GE Responder 2000 - User Manual
GE Responder 2000 - User Manual
GE Responder 2000 - User Manual
2026116-001 Revision B
English
REVISION HISTORY
OVERVIEW
This operators 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
22
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.
The Responder 2000 is suitable for indoor use only. It is not intended for use in vehicles or aircrafts.
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 patients 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.
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.
DANGERS
WARNINGS
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.
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: 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: 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 devices 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.
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 patients 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 SpO2 readings; assess the patient at all times. Inaccurate measurements can be caused
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: Electrode performance may be adversely affected by pre-attaching, storing with defibrillator cable, or
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: Position the patient flat on a hard surface where he/she is electrically insulated. The patient must not be
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: The patients chest must be dry, because moisture can cause unwanted pathways for the defibrillation
current.
PRECAUTION: Recycle or dispose of the lithium-ion battery in accordance with your countrys 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 countrys 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: 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: Occasional gel peel may occur. If gel peel exposes silver area of the pads, discard the pads.
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: 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 patients age. The Responder 2000 does not select the energy
or shock sequences based on the defibrillation pads connection.
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: 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: 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.
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: Anterior / Posterior pads placement may alleviate a PADS SHORTED message.
NOTE: The skin is a poor conductor of electricity, therefore preparation of the patients skin is important to facilitate good
electrode to skin contact. When cleaning the patients 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: The warranty will be void upon unauthorized disassembly or service of the Responder 2000.
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.
CE Marked per the Medical Device Directive 93/42/EEC of the European Union. The
notified body is BSI (ID# 0086).
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.
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.
Lot Number
Manufacturer
The enclosure of the Responder 2000 is protected against the ingress of dripping water in
IP22 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.
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 that Responder 2000 requires service. Please take the Responder
2000 out of service and contact Customer Service.
2 Symbol on Responder 2000 front panel and Apex paddle control indicates Charge
3 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 manual mode on or off.
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.
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.
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.
OVERVIEW
This section presents information on unpacking and setting up the Responder 2000
TOPIC PAGE #
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
35
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
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) Operators 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.
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 21C. In any case, do not exceed 50C.
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.
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.
WARNING: The Responder 2000 should not be stored with the battery inserted. Remove the battery from the
Responder 2000 when storing the device.
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.
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.
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:
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.
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.
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.
To calibrate a battery while inside the Responder 2000, perform a full cycle of charge, discharge, and charge.
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.
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.
The Responder 2000 has SpO2 as an option on certain models. Align the SpO2 connector with the blue port in front
Responder 2000. Push the SpO2 cable firmly into the SpO2 port as shown in Figure 2.4 below.
Lift up on the front printer flap as shown by arrow on the Responder 2000. Pull door flap up and forward to open the
printer.
Place paper roll into the printer with the paper end pulled over the top of the printer roller through the opening in the
printer door. Refer to printer door for proper direction of paper.
Close the printer and press the door into place until it clicks. The paper should be protruding from the slot in the printer
housing. The paper may be torn off flush with the front of the Responder 2000 after installation.
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. Use only printer paper listed in section 7 Accessories.
The Responder 2000 operates safely from the following power sources:
Rechargeable battery
AC power using the supplied power cord
ECG
Cable port
Sp02 port
(Optional)
Power
ON/Off
Button
Rotary Selector
Status LEDS Charge Button Knob
Manual Button
Shock Button
Handle
Paddle/Pad Port
RS-232 Data
Transfer Connection AC Power
SIDE 1 SIDE 2
Paddle Dock
Rechargeable Battery
POWER BUTTON
To Power on and off the Responder 2000, push the green Power button on the front panel of the Responder 2000.
POWER ON
1. Press the green power button to turn on the Responder 2000. As the Responder 2000 powers on, the system
performs a self-test.
2. After the Responder 2000 is powered on, it will automatically go into Manual Mode. The user can also program it to
enter Semi-Auto Mode or Monitor mode upon power on of the device.
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).
POWER OFF
Press the green power button to turn off the Responder 2000.
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 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.
SHOCK BUTTON
The shock button activates (flashes red) only when the system is charged and ready to deliver therapy to the patient.
Press and hold the shock button until therapy is delivered. This button is disabled when the paddles are connected to the
Responder 2000. If pads or spoons are used, the shock button will only be activated with good impedance.
SOFT KEYS
Soft keys are buttons which are displayed on the graphics display and are activated by using the Rotary Selector Knob.
1. HIGHLIGHT the selection by rotating the Rotary Selector Knob to move the highlight around the screen until the
setting you wish to change is highlighted.
2. SELECT the item by pressing the Rotary Selector Knob until it clicks.
PADDLE CONTROLS
The Apex paddle has one button, which controls both charge and shock. Press the Apex paddle button to charge the
Responder 2000. After the Responder 2000 is charged, press both the Apex and Sternum paddle buttons simultaneously
to deliver the shock. Charge and Shock are only activated when the system is in the proper defibrillation mode. If a
button is stuck or remains pressed from before activation of defibrillation, it must be released before a further press is
accepted. When the paddles are connected to the Responder 2000, the charge and shock buttons on the front panel will
be disabled. The charge button is enabled only when the Responder 2000 is in Manual Mode.
INFORMATION BAR
At the top of the screen is the Information bar showing the operating mode of the Responder 2000, the impedance
display, a battery charge status indicator and the current date and time.
MESSAGE AREA
In the middle of the screen, the Responder 2000 displays messages for software and system errors.
If 3-lead or 5-lead ECG cables are connected to the Responder 2000, the ECG monitoring waveform is displayed in
Channel 1. The same waveform can be cascaded (continued) from Channel 1 to Channel 2 if desired. Typically, the
system will display the power-on default of ECG II until a different lead combination is chosen.
Each channel has an input source (the ECG lead number) and Gain information associated with its trace waveform. To
change these settings, simply rotate the Rotary Selector Knob to highlight the field and press the Rotary Selector Knob to
select it. Rotate to cycle through the field value options and press the Rotary Selector Knob again to confirm the new
setting.
The system will display waveforms in channel 1 based on the following conditions:
If just an ECG cable is connected, the input sources available for the operator to select on channel 1 are:
o When an ECG cable is connected: I, II, III, aVR, aVL, aVF, V, Paddles (with Paddles off message)
NOTE: If the ECG cable becomes disconnected or falls off, a warning message is displayed.
If ECG is not connected, but Pads, Paddles, or Spoons are, the channel will automatically convert to the
connected input if the Auto-Switch source is turned on.
If Pads, Paddles, or spoons are connected along with the 5-lead ECG cable, the following source input options
are available:
o I, II, III, aVR, aVL, aVF, V, Pads, Paddles, Spoons
o If the ECG cable or the Pads, Paddles, or Spoons become disconnected or fall off, a warning
message is displayed.
o If no ECG or Pads are connected, it will indicate that no leads are connected by showing dashed line.
CHANNEL 2
1. Rotate the Rotary Selector Knob until the outline of the information box is highlighted then press to select the
information area.
2. Rotate the Rotary Selector Knob again to highlight a particular item within the highlighted box to change the setting.
Press to select the item then turn the knob to scroll through the value range for that item.
3. Press to confirm a new value.
BATTERY INDICATOR
The battery indicator graphically displays the approximate percentage of battery life remaining.
When AC is not present and the display falls to a single bar, the bar turns red to indicate that the battery should be
charged soon, or that a fully charged battery should be inserted.
When the Responder 2000 is connected to AC, a "lightning bolt" indicates that the battery is being charged or charge is
being maintained if the battery is full. When AC is not present, no lightning bolt is displayed.
