инструкция по применению, состав, показания, побочные действия, отзывы

Фармакологические.

Ангиотензин II — главный вазоактивный гормон ренин-ангиотензин-, что играет роль в патофизиологических механизмов развития артериальной гипертензии, сердечной недостаточности и других сердечно-сосудистых заболеваний. Основные физиологические эффекты ангиотензина II, такие как вазоконстрикция, стимуляция альдостерона, регуляция солевого и водного гомеостаза и стимуляция роста клеток, происходят с участием рецепторов типа 1 (АО 1 ).

Кандесартана цилексетил является препаратом-предшественником, пригодным для приема внутрь. Он быстро превращается в активное вещество, кандесартан, путем эфирного гидролиза при всасывания в пищеварительном тракте. Кандесартан является антагонистом рецепторов ангиотензина II (Араи), селективным по рецепторов АТ 1 , с плотным связыванием и медленным отсоединением от рецептора. Ему не свойственна агонистическое активность.

Кандесартан не тормозит АПФ, который превращает ангиотензин I в ангиотензин II и разрушает брадикинин. Не отмечено влияния на АПФ и усиления брадикинина или вещества Р. В ходе исследований, сравнивали кандесартан с ингибиторами АПФ, частота кашля была ниже у пациентов, принимавших кандесартана цилексетил. Кандесартан не связывает и не блокирует рецепторы других гормонов или ионные каналы, которые являются важными в регуляции сердечно-сосудистой системы. Антагонизм к рецепторам ангиотензина II (АТ 1 ) приводит к дозозависимому рост плазменных уровней ренина, ангиотензина I и ангиотензина II, а также к уменьшению плазменной концентрации альдостерона.

артериальная гипертензия

При артериальной гипертензии кандесартан вызывает дозозависимое длительное снижение артериального давления. Антигипертензивное действие происходит за счет уменьшения системного периферического сопротивления без рефлекторного повышения частоты сердечных сокращений. Указания на серьезную или усиленную гипотензию после приема первой дозы или синдрома отмены после прекращения лечения отсутствуют.

После однократного приема кандесартана цилексетила начало антигипертензивного эффекта в большинстве случаев наблюдается в течение 2:00. При длительном лечении основное снижение артериального давления при всех дозах обычно достигается в течение четырех недель и сохраняется на протяжении длительного лечения. Согласно данным метаанализа, средний дополнительный эффект при увеличении дозы с 16 мг до 32 мг 1 раз в сутки был незначительным. Принимая во внимание межиндивидуальные различия, у некоторых пациентов можно ожидать более выраженный, чем средний, эффект. Кандесартана цилексетил при условии приема 1 раз в сутки обеспечивает эффективное и плавное снижение АД в течение 24 часов с незначительным отличием между максимальным и минимальным эффектами во время интервала дозирования.

При применении кандесартана цилексетила вместе с гидрохлоротиазидом наблюдается дополнительное снижение артериального давления. Усиленный антигипертензивный эффект также отмечается, если кандесартана цилексетила комбинируют с амлодипином или фелодипином.

Лекарственным средствам, блокирующие ренин-ангиотензин-альдостероновую систему, присущий менее выраженный антигипертензивный эффект у пациентов негроидной расы (которые обычно составляют популяцию с низким уровнем ренина), чем у представителей других рас. Это также характерно для кандесартана.

Кандесартан усиливает почечный кровоток и соответственно не влияет, или повышает скорость клубочковой фильтрации за счет уменьшения сосудистого сопротивления в почках и фракции фильтрации. Отсутствуют данные о влиянии кандесартана на прогрессирование диабетической нефропатии.

сердечная недостаточность

Лечение кандесартаном цилексетилом снижает летальность, уменьшает количество госпитализаций по поводу сердечной недостаточности и облегчает симптомы у пациентов с систолической дисфункцией левого желудочка.

У пациентов с ХСН и сниженной систолической функцией левого желудочка (фракция выброса левого желудочка, фракции выброса левого желудочка ≤ 40%) кандесартан снижает системное сосудистое сопротивление и давление заклинивания легочных капилляров, повышает активность ренина в плазме крови и концентрацию ангиотензина II, а также снижает уровень альдостерона.

Фармакокинетика.

Абсорбция и распределение

После приема внутрь кандесартана цилексетил превращается в активное вещество кандесартан. Биодоступность кандесартана составляет примерно 40% после приема внутрь раствора кандесартана цилексетила. Относительная биодоступность лекарственной формы таблеток по сравнению с тем же раствором для приема внутрь составляет около 34% из очень незначительной изменчивостью. Рассчитана биодоступность таблетки составляет 14%. Средний пик концентрации в сыворотке крови (C max ) достигается через 3-4 часа после приема. Сывороточная концентрация кандесартана линейно возрастает с увеличением доз в пределах терапевтического диапазона дозирования. Различий в фармакокинетике кандесартана независимо от пола пациента обнаружено. Площадь под кривой «концентрация в сыворотке крови-время» (AUC) кандесартана не претерпит существенных изменений под влиянием пищи.

Кандесартан в значительной степени связывается с белками плазмы крови (99%). Ожидаемый объем распределения кандесартана составляет 0,1 л / кг.

