princ-ch7-presentation

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control system design astrom-ch7

control system design astrom-ch7

stability criterion, see Figure 7.1. Common criteria are the maximum values of the sensitivity functions, i.e. Ms = max S(iω ) ,
ω
Mt = max T (iω )
ω
Recall that the number 1/ Ms is the shortest distance of the Nyquist curve of the loop transfer function to the critical point, see Figure 7.1. Also recall that the closed loop system will remain stable for process perturbations ∆ P provided that ∆ P(iω ) 1 ≤ , P(iω ) T (iω ) see Section 5.5. The largest value Mt of the complementary sensitivity function T is therefore a simple measure of robustness to process variations. Typical values of the maximum sensitivities are in the range of 1 to 2. Values close to one are more conservative and values close to 2 correspond to more aggressive controllers.
Gain and Phase Margins

捷文CS700点商品说明书

捷文CS700点商品说明书
Javelin CS700 Programming Manual
CS700 PROGRAMMING MANUAL
Specifications subject to changed according to further development without notice. Errors and Ommitions to be Expected (E.&O.E.)
2. PROGRAMMING OPERATIONS..................................................................................................................... 3 2.1 Basic Key Functions........................................................................................................................................... 5 2.2 Character Entry Method..................................................................................................................................... 5 2.3 Condition Required for Programming Operations ........................................................................................

飞利浦 阿兹瑞恩 7 型影像导引治疗系统 产品宣传册说明书

飞利浦 阿兹瑞恩 7 型影像导引治疗系统 产品宣传册说明书

With Azurion, performance and superior care become oneAzurion 7Image Guided Therapy System17% reduction of procedure time with Philips Azurion at St. Antonius Hospital.1The ability to treat one more patient per day today, or in the futureAzurion enables you to provide superior careAzurion helps you optimize your lab performanceAn easy-to-use platform supports you in quickly and easily performing diverse proceduresThis is exemplified by our Image Guided Therapy System - Azurion 7. It allows you to easily and confidently perform a wide range of routine and complex procedures with a unique user experience, helping you optimize your lab performance and provide superior care. Azurion is powered by ConnectOS, a real-time multi-workspot technology designed specifically for the Azurion image guided therapy platform.As the interventional space evolves, we continue to integrate essential lab systems and tools onto the Azurion platform for a better user experience. The Azurion integrated lab offers a seamless user experience that gives you control of all compatible applications from a single touch screen at table side, to help make fast and informed decisions without breaking sterility.With Azurion’s industry leading image guided therapy platform, we reinforce our commitment to you and your patients. Our goal is to help you effectively meet today’s challenges so that you are ready for the future.Treating patients. It’s what you do.You strive every day to provide the best patient care, quickly and reliably, no matter which procedure you are performing.So try to imagine an increased number of procedures, for more patients, carried out consistently and efficiently with fewerpreparation errors. Workflow can be optimized and performed on an intuitive platform designed to make your day a lot easier.“ I t (Azurion) profited from the experienceprovided by the users and it’s for sure something which is incredible easy to use.”Prof. Laurent Spelle, Hospital Bicetre AP-HP, Paris, FranceFull control at table side to enhance decision making You can now control all compatible applications in the interventional lab via the central touch screen module and FlexVision Pro. Not only does this improve workflow within the exam room, it helps reduce the need for team members to leave the sterile area and walk to the control room during procedures. This can save time and help avoid delays.Gain advanced physiologic guidance to help improve treatment outcomesYou can access IntraSight, a comprehensive suite of clinically proven 2-6 imaging, physiology and co-registration 7 tools, via the central touch screen module. These tools allow you to go beyond the angiogram and complete your view of the target vessel, to help you make fast, informed clinical decisions.Azurion with FlexArm – more independent control for physiciansThe FlexArm option further evolves Azurion’s table side control with the intuitive Axsys controller to make procedures flow naturally and easily. When changes or complications occur, the physician can quickly and easily take action. This can also reduce the need to move in and out of the sterile field during a procedure.Designed around you and your procedureAll Azurion systems and interventional tools use the same standardized user interface to support training. Use has been further simplified through a sophisticated help function. You can access digital user guides with one click for on-the-spot assistance. Clear and simple to useOn screen, information clearly stands out against the distinctive black background where active applications are highlighted. Backlit icons and distinctly shaped buttons on the Control Module promote intuitive operation. All controls are designed for easy cleaning to meet stringent sterility requirements. Less clutter and faster workflowWith the Azurion integrated lab, controlling allcompatible applications at the touch screen module can reduce extra interfaces and controls table side. The FlexSpot works according to the same principle. It gives you access to all compatible applications in one compact, customizable workplace that can be placed in the control room or exam room where needed.Save time by setting the display to re-arrange and re-size as applications are opened and closed.At Philips, we are guided by you. With Azurion, we’ve brought the userexperience and simplicity of touch screen controls right where it’s needed to make a difference to lab workflow.Outstanding user experienceFlexSpot Touch screen module ProFlexVision Pro“ T he new integrated system saves us time, because we can control all applications via one user interface.”Dr. med. Peter Ong, Robert Bosch Hospital, Stuttgart, Germany.With Azurion we help you to optimize your lab performanceAzurion’s integrated approach can help you achieve measurable improvements in throughput, cost reduction and staff satisfaction.Do more at table sideWith our enhanced touch screen module, you will experience simpler, smoother procedures, based on familiar tablet interactions. For example, you can now easily mark relevant details on 2D images on the touch screen with your fingertip.Azurion allows you to run an entire case without breaking sterilityThe touch screen module offers total control within the sterile field. Run an entire case table side as you quickly diagnose, navigate, annotate and measure to your exact specifications, even when wearing gloves and under a sterile drape. Table side control saves you from having to go to the control room to access applications.Save time through Instant Parallel WorkingThe Azurion 7 image guided therapy system has been specifically designed to save time by enabling interventional team members to do two tasks at the same time in the exam room and control room - without interrupting each other. As an example, while fluoroscopy/exposure is taking place, a technologist in the control room can instantly review previous images from the same patient, prepare the next exam or finish reporting on another patient. This leads to higher throughput and faster exam turnover without compromising quality of care.Simplify workflowEnter patient information once and it is automatically transferred to connected applications to reduce data entry errors. To save time, IntelliSpace Cardiovascular 8 and IntelliSpace Portal launch automatically with the specific patient on the exam room monitor.Azurion’s full system automatic position control (APC) gives you more flexibility to recall the stored position of the C-arm, table and other parameters for a particular image to simplify positioning.Imagine an easier work dayYou can combine different user centric workspots (FlexVision Pro, FlexSpot and touch screen modules) to view, control and run applications where and when needed. At these workspots you can co-register 9 iFR or IVUS data with the angiogram, so you have the tools in hand to manage procedure quality and patient care. Together these flexible workspots allow you to customize your workflow to boost efficiency.Safeguard clinical performance and enhance lab security over time with Windows 10 platform The standard Windows 10 platform can help support compliance with the latest security and standards to protect patient data. It can also accommodate new software options to extend your system’s clinical relevance over time.Clinical demands are getting more specific. So are we. Our clinical suites are tailored to meet your specific challenges, while offering you the flexibility to carry out procedures in the easiest, most efficient way.We have a flexible portfolio of integrated technologies and services to support the full interventional spectrum. We also offer Hybrid OR solutions that create an innovative care environment for performing open and minimally invasive surgical procedures.Simplified set-up and operationThe Azurion 7 uses a range of ProcedureCards to help optimize and standardize system set-up for all your cases. The system will automatically select the appropriate ProcedureCard(s) based on the (CIS/RIS/HIS) code of the scheduled procedure from the information system. ProcedureCards can increase the consistency of exams by offering presets (e.g. most-frequently used, default protocols and user-specified settings) on the procedure, physician or department level.In addition, hospital checklists and/or protocols can be uploaded into the ProcedureCards to help safeguard the consistency of interventional procedures and reduce preparation errors.Enhance patient care with continuous monitoring The Philips Interventional Hemodynamic System is integrated with the IntelliVue X3 patient monitor, allowing continuous patient monitoring throughout procedures in the interventional workflow. There isno need to change cables, minimizing disruption to vulnerable patients and giving you more time to focus on them. Continuous patient monitoring also results in a gap-free patient record.Increase clinical confidence with 3D imagingThe clinical application software SmartCT enriches our exceptional 3D interventional tools for interventional procedures with step-by-step guidance that is designed to remove the barriers to acquiring 3D images in the interventional lab.Easily control advanced 3D visualization and measurements at table side on the touch screen module. Studies have shown that 3D CT-like imaging can enhance diagnostic accuracy 9,10,11 and support improved patient outcomes.Azurion enables you to provide superior careAs patient volumes rise and procedures become more complex, how do you maintain high standards of quality and safety in your healthcare facility?Clinical suites “ W e always stay in the angio suite because the ease of use has really improved and now we can control everything from the side of the patient in the angio lab itself.”Prof. Vincent Costalat, Centre Hospitalier Universitaire de Montpellier, FranceHigh quality images at low X-ray doseOur ClarityIQ imaging technology provides significantly lower dose across clinical areas, patients, and operators.12 In routine coronary procedures13, ClarityIQ technology reduces patient dose by 67% without affecting procedural performance while maintaining equivalent image quality, compared to a system without ClarityIQ.14,15 In interventional Neuro procedures, ClarityIQ technology reduces patient dose by 65%, compared to a system without ClarityIQ.16 Managing dose efficientlyDoseWise is integrated across the Philips image-guided therapy Azurion portfolio. DoseWise consists of a comprehensive range of radiation dose management tools, training, and integrated product technologies that aim to help you take control over patient care, staff safety, and regulatory compliance. Another feature is the Zero Dose Positioning function. It lets you pan the table, change table height or field-of-view on your Last Image Hold (LIH) image. This enables positioning without the use of radiation on previously recorded last image.Managing dose across your organizationPhilips DoseAware provides real-time feedback in the exam room It displays the invisible nature of radiation in real time, so that you and your staff can see it promptly, easily and simply – and rapidly understand the effect of behavior changes and work patterns.DoseAware Xtend is a dedicated solution for treatment rooms that builds on the capabilities of DoseAware and interfaces seamlessly with the Azurion image-guided therapy system. Thanks to this seamless integration, DoseAware Xtend can provide live individual dose rates (live screen) during procedures, and summarized procedure doses (review screen). It also reminds staffto better protect themselves by providing a warning symbol when the lead protection screen is not being used properly.Perform standardized quality assurance verifications in just 5 minutes17To make it easier for you to routinely perform consistent verification tests of radiation dose and image quality, only Philips offers the User Quality Control Mode (UQCM) tool on its Azurion system.With this option, you can independently verify and audit the radiation and image quality related factors of your Azurion system in a standardized way in just5 minutes, as well as carry out a range of validation and quality assurance tests.High standards of safety and low radiation exposureAs you look for new radiation dose management strategies to continue to enhance patient and staff safety, while maintaining and enhancing yourlevel of care, we can support you in meeting your goals.Azurion – a comprehensive image guided therapy platformThe Azurion 7 integrated lab brings together a range of sophisticated interventional tools, including clinically proven 2-6 imaging and physiology tools, advancedhemodynamic measurements and cardiac informatics to support clinical excellence during procedures.Azurion 7 C/F12With its 12" Flat Detector, the 7 Series provides high-resolution imaging over a large field-of-view with flexible projection capabilities, making it ideal for cardiac interventions. The entire coronary tree can be visualized in a single view with minimal table panning.Azurion 7 C/F20Enhance visibility for diverse cardiac and vascular procedures with the excellent image quality and broad coverage of the next generation 20" Flat Detector. This system supports head-to-toe imaging and patient access from all sides.Azurion 7 C20 with FlexArmCreate a Hybrid OR that provides unlimited imaging flexibility for diverse procedures and exceptional positioning freedom for medical teams with the Azurion 7 and the next generation 20" Flat Detector, combined with the ceiling-mounted FlexArm option. You get a highly cost-effective environment that is ready for the procedures of the future.Azurion 7 C20 with FlexMoveMove to a Hybrid OR with confidence, with the Azurion 7 and the next generation 20" Flat Detector, combined with the ceiling-mounted FlexMove option. FlexMove offers exceptional workflow flexibility to perform open and minimally invasive procedures in the same room.Azurion 7 B12/12The Azurion 7 biplane system with two 12" Flat Detectors provides high-resolution imaging and positioning flexibility to reveal critical anatomical information during congenital heart and electrophysiology procedures.Azurion 7 B20/12The Azurion 7 biplane system with a 20” and 12” Flat Detector provides exceptional clarity of detail and navigational precision to support a wide range of challenging cardiac and vascular interventions.Azurion 7 B20/15Enhance insight and certainty during neuro interventions with the Azurion 7 biplane system. It pairs a 20" frontal with a 15" lateral detector.information,pleasecontactyoursalesrepresentativeorsendanemailto:***************************High productivity combined with low cost of ownershipWith Philips, you get the best service performance which enables you totreat more patients, and professional support to help you deliver cost-efficient care.Best service performance18 enables you to treatmore patients19Staying on top of today’s complex healthcareenvironment is challenging enough without aconstant concern of keeping your systems up andrunning smoothly. With Philips, your operationsare protected by the best overall service engineerperformance for imaging systems according to IMVServiceTrak for 5 years in a row. Philips remotelyconnected systems provide 135 more hours ofoperational availability per year, enabling you totreat more patients.Professional support helps you delivercost-efficient careTo help you fully leverage your financial,technological and staffing resources and realizea high return on your investment, we offerprofessional support through our experiencednetwork of over 7,000 field service engineers, aswell as a flexible service offering that includes:• Innovative financing solutions tailored to meetthe needs of healthcare organizations• A broad range of healthcare consulting programsto help your organization further enhance theefficiency and efficacy of your care deliveryprocess• Philips Healthcare Education can help unlockthe full potential of your staff, technology andorganization to meet new challenges throughinnovative, meaningful and evidence-basedhealthcare education.Cost-effectively manage future upgrades withthe Technology Maximizer programTechnology Maximizer is a program that runs intandem with your Philips Service Agreement.20When you opt into the program, you receivethe latest available software and hardware21technology releases for a fraction of the cost ofpurchasing them individually. The TechnologyMaximizer Plus allows you to further tailorupgrades to reduce costs. No need to wait forbudget approval.No need to buy individual upgrades. Just a cost-effective way to manage ongoing technologyupgrades through your operational budget.Doing business responsibly and sustainablyWhen you choose Philips, you are choosing apartner committed to meet sustainability andcircular economy ambitions. As a leading healthtechnology company, our purpose is to improvepeople’s health and well-being through meaningfulinnovation, positively impacting 2.5 billion lives peryear by 2030.The Azurion is the result of our EcoDesign processand offers significant environmental improvements:• 100% product take-back after customers’acceptance of our trade-in offer.• 100% repurposing of the equipment that isreturned to Philips• Up to 90% of material weight is reused duringrefurbishing, depending on type and age ofproduct• At least 10% lower energy consumption over totalproduct life usage22Read more about our Environmental, Social andCorporate Governance (ESG) commitments here:https:///a-w/about/sustainability.html135 more hours of operational availability on average, per year,enabling you to treat more patients.19Philips remotely connected systems provide1.2.3.4.5.6.7.8.9. 10.11.12.13.14.15.16.17.18.20.22.**********************。

