datascope iabp user manual
LINK 1 ENTER SITE >>> Download PDF
LINK 2 ENTER SITE >>> Download PDF
File Name:datascope iabp user manual.pdf
Size: 4380 KB
Type: PDF, ePub, eBook
Category: Book
Uploaded: 28 May 2019, 22:56 PM
Rating: 4.6/5 from 593 votes.
Status: AVAILABLE
Last checked: 16 Minutes ago!
In order to read or download datascope iabp user manual ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account.
✔ Download as many books as you like (Personal use)
✔ Cancel the membership at any time if not satisfied.
✔ Join Over 80000 Happy Readers
datascope iabp user manualSign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. FORUMS View All (18) Ask a New Question 1 Reply -MODI VISHAL 9 months ago 9 months ago SERVICE MANUAL I NEED SERVICE MANUAL OF DATA SCOPE CS100 Reply 1 Reply -Cheseda a year ago a year ago operating manual Need operating manual Reply 1 Reply -Subhash1965 2 years ago 2 years ago Keypad Not working system test states ok and screen is working but keypad not working.The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Class 1 Recall: Maquet Datascope Corporation, Intra-Aortic Balloon. The firm received 106 reports of device malfunctions. There were zero injuries and one death. This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved. CARDIOSAVE Hybrid easily and quickly converts from hospital configuration to transport configuration. Faster pneumatic speed allows the balloon to stay inflated longer during diastole.This allows for larger patient display parameters, improved help screen navigation and customizable control screens. The backlit screens allow visibility in varying lighting conditions with no alternate light source required. CARDIOSAVE Hybrid easily and quickly converts from hospital configuration to transport configuration. Unless otherwise specified, all product and service names on this website are trademarks owned by or licensed to Getinge AB, its subsidiaries or affiliates. No trademark, trade name, or trade dress on this website may be used without the prior written authorization of Getinge AB. Getinge, Getinge Group, Getinge Passion for Life, Maquet, and Atrium are trademarks or registered trademarks of Getinge AB, its worldwide subsidiaries or affiliates. Org No.http://yubesystem.com/yimages/eyelash-tinting-manual.xml
- Tags:
- datascope iabp cs100 service manual, datascope iabp user manual, datascope iabp user manual pdf, datascope iabp user manual download, datascope iabp user manual instructions, datascope iabp user manual free, maquet datascope cs300 iabp user manual.
556408-5032 This website is intended to provide information to an international audience outside of the US. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. Use of these devices may cause serious injuries or death. This recall is being conducted to ensure that all IABP users and servicers follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries, as battery run times and discharge cycles vary between IABP models. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power. Please note, for Cardiosave Rescue and Cardiosave Hybrid IABPs only: Replacement batteries can be ordered through your sales or service representative. The Battery Maintenance Required message indicates that the IABP internal battery requires maintenance. The Battery test due date or Battery Replacement Date predate the current system date at startup or the internal battery has a total accumulated discharge time in excess of 100 total discharge cycles. Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. The FDA issued a recall notice that said if a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. The company said the recall includes 22,853 devices in the United States. The company issued a letter to providers warning them about this issue Nov. 1, 2018. The warning has now been elevated to a full recall.http://leoniscinema.com/userfiles/eyela-rotary-evaporator-manual.xml If battery maintenance is not performed per the operating instructions manual for each IABP, the battery may not provide the expected minimum run time of operating power. The vendor is contacting each customer to schedule a training visit to review a recently developed battery operations, care and maintenance reference guide specific to each IABP based on the operating instructions manual(s) provided with each device. The company said no product returns are required. Replacement batteries can be ordered through a sales or service representative. The battery test due date or battery replacement date predate the current system date at startup or the internal battery has a total accumulated discharge time in excess of 100 total discharge cycles. Landmarks are placed on the site of optimal transseptal access into the left atrium and the mitral PVL. Please enable scripts and reload this page. Try again or register an account. For more information, please refer to our Privacy Policy.If you're not a subscriber, you can: Please try after some time. All rights reserved. Please try after some time. Please try after some time. Please try again soon.All rights reserved. By continuing to use this website you are giving consent to cookies being used. For information on cookies and how you can disable them visit our Privacy and Cookie Policy. According to a statement, the companies recalled all IABPs due to reports of IABP batteries failing to hold a charge, stopping unexpectedly and having a shortened run-time. According to the companies’ statement, they’ll be contacting each affected customer to schedule a training visit to review a recently developed battery operations, care and maintenance reference guide. You can opt out anytime. Although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically-ill patients in healthcare facilities, including during transport, and any interruption in treatment can result in serious patient harm or death. Additionally, a reference guide specific to each IABP based on the Operating Instructions Manual(s) is now provided with each device. The FDA continues to work with the manufacturer to examine and address the root cause of these IABP devices shutting down while running on battery power. FDA has the release. All rights reserved. