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