CHOOSING A DEFIBRILLATION MODE .............................................................................60
MANUAL MODE ...............................................................................................................61
TO USE MANUAL MODE.............................................................................................61
NO SYNC/SYNC OPTION............................................................................................ 63
AUTO SEQUENCE....................................................................................................... 63
2026116-001 Revision B Responder™ 2000 Page iv
SEMI-AUTO SHOCK MODE ............................................................................................64
TO USE SEMI-AUTO SHOCK MODE.......................................................................... 64
ECG
MONITORING...................................................................................................................66
ACTIVATING AND DEACTIVATING FILTERS..................................................................... 66
MONITORING HEART RATE ...............................................................................................66
MONITORING PACEMAKER PATIENTS............................................................................. 67
NON-INVASIVE
PACING (OPTION) .........................................................................................68
TO USE PACING MODE ......................................................................................................69
GUIDELINES
DEMAND
FOR THE APPLICATION OF EXTERNAL PACEMAKERS ................................ 70
PACING..................................................................................................................... 71
FIXED-RATE PACING...............................................................................................................73
PULSE
OXIMETRY (OPTION) ..................................................................................................74
APPLICATION TIPS.............................................................................................................. 75
PRINTING.................................................................................................................................. 76
TO PRINT..............................................................................................................................76
SNAPSHOT ............................................................................................................................... 77
TO TAKE A SNAPSHOT.......................................................................................................77
HISTORY
MENU .......................................................................................................................77
EVENT LOG ..........................................................................................................................77
PATIENT TRENDS................................................................................................................77
RESPONDING
TO ALARMS ..................................................................................................... 78
HIGH PRIORITY ALARMS.................................................................................................... 78
MEDIUM PRIORITY ALARMS ..............................................................................................78
LOW PRIORITY ALARMS ....................................................................................................78
VISUAL ALARM DISPLAYS.................................................................................................. 79
AUDIBLE ALARMS ...............................................................................................................79
ADJUSTING
HEART RATE ALARM LIMITS ............................................................................. 80
SETTING THE ECG SOURCE AND GAIN ................................................................................80
SECTION 4: CONFIGURING THE RESPONDER 2000 SETTINGS............................................81
OVERVIEW................................................................................................................................81
SETTINGS MENU.................................................................................................................82
TO VIEW THE SETTINGS MENU ........................................................................................82
DEFIBRILLATION SETTINGS .............................................................................................. 85
DEFAULT SHOCK ENERGY SETTINGS......................................................................... 86
FIBRILLATION ANALYSIS THRESHOLDS......................................................................86
PACING SETTINGS.............................................................................................................. 87
TO CHANGE PACING SETTINGS FROM SETTINGS MENU ........................................87
TO CHANGE SETTINGS FROM STARTUP MENU ........................................................88
PACING DEFAULT PARAMETERS .................................................................................88
CHANNEL SETTINGS .......................................................................................................... 89
CHANNEL 1 ......................................................................................................................90
CHANNEL 2 ......................................................................................................................90
FILTERS ...........................................................................................................................90
ALARMS/SOUND SETTINGS............................................................................................... 91
AUDIO DEFAULTS...........................................................................................................92
PATIENT TRIGGERS ....................................................................................................... 92
DATE/TIME SETTINGS ........................................................................................................93
USER SETTINGS MENU......................................................................................................95
FACILITY ..........................................................................................................................96
2026116-001 Revision B Responder™ 2000 Page v
SET PASSWORD .............................................................................................................97
SYSTEM SETTINGS MENU ................................................................................................. 98
DISPLAY SETTINGS ........................................................................................................99
POWER-UP SETTINGS .................................................................................................103
POWER-UP MODE DEFAULT................................................................................... 104
RESTORE DEFAULTS ...................................................................................................105
DEFAULT SETTINGS.....................................................................................................106
SECTION 5: MAINTENANCE & SERVICE.................................................................................107
OVERVIEW..............................................................................................................................107
RECOMMENDED
MAINTENANCE AND CARE .....................................................................108
VISUAL INSPECTION......................................................................................................... 109
CLEANING RESPONDER 2000 AND ACCESSORIES .....................................................110
RECOMMENDED CLEANING PRODUCTS....................................................................... 110
CLEANING INSTRUCTIONS ..............................................................................................110
PRINTER CLEANING INSTRUCTIONS ............................................................................. 111
PADDLE AND INTERNAL PADDLE CLEANING INSTRUCTIONS ...................................111
INTERNAL PADDLE STERILIZATION INSTRUCTIONS ................................................... 111
