SIMATIC S7, f programming tool, distributed security v5.4, single user floating license, CD contains e-sw, SW and related documents, class A, three language versions (German / English / French), which can be installed on the basis of STEP7 V5.3 SP3
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The safety guide for optimum machine safety Machine safety is a complex issue. Technical measures for machine safety make a significant contribution. Standardization recommends implementing a structured process.But what exactly might a well-structured process look like?We will show you what aspects are important, what is entailed and how you can plan and implement such a process in an efficient manner.
For example, safety-related tasks can be performed via PC using the Simatic WinAC RTX F. The controller meets the relevant safety requirements and applicable standards EN 954-1 up to Cat. 4, IEC 62061 up to SIL 3, and EN ISO 13849-1 up to PL e. As with the modular Simatic S7 controllers, Siemens Step 7 engineering software is supplemented by the Distributed Safety option package for safety-related applications.
The automation specialist Siemens has developed a fail-safe software controller for PC-based automation. Safety-related tasks can be performed via PC. Simatic WinAC RTX F meets the relevant safety requirements and applicable standards EN 954-1 up to Cat. 4, IEC 62061 up to SIL 3, and EN ISO 13849-1 up to PL e. As with the modular Simatic S7 controllers, the user employs Step 7 as engineering software, supplemented by the Distributed Safety option package for safety-related applications. The product is a Windows XP or eXP-based controller and has an optimized runtime system to be able to process extensive PC applications simultaneously with the control task. It is especially suitable for high-performance tasks with substantial data volumes and simultaneous demanding real-time requirements. The latest technologies such as dual-core processors are used to optimize utilization; for example, with one core for Windows applications, and the other for Simatic WinAC RTX F.
In response to the reviewer's comments and suggestions, we have made a few changes in the recommendations and conclusion sections of the article. Being widely used medications, it is recommended that vulnerable patients for developing respiratory side effects due to gabapentinoids should be identified in order to prevent exposure. The changes made in the revised version highlights two additional high risk population category for developing gabapentinoids induced respiratory depression such as patients with concurrent opioid use and patients administered with gabapentinoids on the day of surgery. The abstract was also amended in line with the reccomendations section mentioning the risk of respiratory suppression when opioids are combined with gabapentinoids. Further, we cited literature confirming gabapentinoids induced respiratory suppression during the immediate post-operative period in a dose-dependent fashion among people who underwent total hip and knee arthroplasties. In the conclusion section, two new points have been added emphasizing the need to exercise more caution while gabapentinoids are used in patients concurrently with opioids, and the need for establishing effective safety monitoring and reporting systems to identify signals and its proper dissemination. The revised version of the article has three new references, 21-23, added to it.
As per the available safety data, the use of gabapentin and pregabalin may cause neuropsychiatric related adverse drug reactions (ADRs) followed by hepatic, cutaneous and hematological reactions 4 . Suicidal ideation, cognitive impairment, motor incoordination, dizziness are also severe forms of ADRs associated with gabapentinoids 5 . The use of pregabalin is associated with hematological ADRs, and gabapentin is also associated with liver toxicity.
There have often been issues like this in the past where safety concerns emerge, mainly from the developed world, with drugs like selective cyclooxygenase-2 inhibitors (coxibs) 13 , cerivastatin 14 and glitazones 15 , and the developing world, due to lack of stringent pharmacovigilance mechanisms, is left with little or no choice but to follow the actions taken by the developed world. In addition, developing countries lack options for communicating pharmacovigilance information 16 among key stakeholders, including consumers, which is another concern. It is astonishing that many developing countries where large quantities of medicines are used still lack strong mechanisms to monitor the safety of their products.
In the current scenario, safety reports of gabapentinoids should be obtained from concerned manufacturers and reviewed for respiratory depression effects. As understood, manufacturers are an important partner in the pharmacovigilance process with the unique advantage of formulation related information. The periodic safety update reviews (PSURs) submitted by the manufacturers of gabapentanoids can be an important source for new signal detection 17 . In addition, the pharmaceutical manufacturer also has an obligation to report serious ADRs to the regulatory authorities 18 .
While these medications are used widely, it is also crucial to identify the vulnerable population at a high risk of developing respiratory side effects. It is evident that concurrent opioid use increases the risk for respiratory depression 22 . Further, a retrospective study involving 175,787 patients who underwent colorectal surgery reported administration of gabapentinoids on the day of surgery was associated with an increased risk of pulmonary complications 23 . In another retrospective analysis involving 858,306 patients who underwent total hip and knee arthroplasties, gabapentinoids showed respiratory suppression during the immediate post-operative period in a dose-dependent fashion 24 . The patients on these two medications (and the ones closely chemically related to them) should be provided with proper counseling. Educating patients can help in the early detection of ADRs and active participation of patients can help identify adverse events and ADRs, describe ADRs, and ultimately prevent drug-related harm 25 . Hospital drug and therapeutics committees play a crucial role in situations like this by disseminating information within the hospital 26 . Social media may also play a crucial role in the signal generation of suspected ADRs in these situations 27 . Hospitals using these medications should develop risk management plans associated with gabapentoinoids usage and must disseminate any safety issues to concerned authorities.
Drug safety is a constantly evolving process and one must be vigilant on the use of these medications. It is suggested to exercise more caution while these drugs are used in patients and concurrent opioid administration. It is also essential to establish effective safety monitoring and reporting systems to identify signals and its proper dissemination. Healthcare professionals, especially prescribing physicians, nurses and pharmacists should be more cautious about using these medications in vulnerable people. Patient education and prescription restrictions of gabapentin and pregabalin may be needed until more data are available.
The adverse effect of perioperative use of gabapentinoids can occur in all countries. While differences in risk across different populations are unclear (for example, the prevalence of pulmonary complications after concurrent use of opioids with gabapentinoids may differ among races), we suggest that a caution be warranted when these drugs are used in combination with opioids. Obviously, it is essential to establish effective safety reporting systems to detect signals of adverse events and disseminate the information to all relevant sections. 2b1af7f3a8