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power. Call or send us a message anytime. In addition to those complications, reports include life-threatening patient injuries such as a sudden drop in blood pressure, pump stopping, the need for resuscitation, and the loss of hemodynamic support.However, the FDA encouraged devices users to refer to the Operating Instructions Manual while the investigation is underway. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.”US Food and Drug Administration. Published November 1, 2018. Accessed November 5, 2018.Read an unlimited amount by logging in or registering at no cost. If you log out, you will be required to enter your username and password the next time you visit.To comment please Log-in.You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion. You must declare any conflicts of interest related to your comments and responses. We reserve the right to remove posts at our sole discretion. You will receive email when new content is published. CRT focuses on the advances and changes in the field of cardiovascular medicine. CRT is designed to provide access to the world’s leading clinicians and the latest research in order to improve practice and treatment outcomes for a variety of health care professionals. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details. Information in this material is not a substitute for the productPlease contact customer service to confirmMC-004446 Rev 0. Abstract: The intra-aortic balloon pump (IABP) was first introduced by Moulopoulos et al. The correct timing of the inflation and deflation of this device is critical to it being clinically advantageous to the patient. The purpose of this study was primarily to examine the Datascope CS100 automated timing of inflation and deflation, and secondarily, to create an awareness of the risks of solely relying on technology for patient treatment decisions in lieu of clinical evaluative skills. Timing data were collected from 165 IABP patients from January 1, 2003 to March 31, 2005 using the Datascope series System 97, System 98, and CS100 IABP consoles. These parameters were evaluated by examining a printed strip from the IABP console after timing selection stabilization. Before implementation of the CS100, 78.6 of inflations and 53.6 of deflations were correct when using the criteria listed above. After implementation of the CS100, 83.3 of inflations were correct and 44.4 of deflations were correct. Although improvement in consistency of IABP inflation quality was observed, a net decrease in the quality of IABP deflations was also observed. Total reliance on the auto-timing operation mode of the CS100 may not be warranted, and imposing clinical judgment in therapeutic application is necessary to avoid dangerous timing errors. An awareness of the dangers of solely relying on technology for patient treatment decisions vs.Keywords: intra-aortic balloon pump, balloon pump timing, counterpulsation, preload, afterload The intra-aortic balloon pump (IABP) is at present the simplest and most frequently used circulatory assist device ( 1 ). It was first introduced by Moulopoulos et al.IABP consoles have become quite technologically sophisticated, including a progression toward increased userfriendliness. It seems it has become possible for the operator to develop a reliance on the machine to establish proper timing. The primary purpose of this study was to evaluate the effectiveness of automatic timing using the Datascope CS100 Intra-Aortic Balloon Pump (Datascope Corp., Fairfield, NJ). The secondary intention of this study was to develop an awareness of the need for absolute understanding of IABP therapy and the evaluative skills necessary for assessing and establishing proper balloon pump timing to improve patient care, as well as exploring the reliance on technology to make health care treatment decisions. Inflation and deflation of the CS100 balloon in the autotiming operation mode is triggered automatically using the electrocardiogram (ECG) or aortic pressure waveform, both of which are automatically and dynamically adjusted by the system to compensate for variations in trigger signal amplitude ( 3 ). In the auto-timing operation mode, the balloon catheter inflates during diastole (counterpulsation), propelling blood to the coronary arteries and the periphery because of the displacement of volume, and resultant pressure increase. This increase in diastolic pressure during the diastolic period leads to increased coronary perfusion ( 4 ). Deflation should be timed to be just before the onset of systole and remaining deflated throughout the cycle. When deflation occurs, there is a sudden decrease of pressure because of the volume displacement loss within the aorta, yielding a decreased aortic end diastolic pressure. This decreased end diastolic pressure provides a decrease in the imposed afterload to the heart ( 4 ). The effects of decreased afterload may and often does yield a