INSERTING THE SPOON ELECTRODE............................................................................111
EXTERNAL COUNTER ELECTRODE FOR INTERNAL DEFIBRILLATION......................112
CARING FOR RECHARGEABLE BATTERIES .................................................................. 112
CALIBRATING THE BATTERY FUEL GAUGE ..................................................................112
RECYCLING THE BATTERIES .......................................................................................... 112
DEFIBRILLATOR
CHECKLIST................................................................................................113
AUTHORIZED REPAIR SERVICE...........................................................................................117
SECTION 6: SPECIFICATIONS & SAFETY...............................................................................119
OVERVIEW..............................................................................................................................119
SPECIFICATIONS...................................................................................................................120
PHYSICAL
ENVIRONMENTAL
DIMENSIONS .......................................................................................................122
REQUIREMENTS....................................................................................122
OPERATING CONDITIONS................................................................................................ 122
STORAGE AND SHIPPING CONDITIONS ........................................................................122
RHYTHM
®
X
ECG ANALYSIS ALGORITHM ............................................................................123
DETECTION RATE ............................................................................................................. 123
FINE VF...............................................................................................................................123
ASYSTOLE..........................................................................................................................123
NOISE DETECTION............................................................................................................123
NON-COMMITTED SHOCK................................................................................................ 123
SYNC MODE....................................................................................................................... 124
SVT (Supraventricular Tachycardia) DISCRIMINATORS................................................... 124
SVT RATE ...........................................................................................................................124
CONTINUOUS MONITORING FOR SHOCKABLE RHYTHM............................................124
PACEMAKER PULSE INFORMATION...............................................................................124
®
STAR
BIPHASIC DEFIBRILLATION WAVEFORM................................................................ 125
ENERGY LEVELS AND PATIENT IMPEDANCE ...............................................................126
SAFETY STANDARDS AND COMPLIANCE REQUIREMENTS...............................................127
ELECTROMAGNETIC
COMPATIBILITY REQUIREMENTS...................................................127
EMISSIONS.........................................................................................................................127
2026116-001 Revision B Responder™ 2000 Page vi
IMMUNITY...........................................................................................................................127
ENVIRONMENTAL STANDARDS........................................................................................... 128
SHOCK AND VIBRATION................................................................................................... 128
STORAGE AND SHIPPING ................................................................................................ 128
ELECTROMAGNETIC
ELECTROMAGNETIC
EMISSIONS TABLE............................................................................ 129
IMMUNITY TABLE..............................................................................130
RF COMMUNICATIONS TABLE .............................................................................................132
EN 60601-1-2 COMPLIANCE..................................................................................................133
COMPLIANT CABLES AND ACCESSORIES ....................................................................133
SECTION 7: ACCESSORIES......................................................................................................135
OVERVIEW..............................................................................................................................135
RESPONDER
2000 ACCESSORIES ......................................................................................136
SECTION 8: CONTACT INFORMATION/CUSTOMER SERVICE.............................................139
OVERVIEW..............................................................................................................................139
CONTACT
INFORMATION / CUSTOMER SERVICE .............................................................140
2026116-001 Revision B Responder™ 2000 Page vii
2026116-001 Revision B Responder™ 2000 Page 8
SECTION 1: INTRODUCTION
OVERVIEW
This operator’s manual provides instructions for the safe and proper operation, as well as set-up, configurations, and
maintenance information.
Be sure to familiarize yourself with the operation of the Responder 2000 prior to its use.
TOPIC PAGE #
RESPONDER 2000 DESCRIPTION 10
INDICATIONS FOR USE/INTENDED USE 11
CONTRAINDICATIONS FOR USE 11
SAFETY TERMS AND CONDITIONS 12
SYMBOL DESCRIPTIONS 19
SAFETY AND PERFORMANCE STANDARDS 21
OPERATOR TRAINING REQUIREMENTS
PRECAUTION: Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by
state law in which he/she practices to use or order the use of the device.
22
2026116-001 Revision B Responder™ 2000 Page 9
RESPONDER 2000 DESCRIPTION
The Responder 2000 is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The
device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive color TFT color display
for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal
rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation,
cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be
either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR®
Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include
external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO
internal storage of event history and remote synchronization to bedside monitor.
The Responder 2000 is suitable for indoor use only. It is not intended for use in vehicles or aircrafts.
), built-in 60 mm thermal printer,
2
2026116-001 Revision B Responder™ 2000 Page 10
INDICATIONS FOR USE/INTENDED USE
The Responder 2000 defibrillator system is intended to be used by personnel who have been trained in its operation.
The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and
symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation,
atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be
unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient’s ECG
rhythm.
The Responder 2000 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or
dysrhythmias and calculation of heart rate.
The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Responder 2000 pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and
pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
CONTRAINDICATIONS FOR USE
CONTRAINDICATIONS FOR MANUAL DEFIBRILLATION THER APY
Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following:
• Responsive
• Spontaneous breathing
• Palpable pulse
CONTRAINDICATIONS FOR SEMI-AUTOMATIC THERAPY
The semi-automatic shock mode is not be used on patients that exhibit one of any combinations of the following:
• Responsive
• Spontaneous breathing
• Palpable pulse
• Less than 8 years of age or 55 lbs. (25kg). Therapy should not be delayed to determine patient’s exact age or
weight.
CONTRAINDICATIONS FOR NONINVASIVE PACING THERAPY
Noninvasive pacing is contraindicated in the treatment of ventricular fibrillation. Noninvasive pacing in the presence of
severe hypothermia may be contraindicated.
2026116-001 Revision B Responder™ 2000 Page 11
SAFETY TERMS AND CONDITIONS
The following is a list of Responder 2000 safety alerts that appear in this section and throughout this manual. You must
read, understand, and heed these safety alerts before attempting to operate the Responder 2000.