pp_ch07

pp_ch07

©The McGraw-Hill Companies, 2003
Two hidden characteristics problems
• Adverse selection • Misrepresentation
©The McGraw-Hill Companies, 2003
Example: Dental insurance
A R
Decision to accept
©The McGraw-Hill Companies, 2003
Example: Insurance
X: Expected benefit or claim payment to buyer
V: Value from risk reduction of insurance
Client
R Decision to accept 0 0 Payoff principal Payoff agent
0 -7
0 -3
©The McGraw-Hill Companies, 2003
Nash equilibrium
Principal: {4,8} Agent of type 3: Yes Agent of type 7: Yes Notice that both types buy insurance
©The McGraw-Hill Companies, 2003
There are 5 types of families
Outlays (in euros)
Percentage of population
200
400 600 800 1000
20
20 20 20 20
Average annual dental outlays for families is 600 euros.

ICH-Q7英文版

ICH-Q7英文版

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINEG OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSRecommended for Adoptionat Step 4 of the ICH Processon 10 November 2000by the ICH Steering CommitteeThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended foradoption to the three regulatory parties to ICHTABLE OF CONTENTS1. INTRODUCTION (1)1.1 Objective (1)1.2 Regulatory Applicability (1)1.3 Scope (1)2. QUALITY MANAGEMENT (4)2.1 Principles (4)2.2 Responsibilities of the Quality Unit(s) (4)2.3 Responsibility for Production Activities (5)2.4 Internal Audits (Self Inspection) (5)2.5 Product Quality Review (6)3. PERSONNEL (6)3.1 Personnel Qualifications (6)3.2 Personnel Hygiene (6)3.3 Consultants (7)4. BUILDINGS AND FACILITIES (7)4.1 Design and Construction (7)4.2 Utilities (8)4.3 Water (8)4.4 Containment (9)4.5 Lighting (9)4.6 Sewage and Refuse (9)4.7 Sanitation and Maintenance (9)5. PROCESS EQUIPMENT (9)5.1 Design and Construction (9)5.2 Equipment Maintenance and Cleaning (10)5.3 Calibration (11)5.4 Computerized Systems (11)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients6. DOCUMENTATION AND RECORDS (12)6.1 Documentation System and Specifications (12)6.2 Equipment Cleaning and Use Record (13)6.3 Records of Raw Materials, Intermediates, API Labelling andPackaging Materials (13)6.4 Master Production Instructions(Master Production and Control Records) (13)6.5 Batch Production Records (Batch Production and Control Records).. 146.6 Laboratory Control Records (15)6.7 Batch Production Record Review (15)7. MATERIALS MANAGEMENT (16)7.1 General Controls (16)7.2 Receipt and Quarantine (16)7.3 Sampling and Testing of Incoming Production Materials (17)7.4 Storage (17)7.5 Re-evaluation (18)8. PRODUCTION AND IN-PROCESS CONTROLS (18)8.1 Production Operations (18)8.2 Time Limits (19)8.3 In-process Sampling and Controls (19)8.4 Blending Batches of Intermediates or APIs (19)8.5 Contamination Control (20)9. PACKAGING AND IDENTIFICATION LABELLING OF APIsAND INTERMEDIATES (20)9.1 General (20)9.2 Packaging Materials (21)9.3 Label Issuance and Control (21)9.4 Packaging and Labelling Operations (21)10. STORAGE AND DISTRIBUTION (22)10.1 Warehousing Procedures (22)10.2 Distribution Procedures (22)11. LABORATORY CONTROLS (23)11.1 General Controls (23)11.2 Testing of Intermediates and APIs (24)11.3 Validation of Analytical Procedures (24)11.4 Certificates of Analysis (24)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients11.5 Stability Monitoring of APIs (25)11.6 Expiry and Retest Dating (25)11.7 Reserve/Retention Samples (25)12. VALIDATION (26)12.1 Validation Policy (26)12.2 Validation Documentation (26)12.3 Qualification (27)12.4 Approaches to Process Validation (27)12.5 Process Validation Program (28)12.6 Periodic Review of Validated Systems (28)12.7 Cleaning Validation (28)12.8 Validation of Analytical Methods (29)13. CHANGE CONTROL (29)14. REJECTION AND RE-USE OF MATERIALS (30)14.1 Rejection (30)14.2 Reprocessing (30)14.3 Reworking (31)14.4 Recovery of Materials and Solvents (31)14.5 Returns (31)15. COMPLAINTS AND RECALLS (32)16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES). 3217. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS,AND RELABELLERS (33)17.1 Applicability (33)17.2 Traceability of Distributed APIs and Intermediates (33)17.3 Quality Management (33)17.4 Repackaging, Relabelling and Holding of APIs and Intermediates (33)17.5 Stability (34)17.6 Transfer of Information (34)17.7 Handling of Complaints and Recalls (34)17.8 Handling of Returns (34)18. SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELLCULTURE/FERMENTATION (35)18.1 General (35)18.2 Cell Bank Maintenance and Recordkeeping (36)18.3 Cell Culture/Fermentation (36)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients18.4 Harvesting, Isolation, and Purification (37)18.5 Viral Removal/Inactivation Steps (37)19. APIs FOR USE IN CLINICAL TRIALS (38)19.1 General (38)19.2 Quality (38)19.3 Equipment and Facilities (38)19.4 Control of Raw Materials (39)19.5 Production (39)19.6 Validation (39)19.7 Changes (39)19.8 Laboratory Controls (39)19.9 Documentation (39)20. GLOSSARY (40)G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTS1. INTRODUCTION1.1 ObjectiveThis document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.In this Guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this Guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this Guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.The Guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.This Guide is not intended to define registration/filing requirements or modify pharmacopoeial requirements. This Guide does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents must be met.1.2 Regulatory ApplicabilityWithin the world community, materials may vary as to the legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide.1.3 ScopeThis Guide applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section 18.Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsThis Guide excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this Guide. In addition, the Guide does not apply to medical gases, bulk-packaged drug (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals.Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products).An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials normally have defined chemical properties and structure.The company should designate and document the rationale for the point at which production of the API begins. For synthetic processes, this is known as the point at which "API Starting Materials" are entered into the process. For other processes (e.g. fermentation, extraction, purification, etc), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical.The guidance in this document would normally be applied to the steps shown in gray in Table 1. It does not imply that all steps shown should be completed. The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps, purification, and packaging. Physical processing of APIs, such as granulation, coating or physical manipulation of particle size (e.g. milling, micronizing), should be conducted at least to the standards of this Guide.This GMP Guide does not apply to steps prior to the introduction of the defined "API Starting Material".Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsTable 1: Application of this Guide to API ManufacturingType ofManufacturingApplication of this Guide to steps (shown in grey) used in this type ofmanufacturing ChemicalManufacturing Production of the APIStartingMaterialIntroduction of the API Starting Material into process Production of Intermediate(s) Isolation and purification Physical processing, and packaging API derived from animal sources Collection oforgan, fluid, ortissue Cutting, mixing, and/or initialprocessingIntroduction of the API Starting Material into process Isolation and purification Physical processing, and packaging API extracted from plant sources Collection of plants Cutting andinitialextraction(s) Introduction of the API StartingMaterial intoprocessIsolation and purification Physical processing, and packaging Herbal extracts used as API Collection of plants Cutting and initial extraction Further extraction Physicalprocessing,andpackagingAPI consisting of comminuted or powdered herbs Collection of plants and/or cultivation and harvesting Cutting/ comminuting Physicalprocessing,andpackagingBiotechnology: fermentation/ cell culture Establishment of master cell bank and working cell bank Maintenance of working cell bank Cell culture and/or fermentation Isolation and purification Physicalprocessing,andpackaging“Classical” Fermentation to produce an API Establishment of cell bank Maintenance of the cell bank Introduction of the cells into fermentation Isolation and purificationPhysicalprocessing,andpackagingGood Manufacturing Practice Guide for Active Pharmaceutical Ingredients2. QUALITY MANAGEMENT2.1 Principles2.10 Quality should be the responsibility of all persons involved in manufacturing.2.11 Each manufacturer should establish, document, and implement an effectivesystem for managing quality that involves the active participation of management and appropriate manufacturing personnel.2.12 The system for managing quality should encompass the organisational structure,procedures, processes and resources, as well as activities necessary to ensure confidence that the API will meet its intended specifications for quality and purity. All quality related activities should be defined and documented.2.13 There should be a quality unit(s) that is independent of production and thatfulfills both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.2.14 The persons authorised to release intermediates and APIs should be specified. 