1. Message 312
When battery voltage is low, Message 312 is displayed. Plug the device into AC to charge the battery, or insert
a fully charged battery.
When battery voltage is very low, the Message 313 and Message 318 alternate, and therapy is inhibited. Plug
the device into AC power to charge the battery, or insert a fully charged battery.
3. Message 314
When battery voltage is critically low, Message 314 is displayed momentarily and the system shuts down. Plug
the device into AC to charge the battery, or insert a fully charged battery. Turn the device back on if in use.
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.
The Responder 2000 will respond to a change in heart rate from eighty (80) bpm to one hundred and twenty (120) bpm in
less than five (5) seconds. The Responder 2000 will respond to a change in heart rate from eighty (80) bpm to forty (40)
bpm in less than ten (10) seconds in the conditions specified in ANSI/AAMI EC13 section 4.1.2.1 f).
WARNING: Do not rely solely on heart rate readings; assess the patient at all times.
OVERVIEW
This section describes how to prepare the Responder 2000 and the patient and using the Responder 2000.
TOPIC PAGE #
RESPONDER 2000 PREPARATION 48
PATIENT PREPARATION 48
USING PADS 48
USING ECG ELECTRODES 53
USING EXTERNAL PADDLES 55
USING INTERNAL PADDLES (SPOONS) 57
CHOOSING A DEFIBRILLATION MODE 60
MANUAL MODEError! Reference source not Error!
found. Bookmark
not defined.
SEMI-AUTO SHOCK MODE 64
ECG MONITORING 66
NON-INVASIVE PACING (OPTION) 69
PULSE OXIMETRY (OPTION) 74
PRINTING 76
SNAPSHOT 77
77
HISTORY MENU
RESPONDING TO ALARMS 78
ADJUSTING HEART RATE ALARM LIMITS 80
SETTING THE ECG SOURCE AND GAIN 80
2. Verify Responder 2000 Indications for Use are being met. Refer to Section 1.
3. Verify Responder 2000 Safety Terms and Conditions are being met. Refer to Section 1.
Prepare the patient according to directions in the PATIENT PREPARATION in this section.
4. Turn on the Responder 2000 by pushing the Power button on the front panel.
6. When the self-tests are complete, the default operating mode is displayed indicating that the
Responder 2000 has successfully passed the start-up self-test and is ready for patient use.
WARNING: Do not use batteries, pads, cables, or optional equipment not specifically approved for the Responder 2000.
The use of unapproved equipment may cause the Responder 2000 to function improperly during a rescue.
PATIENT PREPARATION
Follow these recommendations to prepare the patients skin:
If necessary, shave excessive chest hair. Use care not to nick or cut the skin. Avoid placing pads over broken or
irritated skin.
Briskly dry the skin with a towel or gauze to increase capillary blood flow in the tissues, remove skin cells, dirt and
excess oil.
USING PADS
The Pads listed in Section 7 of this manual are compatible with the Responder 2000. Adhere to the Precaution and
Warnings, Applying PADS, Placement of PADS, Changing of PADS, PADS OFF or SHORTED notifications in this
section.
The pads are not sterile and cannot be sterilized. They are for single patient use and need to be disposed after use.
Once the pads are applied to the patient they should not be repositioned.
After placing the pads on the patient, visually check that the pads are firmly attached.
The skin is a poor conductor of electricity; therefore preparation of the patients skin is important to facilitate good
pads-to-skin contact.
To ensure proper rhythm analysis by the Responder 2000, patient preparation and hook up must be properly
performed. Proper application and placement of the pads are essential for high-quality ECG monitoring. Good
contact between the pad and skin minimizes motion artifact and signal interference.
Thin Patients
Follow the contour of the ribs and spaces when pressing the pad onto the torso. This limits air space or gaps under the
Therapy pads and promotes good skin contact.
1. Turn off the Responder 2000. Connect the pads connector to the Responder 2000.
2. Shave the application points; this improves conductivity and makes the removal of pads easier.
3. Remove the protective liner by starting with the pad cable connection end. Slowly peel back the protective liner from
the pads.
4. Place the anterior (Sternum) pad on the patients right upper torso, lateral to the sternum and below the clavicle.
5. Place the (Apex) Therapy pad lateral to the patients left nipple, with the center of the pad in the midaxillary line, if
possible. For female patients, position the pad under the breast.
6. Starting from one edge, firmly press the pad onto the patients chest to eliminate air pockets between the gel surface
and the skin.
1. Turn off the Responder 2000. Connect the pads connector to the Responder 2000.
2. Shave the application points; this improves conductivity and makes the removal of pads easier.
3. Remove the protective liner by starting with the pad cable connection end. Slowly peel back the protective liner from
the PADS.
4. Place the posterior pad on the left side of the patients back, behind the heart in the intrascapular area. Apply the pad
to the patients skin. Do not place the pad over bony prominence of the spine or scapula.
5. Place the pad on the left side of the patients chest. The upper edge of the pads should be just below the nipple and
apply to the patient skin.
6. Starting from one edge, firmly press the pad onto the patients skin to eliminate air pockets between the gel surface
and the skin.
The pads must be changed after a therapy sequence (defibrillation or one (1) hour of continuous pacing) is delivered.
Turn off pacing and make sure Channel 1 lead source is not Pads.
Exit Manual Mode or Semi-auto Shock before disconnecting pads.
Disconnect pad connector from the Responder 2000.
Remove pads from the patient
Prep skin and attach new pads to the patient, in a slightly different location to avoid irritation or burns.
Attach pad connector to Responder 2000.
Select desired mode from the Systems Menu.
Check to see if pads are placed too close to each other and, if so, separate the pads ensuring that there is enough
distance between the pads
Change pads
NOTE: Anterior / Posterior pads placement may alleviate a PADS SHORTED message.
NOTE: If impedance at the pads/paddles is too low to shock the patient, the ECG in the display will automatically
switch from pads/paddles ECG to ECG II, if this feature is activated from the settings. To go back to pads/paddles ECG
you have to switch back manually.
WARNING: Due to the unique impedance characteristics of the patient, the Responder 2000 may not be able to shock the
patient.
In order to ensure proper demand pacing, the Responder 2000 requires a high quality surface ECG signal between the
patients skin surface and the ECG electrode. Standard 3-lead or 5-lead configuration is used to monitor the patients
electrocardiogram.
NOTE: The skin is a poor conductor of electricity, therefore preparation of the patients skin is important to
facilitate good electrode to skin contact. When cleaning the patients skin, NEVER use alcohol or tincture of
benzoin, as this increases skin resistance.
2. Plug the ECG patient cable into the ECG input connector (green) located on the front panel of the Responder 2000.
3. Prepare the patients skin according to the Patient Preparation section in this manual.
4. Peel the backing off the electrodes and press the electrodes firmly onto the patients skin.
3-Lead Placement
RA/R placement: Directly below the clavicle and near the right shoulder
LA/L placement: Directly below the clavicle and near the left shoulder
LL/F placement: On the left lower abdomen
5-Lead Placement
RA/R placement: Directly below the clavicle and near the right shoulder
LA/L placement: Directly below the clavicle and near the left shoulder
RL/N placement: On the right lower abdomen
LL/F placement: On the left lower abdomen
V/C placement: On the chest; the position depends on the required lead selection.
5. Select a site where the signal will not be interfered with by either movement or bones. Avoid touching the tape and
electrode gel.
6. Make sure there is adequate space (approximately 3 cm) between the pads and the ECG monitoring electrodes.
7. The various ECG leads can be individually selected and viewed on the LCD screen. The ECG Monitoring mode is
the ideal screen for viewing any of the ECG leads without therapy intervention.