decrease in myocardial work, decreased oxygen consumption, and an increase in cardiac output ( 5 ). The correct timing of the inflation and deflation of the IABP is critical to it being clinically advantageous to the patient. Incorrect timing can cause further harm and distress. The actual application of correct timing is often of clinical debate among practicing clinicians, and the absolute determination of ideal inflation and deflation points is usually left to individuals or institutions. It is generally accepted that intra-aortic balloon inflation should occur at the dicrotic notch. This indicator of closure of the aortic valve is a reasonably clear indicator of natural separation from myocardial blood volume contribution to the systemic circulation. Early inflation will cause a premature closure of the aortic valve, which in turn will cause increased left ventricular end diastolic volume and pressure, increased preload, and increased myocardial oxygen demand, and consumption caused by the resultant increase in myocardial wall stress and distension from the increased volume load ( 6 ). Late deflation of the IABP catheter occurs after the dicrotic notch and is generally regarded as relatively harmless. The late inflation usually diminishes clinical therapeutic effect for augmentation support. It is recognized that late deflation of the intra-aortic balloon will result in physical obstruction within the aorta to which the left ventricle must compete to open the aortic valve for systolic volume emptying ( 6 ). Deflation should be set to occur near the end of diastole during isovolumetric contraction immediately before systole ( 4 ). Such determination of proper deflation timing is done by evaluating the assisted aortic end diastolic pressure to ensure that it is less than the unassisted aortic end diastolic pressure. The consequences of late deflation are not only the absence of a reduction in afterload, but an increase in afterload caused by cardiac ejection against the increased greater resistance caused by the inflated balloon ( 6 ). Early deflation of the intra-aortic balloon is defined as deflation before isovolumetric contraction, may result in suboptimal coronary perfusion, the potential for retrograde coronary and carotid blood flow, angina, suboptimal afterload reduction, and an increase in myocardial oxygen demand ( 6 ). MATERIALS AND METHODS The effectiveness of proper IABP timing was evaluated in 64 sequential patients between April 1, 2004 and March 31, 2005. The patient device selection was made by device availability. Four patients were excluded from the evaluation because of improper documentation of device selection. Thirty-six of the patients were treated with the Datascope CS100, and 28 were treated with other Datascope consoles. Once timing was established in the auto-timing operation mode, three parameters were checked to evaluate the proper timing of inflation and deflation of the balloon catheter. The guidelines for proper timing in this evaluation included the following: (a) augmentation setting to just below maximum, (one bar less than the maximum setting), (b) inflation at the dicrotic notch of the central aortic pressure waveform, and (c) deflation resulting in a presystolic decrease of central aortic pressure between 5 and 10 mmHg. These parameters were evaluated by examining a print strip containing both the ECG and arterial pressure waveform after timing was established and the patient was stabilized. Fisher exact test was used to compare the timing (early, correct, or late) of the inflation and deflation of the balloon between the CS100 and devices other than the CS100. The value of p RESULTS Before implementation of the CS100, 78.6 of inflations and 53.6 of deflations were correct when using the three criteria listed above. Inflation occurred early in 3.6 of the cases and late in 10.7 of the cases, whereas deflations occurred early in 3.6 of the cases and late in 28.6 of the cases ( Figure 1 ). Inflation occurred early in 2.8 of the cases and late in 13.9 of the cases, whereas deflations occurred early in 27.8 of the cases and late in 22.2 of the cases ( Figure 2 ). Table 1 shows the association of inflation and deflation timing. Table 2 shows the association between timing and devices when timing is classified as correct vs.When timing was classified in this manner, there were no significant differences detected between the CS100 vs.Open in a separate window Figure 1. Results of timing evaluations using the Datascope CS100 IABP. Open in a separate window Figure 2. Results of timing evaluations using non-Datascope CS100 IABP. Table 1. Association of inflation and deflation timing. The intra-aortic balloon pump is at present the simplest and most frequently used circulatory assist device after pharmacologic treatment, and the correct timing of the inflation and deflation of this device is critical to it being clinically advantageous to the patient ( 1 ). Improper timing of an IABP may cause a reduced benefit to the patient and also has the potential to inflict harm. The consequences of improper timing are noteworthy. Late inflation occurs after the closure of the aortic valve. This results in suboptimal coronary perfusion. Early deflation results in suboptimal coronary perfusion, as well as the potential for retrograde coronary and carotid blood flow. Early deflation also has the potential to cause an increase in myocardial oxygen demand and a less than optimal reduction in afterload. Early inflation occurs before the dicrotic notch and will force premature closure of the aortic