2.15 All quality related activities should be recorded at the time they are performed.2.16 Any deviation from established procedures should be documented and explained.Critical deviations should be investigated, and the investigation and its conclusions should be documented.2.17 No materials should be released or used before the satisfactory completion ofevaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g. release under quarantine as described in Section 10.20 or the use of raw materials or intermediates pending completion of evaluation).2.18 Procedures should exist for notifying responsible management in a timely mannerof regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).2.2 Responsibilities of the Quality Unit(s)2.20 The quality unit(s) should be involved in all quality-related matters.2.21 The quality unit(s) should review and approve all appropriate quality-relateddocuments.2.22 The main responsibilities of the independent quality unit(s) should not bedelegated. These responsibilities should be described in writing and should include but not necessarily be limited to:1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for useoutside the control of the manufacturing company;2. Establishing a system to release or reject raw materials, intermediates,packaging and labelling materials;3. Reviewing completed batch production and laboratory control records ofcritical process steps before release of the API for distribution;4. Making sure that critical deviations are investigated and resolved;5. Approving all specifications and master production instructions;6. Approving all procedures impacting the quality of intermediates or APIs;Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients7. Making sure that internal audits (self-inspections) are performed;8. Approving intermediate and API contract manufacturers;9. Approving changes that potentially impact intermediate or API quality;10. Reviewing and approving validation protocols and reports;11. Making sure that quality related complaints are investigated and resolved;12. Making sure that effective systems are used for maintaining and calibratingcritical equipment;13. Making sure that materials are appropriately tested and the results arereported;14. Making sure that there is stability data to support retest or expiry dates andstorage conditions on APIs and/or intermediates where appropriate; and15. Performing product quality reviews (as defined in Section 2.5).2.3 Responsibility for Production ActivitiesThe responsibility for production activities should be described in writing, and should include but not necessarily be limited to:1. Preparing, reviewing, approving and distributing the instructions for theproduction of intermediates or APIs according to written procedures;2. Producing APIs and, when appropriate, intermediates according to pre-approved instructions;3. Reviewing all production batch records and ensuring that these arecompleted and signed;4. Making sure that all production deviations are reported and evaluated andthat critical deviations are investigated and the conclusions are recorded;5. Making sure that production facilities are clean and when appropriatedisinfected;6. Making sure that the necessary calibrations are performed and recordskept;7. Making sure that the premises and equipment are maintained and recordskept;8. Making sure that validation protocols and reports are reviewed andapproved;9. Evaluating proposed changes in product, process or equipment; and10. Making sure that new and, when appropriate, modified facilities andequipment are qualified.2.4 Internal Audits (Self Inspection)2.40 In order to verify compliance with the principles of GMP for APIs, regularinternal audits should be performed in accordance with an approved schedule. 2.41 Audit findings and corrective actions should be documented and brought to theattention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.2.5 Product Quality Review2.50 Regular quality reviews of APIs should be conducted with the objective ofverifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:− A review of critical in-process control and critical API test results;− A review of all batches that failed to meet established specification(s);− A review of all critical deviations or non-conformances and related investigations;− A review of any changes carried out to the processes or analytical methods;− A review of results of the stability monitoring program;− A review of all quality-related returns, complaints and recalls; and− A review of adequacy of corrective actions.2.51 The results of this review should be evaluated and an assessment made ofwhether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner.3. PERSONNEL3.1 Personnel Qualifications3.10 There should be an adequate number of personnel qualified by appropriateeducation, training and/or experience to perform and supervise the manufacture of intermediates and APIs.3.11 The responsibilities of all personnel engaged in the manufacture of intermediatesand APIs should be specified in writing.3.12 Training should be regularly conducted by qualified individuals and should cover,at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. Records of training should be maintained.Training should be periodically assessed.3.2 Personnel Hygiene3.20 Personnel should practice good sanitation and health habits.3.21 Personnel should wear clean clothing suitable for the manufacturing activity withwhich they are involved and this clothing should be changed when appropriate.Additional protective apparel, such as head, face, hand, and arm coverings, should be worn when necessary, to protect intermediates and APIs from contamination.3.22 Personnel should avoid direct contact with intermediates or APIs.3.23 Smoking, eating, drinking, chewing and the storage of food should be restricted tocertain designated areas separate from the manufacturing areas.3.24 Personnel suffering from an infectious disease or having open lesions on theexposed surface of the body should not engage in activities that could result in compromising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the quality of the APIs until the condition is corrected orqualified medical personnel determine that the person's inclusion would not jeopardize the safety or quality of the APIs.3.3 Consultants3.30 Consultants advising on the manufacture and control of intermediates or APIsshould have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.3.31 Records should be maintained stating the name, address, qualifications, and typeof service provided by these consultants.4. BUILDINGS AND FACILITIES4.1 Design and Construction4.10 Buildings and facilities used in the manufacture of intermediates and APIs shouldbe located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants as appropriate.4.11 Buildings and facilities should have adequate space for the orderly placement ofequipment and materials to prevent mix-ups and contamination.4.12 Where the equipment itself (e.g., closed or contained systems) provides adequateprotection of the material, such equipment can be located outdoors.4.13 The flow of materials and personnel through the building or facilities should bedesigned to prevent mix-ups or contamination.4.14 There should be defined areas or other control systems for the followingactivities:− Receipt, identification, sampling, and quarantine of incoming materials, pending release or rejection;− Quarantine before release or rejection of intermediates and APIs;− Sampling of intermediates and APIs;− Holding rejected materials before further disposition (e.g., return, reprocessing or destruction);− Storage of released materials;− Production operations;− Packaging and labelling operations; and− Laboratory operations.4.15 Adequate, clean washing and toilet facilities should be provided for personnel.These washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.4.16 Laboratory areas/operations should normally be separated from production areas.Some laboratory areas, in particular those used for in-process controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process or intermediate or API.4.2 Utilities4.20 All utilities that could impact on product quality (e.g. steam, gases, compressedair, and heating, ventilation and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded.Drawings for these utility systems should be available.4.21 Adequate ventilation, air filtration and exhaust systems should be provided,where appropriate. These systems should be designed and constructed to minimise risks of contamination and cross-contamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture.Particular attention should be given to areas where APIs are exposed to the environment.4.22 If air is recirculated to production areas, appropriate measures should be takento control risks of contamination and cross-contamination.4.23 Permanently installed pipework should be appropriately identified. This can beaccomplished by identifying individual lines, documentation, computer control systems, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or API.4.24 Drains should be of adequate size and should be provided with an air break or asuitable device to prevent back-siphonage, when appropriate.4.3 Water4.30 Water used in the manufacture of APIs should be demonstrated to be suitable forits intended use.4.31 Unless otherwise justified, process water should, at a minimum, meet WorldHealth Organization (WHO) guidelines for drinking (potable) water quality.4.32 If drinking (potable) water is insufficient to assure API quality, and tighterchemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms and/or endotoxins should be established.4.33 Where water used in the process is treated by the manufacturer to achieve adefined quality, the treatment process should be validated and monitored with appropriate action limits.4.34 Where the manufacturer of a non-sterile API either intends or claims that it issuitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.4.4 Containment4.40 Dedicated production areas, which can include facilities, air handling equipmentand/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosporins.4.41 Dedicated production areas should also be considered when material of aninfectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.4.42 Appropriate measures should be established and implemented to prevent cross-contamination from personnel, materials, etc. moving from one dedicated area to another.4.43 Any production activities (including weighing, milling, or packaging) of highlytoxic non-pharmaceutical materials such as herbicides and pesticides should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic non-pharmaceutical materials should be separate from APIs.4.5 Lighting4.50 Adequate lighting should be provided in all areas to facilitate cleaning,maintenance, and proper operations.4.6 Sewage and Refuse4.60 Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-products frommanufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. Containers and/or pipes for waste material should be clearly identified.4.7 Sanitation and Maintenance4.70 Buildings used in the manufacture of intermediates and APIs should be properlymaintained and repaired and kept in a clean condition.4.71 Written procedures should be established assigning responsibility for sanitationand describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities.4.72 When necessary, written procedures should also be established for the use ofsuitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents to prevent the contamination of equipment, raw materials, packaging/labelling materials, intermediates, and APIs.5. PROCESS EQUIPMENT5.1 Design and Construction5.10 Equipment used in the manufacture of intermediates and APIs should be ofappropriate design and adequate size, and suitably located for its intended use, cleaning, sanitization (where appropriate), and maintenance.5.11 Equipment should be constructed so that surfaces that contact raw materials,intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.5.12 Production equipment should only be used within its qualified operating range.。

Chp7 preparing the master budget(上财 管理会计)

Chp7 preparing the master budget(上财 管理会计)