WARNING: Use only paddles specified in Section 7 of this manual. The use of unapproved equipment may cause the
Responder 2000 to malfunction and may hinder patient treatment.
WARNING: Risk of Skin Burns / Equipment Damage Do not apply the paddles over sternum or clavicle, nipples,
implanted pacemaker or defibrillator devices.
1. Remove the Paddle Set from the Paddle cradles by pulling the paddles outward and out of the paddle docks.
2. Carefully dry the paddles and handles in particular, if they are damp or wet.
3. Apply electrode gel to the paddles. Do not distribute electrode gel by rubbing the paddles together.
4. Apply paddles to the patients bare chest, using the anterior-lateral placement (or in accordance with your
organizations protocol). Apply the paddles on the patient's thorax such that the greatest possible amount of energy
flows through the myocardium. The imaginary line connecting the paddle centers should be identical with the cardiac
median line.
5. Press the paddles firmly onto the thorax (the ECG appears on the monitor screen).
6. Initiate energy storage with the button on the APEX paddle (a).
When the selected energy is stored, the device emits an audio signal and the message "Stand Clear, Push Paddle
Shock appears.
NOTE: When the patient is a child under 8 years of age or weighs less than 55 lbs (25 kg), the Responder 2000
should be used with Pediatric Defibrillation paddles and pediatric energy protocols. These paddles are
integrated into the standard paddle set and are available by removing the adult contact plates off the paddles.
The paddles have two different contact surfaces; a large one (can be removed) for the defibrillation of adults and a smaller
one for the defibrillation of children.
WARNING: Shock Hazard Always switch off the device before exchanging the defibrillation electrodes and internal
spoons.
NOTE: If you are using internal electrodes with the Responder 2000, defibrillator charging and shock delivery
must be initiated with corresponding buttons on the front panel of the Responder 2000.
NOTE: The selectable energy when using internal paddles is as follows: 2, 3, 5, 7, 10, 15, 20, 30, and 50 Joules
2. Connect the internal paddles to the paddle dock on the back of the Responder 2000.
Spoon-shaped electrodes are used for internal defibrillation. Their contact surface must match the dimensions of the
heart. The spoons must make full contact with the heart. There is a choice of 3 different spoon sizes. You can use either
two spoon electrodes or one spoon electrode and one external counter electrode for defibrillation.
Sterilize internal electrodes before each use (see section Maintenance & Service).
Screw the counter nut 2 onto the electrode as far as it will go.
Screw the contact paddle 1 into the handle as far as it will go, then bring it into the appropriate position.
Now fix the contact paddle by screwing the counter nut 2 tight against the handle 3.
Observe the following guidelines to ensure successful and safe defibrillation. Otherwise the lives of the patient, the user
and bystanders are in danger.
WARNING: Defibrillating a patient with normal heart rhythm may induce ventricular fibrillation.
WARNING: Position the patient flat on a hard surface where he is electrically insulated. The patient must not be allowed
to come into contact with metal parts 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: Do not allow the defibrillation electrodes to come into contact with other electrodes or metal parts which are
in contact with the patient.
WARNING: The patient's chest must be dry, because moisture can cause unwanted pathways for the defibrillation
current. After use of flammable skin cleansing agents, wait until they have completely dried.
WARNING: The operator and all assistants must be briefed regarding the preparations for and execution of defibrillation.
All tasks must be clearly assigned.
Immediately prior to the shock: interrupt heart massage and artificial respiration, disconnect tube connections,
and warn bystanders.
Ensure that no conductive connection between the patient and bystanders exists during defibrillation.
Before delivering the shock, verify that the charged and selected energies are the same.
Manual Mode Operator manually selects energy level appropriate for the patients age, manually
charges the unit, and manually delivers therapy to the patient. In this mode, energy
can be selected manually or by using the auto-sequence energy settings. In this
mode, shock can be delivered in Synchronous (Sync) with a R-wave by selecting the
Sync Button. If Sync is selected, the Responder 2000 will attempt to synchronize
the shock. If it is unable to synchronize within 2 seconds, it will not deliver the
shock. Default for manual mode is No Sync.
Semi-Auto Mode In this mode, the operator can analyze the patients heart rhythm. Upon detection of
a shockable rhythm, the Responder 2000 will automatically charge and prompt the
operator to press the shock button to allow therapy to be delivered to the patient. In
Semi-Auto Mode, the Responder 2000 charges the unit to user preset energy
settings.
3. Ensure that the ECG monitor waveform shown in Channel 1 is set to the correct input source and gain. If not, follow
the directions given in Setting the ECG Source and Gain in this chapter to adjust.
Operator manually selects energy level appropriate for the patients age, manually charges the unit, and manually delivers
therapy to the patient. In this mode, energy can be selected manually or by using the auto-sequence energy protocol.
Default method of delivering therapy in the manual mode is No Sync, namely, therapy is delivered as soon as the shock
button is pressed. If the user chooses the Sync mode in the Manual Mode screen, therapy will not be delivered if the
device cannot synchronize with the patients R-wave within 2 seconds after the shock button is pressed.
Manual Mode can be selected from the System Menu or by pressing the Manual button. If Manual Mode is set as the
default mode, the Responder 2000 will power up in Manual Mode after turning the Responder 2000 on. It will then flash
the yellow Charge button.
1. To select the desired energy level appropriate for the patients age, turn Rotary Selector Knob counterclockwise to
go up and down the list. The operator will be able to select the following energy values:
PRECAUTION: Select the energy level appropriate for the patients age. The Responder 2000 does not select the
energy or shock sequences based on the defibrillation pads connection.
For pads and paddles:
2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, and 270 Joules
For internal paddles/spoons:
2, 3, 5, 7, 10, 15, 20, 30, and 50 Joules
6. The message Shock Delivered displays for eight (8) seconds once the shock has been delivered.
7. At any time during the manual defibrillation sequence, the operator can change the energy setting or exit the mode
completely by turning the Rotary Selector Knob and pressing Exit OR by pushing the Manual button.
NOTE: The operator has thirty (30) seconds to deliver therapy before the Responder 2000 disarms and
aborts therapy.
NOTE: Alarm Silence symbol is displayed, indicating that no audible tone warnings will be heard, only
written warning message will be displayed on the graphics display.
The Responder 2000 has a No Sync/Sync Option available in Manual Mode only. If No Sync is selected, shock is
delivered immediately. When Sync is selected, full length R-wave sync marks are drawn on display and shock delivery is
synchronized with the R-wave. No Sync is selected by default.
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.
NOTE: Every time after a Sync Shock is delivered; the device resets to No Sync.
NOTE: Select a lead that provides a unipolar R-wave with a minimum amplitude of 1 mV and a low-amplitude T-
wave.
AUTO SEQUENCE
In Manual Mode, there is also an Auto Sequence option. In Auto Sequence, three energy levels can be pre-set. When
this option is selected, the Responder 2000 automatically selects the first pre-set energy and prompts the operator to
push the Charge button. After the Responder 2000 is charged, it will prompt the operator to push the Shock button(s).
After a shock is delivered, the Responder 2000 automatically selects the next energy level. After all three pre-set shocks
have been delivered; the Responder 2000 selects the last energy level. All shocks after the third shock will be at that
level.
NOTE: In Auto Sequence if the user wants to deliver a Sync Shock, Sync must be selected individually for all
shocks in Auto Sequence.
In this mode, the Responder 2000 will analyze the patients heart rhythm. Upon detection of the shockable rhythm, the
Responder 2000 will automatically charge and prompt the operator to press the shock button to allow therapy to be
delivered to the patient.