The signal words shown below identify the potential hazard categories. The definition of each category is as follows:
DANGER: This alert identifies hazards that will cause serious personal injury or death.
WARNING: This alert identifies hazards that may cause serious personal injury or death.
PRECAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.
NOTE: Notes contain additional information on usage.
DANGERS
DANGER: Fire and Explosion Hazard
Do not operate the Responder 2000 in the presence of flammable gases (including concentrated oxygen) to avoid
possible explosion or fire hazard.
WARNINGS
WARNING: The Responder 2000 is restricted to a single patient at a time.
WARNING: Shock Hazard
Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard. To avoid
this hazard during defibrillation abide by all of the following:
• Do not touch the patient
• Do not touch conductive fluids such as gel, blood, or saline
• Do not touch metal objects in contact with the patient such as a bed frame or stretcher
• Keep defibrillation pads and ECG electrodes clear of other pads or metal parts in contact with patient
• Disconnect all equipment that is not defibrillator proof from the patient before defibrillation
WARNING: Shock Hazard
Do not immerse any portion of this device in water or other fluids. Avoid spilling fluids on device or accessories. Do not
clean with flammable agents. Do not autoclave or sterilize this device or accessories unless otherwise specified.
WARNING: Shock Hazard
Do not disassemble the Responder 2000! Failure to observe this warning can result in personal injury or death. Refer
maintenance issues to authorized service personnel.
WARNING: Shock Hazard
Do not use the Responder 2000 on a conductive surface, including any wet surface.
WARNING: The Responder 2000 is not intended to be deployed in settings or situations that promote use by untrained
personnel. Operation by untrained personnel can result in injury or death.
WARNING: When transporting the Responder 2000, it is important to position it with the display facing away from the
body. If not, the buttons or Rotary Selector Knob may be bumped and inadvertently moved from its current position.
2026116-001 Revision B Responder™ 2000 Page 12
WARNINGS (CONTINUED)
WARNING: Remain attentive to the patient during the delivery of therapy. Delay in delivering a shock may result in a
rhythm that was analyzed as shockable converting spontaneously to non-shockable and could result in inappropriate
delivery of a shock.
WARNING: Do not use batteries, pads, cables, or optional equipment other than those specified by GE Healthcare. The
use of unapproved equipment may cause the Responder 2000 to function improperly during a rescue.
WARNING: Adjacent and/or Stacked Equipment
The Responder 2000 should not be used immediately adjacent to or stacked on top of other equipment. If adjacent or
stacked use is necessary, the Responder 2000 should be observed to verify normal operation in the configuration in which
it will be used.
WARNING: Responder 2000 Disposal with Battery
Disposal of the Responder 2000 with the battery inserted presents a potential shock hazard.
WARNING: Responder 2000 Disposal Contamination
To avoid contaminating or infecting personnel, the environment, or other equipment, make sure you disinfect and
decontaminate the Responder 2000 appropriately prior to disposal.
WARNING: Do not allow pads to touch each other, ECG electrodes, lead wires, dressings or transdermal patches, etc.
Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy
away from the heart muscle. See Section 3 for correct usage.
WARNING: Pacemaker Patients
Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest for some arrhythmias. Do
not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See this manual for
disclosure of pacemaker pulse rejection capability of this instrument.
WARNING: For treatment of patients with implantable devices such as permanent pacemakers or cardioverter
defibrillators, consult a physician and the instructions for use provided by the device’s manufacturer.
WARNING: The use of accessories and cables other than those specified may result in increased electromagnetic
emissions or decreased immunity of the equipment.
WARNING: The Responder 2000 should not be stored with the battery inserted. Remove the battery from the Responder
2000 when storing the device.
WARNING: A protective ground connection by way of the grounding conductor in the power cord is essential for safe
operation. To avoid electrical shock, plug the power cord into a properly wired receptacle, use only the power cord
supplied with the device, and make sure the power cord is in good condition.
WARNING: If the integrity of the external power earth conductor arrangement is in doubt, unplug the device from the
mains AC and operate it from a Responder 2000 rechargeable battery that is charged.
WARNING: The Responder 2000 will not power on if AC power is lost when the battery is low or not inserted in the
Responder 2000.
WARNING: Due to the unique impedance characteristics of the patient, the Responder 2000 may not be able to shock the
patient.
WARNING: Pads should be kept clear of other ECG electrodes or metal parts in contact with the patient.
WARNING: Defibrillation may cause implanted electrical devices (i.e., pacemakers, infusion pumps) to malfunction. Do
not place pads over implanted electrical devices. Check implanted device function after defibrillation.
2026116-001 Revision B Responder™ 2000 Page 13
WARNINGS (CONTINUED)
WARNING: When the patient is a child under 8 years of age or weighs less than 55 lbs (25kg), the Responder 2000
should be used with pediatric defibrillation pads. Therapy should not be delayed to determine the patient’s exact age or
weight. The Responder 2000 does not select the energy or shock sequences based on the defibrillation pads connection.
WARNING: Use demand mode pacing whenever possible. Use fixed mode pacing when motion artifact or other ECG
noise makes R-wave detection unreliable or when ECG monitoring electrodes are not available.
WARNING: Do not rely solely on SpO
by:
• Incorrect sensor application or use.
• Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin)
• Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin or
carboxyhemoglobin
• Exposure to excessive illumination such a surgical lamps (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, or direct sunlight.)
WARNING: Failure on the part of all responsible individuals, hospitals, or institutions, employing the use of Responder
2000, to implement the recommended maintenance schedule may cause equipment failure and possible health hazards.
The manufacturer does not, in any manner, assumes the responsibility for performing the recommended maintenance
schedule. The sole responsibility rests with the individuals, hospitals, or institutions utilizing the Responder 2000.
WARNING: After the visual inspection, if the Responder 2000 and/or its accessories are damaged please contact
Customer Service. The Responder 2000 will need to be returned for repair. The accessories should be disposed of
appropriately and replacement parts shall be ordered.
WARNING: Cleaning liquids: DO NOT submerge the device in liquids or pour cleaning liquids over, into or onto the
device.
WARNING: Do not trigger more than five (5) consecutive test discharges (or internal safety discharges) within thirty (30)
minutes.
WARNING: Do not disassemble the Responder 2000! Failure to observe this warning can result in personal injury or
death. Refer maintenance issues to authorized service personnel.
WARNING:
exposure to air for long periods of time. These electrodes are not recommended for electrosurgery.
WARNING: Defibrillating a patient with normal heart rhythm may induce ventricular fibrillation.
WARNING:
allowed to come into contact with metal parts, e.g., bed or liner, to prevent unwanted pathways for the defibrillation current
which may endanger the assistants. For the same reason, do not position the patient on wet ground (rain, accident in
swimming pool).
WARNING:
current.
Electrode performance may be adversely affected by pre-attaching, storing with defibrillator cable, or
Position the patient flat on a hard surface where he/she is electrically insulated. The patient must not be
The patient’s chest must be dry, because moisture can cause unwanted pathways for the defibrillation
readings; assess the patient at all times. Inaccurate measurements can be caused
2
2026116-001 Revision B Responder™ 2000 Page 14
PRECAUTIONS
PRECAUTION: Storage of batteries at elevated temperatures will significantly reduce capacity. It is recommended that
batteries be stored and recharged only at room temperature, about 21°C. In any case, do not exceed 50°C.
PRECAUTION: Temperature/Humidity/Pressure Extremes
Exposing the Responder 2000 and battery to extreme environmental conditions outside of its specified parameters may
compromise the ability of the Responder 2000 and battery to function properly.
PRECAUTION: Recycle or dispose of the lithium-ion battery in accordance with your country’s regulations. To avoid fire
and explosion hazard, do not burn or incinerate the battery.
PRECAUTION: Prior to disposal, remove the batteries from the Responder 2000. Then dispose of the device in
accordance with your country’s regulations for equipment containing electronic parts.
PRECAUTION: Dispose of the pads or electrodes in accordance with all federal, state and local laws.
PRECAUTION: Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by
state law in which he/she practices to use or order the use of the device.
PRECAUTION: Do not use pads that are damaged or expired. This may result in improper Responder 2000
performance.
PRECAUTION: Viewing the Responder 2000 display, LEDs, and flashing buttons may cause seizures in individuals prone
to this condition.
PRECAUTION: Avoid excessive mechanical shock to the Responder 2000.
PRECAUTION: The Responder 2000 attached cables may cause a trip hazard while cables are attached to the
Responder 2000.
PRECAUTION: Electrosurgery equipment may cause interference in the Responder 2000 if operated on or nearby the
patient. Disconnect Responder 2000 from the patient before using electrosurgery equipment.
PRECAUTION: The use of any pads may irritate the skin or cause an allergic reaction. If skin irritation develops, change
the location of pads. The affected area can be treated with a topical ointment, according to patient care protocols for skin
irritations. If a severe allergic reaction occurs, discontinue use.
PRECAUTION: The pads must not be used if:
The packaging has been damaged
The expiration date has passed
The pad gel is dried out
The pads are discolored
The pad wires are damaged
PRECAUTION: Occasional gel peel may occur. If gel peel exposes silver area of the pads, discard the pads.
PRECAUTION: Pads packaging should only be opened immediately prior to use.
PRECAUTION: Pads are not reusable and not sterile.
PRECAUTION: Pads should be stored in a cool and dry place.
PRECAUTION: During defibrillation, air pockets between the skin and pads may cause skin burns. Apply pads so that the
entire pad adheres to skin. Do not reposition the pads once applied. If pad position must be changed, remove and replace
with new pads.
PRECAUTION: Prolonged non-invasive pacing may cause skin irritation and burns, especially with higher pacing current
levels. Discontinue non-invasive pacing if skin becomes burned and another method of pacing is available. Discontinue
use of pads if allergic or adverse skin reaction occurs.
2026116-001 Revision B Responder™ 2000 Page 15
PRECAUTIONS (CONTINUED)
PRECAUTION: Pads that are dried out or damaged may cause electrical arcing and patient skin burns during
defibrillation. Do not use pads beyond the expiration date.
PRECAUTION: The maximum duration of pacing is recommended at one (1) hour. If patient condition requires prolonged
continuous pacing it is recommended that pads should be replaced to ensure maximum patient benefit. Prolonged pacing
particularly in neonates or adults with severely restricted blood flow, may cause burns. Periodic inspection of the
underlying skin is recommended.