Benefits of Budgets
Compel managers
to think ahead
Provide an opportunity to reevaluate existing activities
and evaluate new ones.
Aid managers in communicating objectives and coordinating
4. Explain the difficulties of sales forecasting.
5. Explain the major features and advantages of a master budget.
6. Follow the principal steps in preparing a master budget.
Steps in Preparing the Master Budget
2. Operating Budget: Prepare budgeted income statement using basic data in step 1.
3. Financial Budget: Prepare forecasted financial statements:
7. Prepare the operating budget and the supporting schedules.
8. Prepare the financial budget.
9. Use a spreadsheet to develop a budget (Appendix 7).
Learning Objective 1
1. Explain how budgets facilitate planning and coordination.

presentation的衡量标准

presentation的衡量标准

presentation的衡量标准在制作和进行演示时,我们需要一些衡量标准来评估我们的表现和演示效果。

以下是一些常见的参考内容,旨在帮助你在各个方面提高你的演示技巧和效果。

1.内容准备和组织:演示的内容是最重要的方面之一。

参考内容可以包括:- 清晰的目标和主题:确保你的演示有一个明确的目标和主题,这有助于集中你的讲话和组织你的思维。

- 结构化的大纲:制定一个清晰的大纲,帮助你有条理地组织你的演示内容,确保它们与主题相关且逻辑清晰。

- 有说服力的信息:提供有价值的信息和证据,以增加你的演示的可信度和说服力。

2.演示技巧和语言表达:除了演示的内容外,你的演示技巧和语言表达也是评估的重要方面。

以下是一些参考内容:- 肢体语言和面部表情:注意你的肢体语言和面部表情,它们应该与你的演示内容一致并增强你的表达。

- 声音和音调:确保你的声音清晰和响亮,使用适当的音调和语调来吸引听众的注意力和保持他们的兴趣。

- 讲话节奏和节奏感:控制你的讲话节奏和节奏感,避免讲得太快或太慢,让听众能够跟上你的演示。

3.视觉辅助工具和设计:视觉辅助工具是帮助你传达信息和增强你的演示效果的重要工具。

以下是一些参考内容:- 清晰的字体和排版:选择易读的字体和排版,确保字体大小足够大,以便远离屏幕的人也能够轻松阅读。

- 简洁和有序的信息布局:避免在一张幻灯片上放太多信息,保持幻灯片的简洁和有序,以提高信息的可读性和理解性。

- 图表和图像的使用:使用图表和图像来可视化复杂的数据和信息,让它们变得更易于理解和记忆。

4.互动和参与度:与听众进行互动可以增加他们的参与度和注意力。

以下是一些参考内容:- 面对听众:与听众保持眼神接触,并定期与他们交流,通过这种方式建立联系和互动。

- 提问和回答:引入提问和回答的环节,鼓励听众参与讨论和提问问题,以促进思考和互动。

- 演示的参与活动:为听众设计一些参与活动,例如小组讨论、案例研究或问卷调查,以增加他们的参与度和学习效果。

ICH-Q7(中英文对照)

ICH-Q7(中英文对照)

ICH-Q7(中英⽂对照)Q7a(中英⽂对照)FDA原料药GMP指南Table of Contents ⽬录1. INTRODUCTION 1. 简介1.1 Objective 1.1⽬的1.2 Regulatory Applicability 1.2法规的适⽤性1.3 Scope 1.3范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1总则2.2 Responsibilities of the Quality Unit(s) 2.2质量部门的责任2.3 Responsibility for Production Activities 2.3⽣产作业的职责2.4 Internal Audits (Self Inspection) 2.4内部审计(⾃检)2.5 Product Quality Review 2.5产品质量审核3. PERSONNEL 3. ⼈员3.1 Personnel Qualifications 3.⼈员的资质3.2 Personnel Hygiene 3.2 ⼈员卫⽣3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施4.1 Design and Construction 4.1 设计和结构4.2 Utilities 4.2 公⽤设施4.3 Water 4.3 ⽔4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 排污和垃圾4.7 Sanitation and Maintenance 4.7 卫⽣和保养5. PROCESS EQUIPMENT 5. ⼯艺设备5.1 Design and Construction 5.1 设计和结构5.2 Equipment Maintenance and Cleaning 5.2 设备保养和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. ⽂件和记录6.1 Documentation System andSpecifications6.1 ⽂件系统和质量标准6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使⽤记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (MasterProduction and Control Records)6.4 ⽣产⼯艺规程(主⽣产和控制记录)6.5 Batch Production Records (BatchProduction and Control Records)6.5 批⽣产记录(批⽣产和控制记录)6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7批⽣产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 控制通则7.2 Receipt and Quarantine 7.2接收和待验7.3 Sampling and Testing of IncomingProduction Materials7.3 进⼚物料的取样与测试7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. PRODUCTION AND IN-PROCESSCONTROLS8. ⽣产和过程控制8.1 Production Operations 8.1 ⽣产操作8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 ⼯序取样和控制8.4 Blending Batches of Intermediates orAPIs8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9. 原料药和中间体的包装和贴签9.1 General 9.1 总则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与控制9.4 Packaging and Labeling Operations 9.4 包装和贴签操作10. STORAGE AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 ⼊库程序10.2 Distribution Procedures 10.2 分发程序11. LABORATORY CONTROLS 11.实验室控制11.1 General Controls 11.1 控制通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的测试11.3 Validation of Analytical Procedures 11.3 分析⽅法的验证11.4 Certificates of Analysis 11.4 分析报告单11.5 Stability Monitoring of APIs 11.5 原料药的稳定性监测11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. V ALIDATION 12.验证12.1 Validation Policy 12.1 验证⽅针12.2 Validation Documentation 12.2 验证⽂件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4 ⼯艺验证的⽅法12.5 Process Validation Program 12.5 ⼯艺验证的程序12.6 Periodic Review of Validated Systems 12.6验证系统的定期审核12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析⽅法的验证13. CHANGE CONTROL 13.变更的控制14. REJECTION AND RE-USE OFMATERIALS14.拒收和物料的再利⽤14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 返⼯14.3 Reworking 14.3 重新加⼯14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)16.协议⽣产商(包括实验室)17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪⼈、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 17.1适⽤性17.2 Traceability of Distributed APIs andIntermediates17.2已分发的原料药和中间体的可追溯性17.3 Quality Management 17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5稳定性17.6 Transfer of Information 17.6 信息的传达17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18. ⽤细胞繁殖/发酵⽣产的原料药的特殊指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and RecordKeeping18.2细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 18.4收取、分离和精制18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤19.APIs for Use in Clinical Trials 19.⽤于临床研究的原料药19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production 19.5 ⽣产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 ⽂件20. Glossary 20. 术语Q7a GMP Guidance for APIs Q7a原料药的GMP指南1. INTRODUCTION 1. 简介1.1 Objective 1.1⽬的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. 本⽂件旨在为在合适的质量管理体系下制造活性药⽤成分(以下称原料药)提供有关优良药品⽣产管理规范(GMP)提供指南。

Pringle Type CBC 切换器安装、运行与维护说明书

Pringle Type CBC 切换器安装、运行与维护说明书

Eaton Corporation 1000 Cherrington Pkwy Moon Township, PA 15108-4312 United States Tel: 877-ETN-CARE
© 2008 Eaton Corporation All Rights Reserved Printed in USA Publication No. IL00808003E December 2008
4. Operate the switch in a test fashion several times to work the lubricant between the contacts.
5. Apply CRC 3-36 (or equivalent) to pivot points and bearings of dead front mechanism.
Installation, Operating & Maintenance
Instructions for Pringle Type CBC Switches
Instruction Sheet G
December 2008
WARNING
Do not attempt to install switches or perform maintenance on equipment while it is energized. Failure to following this warning could lead to death or severe injury. Always verify that no voltage is present on all switch terminals prior to servicing. While energized, an arc flash and shock hazard exists. Consult NFPA 70E and OSHA guidelines for operator safety prior to servicing equipment.

CX7000 Customer Presentation

CX7000 Customer Presentation

Polycom Solutions for Microsoft Unified Communications
4
Polycom Advantage - Customers
Total collaboration through end-to-end solution offering and services
Differentiated Partnership
• Polycom is the ONLY company offering integrated HD voice and visual communication solutions for Microsoft® Lync™ and other Microsoft UC suites for complete end-to-end UC offering
ቤተ መጻሕፍቲ ባይዱ
Integrated into daily workflow (CEBP)
Direct Integration with Microsoft Infrastructure
Solution for the future – on premises or cloud-based
Polycom Solutions for Microsoft Unified Communications
Polycom and Microsoft continue to invest in product development and go-tomarket initiatives to deliver high quality UC options for customers, with rich integration across the Microsoft and Polycom portfolio.

toyota 7 inch Basic AVX使用者手冊说明书

toyota 7 inch Basic AVX使用者手冊说明书

Article 3 (Terms of License)1.I n assigning this product, User may not retain the original copy of the embedded Licensed Software (including associated literature, updates and upgrades) and any duplicates and associated literature with regard tothe license to use Licensed Software. User may transfer Licensed Software only to the condition of binding the assignee to abide by the terms of this Software License Agreement.2.U ser may not reverse-engineer, disassemble, decompile or otherwise analyze the source code of Licensed Software.Article 4 (Rights to Licensed Software)All rights to Licensed Software and the associated literature, including copyrights, shall reside with Licensor orthe original right holder who has granted the Right of Use and right to sublicense to Licensor (hereinafter referred to as “Original Right Holder”), and User does not have any rights other than Right of Use granted hereunder with regard to Licensed Software and the associated literature. Article 5 (Exemption Granted to Licensor)1.L icensor and Original Right Holder do not assume any responsibility for damages caused to User or third parties resulting from the exercise by User of the license granted hereunder, unless otherwise provided by any law to the contrary.2.L icensor does not warrant Licensed Software to be merchantable, compatible and fit for specific purposes.Article 6 (Responsibility for Third Parties)If disputes over the infringement of third parties’intellectual property rights, such as copyrights and patent rights, arise out of the use of Licensed Software by User, User shall resolve these disputes at User’s own expenses while keep Licensor and Original Right Holder harmless.Article 7 (Secrecy Obligation)User shall keep confidential Licensed Software provided hereunder, information contained in the associated literature or the like and those provisions of this agreement not yet in public knowledge and may not disclose or leak these to third parties without prior written consent from Licensor.Article 8 (Cancellation of the Agreement) Licensor reserves the right to cancel thisagreement forthwith and claim compensation from User for the damages caused by such cancellation when User:(1)B reaches any of the provisions of thisagreement, or(2)H as received a petition for seizure, provisionalseizure, provisional disposition or any otherkind of compulsory execution.Article 9 (Destruction of Licensed Software)If this agreement is terminated under the provision of the foregoing paragraph, User shall destroy Licensed Software, along with all associated literature and its duplicates, within two (2) weeks from the date of termination. Article 10 (Copyright Protection)1.C opyrights and all other intellectual property rights relating to Licensed Software shall reside with Licensor and Original Right Holder and in no circumstances with User.2.U ser shall abide by the laws relating to copyrights and intellectual property rights in using Licensed Software.Article 11 (Export Control)1.L icensed Software and the associated literature or the like may not be exportedto places outside the Country (including transmission outside the Country over the Internet or the like).2.U ser agrees that Licensed Software is subjectto export controls imposed by the Country and the United States of America.3.U ser agrees to comply with all the international and domestic laws that applyto this software (U.S. Export Administration Regulations and regulations established bythe U.S., the Country and their governmental agencies regarding usage by end users and export destinations).Article 12 (Miscellaneous)1.E ven if this agreement is invalidated in part by law, all other provisions shall remain in effect.2. L icensor and User shall consult each other in good faith to resolve any matters not provided for in this agreement or questions arising from the interpretation of this agreement.3.L icensor and User agree that this agreementis governed by the law of Japan and that all disputes involving claims and obligations that may arise out of this agreement will be settled by arbitration at the Tokyo District Court asthe court of first instance.ii基本操作6基本操作前面板按鈕功能57 12346右手驅動機型1237 564左手驅動機型注意• 本指南中的面板是用作清晰說明操作的範例。