Use of spoons is not be allowed in Semi-Auto Shock Mode. If spoons are attached to the Responder 2000 during power
on, selection of Semi-Auto Mode, or while already in Semi-Auto mode, the device will automatically switch to Manual
Mode immediately. The Message Area will display Switched to Manual Mode for six seconds.
Semi-Auto Shock mode can be selected from the System Menu. If Semi-Auto Shock mode is set as the default mode, the
Responder 2000 will automatically go into Semi-Auto Shock mode after turning the Responder 2000 on.
2. If a shockable rhythm is detected, the Responder 2000 will automatically charge to the appropriate energy level. The
sequence starts with the first displayed value then increments through the three increasing values.
3. When the charge is complete, the operator is prompted to push Shock button(s).
NOTE: The operator has thirty (30) seconds to deliver therapy before the Responder 2000 disarms and aborts
therapy.
4. After three (3) shocks in Semi-auto Shock mode, the Responder 2000 continues to use the last delivered energy.
The Responder 2000 can be used for ECG monitoring. The monitoring function allows the operator to monitor through:
Pads
3-lead ECG Electrodes
5-lead ECG Electrodes
If both pads and monitoring electrodes are connected, monitoring allows you to select a lead from the 3-lead, 5-lead ECG
source, or to monitor through the pads.
Configurable heart rate and arrhythmia alarms clearly communicate patient status, both audibly and visually.
See Setting the ECG Source and Gain in this section for changing these settings.
NOTE: Active filters will alter the ECG signal. Switch off the filters to obtain a diagnostic ECG.
NOTE: ECG signals acquired with pads, paddles, or spoons cannot be used for diagnostic purposes.
NOTE: The defibrillator can be set up to automatically activate the alarm tone on power up. The default alarm
limits can also be adjusted in the setup menu.
During patient transport the device may fail to identify arrhythmias due to motion artifact.
The default heart limits are 40 and 180 bpm and the audio alarm is disabled. The audio alarm can be enabled
permanently from the setup menu.
The defibrillator reports an alarm condition if the HR exceeds one of the alarm limits for more than 10 seconds:
The audio alarm sounds (configurable)
The recorder starts (configurable)
The alarm is indicated on the display
When the parameter reading returns to normal range, the audio alarm stops.
For information on setting and changing alarm parameters, refer to chapter Responding to Alarm and chapter Adjusting
Heart Rate Alarm Limits in this section.
WARNING: No HR Alarm If several adverse conditions exist at once during monitoring of pacemaker patients, the
possibility that pacer pulses are interpreted (and counted) as QRS complexes should be considered. Therefore,
pacemaker patients should always be watched closely.
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 devices manufacturer.
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.
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: If the battery is removed while pacing and there is not AC Power, the pacing settings need to be re-set
when the battery is inserted again.
NOTE: The message Please wait will be displayed during the period when the Responder 2000 is not pacing,
because of change of lead. The Responder 2000 will not pace during this time.
To Enable Pacing:
7. Use Rotary Selector Knob to move focus Pacing Info box, at the displays lower right.
8. Select the Pacing Info box. If pacing is not enable, the Pacing Info box is not selectable.
10. Turning clockwise, the following items should be selectable, in order, wrapping around:
12. When Pacing is turned on, focus automatically goes to the Pacing Current selection. Set desired pacing current.
13. Turn the rotary knob to select pacing rate and set desired options for pacing rate.
To Stop Pacing:
The user is responsible for the safe application of the devices. Observance of the instructions given in the operators
manual and of the guidelines below is therefore of utmost importance:
a) Pacemaker must only be used under the supervision of qualified and authorized staff.
b) The prerequisite for safe application is the use of intact devices in rooms that meet the applicable requirements.
Expert knowledge, good organization and special care in selecting the technical installation as well as regular
maintenance are required to ensure such operating conditions.
c) Medical electrical devices such as the Responder 2000 must only be handled by persons who are trained in the
use of such equipment and are capable of applying it properly.
d) Before using the device, the operator is obliged to verify that it is in correct working order and operating
condition.
e) It is assumed that the patients ECG is being monitored to be able to assess the effect of pacing. Furthermore,
at least one of the persons present must be trained in the use of the defibrillator.
g) The pulse current output of the pacemaker is ungrounded. This ensures that the pacer current only flows
between the pacemaker electrodes.
h) If the patient needs to be defibrillated while the pacemaker is on, the pacemaker first must be turned off. After
delivery of the defibrillation shock you have to restart the pacemaker and adjust the pacemaker settings.
In demand mode, the pacemaker does not deliver pacing pulses as long as the patient's intrinsic heart rate exceeds the
set pacing rate. When the heart rate drops below the pacing rate, the pacemaker starts emitting stimulation pulses. This
can only be ensured by continued electronic monitoring of the ECG. The necessary synchronization pulses are
automatically sent to the pacemaker.
NOTE: Even in unfavorable situations, the electrode gel will penetrate the patient's skin in 5 to 7 minutes,
reducing the electrode-skin contact impedance. If this is sufficient to improve the signal quality, pacing in the demand
mode will then become possible.
The demand mode is the recommended pacing mode when the patient is at risk of developing bradycardia or even
cardiac arrest as a result of a critical event. As the pacemaker function is controlled by the patient's ECG, the harmful
competition between intrinsic and external stimulation which could induce ventricular fibrillation is excluded.
1. Check that the ECG electrodes and the pace pads are correctly applied and connected to the device.
1. Select the Pacing Info Box by turning the Rotary Selector Knob.
5. Now increase the pacer current output slowly until the heart reliably responds to the stimulation.
8. You can pause the stimulation and resume pacing with the same settings by turning focus to the On field and
selecting Pause with the Rotary Selector Knob.
9. After therapy, turn off the pacemaker before removing the pace pads carefully.
PRECAUTION: The pacer pulses are delivered via the adhesive defibrillation electrodes. Separate electrodes can be
applied for acquisition of the ECG signal. Without ECG electrodes the ECG cannot be displayed.
In fixed-rate mode, the device delivers pacing pulses at the selected rate and current. The selected rate remains constant
and is not affected by intrinsic actions of the patient's heart. This is the preferred mode for cases of cardiac arrest.
NOTE: The default pacer rate can be configured. End the therapy as described under "Demand Pacing above.
1. Check that the ECG electrodes and the pace pads are correctly applied and connected to the device.
2. Use the Rotary Selector Knob to turn on the pacemaker. The device defaults to the Demand Mode, if separate
electrodes are applied and selects a pacer rate of 60 PPM (configurable).
3. Turn the Focus to the Demand field to activate the fixed-rate pacing mode by selecting Fix Mode, using the Rotary
Selector Knob.
5. Now increase the pacer current output slowly until the heart reliably responds to the stimulation.
1. Turn the Rotary Selector Knob until the Channel 2 source wave heading is highlighted and press the Rotary Selector
Knob.
2. Turn the Rotary Selector Knob until SpO2 displays and press to select. The waveform changes to show the SpO2
trace.
WARNING: Do not rely solely on SpO2 readings; assess the patient at all times. Inaccurate measurements can be caused
by:
NOTE: The SpO2 alarms can be cleared either by changing the Channel 2 Source to Cascade or by reconnecting
the SpO2 sensors.
NOTE: Use only sensors that are recommended in Section 7 of this manual.
WARNING: No Alarm
Under certain conditions the device may not be able to identify a signal disturbance when monitoring the patient. In this
situation artifacts are capable of simulating a plausible parameter reading, so that the monitor fails to sound an alarm. In
order to ensure reliable patient monitoring the proper application of the probe and the signal quality must be checked at
regular intervals.
General Tips
Use only the probes listed in chapter 7 "Accessories". Apply the probes as described in their instructions for use.
Carefully observe all information and cautions given in these instructions.