PRECAUTION: Check that pad adhesive is intact and undamaged.
PRECAUTION: Do not discharge using standard paddles on top of pads.
PRECAUTION: Do not use isopropyl alcohol on the Responder 2000 pads.
PRECAUTION: Use only the specified electrodes in Section 7 of this manual with the Responder 2000. Some electrodes
maybe subject to large offset potentials due to polarization. Recovery time after application of defibrillator pulses may be
especially compromised. Squeeze bulb electrodes may be particularly vulnerable to this effect.
PRECAUTION: Printer paper may jam if paper is wet. Printer may be damaged if wet paper is allowed to dry while in
contact with printer elements.
PRECAUTION: Select the energy level appropriate for the patient’s age. The Responder 2000 does not select the energy
or shock sequences based on the defibrillation pads connection.
PRECAUTION: Check that pad adhesive is intact and undamaged.
PRECAUTION: To prevent damage to equipment, do not clean any part of the Responder 2000 or its accessories with
phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the
Responder 2000 or accessories.
PRECAUTION: Environment of use
Responder 2000 is designed for indoor use. Operator must confirm that the environment of use meets the required
operating environmental specifications before using.
PRECAUTION: Cold Environments
If the Responder 2000 is stored in an environment with a temperature below the operating temperature, the unit should be
allowed to warm up to the needed operating temperature before using.
PRECAUTION: Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by
state law in which he/she practices to use or order the use of the device.
PRECAUTION: Line isolation monitor transients may resemble actual cardiac waveforms, and thus inhibit heart rate
alarms. To minimize any possible interference, apply electrodes correctly as indicated in this manual. Arrange lead wires
away from the line isolation monitors and power cords, and use independent means to verify the correct heart rate is
being displayed.
PRECAUTION: Possible electrical interference with device performance
Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which
could affect the performance of this device. RFI may result in distorted ECG and failure to detect a shockable rhythm.
Avoid operating the Responder 2000 near cauterizers, diathermy equipment, FM 2-way radios, or cellular phones. Turn
power off to radio, cellular and other like equipment near the Responder 2000. Refer to the EMI tables in section 6.
PRECAUTION: Possible Interference with Implanted Pacemaker
Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the
patient is unconscious and not breathing. The Responder 2000 has pacemaker detection and rejection; however with
some pacemakers the Responder 2000 may erroneously count pacemaker spikes and not advise a defibrillation shock. If
possible, it is recommended that the Responder 2000 be used in Manual Mode for patients with implanted pacemakers.
2026116-001 Revision B Responder™ 2000 Page 16
PRECAUTIONS (CONTINUED)
PRECAUTION: Moving the Patient while Responder 2000 is attached
During a rescue attempt, excessive jostling or moving of the patient may cause the Responder 2000 to improperly analyze
the patient’s cardiac rhythm. Stop all motion or vibration before attempting to use the Responder 2000.
PRECAUTION: Systems Statement
Equipment connected to the Responder 2000 must be certified to the respective IEC Standards (i.e. IEC 950 for data
processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the
system standard IEC 60601-1-1. Anybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore, responsible that the system complies with the requirements of the system
standard IEC 60601-1-1. The Responder 2000 Service Port is only intended for use during maintenance by authorized
service personnel.
PRECAUTION: Monitors, defibrillators, and their accessories (including pads and cables) contain ferromagnetic materials
and must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device.
The high magnetic field created by an MRI device will interact with ferromagnetic equipment that may cause serious injury
to persons between the equipment and the MRI device. Skin burns will also occur due to heating of electrically conductive
materials, such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information on
interaction with ferromagnetic materials and equipment.
PRECAUTION: Observe the ECG rhythm. Confirm that the full length sync bar appears near the middle of each QRS
complex. If the sync bars do not appear or are displayed in the wrong locations change the lead source.
2026116-001 Revision B Responder™ 2000 Page 17
NOTES
NOTE: Responder 2000, pads, and electrodes are latex-free.
NOTE: Keep valid certificates of training and certification as required by state, province, or country regulations.
NOTE: If the Battery Charger Charge Status light blinks red, a battery error has occurred during charging. If the Charge
Status light is solid red, a charger error has occurred during charging. Contact Customer Service in the event of an error
during charging.
NOTE: If the Responder 2000 indicates an error code when powering on the device:
Do not use the Responder 2000 (Remove from patient)
Contact Customer Service with the error code(s).
NOTE: If the system is pacing when the power button is pressed, a confirmation box displays requiring an additional press
of the Rotary Selector Knob before the system will turn off.
NOTE: If the power button is pressed for five (5) seconds, the Responder 2000 will power down.
NOTE: If AC power is not connected and the battery voltage becomes critically low, the system will display an error
message and then will power off.
NOTE: If the ECG cable becomes disconnected or falls off, a warning message is displayed.
NOTE: As the battery ages, it will discharge faster and there will be less operating time available before low battery
warning, therapy inhibit and system shutdown. Replace an aged battery to restore the operating time.
NOTE: If the Responder 2000 issues an Error during this process:
Do not use the Responder 2000 (Remove from patient)
Write down any displayed error codes and contact Customer Service
NOTE: Anterior / Posterior pads placement may alleviate a PADS SHORTED message.