Prius_User-Guide

Prius_User-Guide

Toyota Prius User-Guide Seventh Edition, Second Revision for the HSD (2004-2007) modelDRIVING (2)Just Drive It ! (2)Startup (2)Shutdown (3)Cruise-Control (3)Neutral (3)Reverse (4)Hybrid Driving (5)Brakes (5)Stealth Driving (6)"B" Mode (6)Charge-Level (7)Radio (7)Multi-Display (8)Steering-Wheel (8)CD Player (8)Audio Buttons (8)Inside Air (8)Outside Air (9)UNDERSTANDING (10)MPG Measurement (10)Increasing MPG (10)EPA Estimates (13)Seasonal Cycles (15)Emissions (16)Gas Prices (17)NURTURING (18)Filling the Tank (18)Multi-Display Care (19)Long-Term Storing (19)Polishing (20)Tire Care (20)Tire Upgrades (22)Washing (24)Valet Use (24)MAINTENANCE (25)Oil Changes (25)Engine Air-Filter (26)Window Wipers (27)Fuel Door (28)Air-Conditioning (29)OPTIONS (30)SKS: Smart-Entry (30)SKS: Smart-Start (30)Homelink (31)Electrochromic Mirror (31)Navigation (32)Bluetooth (32)Voice-Recognition (32)VOICE-RECOGNITION (33)Help (33)Navigation - Commands (33)Navigation - Locations (34)Audio (35)Climate (35)Screen (35)OTHER (36)Battery-Pack (36)Rear Hatch (36)External Cargo (39)Side Mirrors (41)Internal Storage (42)Transmission (42)Information Sources (43)Informational Materials (45)GLOSSARY (50)Disclaimer:All the information stated in this document was provided by Prius owners. None were affiliated with Toyota Motor Corporation, except as customers.This document is not sanctioned by Toyota Motor Corporation or any of its affiliates.The ideas, suggestions, and opinions offered in this document have not been endorsed by the manufacturer of those specific components or Toyota Motor Corporation.Any harm or damage that may result from the application of or the following of any ideas, suggestions, or opinions contained in this document is the sole responsibility of the individual that applied or followed said ideas, suggestions or opinions.The authors of this document hereby declare that they cannot and will not be held liable, in any fashion, for the content or the useDRIVINGJust Drive It !Vital Info Ignore the advanced technology!It's too easy to get preoccupied with everything Prius automatically does for you, especially withthe Multi-Display providing constant performance information. The hybrid system was designedso you could to drive it like a traditional car. That way, you can enjoy the remarkably smooth &quiet ride. Let the computer worry about how to save gas and reduce emissions.StartupStep On the Brake New owners sometimes fall victim to this, not being able to figure out why the car won’t start.For safety, stepping on the brake before starting has always been highly recommended in all typesof vehicles anyway. But in Prius, it is required. Because if you don’t, you’ll find that only theaccessories will power-up. The hybrid system itself won’t start until you push the power buttonwhile also stepping on the brake at the same time.If you do make the mistake of not pressing the brake pedal far enough to the floor, a collection ofwarning the lights by the speedometer will come on. In that case, lift your foot off the brake. Waita few seconds, and then press it again... only harder this time. Wait a few more seconds, and thenpress the PARK button. That will reset the system.12-Volt Jumping If the 12-volt auxiliary battery is ever drained completely, you can jump it similar to a traditionalvehicle. With the Prius OFF (hybrid system & lights), connect the positive-cable to the jump-startterminal (within the black plastic fuse-box, under the Prius hood) then to the positive-terminal onthe 12-volt battery of the supplying vehicle (as it is running). Next, connect the negative-cable tothe negative-terminal on the 12-volt battery of the supplying vehicle. Then the other end of thenegative-cable can be connected to an unpainted metal component under the hood; a very goodplace for this is the support attaching the engine & motor to the body of the vehicle in the frontdriver's side corner under the Prius hood. At this point, start the hybrid system. When "READY"appears on the Prius speedometer cluster, you should then disconnect the cables following theopposite order they were connected.For safety information, greater detail, and illustrations, please refer to your Owner's Manual.A very simple way to confirm you have a good electrical connection before attempting to start is tojust turn on the ceiling light. If it illuminates brightly, you know that the supply coming from thedonor vehicle is sufficient to successfully jump the Prius. If the light is dim, the connection is badand you must fix it before proceeding.Winter Heat Creating heat for the emissions system and heat to keep you warm is fastest and most efficient ifyou simply drive gently immediately after starting the Prius in the winter. Allowing the engine torun while the Prius is parked takes longer and is less efficient. "Just Drive It!"Once the heater warms up, resist the temptation to turn up the fan-speed on too high. That willactually decrease the potential heat. Air blasting over the fins of the core too quickly prevents theopportunity to absorb as much heat as possible. Slower air doesn’t. In other words, don't exceedthe medium speed setting.Engine Warm-Up Reducing Emissions is the highest priority for Prius. It strives to remain a AT-PZEV (AdvancedTechnology - Partial Zero Emission Vehicle) at all times, which means the catalytic-converter mustbe kept hot… even if it requires consuming some gas to accomplish that. Fortunately, you still getbetter than average mileage, even though the engine may run more than you’d expect. ShutdownOff Confirm Use the remote or push a door-button (or the one on the hatch) when leaving your Prius. That willconfirm that all the doors really did get shut tightly and the power for the hybrid system is off. Ifyou don't, the 12-volt auxiliary battery may get drained completely or the alarm might not be ableto protect the car.Whirring Sound There is a small electric-pump that pumps 3 liters of coolant into a thermal container (to keep it hot)every time you turn the hybrid system power OFF. When the power is turned back ON, the coolantis pump back into the engine. This process reduces emissions, by achieving warm-up much fasterthan with an engine that would normally have to heat itself up. This process also helps to reducewear & tear on the engine.Cruise-Control24 MPH minimum Slowing down to less than 24 MPH (39 km/h) will cause the cruise-control "resume" memory toreset. So if you have to slow down or stop, you'll need to set the speed again.MPG Some owners have observed an increase in MPG from using the cruise-control, others have not.Results vary depending on your particular driving habits and road conditions.Stealth If you don't have a sensitive enough foot but would still like to enjoy stealth driving on a lighttraffic road, just set the cruise-control. This can be done all the way up to 42 MPH (68 km/h) onflat or declining terrain without making the engine startup.Smooooooth The CVT (Continuously Variable Transmission, "Planetary" type) makes the cruise-control in Priusremarkably smooth. You'll notice the "no shifting" characteristic of the drive when going up hillsand accelerating aggressively. Many consider this smoothness as a luxury feature.NeutralNo Engine To shift into neutral and keep it there without any chance of the engine starting, do the following:1.Insert the FOB (not necessary if you have SKS, formally known as SE/SS).2.Without stepping on the brake pedal, press the "Power" button twice.e the lever to shift in the Neutral position.ReverseBeeper Disable Some people find the reverse beeper distracting. Although there isn't a method to change therepetitive beeping to just a short warning, there is a way to disable it completely. To do that,carefully follow these steps:1.Switch to the odometer/trip value to display "ODO" by pushing the “ODO TRIP” buttonshown in the lower-right corner of the photo below. If the speedometer-cluster wasalready showing “ODO”, make sure to cycle thru each option back to “ODO” again.2.Power OFF (push the "Power" button).3.Power ON (push the "Power" button again).4.Within 6 seconds of powering back ON, push & hold the button for “ODO” for aminimum of 10 seconds.5.While still holding the button for "ODO", shift into "R" (Reverse), then to "P" (Park).6."b-on" should display on the odometer/trip-meter now. Push the "ODO TRIP" buttonto switch the mode to "b-oFF", as shown here:7.Power OFF (push the "Power" button). That’s it! The beep should now be disabled.Note #1:If the sequence above failed, it may have due to the "ODO" setting not having been visiblerecently. In that case, all you have to do is drive with it that way for a few miles. The nexttime you try to disable the beeper, the process should work.Note #2:If you ever disconnect the 12-volt auxiliary battery from the system (or drain it dead),you may have to repeat the disable process again.From a Stop The gasoline engine is most efficient when running around 70% maximum. So if you can't presslightly enough on the pedal to accelerate using only electricity, go ahead and press a little harderthan usual. That brisk (but not aggressive) increase in speed will save a small amount of gas,resulting in an overall efficiency gain.Climbing Hills The hybrid system has two electric motors. When you encounter a large hill, those motors areautomatically taken advantage of. The gasoline engine will rev to its most efficient high-powerRPM. That provides thrust directly to the tires, generates electricity for the motor, and rechargesthe battery-pack all at the same time. So to the surprise of many new owners, large hills don’t drainthe system. You’ll still have plenty of reserve power available when you reach the top.On the Highway Just like with traditional vehicles, efficiency drops the faster you drive on the highway. 60 MPH(96 km/h) is more efficient than 70 MPH (113 km/h). Speeding up to 75 MPH (121 km/h), you'llobserve MPG drop even more. It is beneficial to drive slower.Without the Pack The large electric motor doesn't actually need electricity from the battery-pack. The gasolineengine generates electricity while you drive for immediate use. So quite frequently, you’ll see onthe multi-display that the motor is being fed directly from the engine and the battery-pack isn'tbeing used. Sometimes, while both the engine and motor are providing thrust, the engine will alsorecharge the battery-pack at the same time.A/C Instead At highway speeds, using the A/C (air-conditioner, cold setting) or vent to remain cool will likelyresult in slightly higher MPG than having the windows open.Cruising A beneficial technique for efficient cruising is to feather the accelerator pedal at particular times.Learning to do this is simple and will quickly become second nature with very little practice. (Infact, you may already have that foot control if you in-line skate or bicycle occasionally.) To do it,just lightly reduce pressure on the accelerator-pedal whenever you encounter a section of roadthat’s perfectly flat or has a slight decline. The MPG indicator will sometimes jump all the way tothe +100 mark, even though your speed ends up dropping only 1 MPH. Then lightly push theaccelerator-pedal to efficiently regain that speed afterward. Overall, MPG will climb a little bitwhen each time you do that.You’ll end up taking advantage of the hybrid design. Changes in the road pitch naturally causechanges in speed anyway. Using the multi-display and large digital speedometer helps youdiscover when gains from that are possible.BrakesRegenerator When you reduce pressure on the accelerator-pedal or use the brake-pedal, excess speed turns amotor, causing regeneration of electricity to recharge the battery-pack. The regenerator takesadvantage of the kinetic energy that would have otherwise been lost. The brake pads & shoes arenot used as much as in a traditional vehicle. This not only makes the Prius more efficient, it alsoindicates the brakes will last longer.Engine Off While the gasoline engine is off and you’re driving using just battery power, the mode you’re in iscalled "stealth" (since the vehicle motion is totally silent).Invoking "stealth" is easy once the engine has warmed up (and you aren't running the A/C or Heatertoo heavily). While driving, just find a street section without any inclines then lift your foot fromthe accelerator-pedal. The engine will shut off within a few moments. Once it does, lightly placeyour foot back on the accelerator-pedal to continue driving with only electricity. Another way toinvoke stealth is to just stop completely, that will make the engine shut off.Up to 42 MPH The 50 kW electric motor is designed to propel the Prius up to 42 MPH (68 km/h). It takes a steadyfoot though. Slower speeds, like 35 MPH (56 km/h) and 30 MPH (48 km/h), are easier. Beyondthat maximum speed or in conditions when additional power is needed, the electric motor works incombination with the gasoline engine. Though, you will discover above 42 MPH (68 km/h) thatthere are times when the engine will spin (pistons in motion) without any fuel being consumed; it isa normal function of the Planetary-CVT.Acceleration Accelerating in "stealth" can be very slow. Also using the gasoline engine is both quicker and moreefficient, so don't be afraid to consume a little bit of gas. Remember that even if you use the batteryand get "+100 MPG", the engine must run later