Take care that the probe does not exert too much pressure when applied to avoid erroneous readings and blistering.
Inadequate oxygen supply to the skin, not heat, causes blisters.
Change the probe site at least every 24 hours to allow the skin to breathe.
Be careful to ensure continued circulation at the probe site.
Incident light may cause inaccurate readings. Cover the measuring site with a cloth, if necessary.
It may not be possible to measure SpO2 values, if cardiac output is determined at the same time by means of the
dye dilution technique.
It may not be possible to measure SpO2 values or the pulse rate, if the circulation is impaired (e.g. by a blood-
pressure cuff or by an extremely high vascular resistance).
Remove nail polish and artificial finger nails before applying the probe. Both may lead to inaccurate readings.
Do not apply the finger probe to the same arm as the blood-pressure cuff.
TO PRINT
NOTE: Verify printer has adequate paper on its roll for use.
Rotate the Rotary Selector Knob until the Print icon highlights and press to initiate printing. A single press starts the print
sequence. While printing, a second press of the Rotary Selector Knob stops printing the record information.
The printer will annotate the following information along the length of the print out.
a. Patient Name:
b. Patient Birth Date:
c. User Name:
d. Comments:
e. Date:
f. Time:
g. Selected: (Energy) or Mode: (Fixed or Demand)
h. Delivered: (Energy) or Rate and Current
i. ECG Alarm Low:
j. ECG Alarm High:
k. SpO2 Alarm Low:
l. SpO2 Alarm High:
NOTE: The ECG channel waveform will be printed with fixed gain and does not depend on the gain set for the
displayed ECG.
NOTE: If activated in the settings, the printer starts automatically with each new alarm activation. Active
printouts will be interrupted immediately.
NOTE: If activated in the settings, the printer starts automatically with each Shock Recommended message
in the Semi-Auto Mode.
TO TAKE A SNAPSHOT
1. Turn the Rotary Selector Knob to the camera icon and push to take a snapshot of Channel 1 and have it displayed in
Channel 2. Channel 1 continues to monitor in real time.
HISTORY MENU
From the history menu the operator can view the event log and patient trends.
EVENT LOG
The Responder 2000 logs patient events, operator actions, and system errors and warnings. This information can be
viewed or printed.
Logged Events show the name, event code, time of occurrence and associated information with the event.
Up to 5000 of the most current events can be viewed. The operator can select a range of events to print.
Patient events also store their associated ECG waveform, which can be printed from the event log menu. Only the
forty (40) most current event waveforms are saved.
PATIENT TRENDS
Trend data of Heart Rate and SpO2 Saturation is available in 45 minute or 9 Hour intervals. The Patient Trends need to
be cleared every time a new patient is connected. A vertical line with a pointed arrow on the trend indicates a power cycle.
The beginning and ending date/time are printed on the trend data printout.
Depending on their category, alarms have different visual and/or audible indicators. Higher priority alarm(s) overrides any
medium or lower priority alarms.
AUDIBLE ALARMS
The Responder 2000 has a speaker built in to the front panel of the device to sound audible alarms when appropriate.
The alarm icon at the bottom of the screen allows you to silence all high, medium, and low alarm(s).
This button toggles between three states: On, Off, Pause
PRECAUTION: It is not recommended to select Off to turn off the audible alarms.
Pause will display a countdown 120 seconds before the alarm becomes active again. When the Responder 2000 is
fully charged and ready to deliver a shock, the user cannot silence or turn down the beeping.
2. Rotate Rotary Selector Knob and Select Low Alarm Limit Range
Available Low Alarm Settings: Off, 25-120 (in increments of 5)
Default: 40
4. Rotate Rotary Selector Knob and Select High Alarm Limit Range
Available Settings: 40-300 (increments of 5), Off
Default: 180
1. To set the source for the ECG waveforms, rotate the Rotary Selector Knob to highlight the current ECG selection.
3. Turn the Rotary Selector Knob again to increment the source selection. The options are:
ECG I, ECG II or ECG III
aVR
aVF
aVL
V
Paddles
5. To set the Gain for the displayed waveform, rotate the Rotary Selector knob to highlight the gain value.
NOTE: The gain in display does not affect the gain on the printout. The printout is always at 1x gain.
7. Press the Rotary Selector Knob to confirm your choice. The waveform size will adjust accordingly.
OVERVIEW
The Responder 2000 features a flexible configuration set-up. Menus with controls and options specific to each function of
the Responder 2000 are easily accessible and configurable through the Menu Select and Rotary Selector Knob located
on the front panel. Menus are used to adjust settings for defibrillation, pacing, channel display, alarms, system, date and
time, and user settings.
TOPIC PAGE #
SETTINGS MENU 82
DEFIBRILLATION 85
PACING 87
CHANNEL SETTINGS 89
ALARMS/SOUND 91
DATE/TIME 93
USER SETTINGS 95
6. To enter the password, push the Rotary Selector Knob. It will highlight the first space. There is no default password.
If a password needs to be reset, enter VASCULAR.
7. Push the Rotary Selector Knob and rotate the Rotary Selector Knob to scroll through the alphabet and numbers in
this field.
8. Push the Rotary Selector Knob when the letter you want is displayed. Repeat this for each space until the password
is complete.
9. When you are finished entering the password, turn the Rotary Selector Knob clockwise until the password box is
highlighted. Push the Rotary Selector Knob.
10. Turn the Rotary Selector Knob to Accept and push the Rotary Selector Knob.
11. After successfully entering the password, the Setting menu will now appear.
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.
The Responder 2000 Defibrillation Settings can be configured to the desired setting.
1. From the Settings menu, rotate the Rotary Selector Knob to Defibrillation Settings.
The Responder 2000 Pacing settings can be configured to the desired setting from the Settings or Pacing mode box on
the startup menu. Pacing mode is turned off by default.
1. From the Settings menu, rotate the Rotary Selector Knob to Pacing Settings and push Rotary Selector Knob to
select.
2. Select Pacing Default Parameters Mode and Rate (PPM) by rotating Rotary Selector Knob to each setting. Push to
select setting, rotate to select option, and push to select desired default setting.
4. Use Rotary Selector Knob to move focus to Pacing Mode Edit box and press Rotary Selector knob to select it.
The Responder 2000 Channel Settings can be configured to the desired setting.
1. From the Settings menu, rotate the Rotary Selector Knob to Channel Settings.
The Channel 1 menu allows default settings to be selected for Source and Gain.
Gain
Factory Default: 1x
Available Settings: .25x, 0.5x, 1x, 2x, 4x
CHANNEL 2
The Channel 2 menu allows default settings to be selected for Source and Gain.
Source Gain
Factory Default: SpO2 with Option, Otherwise Cascade Factory Default: 1x
Available Settings: Cascade, SpO2 Available Settings: .25x, 0.5x, 1x, 2x, 4x
FILTERS
The Filters menu allows default settings to be selected for Line Filter (Hz) and Muscle Filter.
Selection only valid for ECG channel, but not for pads/paddles channel.
The Responder 2000 Alarm/Sound Settings can be configured to the desired setting.
1. From the Settings menu, rotate the Rotary Selector Knob to Alarms/Sound Settings.
PATIENT TRIGGERS
Low Heart Rate (BPM) High Heart Rate (BPM)
Factory Default: 40 Factory Default: 180
Available Settings: Off, 25-120 Available Settings: 40-300, Off
(increments of 5) (increments of 5)
1. From the Settings menu, rotate the Rotary Selector Knob to Date/Time Settings.
4. For each setting, rotate the Rotary Selector Knob clockwise and counterclockwise to select the desired value.
5. Push the Rotary Selector Knob to select desired setting.
6. To save the time, date, and date format settings, rotate Rotary Selector Knob to Accept and push.
The Responder 2000 User Settings Menu allows you to store the name of your institution in the device and create a new
password.