NOTE: The skin is a poor conductor of electricity, therefore preparation of the patient’s skin is important to facilitate good
electrode to skin contact. When cleaning the patient’s skin, NEVER use alcohol or tincture of benzoin, as this increases
skin resistance.
NOTE: The selectable energy when using internal paddles is as follows: 2, 3, 5, 7, 10, 15, 20, 30, and 50 Joules.
NOTE: Alarm Silence symbol is displayed, indicating that no audible tone warnings will be heard; only written warning
messages will be displayed on the graphics display.
NOTE: The operator has thirty (30) seconds to deliver therapy before the Responder 2000 disarms and aborts therapy.
NOTE: In Auto Sequence if the user wants to deliver a Sync Shock, Sync should be selected individually for all shocks in
Auto Sequence.
NOTE: Every time after a Sync Shock is delivered; the device resets this toggle button to “No Sync”.
NOTE: Verify printer has adequate paper on its roll for use.
NOTE: To change the password, see TO CHANGE THE PASSWORD in this section of the manual.
NOTE: All changes to the settings of the Responder 2000 must be performed before connecting the Responder 2000 to
the patient.
NOTE: Changes to the power-up default in Menu, do not change on display.
NOTE: The warranty will be void upon unauthorized disassembly or service of the Responder 2000.
2026116-001 Revision B Responder™ 2000 Page 18
SYMBOL DESCRIPTIONS
The following symbols may appear in this manual, on the Responder 2000, or on its accessories. Some of the symbols
represent standards and compliances associated with the Responder 2000 and its use.
Consult instructions for use of the Responder 2000 and/or its accessories.
Precaution: Consult accompanying documents
Authorized Representative in the European Community
CE Marked per the Medical Device Directive 93/42/EEC of the European Union. The
notified body is BSI (ID# 0086).
CE Mark: The Responder 2000 battery charger conforms to essential requirements of
Directive EMC 83/336/EEC.
Classified by ETL Semko with respect to electric shock, fire and mechanical hazards only in
accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, IEC 60601-1 and IEC
60601-2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard C22.2
No. 601.1-M90.
Dangerous Voltage: The defibrillator output has high voltage and can present a shock
hazard. Please read and understand all safety alerts in this manual before attempting to
operate the Responder 2000.
Month and Year of manufacture.
xx/xxxx
Defibrillation-proof Type BF Applied Part = The SpO2 sensor/cable is isolated and can
withstand the effects of an externally applied defibrillation shock to the patient.
Defibrillation-proof Type CF Applied Part = The ECG, Pads, Paddles, and Spoon are
isolated, can withstand the effects of an externally applied defibrillation shock to the patient,
and are specifically designed for applications where a conductive connection directly to the
heart is established.
Device Model Number. Battery Model Number.
For use by or on the order of a Physician, or persons licensed by state law.
Lot Number
Manufacturer
Points to important information regarding the use of the Responder 2000.
2026116-001 Revision B Responder™ 2000 Page 19
IP22
Power button: When pressed, turns the Responder 2000 on and off. This symbol also
indicates when the Responder 2000 has power.
The enclosure of the Responder 2000 is protected against the ingress of dripping water in
accordance with EN 60529. The enclosure of the Responder 2000 is protected against
ingress of solid foreign objects greater or equal to 12.5 mm in accordance with EN 60529.
The enclosure of the Responder 2000 also provides protection for user fingers against
access to hazardous parts in accordance with EN 60529.
The Z-bar provides a relative visual indicator of the total transthoracic impedance between
the two defibrillation pads.
This symbol indicates protective earth (ground).
This symbol indicates the equipment is suitable for alternating current.
SN
1
2
Specifies serial number of the Responder 2000
Do not burn or incinerate rechargeable battery.
Rechargeable battery
Recycle or dispose of the lithium-ion battery in accordance with all federal, state and local
laws.
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately. Please contact an
authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Lithium Ion
This symbol indicates the Responder 2000 battery is charging.
This symbol indicates that Responder 2000 requires service. Please take the Responder
2000 out of service and contact Customer Service.
Symbol on Responder 2000 front panel control indicates Power on/off
Symbol on Responder 2000 front panel and Apex paddle control indicates Charge
3
Manual
Symbol on Responder 2000 front panel and Apex and Sternum paddles indicates Shock
Symbol on Responder 2000 front panel indicates Manual Mode. This blue button can turn
manual mode on or off.
2026116-001 Revision B Responder™ 2000 Page 20
SAFETY AND PERFORMANCE STANDARDS
The Responder 2000 has been designed and manufactured to conform to the highest standards of safety and
performance including electromagnetic compatibility (EMC). The Responder 2000 conforms to the applicable
requirements of the following:
CE marked by BSI 0086 per the Medical Device Directive 93/42/EEC of European Union
ETLClassified by ETL Semko with respect to electric shock, fire and mechanical hazards
only in accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, IEC 60601-1 and
IEC 60601-2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard
C22.2 No. 601.1-M90.
