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The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. The RMU-2000 must only be used in cases where chest compressions are likely to help the patient. The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to: · Provide consistent depth and rate chest compressions. • Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport. - Be applied to the patient with minimal interruption of CPR. The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions. The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module. Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge. A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.

The RMU-1000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is designed to: - Provide consistent depth and rate chest compressions. - Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport. - Be applied to the patient with minimal interruption of CPR. The major elements of the RMU-1000 ACC are the Backboard, Frame and Compression Module. The Backboard is placed under the patient to provide a base for the RMU-1000 ACC system. The Frame is placed over the patient and snaps into the Backboard with two self-locking latches, one on each side of the Frame. The Compression Module mounts into the Frame and contains the user interface, the replaceable lithium ion battery and the piston drive (and motor) used to generate the chest compressions. A replaceable, single-use Patient Interface Pad at the distal end of the Piston contacts the patient's chest and serves to soften the edges of the Piston during compressions. Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated using a simple three-step operational sequence once the RMU-1000 ACC has been applied to a patient: - the Compression Module is turned on by pressing the power button; - the Piston height adjusted for the patient's chest size by pressing the appropriate height adjust button; and - the appropriate compressions button pushed (either continuous compressions or an automatic pause for breaths). Additional user interface features include a compression pause function button, service warning indicator, warning mute button, and battery capacity gauge. The RMU-1000 ACC can be operated using a replaceable, rechargeable lithium-ion battery pack or with an external power supply. A fully-charged, new battery can provide continuous operation for over an hour and can be recharged while in the Compression Module. A USB port on the Compression Module allows maintenance functions to be performed (outside of emergency use) through a connection to a personal computer. The RMU-1000 ACC fits in a carry case that holds all the various System elements and accessories, spares (optional) and labeling.

The DDU-1000 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: - · Unconscious and unresponsive - · Not breathing For patients under 8 years old, or less than 55 pounds (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight. The DDU-1000 AED must be used by or on the order of a physician.

The DDU-1000 is a portable, Semiautomatic External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery pack and supports both adult and pediatric user-replaceable singleuse defibrillation/monitoring pads. The DDU-1000 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed, the DDU-1000 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device. Voice prompts provide simple instructions for the operator. The DDU-1000 AED is capable of recording event information including electrocardiogram (ECG), audio data and SHOCK/NO SHOCK recommendations.

The DDU-120 AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is: - Unconscious and unresponsive. - Not breathing. For patients under 8 years old, use child/infant electrode pads. Do not delay therapy to determine exact age. The DDU-120 AED must be used by or on the order of a physician.

The DDU-120 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads. The DDU-120 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed, the DDU-120 delivers a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs. Voice prompts provide simple instructions for the operator. The DDU-120 AED is capable of recording event information including ECG, audio data and SHOCK NO SHOCK recommendations.

The DDU-2400/2450 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: - . Unconscious and unresponsive - . Not breathing For patients under 8 years old, or less than 55 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight. The DDU-2400/2450 AED must be used by or on the order of a physician.

The DDU-2400/2450 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads. The default mode of operation for the DDU-2400/2450 AED is Semiautomatic External Defibrillator (AED mode). In AED mode, after applying the defibrillation pads to the patient's chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and, if needed, advises the operator to push the button and deliver a shock. The AED guides the operator through the rescue protocol using a combination of voice and text prompts, audible alerts, and visible indicators. The LCD display shows instructional videos and text prompts. The DDU-2400/2450 provides some optional features for the advanced user. When used in AED mode, the user can set the LCD display to show the patient's ECG trace. These models also provide a non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring using an optional 3-wire monitoring pads adaptor with standard ECG electrodes. The DDU-2400 (only) supports a Manual override mode. Manual mode permits the user to override the AED features of the defibrillator. Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. Manual mode provides a display of the patient's ECG trace. operator-selected energy level along with charge, shock, and disarm functions. The DDU-2400/2450 has a compact design and offers an easy-to-understand user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2400/2450 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.

The DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: - · Unconscious and unresponsive - · Not breathing For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight. The DDU-2300 AED must be used by or on the order of a physician.

The DDU-2300 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads. The DDU-2300 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed the DDU-2300 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs. The DDU-2300 has a compact design and offers an improved user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2300 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.

The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is: - Unconscious and unresponsive - Not breathing - Less than eight years old Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician. Do not delay therapy to determine exact age or weight.

Defibtech Attenuated Defibrillation/Monitoring Pads are intended for use only with Defibtech DDU-100 Series AEDs or compatible Defibtech AEDs, on patients who are less than eight years of age. Attenuated Defibrillation/Monitoring Pads are indicated for use on victims of sudden cardiac arrest (SCA) when the patient is: - Unconscious and unresponsive - - ・ Not breathing - -Less than eight years old A pulse check is not required based on the recommendations of the American Heart Association Guidelines 2000 for CPR and ECC. Attenuated Defibrillation/Monitoring Pads consist of two self-adhesive defibrillation/ monitoring pads used to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules. They are provided as a packaged, single-use disposable assembly. The impedance between the two pads is monitored to ensure proper pad-to-patient contact. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. The pads incorporate an attenuator that decreases the energy delivered to the patient to 50 Joules. Delivered energy does not change significantly with patient impedance, although the duration of the generated waveform will vary. The Defibtech Series AED is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms.

FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES.

The Defibtech Electrode Adapter provides an interface between Defibtech electrodes and various automatic and manual external defibrillators. Each adapter is reusable and is either a stand-alone accessory or can be preattached to a Defibtech electrode package.

The Sentry AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is: - Unconscious and unresponsive . - Not breathing ● - At least eight vears old . The Sentry AED must be used by or on the order of a physician. The DDP-100 defibrillation pads are used in conjunction with the Defibtech Sentry semiautomatic external defibrillator and act as a conductive interface between the Sentry and the patient's skin. The disposable electrodes are non-sterile and for single patient use only. The pads are intended for external defibrillation and ECG monitoring in combination with a Defibtech defibrillator.

The Sentry is a semiautomatic external defibrillator (AED) designed to be portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The Sentry AED is capable of recording event information including ECG, audio data (optional) and SHOCK/NO SHOCK recommendations. When connected to a patient who is unconscious and not breathing the Sentry AED performs the following tasks: - . Prompts the operator to take necessary actions to enable analysis - Automatically analyzes the patient's ECG ● - Determines whether a shockable rhythm is present ● - Charges the defibrillation capacitor if the rhythm is shockable . - . Arms the SHOCK button and prompts the operator to press the SHOCK button when the device is ready and a shock is recommended - Delivers a shock if the user presses the SHOCK button and the device has . determined that a shock is required The Sentry AED will NOT shock a patient automatically; it will only advise the operator. The SHOCK button is only enabled when a shockable rhythm is detected and the device is charged and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must press the SHOCK button to initiate deffbrillation. The Sentry AED uses two non-sterile self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are provided as a single patient use, packaged, disposable assembly. The Sentry AED determines proper pad-to-patient contact by monitoring the impedance between the two pads. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The Sentry AED has two pushbutton controls and several LED indicators. Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. Energy delivered does not change significantly with patient impedance. although the duration of the generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 - 150 ohms. Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) Lithium/Manganese Dioxide Battery Pack. Battery Packs are available in several configurations that are optimized for use in specific applications. Each Pack is marked with an expiration date. The Sentry AED records event documentation internally and optionally, on Defibtech Data Cards (DDC). The optional DDC enables the AED to record event documentation. and audio, if enabled. Audio recording is available only for units with Defibtech Data Cards installed. Event documentation stored internally can be downloaded onto a DDC for review.