1. From the Settings menu, rotate the Rotary Selector Knob to User Settings Menu.
The Facility menu allows you to store the name of the institution in the device.
1. Push the Rotary Selector Knob to bring the cursor to the first space.
2. Push the Rotary Selector Knob again to select the letter, number, punctuation.
3. Turn the Rotary Selector Knob to scroll through the English only alphabet and numbers in this field.
4. Push the Rotary Selector Knob when the letter you want is displayed. Repeat this for each space until the name is
complete.
5. When you are finished entering the desired name, turn the Rotary Selector Knob clockwise until the name box is
highlighted. Push the Rotary Selector Knob.
6. Turn the Rotary Selector Knob to Accept and push the Rotary Selector Knob.
The Responder 2000 Set Password Menu allows you create a unique password.
1. To open the Set Password menu, turn the Rotary Selector Knob to Set Password and press the Rotary Selector
Knob.
2. Push the Rotary Selector Knob to bring the cursor to the first space.
3. Push the Rotary Selector Knob again to select the letter or number.
4. Turn the Rotary Selector Knob to scroll through the English only alphabet and numbers in this field.
5. Push the Rotary Selector Knob when the letter you want is displayed. Repeat this for each space until the name is
complete.
6. When you are finished entering the desired password, turn the Rotary Selector Knob clockwise until the name box is
highlighted. Push the Rotary Selector Knob.
8. Turn the Rotary Selector Knob to Accept and push the Rotary Selector Knob.
9. When you are finished re-entering the password, turn the Rotary Selector Knob clockwise until the name box is
highlighted. Push the Rotary Selector Knob.
10. Turn the Rotary Selector Knob to Accept and push the Rotary Selector Knob.
The Responder 2000 Display Settings menu allows you to configure the backlight of the graphics display.
1. From the Settings menu, rotate the Rotary Selector Knob to Display Settings
The Responder 2000 Printer Settings menu allows you to configure printer options.
1. From the Settings menu, rotate the Rotary Selector Knob to Printer Settings
The Responder 2000 Power-up Settings menu allows you to configure and set the default mode.
1. From the Settings menu, rotate the Rotary Selector Knob to Power-Up Settings
The Responder 2000 Restore Defaults menu allows you to restore all settings to factory recommended defaults.
1. From the Settings menu, rotate the Rotary Selector Knob to Restore Defaults Settings
2. Push the Rotary Selector Knob to view Restore Defaults Settings settings.
OVERVIEW
Proper maintenance of the Responder 2000 is very simple, yet it is an important factor in its reliability. This section
describes the maintenance and service required for the Responder 2000 and its accessories.
TOPIC PAGE #
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
CARING FOR RECHARGEABLE BATTERIES 112
CALIBRATING THE BATTERY FUEL GAUGE 112
RECYCLING THE BATTERIES 112
DEFIBRILLATOR CHECKLIST 113
117
AUTHORIZED REPAIR SERVICE
To ensure the Responder 2000 is always functional when required, the following maintenance must be performed:
It is recommended that the Responder 2000 be plugged into a power source at all times. This will ensure your
battery is fully charged and the Responder 2000 is ready to use. Battery charging /charge maintenance will occur as
long as the Responder 2000 is plugged into a properly functioning electrical outlet source.
It is important that the Responder 2000 is stored at the operating temperature range if it is expected to be used.
Optimal battery life will be obtained if stored and operated at room temperature. See Section 7 for Temperature
Specifications.
The Responder 2000 requires no calibration except for periodic calibration of the fuel gauge in the rechargeable
battery.
Verify that the Safety label on back of the Responder 2000 is clearly legible
With unit plugged into an active Battery Indicator is showing battery Plug Responder 2000 in using power
AC outlet, turn power on low cord to charge battery.
Examine disposable accessories Expired ECG or Responder 2000 Replace any products approaching
pads or past their expiration dates.
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 repaired. The accessories should be disposed of appropriately
and replacement parts shall be ordered.
Listed below are recommendations for cleaning the Responder 2000 and its accessories.
3% Hydrogen Peroxide
100% Ethyl Alcohol
91% Isopropyl Alcohol
Mild soap and water
Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners.
Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may occur
Do not clean electrical contacts or connectors with bleach.
CLEANING INSTRUCTIONS
1. Before cleaning the Responder 2000, turn the device off, disconnect the power cord, and remove battery.
2. Before cleaning, also remove all adherent soil (tissue, fluids, etc.) and wipe thoroughly with a cloth dampened with
water before applying the cleaning solution.
5. Avoid pouring fluids on the device, and do not allow fluids to penetrate the exterior surfaces of the device.
PRECAUTION: To prevent damage to equipment, do not clean any part of the Responder 2000 or its accessories (with
the exception of internal paddles/spoons) with phenolic compounds. Do not use abrasive or flammable cleaning agents.
Do not steam, autoclave, or gas-sterilize the Responder 2000 or accessories.
WARNING: Cleaning liquids: DO NOT submerge the device in liquids or pour cleaning liquids over, into or onto the
device.
PRECAUTION: Electrode Damage Do not sterilize the electrodes for internal defibrillation (spoons) with hot air.
Cable Damage Disconnect the cable from the electrodes before sterilization.
The electrodes and connecting cables should be sterilized by the low-temperature plasma sterilization method. Alternative
methods are ETO sterilization, water vapor (134 C) or ionizing radiation. Ensure that internal defibrillation electrodes are
sterilized before each use.
NOTE: Having loosened the counter nut 2, you can easily alter the position of the contact paddle.
Daily maintenance activities involve verifying output energy, testing key controls and functions, making sure all necessary
accessory items are present, assuring date coded items are within their effective terms, checking for obvious damage
(worn or frayed cables, case cracks, etc.), and confirming/testing battery performance.
The following daily checklist is recommended to be utilized when checking the defibrillator:
e) Verify that the battery latch is working properly If latch is not working properly,
Contact Customer Service
d) Remove the adult surface plate from the paddles. Replace paddles if necessary
Verify pediatric paddles are clean, not pitted or
damaged.
e) Verify the paddle holder latches are working properly. If latches are not working properly,
Contact Customer Service.
b) Verify that connectors are engaged securely If this is not the case, please contact
Customer Service.
(Green) Power button light illuminated If this is not the case, please contact
Customer Service.
(Red) Service LED stays illuminated Take the device out of use and call
Customer Service.
(Yellow) Charging button light illuminates If thats not the case, please contact
Customer Service.
b) Verify AC Power, Service Required, and Battery If this is not the case, please contact
Charging LEDs turn on momentarily during power on. Customer Service.
c) During power on, verify a brief audible tone is output. If this is not the case, please contact
Customer Service.
d) Verify Charge button backlight is momentarily turned If this is not the case, please contact
on during power on. Customer Service.
e) Verify Shock button backlight is momentarily turned If this is not the case, please contact
on during power on. Customer Service.
f) Press Manual button. Verify Manual Mode is exited. If this is not the case, please contact
Press Manual button again and verify Manual Mode Customer Service.
is entered.
g) Verify Power cable connected to Responder 2000 No Action
h) Verify AC Power LED is turned on. If this is not the case, please contact
Customer Service.
i) Verify Display is working correctly and no error If display is working incorrectly, take
messages are indicated. the device out of use. Please
contact Customer Service.
j) Place battery in unit and connect AC power. A green If this is not the case, please contact
and a yellow LED shall be turned on the front panel, Customer Service.
indicating AC is connected and battery is charging.