Electrical, Construction, Safety and Performance
IEC 60601-1 (1988), Amendments 1 (1991) & 2 (1995)
IEC 60601-2-4 (2002)
ANSI/AAMI DF-80 (2003)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 (2001)
IEC 60601-2-4 (2002) Section 36
ANSI/AAMI DF-80(2003) Section 36
The Responder 2000 needs to be installed and put into service according to the EMC information specified in this manual.
Refer to Section 6 of this manual for a complete list of all Safety Standards.
2026116-001 Revision B Responder™ 2000 Page 21
OPERATOR TRAINING REQUIREMENTS
Persons authorized to operate the Responder 2000 must have all of the following minimum training.
• Defibrillation training and other training as required by state, province, or country regulations.
• Training on operation and use of the Responder 2000.
• Training in manual defibrillation
• Additional training as required by the physician or Medical Director.
• A thorough understanding of the procedures in this manual.
NOTE: Keep valid certificates of training and certification as required by state, province, or country regulations.
WARNING: The Responder 2000 is not intended to be deployed in settings or situations that promote use by untrained
personnel. Operation by untrained personnel can result in injury or death.
2026116-001 Revision B Responder™ 2000 Page 22
SECTION 2: GETTING STARTED
OVERVIEW
This section presents information on unpacking and setting up the Responder 2000
TOPIC
UNPACKING AND INSPECTING 24
SETTING UP THE RESPONDER 2000 25
RECHARGEABLE BATTERY INSTALLATION AND REMOVAL 25
USING THE BATTERY CHARGER 27
CONNECTING PADDLES OR PADS 29
STORING THE PADDLES 29
CONNECTING THE ECG LEADS 30
CONNECTING THE SPO2 CABLE (OPTIONAL FEATURE) 30
INSTALLING PAPER INTO THE PRINTER 31
POWERING THE RESPONDER 2000 32
RESPONDER 2000 FRONT AND BACK CONTROLS AND INDICATORS 33
RESPONDER 2000 SIDE CONTROLS AND INDICATORS 34
Z-BAR™ INDICATOR
BUTTONS 36
ROTARY SELECTOR KNOB 39
SOFT KEYS 39
STATUS LEDS 40
PADDLE CONTROLS 40
RS-232 DATA TRANSFER CONNECTION 40
GRAPHICS DISPLAY 41
PAGE #
35
2026116-001 Revision B Responder™ 2000 Page 23
UNPACKING AND INSPECTING
Every attempt is made to ensure your order is accurate and complete. However, to be sure that your order is correct,
verify the contents of the box against your packing slip.
The Responder 2000 is designed for simplicity of operation and set-up and requires minimal assembly. The following
items are included in the Responder 2000 box:
One (1) Responder 2000
One (1) Set of external paddles
One (1) Rechargeable battery
One (1) Operator’s manual
One (1) Power cord
One (1) Roll of Printer paper
Carefully inspect each item as it is unpacked for any signs of damage which may have occurred during shipment.
• Check the components according to the packing list.
• Check for any damage or defects. Do not attempt to setup the Responder 2000 if anything is damaged or defective.
Contact Customer Service immediately if anything is damaged or defective.
2026116-001 Revision B Responder™ 2000 Page 24
SETTING UP THE RESPONDER 2000
This section provides the basic set up information you need to prepare the Responder 2000 for operation and to connect
the optional monitoring accessories.
RECHARGEABLE BATTERY INSTALLATION AND REMOVAL
The Responder 2000 uses a rechargeable battery. The rechargeable battery is not shipped fully charged and it is
recommended that you charge the battery fully before using. With a new battery at room temperature, the Responder
2000 will first indicate "Low Battery" while there is still sufficient charge remaining to perform at least five (5) rescues. As
the battery ages, there will be progressively less operating time available before low battery warning, after low battery
warning before therapy inhibit, and after therapy inhibit before system shutdown. Operation at other than room
temperature, especially at low temperature, will also reduce battery capacity. It is recommended to recharge the battery
as soon as practical after the "Low Battery" indication. Always have immediate access to a fully charged, properly
maintained battery. Replace the battery or connect the Responder 2000 to AC power when the device displays a low
battery warning. The remaining capacity of the battery can be estimated by pressing the test button on the battery.
PRECAUTION: Storage of batteries at elevated temperatures will significantly reduce capacity. It is recommended that
batteries be stored and recharged only at room temperature, about 21°C. In any case, do not exceed 50°C.
NOTE: As the battery ages, it will discharge faster and there will be less operating time available before low
battery warning, therapy inhibit and system shutdown. Replace an aged battery to restore the operating time.
NOTE: When storing batteries for extended periods of time, store at 25-50% state of charge for best battery life.
NOTE: Battery state of charge will decline during storage. Be sure to charge the battery fully before using and
after storage.
TO INSTALL THE RECHARGEABLE BATTERY
1. Place the Responder 2000 onto a secure, level surface.
2. With the label uppermost and the connector facing inward, insert the battery in the slot on the left side of the
Responder 2000 as shown.
3. Push the battery in until the battery securing latch clicks into place.
2026116-001 Revision B Responder™ 2000 Page 25
TO REMOVE THE BATTERY
1. Press the battery release until the battery ejects.
2. Pull the battery straight out until it clears the housing.
WARNING: The Responder 2000 should not be stored with the battery inserted. Remove the battery from the
Responder 2000 when storing the device.