to recharge it. So short-term gains may actuallyresult in an overall loss.A/C&Heater Only the lowest setting for the air-conditioner & heater work in "stealth". Higher settings andairflow durations longer than a minute or two will require the gasoline engine to run.Be Careful ! Be careful while driving in "stealth", especially in parking lots. Some people use only their ears toverify that it's safe, not their eyes! So having a car that's completely silent means you'll probablyhave someone step out in front of it without even realizing you’re driving right at him or her. Andfortunately, the quiet actually makes it easier to hear children (who commonly don’t look anyway). "B" ModeOn/Off Anytime You can engage or disengage engine-braking at anytime while driving.Engine-Braking Avoid using this mode unless absolutely necessary, since it will cause MPG to drop. There is nocharging benefit over regular (foot pedal) braking either."B" mode works like an exhaust brake on a large truck (except, it's totally silent). The engine isused to slow down the vehicle, allowing you to reduce reliance on the regular brakes. So for steepdeclines, like driving down a mountain, it's a great way to avoid overheating caused by frictionfrom the brake drums & shoes.Winter Slowing A special use of "B" is the ability to shift into it on-the-fly without having to take your eyes off theroad. Finding yourself taking a turn on snow or ice a little bit too fast, you'll discover "B" does anabsolutely fantastic job of slowing the car enough to retain traction without any risk whatsoever ofthe wheels slipping from braking too hard... since you aren't using the brakes at all.Charge-Le e velGreenBluePinkRaddioChannel Sc Tuner AdjucanustPress the "S it does findsthe "SCAN"If you pressIn additions the radio viayour left thuWhen the exceeds 6 feature toOnce the lcontinues.actually jushortens thWhen theThis level ideal. So ySOC withiIn short, dfor you auFrom time below 3 baWhen thisabsolutely running soEven withavailable. battery-pa anything bCAN " button b s a station, a few " button again w then hold the to using the kna the buttons onumb. charge-level o bars, the colormake the SOClevel reaches 8 That is becau ust 80% capacit he lifetime of t SOC is 3 to 6 b is what the batyou’ll often wi in this range. don’t get too pr utomatically. e to time, you m ars. s happens, don’y nothing wrong oon to replenish hout any bars sh But since deep ack) are automa below that leve of the battery-p r will change to C (State-Of-Cha bars, no furthe use the battery-ty. The range the battery-pack bars, the color ttery-pack will itness behavior reoccupied with may witness th ’t panic! New g. It is simply h the SOC. Th howing at all, t p-discharges (a atically prevent el. So, it doesn ack (displayed o Green . This arge) easier to er detail is show -pack isn’t actu above that is r k. So, it isn’t i will be display l be at the most r on the Energy h SOC. The sy he Pink color. owners often d an indication t hat’s all. the battery-pac a condition tha ted, there is no n’t. d on the Energy is simply a co notice. wn even thoug ually full. Wha arely utilized, included on the yed as Blue . t. For maximu y Screen that c ystem will prop That’s when th do, even thoug that the engine ck still has 40%at shortens the o reason to ever y Screen)onvenience gh charging at you see issince that e display.um life, it is the contributes to a perly maintain he SOC drops gh there is e will begin % capacity life of the r display e a it by the radio tu w seconds will when you wan "SCAN" butto nob on the das n the steering-w uner knob. It w l play, then it w nt the scanning n, only your prhboard, you al wheel. Just pr will begin scann will automatica to stop. reset radio cha lso have the op ess & hold eith ning for radio c ally scan for th annels will be s ption of adjustin her the up or do channels. Whe he next. Press scanned. ng the tuner fo own button wit enor thMulti-DisplayScreen Off ! Many new owners accidentally discover the off button. Innocently pressing it causes them to panic,because the Multi-Display unexpectedly goes black. Don’t worry though. It’s easy to turn back on.1.Press the "INFO" button on the left, next to the Multi-Display.2.On the screen that appears, press the "Trip Info" button.That’s it!Steering-WheelTilting You won’t notice the lever unless you’re specifically looking for it. Reach underneath, feeling foran opening. When you find it push forward. The lever will swing out, releasing the steering-wheel.Then you can tilt it. Pulling the lever back toward you afterward will lock the steering-wheel intothe new position.CD PlayerChanging Holding the track-change button on the steering-wheel, rather than just quickly pressing it, willcause the CD to be changed instead.Audio ButtonsAudio Button Pressing the "Audio" button next to the Multi-Display will reveal the Radio Preset or CD Controlscreen, depending on what is playing at that moment.Pressing the "Audio" button an additional time will return you to the screen you were previouslyviewing, "Consumption" or "Energy Monitor" or "Navigation".Mode Button Pressing the "Mode" button on the Steering-Wheel toggles between the AM, FM1, FM2, and CDmodes of the audio system.Holding the "Mode" button for a few seconds will toggle the power for the audio system on & off. Inside AirRecirculate Avoid using this mode during the winter, since it contributes to frost on the inside of the windows.Recirculating warm inside air will prevent the engine from needing to run as often; however, themoisture you naturally exhale will build up after awhile. Allowing the fresh cold air from outsideto be drawn in will keep the humidity low. The resulting minor MPG penalty is well worth alwayshaving clear glass.Ou u tside Ai i rVentChanging th than allowin easily once yMany peoplwant to avoiHere’s how:1. Pre2. Pre3. RedThe Multi-Dthe newer mYou may altof the 7 settihe "Air Conditi ng it to be influ you know how le call this "ope id having to tur : ess the "A/C" b ess the circulati duce the tempe Display will the model; different ter the blowingings available.ioner" mode to uenced by the h w. ening the vent"rn on the A/C.button so the ye ion button so th erature to the lo en resemble the t settings are eng location to an o draw in air dir heater-core isn " and it is used ellow-bar abov he yellow-bar owest setting, c e example abov nabled (not venny of the 4 setti rectly from the ’t an obvious p most frequent ve it disappears above the "out called "Max C ve. Below is a nt). ings availablee outside for co process, but it i ly in the summ s.tside car arrow old".a photo of the band the blowin ooling rather is surprisingly mer when you w" appears.button layout fo ng speed to anyforyUNDERSTANDINGMPG MeasurementLifetime LIFETIME is the most useful measurement. Total miles driven, divided by total gallons consumed,informs you how efficiently the car has performed overall.Tank TANK is the measurement between each fill up. You press the RESET button when the tank isfull. The results are informative, but not perfectly accurate. In cold weather, the bladder inside thegas tank shrinks. This reduces the overall capacity making the "full" level variable. Also, "full"can be misrepresented if the pump doesn't shut off at the proper time. These factors makecalculations based on fill-up less accurate.Trip TRIP is mostly for fun, since a multitude of variables can affect the measurement to a singledestination. Watch the 5-minute summary segments shown on the multi-display. Rememberthough, if you were to start a drive downhill, with a tail wind, a warm engine, a fully chargedbattery-pack, and a warm outside temperature, the MPG would be very impressive for thatparticular trip. But then if the return trip back was uphill, against the wind, with a cold engine, adrained battery-pack, and a cold outside temperature, the MPG would appear very disappointing.In summary, trip results can vary greatly. The overall average is what really matters.Sudden Drop Tire pressure may have gone down. For every 10 F degrees colder, pressure will naturally decreaseby 1 PSI. Verify you still have as much air in the tires as you think they do.Increased use of the heater or air-conditioner (which includes the defroster) will force the engine torun more often. Try a less demanding setting.When the temperature drops below freezing, you’ll probably notice the engine has to run quite a bitlonger to create heat for the catalytic-converter. This is to keep the Prius emissions extremely low.Avoid driving short trips; instead, take advantage of the time after warm up is complete by runningseveral errands at once.A dirty engine air-filter will also cause the MPG to drop. Check it routinely, especially as theseasons change. Once flow becomes visibly restricted (dark colored rather than white), the timehas come replace it.Tire Break-In Don’t forget that new tires require a break-in period. Before that the tire surface and tread edgeswill be rough, causing MPG to be lower than you expect. It takes about 1,000 miles (1,600 km)before enough wear (barely visible to a trained eye) occurs to allow less abrasive contact with theroad. And since front tires wear more than those in the rear, expect another break-in period the firsttime the rear tires are rotated to the front. Fortunately, that reduced MPG will only last a fewhundred miles.Increasing MPGA/C & Heater Minimal use is the key. Using the Heater or the A/C (which includes the defroster) on anything buta low setting may prevent the engine from shutting off. That will reduce MPG. So, try to avoidhigh demand use. Fortunately, on the highway using the A/C is still more efficient than openingthe windows.On the Highway Just like with traditional vehicles, efficiency drops the faster you drive on a highway. 60 MPH(96 km/h) is more efficient than 70 MPH (113 km/h). Speeding up to 75 MPH (121 km/h), you'llobserve MPG drop even more. It pays to drive slower (obey the speed-limit). Think of it thisway, pedaling a bicycle rapidly takes much more energy than pedaling at a moderate rate.YMMV "Your Mileage May Vary" That simple statement about the EPA estimates shown on the newvehicle window sticker is often overlooked, yet it makes a significant difference depending on thetype of driving you do. Reading this quote provided by the EPA about Prius reveals why: "ActualMileage will vary with options, driving conditions, driving habits and vehicle's condition. Resultsreported to EPA indicate that the majority of vehicles with these estimates will achieve between 51and 69 mpg in the city and between 43 and 59 on the highway."EPA tests are basic generalizations (performed under ideal conditions) intended to make vehiclecomparisons easier, not to specify what MPG you will actually get. In fact, they rarely actuallyreflect the MPG in real-world driving experiences.Driving Brisk Acceleration is an often misunderstood benefit. There's no need to hold back. A gasolineengine works more efficiently when running at higher RPM, about 70 percent of maximum. Takeadvantage of that by getting to cruising speed quickly (but not aggressively, please drive safely).And remember, while the engine running it is also generating electricity for later use.Coast whenever you have the opportunity. Using the feather technique helps. By lifting your footlightly from the accelerator-pedal, you can invoke an efficient computer-controlled glide withoutdecelerating much at all (less than 1 MPH). With good road conditions and a bit of practice, you'llfind yourself doing this instinctively.Look Ahead. If you see a light turning red or a need to slow down in the distance, there's noreason to continue holding the accelerator-pedal. Remove your foot and allow the generator todecelerate the Prius. That will increase your MPG, charge the battery-pack, and prolong the lifeof your brakes.Tire Care 42/40PSI (2.9/2.8 bar) is what many Prius owners strongly recommend. The original tires for the Classic Prius support a maximum cold pressure of 50 PSI (3.4 bar) and for the HSD Prius 44 PSI(3.0 bar). So that pressure increase is well within the design specifications. Many of the alternatetires available support a maximum cold pressure of 44 PSI (3.0 bar) too. Whatever you decide, justremember that low pressure results in a MPG drop and the tires wear out faster. Tires will notbulge like in decades past; manufacturers provide much better quality now which maintains a flatcontact surface all the way up to the maximum pressure.Every 5,000 miles (8,000 km) the tires should be rotated, for best lifetime performance. Rotationis preferred in a roll-back, roll-forward pattern.Measuring the PSI should be done only when the tires are cold, since driving heats up the airinside the tires making the results inaccurate... giving you the impression more pressure is higherthan it really is.Check Often since temperature causing pressure to drop, 1 PSI for every 10 F degrees. Air willnaturally leak out from normal use too.87 Octane Gas Prius was designed to run with 87 Octane gasoline (85 in high altitudes). Some owners haveexperimented with higher octanes, but found there wasn't any MPG improvement. Also, bear inmind that higher octane gasoline may trigger an emission sensor alert. So just save money andcontinue using the less expensive 87 octane gas."B" Mode Avoid using this mode unless absolutely necessary, since it will reduce MPG.。