Verify the delivered energy is not more than 15% or If the Responder 2000 is unable to
4 joules (whichever is greater) from the selected charge to the selected energy so the
value. selected energy or the stored energy
differs, contact Customer Service.
a) Make sure the battery is at least partially charged. If the battery is not partially charged,
wait and partially charge the battery.
Power the Responder 2000 from the battery only, i.e.
disconnect AC power input to the device.
b) Connect the ECG leads of the Responder 2000 to If the Responder 2000 is unable to
the simulator. Turn on the simulator. Select a turn on, or unable to select all leads,
normal sinus rhythm on the simulator. Make sure or the ECG signal is not present, or
you are able to select all leads, and that the ECG is distorted or noisy, contact
signal is present, and is not distorted or noisy. Make Customer Service.
sure there are no false pace pulse detections.
d) Connect the pads cable from the Responder 2000 to If the Responder 2000 is unable to
the simulator. Turn on the simulator. Select a turn on, or if the ECG signal is not
normal sinus rhythm on the simulator. Make sure the present, or is distorted or noisy,
ECG signal is present, and is not distorted or noisy. contact Customer Service.
Make sure there are no false pace pulse detections.
10. Pacing
The performance of the pacemaker can be tested with the 2025269-003 Simulator.
Connect the pads cable from the Responder 2000 to the If this is not the case, please contact
simulator. Turn on the simulator and the Responder 2000. Customer Service.
Turn on the pacer and select pacer current > 60 mA.
Verify pacer pulse LED at the simulator is flashing in the
rhythm of the pace pulses.
a) Verify that the paper used is manufactured or If this is not the case, replace it by
recommended by GE Medical Systems Information paper manufactured or
Technologies. recommended by GE Medical
Systems Information Technologies.
b) Confirm paper advances when Print is pressed If this is not the case, please contact
Customer Service.
c) Select Print from main menu. Verify contents printed If Responder 2000 contents are
correctly. printed incorrectly, please contact
Customer Service.
12. Reconnect Responder 2000 to electrical outlet. It is now ready for use.
NOTE: The warranty will be void upon unauthorized disassembly or service of the Responder 2000.
OVERVIEW
This section presents the specifications and safety standards of the Responder 2000.
TOPIC PAGE #
SPECIFICATIONS 120
PHYSICAL DIMENSIONS 122
ENVIRONMENTAL REQUIREMENTS 122
RHYTHMx ECG ANALYSIS ALGORITHM 123
STAR BIPHASIC DEFIBRILLATION WAVEFORM 125
127
ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS
128
ENVIRONMENTAL STANDARDS
ELECTROMAGNETIC EMISSIONS TABLE 129
ELECTROMAGNETIC IMMUNITY TABLE 130
RF COMMUNICATIONS TABLE 130
Saturation Accuracy +/- 2 digits from 70% SpO2 to 100% SpO2 with D-O probes, except +/- 3
digits for D-O Ear Probe. OEM board accuracy +/-3 digits from 70%
Weight: Less than 10lbs/4.5kg, excluding battery, paddles, and a full roll of paper.
ENVIRONMENTAL REQUIREMENTS
OPERATING CONDITIONS
Temperature: 0C to 50C (32 F to 122F)
NOTE: Do not exceed 38C (100F) for periods greater than 6 months in duration. Always store the pads in
their pouch to maintain freshness. Do not use if gel has dried out.
WARNING: Electrode performance may be adversely affected by pre-attaching and storing with defibrillator cable or
exposure to air for long periods of time. These electrodes are not recommended for electrosurgery.
The Responder 2000 rejects all T-waves that are 1 millivolt or less in the conditions specified in ANSI/AAMI EC 13 section
4.1.2.1c.
The Responder 2000 will alarm tachycardia in the conditions specified in ANSI/AAMI EC 13 section 4.1.2.1 g) in less than
10 seconds.
For the alternating ECG complexes specified in ANSI/AAMI EC 13 figure 3, the Responder 2000 will indicate the following
heart rates:
Figure 3a 40 bpm
Figure 3b 52 bpm
Figure 3c 59 bpm
Figure 3d 122 bpm
DETECTION RATE
All ventricular fibrillation (VF) and ventricular tachycardia (VT) rhythms at or above this rate will be classified as shockable.
All rhythms below this rate will be classified as non-shockable. This rate is configurable between 120 bpm (beats per
minute) and 240 bpm. The default Detection Rate for the Responder 2000 is 160 bpm.
FINE VF
Fine VF is classified by the signal amplitude less than 0.2 mV peak-to-peak for eight (8) consecutive seconds, preceded
by a shockable arrhythmia or the peak-to-peak amplitude less than 0.9 mV, the amplitude distribution indicator is less than
amplitude distribution threshold, the derivative probability density function is satisfied, the RR interval index is not regular,
and it is preceded by a shockable rhythm. Fine VF is a shockable arrhythmia.
ASYSTOLE
The signal amplitude is less than 0.2 mV peak-to-peak for 8 consecutive seconds and is not preceded by a shockable
rhythm; the rhythm will be classified as Asystole. Asystole is not shockable.
NOISE DETECTION
The Responder 2000 will detect noise artifact in the ECG. Noise could be introduced by excessive moving of the patient
or electronic noise from external sources like cellular and radiotelephones.
NON-COMMITTED SHOCK
After the Responder 2000 advises a shock, it continues to monitor the patient ECG rhythm. If the patients rhythm
changes to a non-shockable rhythm before the shock button is pressed, the shock will be cancelled.
IEC 60601-2-4 (2002) and ANSI/AAMI DF 80 (2003), clause 104c states that the maximum delay from the peak of the
QRS to the peak of the defibrillator output waveform shall be 60ms. Verification testing has shown that the Responder
2000 meets this requirement of the standards.
Some ECG leads may exhibit a bipolar QRS waveform complex, and in these cases, the RHYTHMx software in the
Responder 2000 will pick the highest peak of the QRS complex for synchronization. The peak of the defibrillator output
will occur in less than 60ms from this peak, and therefore the Responder 2000 meets the synchronization requirement of
the standards.
In the case of these leads, certain defibrillator testers may use a different part of the QRS complex (for example the first,
smaller peak) to measure synchronization time of defibrillation. This may give a measurement result that exceeds 60ms.
Investigation has shown that the Responder 2000 does synchronize appropriately from the peak of the QRS complex, and
meets the requirement of the standards in cases where a particular defibrillator tester does not measure the defibrillation
delay from the peak of the QRS complex.
SVT RATE
All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT
Discriminators to classify them into VF/VT or SVT. Rhythms classified as SVT between the two set rates are not
shockable. All rhythms above the rates will be classified as shockable. The SVT Rate must be greater than the Detection
Rate and is selectable between 125 and 240 bpm. The default SVT rate is 240.
Pacemaker pulses with overshoot, in all the conditions specified in ANSI/AAMI EC 13 section 4.1.4.2, in the range of
20mV to 700MmV and 0.1 milliseconds to 2 milliseconds wide, will be rejected by the Responder 2000.
The pacer pulse detector will not respond to the waveform of ANSI/AAMI figure 5d, since this waveform is below the
threshold of the Responder 2000 pacer pulse detector. The minimum typical slew rate in V/s RTI that will trip the pacer
detector is 6.2 V/s for the 3 and 5 lead ECG. The minimum typical slew rate in V/s RTI that will trip the pacer detector is
9.8 V/s for paddles.
The waveform generated by the Responder 2000 is a BIPHASIC TRUNCATED EXPONENTIAL waveform that is
compliant with ANSI/AAMI DF80.