valve increasing ventricular wall stress, myocardial oxygen demand from the increased left ventricular end diastolic volume, and left ventricular end diastolic pressure. The consequences of late deflation of the IABP are an absent reduction in afterload, and impedance on left ventricular ejection, which will likely increase the afterload. An increase in myocardial oxygen consumption is the result of the left ventricle ejecting against a greater resistance caused by the inflated balloon. A prolonged isovolumetric contraction phase in the cardiac cycle may also arise with late balloon deflation. The secondary intention of this study was to develop an awareness of the need for absolute understanding of IABP therapy and the evaluative skills necessary for assessing and establishing proper balloon pump timing to improve patient care. The technology of the IABP has become sophisticated, although there has been a progression toward increased user friendliness. With this ease of use, it has become possible for the operator to develop a reliance on the machine to establish proper timing. It is not the intention of this author to discredit Datascope in any way, and in fact the company is to be commended for developing such ingenious software to help guide the busy clinician through the myriad of responsibilities they face. In personal communication with Datascope engineers by the author of this paper, they stressed the company’s position of the importance of using clinical judgment in conjunction with the available technology to best establish IABP timing to best serve the patient. It is the position of Datascope that the deflation algorithm is one that needs end-user confirmation of proper technique. Advancements in technology for devices used in health care may have increased ease of use and decreased the time needed to obtain results, but without user training and judgment, these advancements may not necessarily result in increased accuracy in patient treatment. A study by Latman et al. ( 7 ) evaluated the accuracy of digital oral and tympanic thermometers vs.The comparison of Latman et al.An article published in the British Journal of Sports Medicine examined the reliability of commercial heart rate monitors. Similar findings were reported in Biomedical Instrumentation and Technology concerning the accuracy of blood glucose monitors ( 9 ) and in Regional Anesthesia and Pain Medicine in regard to the accuracy of portable infusion pumps used for patients for pain management ( 10 ). Advances in technology can also result in an increase in convenience without compromising accuracy, as found by Gardner ( 11 ) in evaluating the accuracy and reliability of disposable pressure transducers. All of the disposable transducers tested by Gardner were more accurate than the standards established by the American National Standards Institute (ANSI), and even the worst case transducers were more than twice as accurate as the ANSI requirements. Advances in technology have benefited medical care practices; however, technology cannot and should not replace sound clinical judgment. It is only with the combination of technology and clinical training that health care service can be optimized for the best possible patient outcomes. The trend toward an easier, faster diagnosis and treatment may come at a cost of less reliable results of which practitioners must be aware. Health care providers must make treatment decisions based on all available information, trusting their judgment and clinical skills if a device’s information seems inaccurate. Technology has positively affected health care but can only do so with human involvement. ACKNOWLEDGMENTS We thank Lynette M. Smith, MS, University of Nebraska Medical Center, for statistics expertise. REFERENCES 1. Gravlee GP, Davis RF, Kurusz M, Utley JR. Datascope Corp., Fairfield, NJ: Biomed Instrum Technol. Br J Sports Med. Biomed Instrum Technol. Ilfeld BM, Morey TE, Enneking FK. Reg Anesth Pain Med. Crit Care Med. The FDA also highly encourages voluntary reports to be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program while it continues to obtain more information with plans of alerting the public about significant changes or recommendations in the future. Contact Us to Register Your Interest Already a member. Manufactured by: Datascope Corp. 1300 MacArthur Blvd. WARNINGS, CAUTIONS AND NOTES Please read and adhere to the following list of warnings, cautions and notes; some of which are repeated in the appropriate areas throughout this manual. A WARNING is provided if there is reasonable evidence of an association of a serious hazard with the misuse of this device or when special attention is required for the safety of the patient. A CAUTION is provided when any special care is to be exercised by the practitioner to avoid causing damage to this device or other property. They may also include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. A NOTE is provided when extra general information is applicable. Notes appear in the appropriate areas throughout the manual. WARNINGS WARNING: The Augmentation Alarm, which is automatically set at power-up, provides back-up to IAB alarms (gas loss and IAB catheter alarms) at higher heart rates. Therefore, this alarm should not be manually disabled. WARNING: If more than one pump is being used in close proximity, ensure that the source of the alarm sound is correctly identified by confirming the corresponding visual indication. WARNING: Pneumatic Module Leak Test MUST NOT be performed with the pump connected to a patient's IAB. WARNING: Calibration