TO CHECK THE BATTERY
1. Press the test button on the top of the battery.
2. The row of lights will all light up when the battery is fully charged.
3. If the lights do not light up, or only partially light up, the battery is fully or partially discharged.
2026116-001 Revision B Responder™ 2000 Page 26
USING THE BATTERY CHARGER
With a new battery at room temperature, the Responder 2000 will first indicate “Low Battery” while there is still sufficient
charge remaining to perform at least five (5) rescues. As the battery ages, there will be progressively less operating time
available before low battery warning, after low battery warning before therapy inhibit, and after therapy inhibit before
system shutdown. Operation at other than room temperature, especially at low temperature, will also reduce battery
capacity. It is recommended to recharge the battery as soon as practical after the “Low Battery” indication.
Figure 2.1 Battery Charger and Power Supply
1. Remove the rechargeable battery from the Responder 2000.
2. Plug the power cord into the power supply, plug the power supply into the battery charger, and plug the power cord
into an AC outlet.
3. Insert the battery into the charger and ensure the following:
• Operating Mode light is solid green
• Charge Status light is flashing green.
4. Battery charging starts automatically when battery is put in the battery charger.
Do not push the Calibrate button unless a calibration cycle is desired.
5. The battery will take up to 4 (four) hours to charge in the charger.
6. Remove the battery from the charger when it is charged. The battery is fully charged, when the Mode light is solid
green and the Status light is off.
7. Charging may be terminated early by removing the battery from the charger.
NOTE: If the Charge Status light blinks red, a battery error has occurred during charging. If the Charge Status
light is solid red, a charger error has occurred during charging. Contact Customer Service in the event of an
error during charging.
2026116-001 Revision B Responder™ 2000 Page 27
THE BATTERY CALIBRATION CYLE
Time, repeated partial charges and discharges, and battery aging will lead to inaccuracy of the battery fuel gauge. This is
corrected by performing a battery calibration cycle. To initiate a calibration cycle, press the Calibrate button after the
battery has been inserted into the charger. The Mode light will turn red indicating a calibration cycle is in progress. The
calibration cycle consists of a full charge, full discharge, and full charge of the battery. The cycle may take up to 20 hours
to complete. If it is desired to abort the calibration cycle, press the Calibrate button again. When a calibration cycle is
aborted, the Mode light will turn green and the charger will charge the battery. When the calibration cycle is complete, the
Mode light will turn green.
CALIBRATING BATTERY WHILE INSIDE THE RESPONDER 2000
To calibrate a battery while inside the Responder 2000, perform a full cycle of charge, discharge, and charge.
Perform a full cycle of charge for at least 8 hours (see below).
Disconnect the Responder 2000 from AC power. Turn the Responder 2000 on and wait until the device shuts down.
Perform a full cycle of charge for at least 8 hours (see below). When the battery is fully charged, the battery indicator will
display “full battery” (see also section ON-SCREEN INDICATORS).
CHARGING BATTERY WHILE INSIDE THE RESPONDER 2000
Connect the supplied power cord to the socket at the rear of the Responder 2000 then plug in to a suitable AC power
source. The battery will automatically charge when the power cord is connected to the Responder 2000. The battery will
take up to eight hours to charge in the Responder 2000.
WARNING: A protective ground connection by way of the grounding conductor in the power cord is essential for safe
operation. To avoid electrical shock, plug the power cord into a properly wired receptacle, use only the power cord
supplied with the device, and make sure the power cord is in good condition.
WARNING: If the integrity of the external power earth conductor arrangement is in doubt, unplug the device from the
mains AC and operate it from a Responder 2000 rechargeable battery that is charged.
WARNING: If battery is missing or low, the Responder 2000 will not power on if AC power is lost.
2026116-001 Revision B Responder™ 2000 Page 28
CONNECTING PADDLES OR PADS
The defibrillator paddle connector attaches to the rear of the Responder 2000. The connector for defibrillator paddles and
pads attaches at the same location. With the label facing out, align the connector over the port and press firmly into place.
STORING THE PADDLES
The paddles dock easily on each side of the Responder 2000. Simply push and click to secure as shown in Figure 2.2
below. The paddles can be docked with the cables pointing up or down as preferred.
Figure 2.2 Docking the Paddles
2026116-001 Revision B Responder™ 2000 Page 29
CONNECTING THE ECG LEADS
The Responder 2000 accepts either 3-lead or 5-lead ECG cables. Align the ECG connector with the green port in front
Responder 2000. Push the ECG cable firmly into the ECG port.
Once the ECG connector is attached, a 3-lead or 5-lead wire can be connected to the other end of the cable as shown in
Figure 2.3 below.
Figure 2.3 Attaching the ECG connector to a 5-lead wire
CONNECTING THE SPO2 CABLE (OPTIONAL FEATURE)
The Responder 2000 has SpO
Responder 2000. Push the SpO
as an option on certain models. Align the SpO2 connector with the blue port in front
2
cable firmly into the SpO2 port as shown in Figure 2.4 below.
2
Figure 2.4 Attaching the Oximetry Sensor Lead
2026116-001 Revision B Responder™ 2000 Page 30
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