2000.0
1500.0
1000.0
500.0
Volts
270J/50ohm
0.0
-500.0
-1000.0
-1500.0
-1.000 0.000 1.000 2.000 3.000 4.000 5.000 6.000 7.000 8.000 9.000 10.000
Time [ms]
IEC 60601-1, (1988 + A1:1991 + A2:1995), Medical Electrical Equipment Part 1 General Requirements for Safety
nd
EN 60601-1, (1990 + A1:1993 + A2:1995), 2 Edition Medical Electrical Equipment, Part 1: General Requirements for
Safety
IEC 60601-1-1, (2000), Medical Electrical Equipment - Part 1: General Requirements for Safety 1: Collateral Standard:
Safety Requirements for Medical Electrical Systems
IEC 60601-2-4, (2002), Medical Electrical Equipment Part 2-4: Particular Requirements for the Safety of Cardiac
Defibrillators
IEC 60601-2-49, (2001), Medical Electrical Equipment - Part 2-49: Particular Requirements For The Safety Of
Multifunction Patient Monitoring Equipment
IEC 60601-2-27, (1994), Medical electrical equipment, part 2: Particular requirements for the safety of
electrocardiographic monitoring equipment
UL 60601-1, (2003), Medical Electrical Equipment Part 1, General Requirements for safety
CAN/CSA-C22.2 No. 601.1-M90, Medical electrical equipment Part 1: General Requirements for Safety
ANSI/AAMI DF80-2003, Medical Electrical Equipment Part 2-4: Particular Requirements for the Safety of Cardiac
Defibrillators (including automated external defibrillators)
IEC 60601-1-2 (2001), Medical electrical equipment Part 1: General requirements for safety 2. Collateral standard:
electromagnetic compatibility - Requirements and tests.
EMISSIONS
Electromagnetic Fields: CISPR 11 (2003), Industrial, scientific and medical (ISM) radio-frequency equipment - radio
disturbance characteristics - limits and methods of measurement; Group 1, Class B. IEC 60601-2-4 (2002), Section
36.201.1.
Harmonic distortion: IEC 61000-3-2 (2004), Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits For Harmonic
Current Emissions (Equipment Input Current Less Than Or Equal To 16 A Per Phase).
Voltage fluctuations and flicker: IEC 61000-3-3 (2002), Electromagnetic Compatibility (EMC) - Part 3-3: Limits - Limitation
Of Voltage Changes, Voltage Fluctuations And Flicker In public Low-Voltage Supply Systems, For Equipment With Rated
Current Less Than Or Equal To 16 A Per Phase.
IMMUNITY
Electromagnetic: IEC 61000-4-3 (2003), Electromagnetic compatibility (EMC) - part 4-3: Testing and measurement
techniques - radiated, radio-frequency, electromagnetic field immunity test; Level 3 (10V/m) and X (20V/m). IEC 60601-2-
4 (2002) Section 36.202.3.
Magnetic: IEC 61000-4-8 (1994), Electromagnetic compatibility (EMC) - part 4. Testing and measurement techniques -
section 8. Power frequency magnetic field immunity test basic EMC publication; Level X (3 A/m). IEC 60601-2-4 (2002),
Section 36.202.8.
Conducted: IEC 61000-4-6 (2003), Electromagnetic compatibility (EMC) - part 4-6: testing and measurement techniques -
immunity to conducted disturbances, induced by radio-frequency fields. IEC 60601-2-4 (2002), Section 36.202.6.
Fast transients and bursts: IEC 61000-4-4 (2001), Electromagnetic compatibility (EMC) - part 4: Testing and
measurement techniques - section 4: Electrical fast transient/burst immunity test. IEC 60601-2-4 (2002), Section
36.202.4.
Surges: IEC 61000-4-5 (2001), Electromagnetic compatibility (EMC) - part 4: Testing and measurement techniques -
section 5: Surge immunity test. IEC 60601-2-4 (2002), Section 36.202.5.
Voltage dips, short interruptions and voltage variations on power supply input lines: IEC 60601-4-11 (2004),
Electromagnetic Compatibility (EMC) - Part 4-11: Testing And Measurement Techniques - Voltage Dips, Short
Interruptions And Voltage Variations Immunity Tests.
ENVIRONMENTAL STANDARDS
SHOCK AND VIBRATION
The Responder 2000 is tested per the following when in the unpackaged condition:
Bump: IEC 60068-2-29 (1987), Test EB: bump; 25g, 6 ms, 0.9 m/s V, and 1000 bumps in each direction
Sine Vibration: IEC 60068-2-6 (1995), Environmental testing - part 2. tests - test FC: Vibration (sinusoidal); 0.15mm
displacement amplitude, 10-55Hz, 10 sweep cycles in each axis
Random Vibration: IEC 60068-2-64 (1993), Environmental testing - part 2: test methods - test FH: Vibration broadband
random (digital control) and guidance: 1-100Hz, 0.01g2/Hz 30 minutes.
Free Fall Drop: IEC 60068-2-32 (1975 + A1:1990), Environmental testing - test methods - test ED: free fall; 18 inches
Enclosure Protection: IEC 60529 (2003), Degrees of protection provided by enclosures (IP code); IP22.
ISTA Preshipment Test 2A (2001), Simulation Performance Test Procedure - Packaged-Products 150lb(68 kg) or Less
IEC 61000-3-3
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location in
magnetic field a typical commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
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.
RF COMMUNICATIONS TABLE
Recommended separation distances between portable and mobile RF communications equipment and the
Responder 2000
The RESPONDER 2000 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the RESPONDER 2000 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
RESPONDER 2000 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter
150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W outside ISM bands in ISM bands
d = 1.2P d = 1.2P
d = 1.2P d = 2.3P
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 to 40.70 MHz.
NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the
ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
WARNING:
The use of accessories, transducers and cables other than those specified in Section 7 of this manual may increase
emissions or decrease immunity performance of the device/system.
The table below lists cables, transducers, and other applicable accessories with which GE Medical Systems claims EMC
compliance.
NOTE: Any supplied accessories that do not affect EMC compliance are not included.
2021141-001 3 lead wire set IEC , combined cable and lead wire 4.8 m / 16 ft
2021141-002 3 lead wire set AHA , combined cable and lead wire 4.8 m / 16 ft
Defibrillator Cables
Power cords
OVERVIEW
This section contains a list of parts and accessories for Responder 2000. To place an order, contact your representative
or distributor.
TOPIC PAGE #
RESPONDER 2000 ACCESSORIES 136
WARNING: The use of accessories and cables other than those specified may result in increased emissions or
decreased immunity of the equipment.
ECG ELECTRODES
Part Number Description
2014786-001 ECG electrodes, rectangular, foam, ten (10) 30-electrode pouches
POWER CORDS
Part Number Description
2019204-007 Power Cord, North America
2020387-002 Power Cord, Europe
2020387-003 Power Cord, Argentina
2020387-004 Power Cord, Denmark
2020387-005 Power Cord, India & South Africa
2020387-006 Power Cord, Italy
2020387-007 Power Cord, Japan
2020387-008 Power Cord, Switzerland
2020387-009 Power Cord, UK
2020387-010 Power Cord, Israel
2020387-011 Power Cord, Australia
OVERVIEW
This section contains a list of parts and accessories for Responder 2000. To place an order, contact your representative
or distributor.
TOPIC PAGE #
CONTACT INFORMATION / CUSTOMER SERVICE 140
Responder is a trademark owned by GE Medical Systems Information Technologies, a General Electric Company, going
to market as GE Healthcare. STAR, IntelliSense, RHYTHMx, are trademarks and registered trademarks of Cardiac
Science Corporation. All other trademarks are property of their respective owners.
2006 General Electric Company. All rights reserved.