should not be done while the system is connected to a patient. WARNING: Preventive Maintenance should never be performed when the IABP is attached to a patient. WARNING: Batteries have the risk of fire, explosion or severe burn hazards. Replace only with Datascope Corp. CAUTIONS CAUTION: Do not set the alarm volume to such a low level that it cannot be readily heard over the ambient noise level of the venue in which the IABP is used. CAUTION: The internal helium tank may contain up to 250 PSI of helium. This tank must be emptied prior to shipping the system via commercial ground and air carriers. Use the procedure below to purge the tank prior to shipment. If this cannot be accomplished, or the system is non-functional, then the internal helium reservoir must be manually vented. CAUTION: The troubleshooting charts are not intended as a rapid course on how to repair devices of this type. Rather, they are intended as a guide for MAQUET factory trained and certified technical personnel only. The instrument covers should only be removed by MAQUET factory trained and certified personnel who have received supplementary instructions regarding maintenance of medical electronic equipment or have had equivalent experience in this area. CAUTION: The accidental shorting of component leads can easily over stress components, resulting in a second unnecessary failure (aside from creating a possible safety risk). CAUTION: Preventive Maintenance is to be performed by a MAQUET factory trained and certified technician. CAUTION: Do not remove circuit boards without first removing AC power AND all battery packs. Permanent damage to the unit may occur if this is not done. Help Screens are context sensitive and available based on the information displayed on the Monitor. For example: The Help Screens for alarm messages are only available while an alarm condition or informational message exists. Navigating the Help Screens: 1. Press the Help Available key on the Touchscreen. The priority order is as follows: Technical Alarms, High Priority Alarms, Medium Priority Alarms, Low Priority Alarms, and Informational Messages. 2. If only a single alarm or informational message exists, the corresponding Help Screen will be immediately displayed. If multiple alarm or informational messages exist, a Multiple Alarm Display will be provided in the Help Screen Area. Each listed alarm or informational message is actually a key that, when selected, displays the associated Help Screen. 3. In the Help Screen, use the Page Up and Page Down keys to navigate through the available help information. 4. If the Help Screen is only displaying a single alarm or informational message, pressing the Exit Key will close the Help Screen. However, if a single alarm or informational message is being displayed, and there are multiple alarm or informational messages present, pressing the Back Key will close the current Help Screen, and display the Help Screen for multiple alarm or informational messages. If the Help Screen is displaying multiple alarm or informational messages, pressing the Exit key will close the Help Screen. Auditory alarm signals (tone sequences) are primarily intended to attract the attention of the operator. They were carefully developed to communicate the urgency of the response, as well as the pump's location. Auditory signals are effective over a relatively broad range of operator positions. CAUTION: Do not set the alarm volume to such a low level that it cannot be readily heard over the ambient noise level of the venue in which the IABP is used. Visual alarm signals consist of both symbols and text. The displayed information further reinforces the urgency of the alarm (color, flashing property and symbol shape) and also identifies the alarm via a specific text message. Textual information is legible at the operator's position, up to 1 meter from the front of the Monitor. Additionally, alarms are further complimented by an option to display context sensitive help information to aid in the understanding and guide in the resolution of the alarm condition. Alarm and informational messages are grouped into the following categories in order to facilitate operator awareness and understanding: Technical Alarms, High, Medium and Low Priority Alarms, and Informational Messages. These messages are displayed based upon the priority of the condition(s) that prompted them. Technical Alarms and High Priority Alarm messages are displayed first at the top of the Message Display Area on the Monitor Display. These alarms require the Operator's immediate response. Technical Alarms initiate a continuous alarm tone and suspend pumping. High Priority Alarms initiate the High Priority Alarm Tone, and, in a majority of cases, suspend pumping. The associated Help Screens Area is organized to reflect the order of priority. When Medium Priority Alarms are displayed, depending on IABP conditions, IAB assist will not be suspended and the Medium Priority Alarm tone is sounded. Medium Priority Alarms require the Operator’s prompt response. When Low Priority Alarms are displayed, IAB assist is not suspended and the Low Priority Alarm tone is sounded. Low Priority Alarms require the Operator’s awareness. Informational messages typically provide awareness of conditions that do not require immediate action and may persist for longer periods. These messages may also be accompanied by an infrequently repeated audio reminder tone. Note: The CARDIOSAVE maintains a non-volatile event log which is accessible in Service Diagnostics Mode. For more information, see the Service Manual. 1.2.