Principles of Marketing Engineering - Ch7 - The Marketing Mix

Principles of Marketing Engineering - Ch7 - The Marketing Mix

数反映每个销售实体中销售努力与销售额之 间的关系。
Syntex模型为解决销售队伍规模和分配问题
提供了通用的方法。该模型最初是专为 Syntex制药公司建立的,目的是通过增加销 售人员,期望能提高企业在不同细分市场上 的销售额。这是一种有效的资源分配模型, 该模型也可以用于其他企业的类似问题。
© CUMT2011 Principles Chapter 7: The Marketing Mix - 15
运用德尔菲法。要求高层经理们各自回答一
些问题,如每种药品的销售会对销售努力做 出怎样的反应,以及每个细分市场上的内科 医生会对不同的销售努力有怎样的反应。
© CUMT2011 Principles Chapter 7: The Marketing Mix - 18
Delphi method for Calibrating Sales Response Function
rings to seal valves on pipes that carry corrosive materials. The plant pays $5 for each O-ring and must change them during regular maintenance every two months.
些问题,每位经理的答案分别为X0 , X0.5 , X1.5 和 X∞,然后用计算机将这些答案汇总并向 各位参与者提供汇总结果。 经理们研究汇总结果后,思考自己的反应与群体 平均值的差别,然后再次回答这些问题,在 Syntex研究中,第二轮要求大家意见一致(实 际操作中可能需要到第三轮或第四轮才能得到一 致的估计值)。 这些达成一致意见的估计值为校准ADBUDG函 数提供了输入信息,对函数中的参数加以估计。

PICO-PI-IMX7 Quickstart Guide

PICO-PI-IMX7 Quickstart Guide

3.1 Connect the parts3.2 Wi-Fi antenna3.3Camera module (optional)PICO-PI-IMX7Quickstart Guide3 Installation InstructionsThis installation guide will help you to assemble your development kit using step-by-step instructions to make sure all parts (development board, Wi-Fi antenna, camera module and display) are working.Please follow the steps below to properly install the Wi-Fi antenna.Step 1: Prepare Wi-Fi antenna, extender cable and development board.Step 2: Locate the round antenna pin on the development board. Make sure the connector is aligned with the pin. Press the small round connector at the end of the extender cable onto this pin. You will need to press down until you hear a click sound.Step 3: Screw the extender cable into the base of the Wi-Fi antenna.Connect the parts in the following order. Please note that some versions of the PICO-PI-IMX7 evaluation kit do not include the camera, multi-touch display, and/or cardboard stand.Tips: Do not power your board during the installation process.Step 4: Swivel the retaining clip back down to hold the FPC cable in place.Steps 5 and 6: Repeat these same steps with the other end of the cable and the connector on the board.Tips: After installation remove the protective blue film from the camera lens.INNOVATORS OF TECHNOLOGY2 Dimensions1 Safety PrecautionsThank you for purchasing a T echNexion PICO series evaluation kit based on NXP i.MX7 Dual applications processor. This installation guide will be helpful in the installation, wiring and inspection of your T echNexion evaluation kit. Before using the product, please read this guide to ensure correct use. You should thoroughly understand all safety precautions before proceeding with the installation, wiring, and operation. Place this instruction sheet in a safe location for future reference.• Keep the device dry. Precipitation, humidity, and all types of liquids or moisture can contain minerals that will corrode electronic circuits. If your device does get wet, allow it to dry completely.• Do not use or store the device in dusty or dirty areas. Its parts and electronic components can be damaged.• Do not store the device in hot areas. High temperatures can shorten the life of electronic devices, damage batteries, and warp or melt certain plastics.• Do not store the device in cold areas. When the device returns to its normal temperature, moisture can form inside the device and damage electronic circuit boards.• This product is designed for specific applications and needs to be installed by qualified personnel.• Do not drop, knock, or shake the device. Rough handling can break internal circuit boards and fine mechanics.• Do not paint the device. Paint can clog the parts and prevent proper operation.• Unauthorized modifications or attachments could damage the device and may violate regulations governing radio devices.• Do not touch any internal or exposed parts of the device as electrical shock may result.• Do not open the device while power is on. Otherwise electrical shock may result.• Do not use harsh chemicals, cleaning solvents, or strong detergents to clean the device.• Be sure the ventilation holes are not obstructed during operation. Otherwise malfunction may result due to bad ventilation or overheating.These suggestions apply equally to your device, battery, charger, or any enhancement. If any device is not working properly, take it to the nearest authorized service facility for service.• Make sure that the available power source matches the required input power of the device. Failure to observe this caution may result in electric shock or fire.1.1 Storage and Installation1.2 Wiring1.3 Maintenance and Inspection!Unit : mm123.5 Display (optional)3.6 Cardboard stand (optional)5 External ConnectorsTime to set up the cardboard stand. It only takes a few minutes.Step 1: Separate the shapes from the cardboard.Step 2: Bend and fold the pieces along their scored lines.Step 3: Turn the stand upside down and insert the lettered tabs into the matching lettered slots.Step 4: Turn the stand back and lift the tabs.3.7 Final steps (optional)Now your kit is almost assembled.Step 1: Insert the camera through the opening on the top side. Loop it around the back and to the top. Press the camera into the square opening. Reattach the FPC cable to the camera module.Step 2: Adjust the antenna to a 90-degree angle. Insert it into the circular portion of the cutout and push it back until the joint is flush with the stand. Now push the antenna down for a snug fit. Reattach the extender cable to the antenna.Step 3: Hold the display and board in front of the display and development board opening. Lower the display and board in position and gently press the edges into the stand. Connect the USB Type-C cable to power up the evaluation kit.T op side view:Rear side view:• All Rights Reserved. No part of this document may be photocopied, reproduced, stored in a retrieval system, or transmitted, in any form or by any means whether, electronic, mechanical, or otherwise without the prior written permission of T echNexion Ltd.• No warranty of accuracy is given concerning the contents of the information contained in this publication. T o the extent permitted by law no liability (including liability to any person by reason of negligence) will be accepted by T echNexion Ltd., its subsidiaries or employees for any direct or indirect loss or damage caused by omissions from or inaccuracies in this document.• TechNexion Ltd. reserves the right to change details in this publication without notice. Please download the most updated version at: https:///support/download-center/Phone: +886-2-82273585 Web: 16F-5, No. 736, Zhongzheng Road, ZhongHe District, 23511, New Taipei City, Taiwan © 2001-2019 T echNexion Ltd.2020-12-156 Software InstallationThe unit is preloaded with software that can download and install a selection of OS images over hardwired network. Simply connect a network to the unit through the LAN RJ45 connector and power it up, then follow the steps on the screen to load the software. Local proxies will interfere with this process. For more information, go to our Knowledge Base at: https:///support/knowledge-base/Description No. No. Description 123456121314157891011Reset buttonUSB OTG (Type-C) connector 3.5mm jack audio out LAN RJ45 connectorJP2 mikroBUS connector USB Host connectorJP1 mikroBUS connector Console connectorIS2 Bus jumper Boot pin header40-pin Expansion headerWiFi antenna MHF4 connector Touch connectorMIPI Display connector MIPI Camera connector3414BACE FDPlease follow the steps below to properly install the VOICEHAT.3.4 VOICEHAT (optional)Step 1: Locate four standoff holes, insert screws into the holes and screw standoffs on top. Then locate three module holes, insert screws into the holes. Place and tighten nuts on top.Step 2: Insert slowly the module and gently press into the development board to secure it.Step 3: Connect both speakers to the VOICEHAT. Make sure the speaker cables exit on the left side.Step 4: Align the 40-pin female connector next to the 40-pin male connector on the development board and gently press the connector on the back of the VOICEHAT onto the connector on the board. Then secure it with screws.4 Pin Definition4.1 IMX7-EMMC BOOT Jumper Settings4.2 I²S Bus SettingsSD(Module)Jumper #eMMC Serial DownloaderJumper 1Jumper 1Jumper 22-4 , 3-52-4 , 1-34-6 , 1-32-4 , 1-32-4 , 3-54-6 , 3-5123456121110987135246135246Jumper #I²S1I²S31-24-58-911-122-35-67-810-11Jumper 1Jumper 2Jumper 3Jumper 4Jumper 2。

notify-fire-net系统下的PRN-7打印器说明书

notify-fire-net系统下的PRN-7打印器说明书

PRN-7PrinterDN-60897-C • G-156GeneralThe PRN-7 printer is used with Notifier fire alarm control panels (FACPs) with printer capability to provide a written record of sys-tem events and status changes. In NOTI•FIRE•NET™ applica-tions, PRN-7 can be used with the NCA-2, NCA, Onyxworks. Features•Provides a hard copy printout of all system events and status changes.•Time stamps printed on the record of each event and status change with the current time-of-day and date.•Uses standard 9” x 11” tractor-feed fan-fold paper.•Provides 80 columns of data at 10 characters per inch.•Provides printed records of system configuration and addressable device parameters.•24-pin print head.•Very quiet (approximately 52 dBA).ApplicationsPrinted transaction records reduce the man-hours required to install and maintain a system. A printed record of all system events (alarms, troubles, etc.) and status changes can be espe-cially valuable in the event of a disputed incident. Construction and OperationThe printer is housed in its own separate enclosure and is suit-able for placement on a desk top, counter, or table. InstallationThe PRN-7 should be placed in a secure area to prevent theft of the printer and/or printed records.The PRN-7 must not be located further than 20 ft/6.10 m (actual cable length) from the control panel.Consult the control panel installation manual for the proper method and PIN numbers used to complete the electrical con-nection to the control panel.NOTE: If printer operation is required during failure of primary power, use of a separate UL-listed Uninterruptable Power Supply (UPS) system is recommended.Printer SpecificationsPrinter Method Serial printing with 24-pin matrix print head. Printing Speed (copy draft) 333 cps at 10 cpi.Character Density 10 cpi standard (12, 15, 17.1, and 20 cpi available via front panel).Graphic Resolution (VxH) Up to 360 x 360 dpi.Ribbon Life (approx.) 6 million characters (DPQ).Acoustic Noise Level 52 dBA (approx.).Dimensions18”(45.8cm)W x 7.9” (20.01cm)H x 10.4 (27.8cm)D. Weight 18.9 pounds (8.6 kg).Power Supply 110-230 VAC auto ranging, auto sensing. Power Consumption 40 watts (printing).Operating Environment Temperature 50°F to 104°F (10°C to 40°C).Operating Environment Humidity 10% to 85% (non-condens-ing).Agency Listings and ApprovalsThese listings and approvals apply to the modules specified in this document. In some cases, certain modules or applications may not be listed by certain approval agencies, or listing may be in process. Consult factory for latest listing status.•UL Listed: S35611•ULC Listed: E351188•CSFM Listing: 7305-0028:0501•FDNY: COA# 6206, 6211, 6212Product Line InformationPRN-7: 24-pin dot-matrix printer, 110-230 VAC power.DN-60897-C • 9/27/17 — Page 1 of 2Page 2 of 2 — DN-60897-C • 9/27/17NOTI•FIRE•NET™ is a trademark, and NOTIFIER® is a registered trademarkof Honeywell International Inc.©2017 by Honeywell International Inc. All rights reserved. Unauthorized useof this document is strictly prohibited.This document is not intended to be used for installation purposes.We try to keep our product information up-to-date and accurate.We cannot cover all specific applications or anticipate all requirements.All specifications are subject to change without notice.For more information, contact Notifier. Phone: (203) 484-7161, FAX: (203) 484-7118.。

FAIRCHILD SA227-DC Type Acceptance Report TAR 0 21

FAIRCHILD SA227-DC Type Acceptance Report TAR 0 21

The SA227-CC model had been previously type accepted by the CAA in October 1994, when two examples were imported and are still operated by Airwork (NZ) Ltd. (See TA Report No. 3/94.) The Metro 23 was FAA approved in June 1990 initially at a MAUW of 16,100 lb., although this was increased to 16,500 lb. for all production aircraft.
Specifically the report aims to:
(a) Record the airworthiness certification standard used for type acceptance of the applicable model in New Zealand;
(b) Summarise any outstanding requirements which must be complied with for the issue of a NZ Airworthiness Certificate to any models covered by the Type Acceptance Certificate.
(3) Certification compliance listing:
Fairchild Aircraft Report No. UNPF-R1269 – FAA Compliance Checklist SA227DC
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货币制度
15
银行与货币供给:一个例子
例 3:部分准备金银行制度 这个过程不断进行,每笔新贷款都创造出货币
初始存款 = $ 100.00
第一国民银行贷款 = $ 90.00
第二国民银行贷款 = $ 81.00
第三国民银行贷款 = $ 72.90
...
...
货币供给总量 = $1000.00
在这个例子中, 100美元的准备金 产生了1000美元
货币制度
法定货币: 没有内在价值、由政府法令确 定作为通货使用的货币 例如:美元
4
货币供给
货币供给(或货币存量):经济中流通的货币量 什么样的资产看作货币供给?
两种:
通货:公众手中持有的纸币钞票和铸币 活期存款:储户可以通过开支票而随时支取的
银行账户余额
货币制度5美国经来自中货币存量的衡量指标7 C H A P T E R
宏观经济学
N. 格里高利·曼昆
货币制度
© 2009 South-Western, a part of Cengage Learning, all rights reserved
本章我们将探索这些问题的答案:
哪些资产可以看作“货币”?货币有什么作用?有
什么类型?
什么是美联储? 银行在货币制度中扮演什么样角色?银行如何“创
货币
货币制度
18
货币乘数
货币乘数:银行体系用1美元准备金所产生的货币

货币乘数等于1/R
在我们的例子中,R = 10%
货币乘数 = 1/R = 10 100美元的准备金产生了1000美元的货币
货币制度
19
主动学习 1
银行与货币供给
你打扫房间时在沙发坐垫下找到一张50美元的钞票 (和吃了一半的墨西哥煎玉米面卷)。你把钱存入支票 账户,美联储规定的法定存款准备金率是20%
货币制度
11
银行与货币供给:一个例子
情形 1:没有银行体系 人们持有$100通货 货币供给 = $100
货币制度
12
银行与货币供给:一个例子
情形 3:部分准备金银行制度 货币供给怎么会突然增加? 当银行发放贷款,他们创造了货币 借贷者得到
$90 通货(资产) $90 新债(负债)
部分准备金银行制度创造货币,但不创造财富
包括理事会成员和地区银行总裁 中的一部分组成。联邦公开市场 委员会决定货币政策
本·伯南克 联邦公开市场委
员会主席,
2006年2月 – 至 今
货币制度
8
银行准备金
在部分准备金银行制度下,银行将部分存款作为
准备金,把其他存款用来贷款
美联储规定法定准备金:银行必须持有的准备金
量的最低水平
银行可以持有高于法定最低量的准备金
21
主动学习 1
参考答案
你在支票账户存款50美元 A. 货币供给量增加的最大数量是多少?
答案:200美元 B. 货币供给量增加的最小数量是多少?
答案:0 美元 如果银行没有用你的存款去放贷,那通货减少50美元, 存款增加50美元,货币供给没有发生变化
22
美联储控制货币的三种工具
1. 公开市场操作:美联储买卖美国政府债券
M1:通货,活期存款,旅游支票,其他支票存款
M1 = 1.4万亿美元 (2008年6月)
M2: M1中的每一项加上储蓄存款,小额定期存
款,货币市场共同基金和几种不重要的项目 M2 = 7.7 万亿美元 (2008年6月)
就本课程的目的而言,我们在讨论货币供给时, M1与M2 之间的区别并不重要
A. 货币供给量增加的最大数量是多少? B. 货币供给量增加的最小数量是多少?
20
主动学习 1
参考答案
你在支票账户存款50美元 A. 货币供给量增加的最大数量是多少?
如果银行没有超额准备金,那: 货币乘数 = 1/R = 1/0.2 = 5
存款增加的最大数量是: 5 x $50 = $250
由于货币供给包括通货,它减少了50美元 所以, 货币供给量增加的最大数量 = $200.
和劳务的一组资产)之后,这样的搜寻就变得没有 必要
货币制度
2
货币的三种职能
交换媒介:买者在购买物品与劳务时给予卖者的
东西
计价单位:人们用来表示价格和记录债务的标准
价值储藏手段:人们可以用来把现在的购买力转
变为未来的购买力的东西
货币制度
3
两种类型的货币
商品货币: 以有内在价值的商品为形式 的货币 例如:金币,战俘营中的香 烟
准备金率, R
= 银行作为准备金持有的存款比例 = 准备金占所有存款的比例
货币制度
9
银行与货币供给:一个例子
如果流通的通货是100美元 为决定银行对货币供给的影响,我们计算三种不同 情形的货币供给: 1. 没有银行体系 2. 100%准备金银行制度:
银行将所有存款都作为准备金,没有贷款 3. 部分准备金银行制度
货币政策工具之一
货币制度
24
美联储控制货币的三种工具
2. 法定准备金:影响银行通过放贷创造的货币量
为增加货币供给,美联储减少法定准备金
银行用每一美元准备金可以发放更多的贷款,增加 货币乘数与货币供给
为减少货币供给,美联储增加增加法定准备金,这
为增加货币供给,美联储购买政府债券,增加新美元
……这些新增的美元存入在银行,增加准备金 ……银行用新增的美元来放贷,增加货币供给
为减少货币供给, 美联储的做法正好相反,它出售政
府债券,减少流通中的货币量
货币制度
23
美联储控制货币的三种工具
1.公开市场操作:美联储买卖美国政府债券
公开市场操作是容易进行的,是美联储可选择的
货币制度
6
中央银行与货币政策
中央银行:为了监管银行体系和调节经济中的货
币量而设计的机构
货币政策:中央银行的决策者对货币供给的安排
联邦储备(美联储):美国的中央银行
货币制度
7
美联储的结构
美联储体系由以下部分组成:
理事会(有7名成员)位于华盛顿 12个地区联邦储备银行
分布在全国
联邦公开市场委员会(FOMC)
造货币”?
美联储如何控制货币供给?
1
什么是货币以及它为什么重要
没有货币,贸易只能依靠物物交换—用一种物品或
劳务交换另一种物品或劳务
交易要求欲望的双向一致性—一种不大可能的偶然
巧合,即两个人中每个人都有对方想要的物品或劳 务
许多人都要花时间去搜寻其他人与之贸易—这是对
资源的巨大浪费
有了货币(经济中人们经常用于向其他人购买物品
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