Биодоступность кандесартана не претерпит изменений под влиянием пищи.

Метаболизм и выведение

Кандесартан выводится преимущественно в неизмененном виде с мочой и желчью и только незначительно — за счет печеночного метаболизма (CYP2C9). Исходя из данных in vitro исследований, не ожидается in vivo взаимодействия с препаратами, метаболизм которых зависит от изоферментов CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 или CYP3A4 цитохрома Р450. Конечный период полувыведения кандесартана составляет примерно 9:00. Кумуляции после многократных доз нет.

Общий клиренс кандесартана составляет примерно 0,37 мл / мин / кг с почечным клиренсом около 0,19 мл / мин / кг. Вывод кандесартана почками происходит как путем клубочковой фильтрации, так и с помощью активной канальцевой секреции. После приема внутрь меченого радиоизотопом 14 С кандесартана цилексетила примерно 26% дозы выводится с мочой в виде кандесартана и 7% — в виде неактивного метаболита, тогда как примерно 56% дозы восстанавливается в кале в виде кандесартана и 10% — в виде неактивного метаболита.

Фармакокинетика в особых категорий пациентов

У пациентов пожилого возраста (старше 65 лет) C max и AUC кандесартана повышались примерно на 50% и 80% соответственно по сравнению с молодыми пациентами. Однако реакция артериального давления и частота нежелательных явлений были подобными после приема препарата молодыми пациентами и пациентами пожилого возраста.

У пациентов с легкой и умеренной почечной недостаточностью C max и AUC кандесартана росли при повторном приеме примерно на 50% и 70% соответственно, но t 1/2 оставался неизменным по сравнению с пациентами, которые имели нормальную функцию почек. Соответствующие изменения у пациентов с тяжелой почечной недостаточностью составляли примерно 50% и 110% соответственно. Конечный t 1/2 кандесартана был приблизительно удвоенным у пациентов с тяжелой почечной недостаточностью. AUC кандесартана у пациентов, находящихся на гемодиализе, была близка к показателю у пациентов с тяжелой почечной недостаточностью.

Опыт применения препарата пациентам с тяжелой печеночной недостаточностью отсутствует.

90000 Instructions for Use 90001 90002 90003 Before beginning use of our products, please carefully read the directions for use which can be found on our packaging. Our products should be introduced slowly, and each product has a different introductory period. Please carefully follow the directions for use of our products, as the body needs the opportunity to familiarize itself with the Welltex fabric’s effects. 90004 90005 90002 Due to the increased blood circulation that can happen when using Back on Track products, we recommend introducing our products gradually.During the introductory period, start with product use for 2-4 hours per day for the first 3-5 days. If you experience discomfort, which is likely due to increased blood circulation, reduce the use of the product. 90005 90002 After the introductory period, it is important to continue the use of the product for at least 10-20 days before assessing it’s impact. Since the Welltex fabric reflects more of the body’s energy the more you move, the effect is greatest if you use our products when active.However, Back on Track products do work when resting, as well as while sleeping. 90005 90002 Continue to use the products according to your routine, and be sure to take breaks from use of the product around week three, in order to avoid dependency. The sensitivity of dependency varies from individual to individual. For maximum effect, the Welltex fabric should be in direct contact with your skin. 90005 90012 90003 Specific Instructions for Use of Back on Track Products with Horses and Dogs 90004 90015 90002 The effect of Back on Track products increases with movement as the body’s energy increases, so in addition to using pads and blankets in the stables, the horse should also use our products when moving, especially with products such as our leg wraps, saddle pads , exercise sheets, and blankets.For long term issues, your horse or dog may need to use Back on Track products for an extended period. After use for 2-3 weeks, you can take a one week break to assess the issues and determine if the products are working. 90005 90002 When using Back on Track products, be sure to take regular breaks from use. 90005 90002 For long-running issues in dogs, Back on Track products should be used for several weeks, at least 8 hours per day, with regular breaks in order to achieve desired results. 90005 90012 Washing Back on Track Products 90015 90002 Back on track products can be machine washed at 40 degrees Celsius / 104 degrees Farenheight with a mild detergent.Because Back on Track Welltex technology is permanently infused into our fabrics, our products can be laundered with no loss of benefit. Do not bleach our products. Do not tumble dry our products. Line dry only. If necessary, products may be ironed at a maximum temperature or 122 degrees Farenheight. 90005 .90000 Instructions for Form 8802 (11/2018) 90001 90002 90003 90004 Purpose of Form 90005 90002 Form 8802 is used to request Form 6166, a letter of U.S. residency certification for purposes of claiming benefits under an income tax treaty or VAT exemption. You can not use Form 6166 to substantiate that U.S. taxes were paid for purposes of claiming a foreign tax credit. 90003 90002 You can not claim a foreign tax credit to reduce your U.S. tax liability with respect to foreign taxes that have been reduced or eliminated by reason of a treaty.If you receive a refund of foreign taxes paid with the benefit of Form 6166, you may need to file an amended return with the IRS to adjust any foreign tax credits previously claimed for those taxes. 90003 90002 90003 90004 When To File 90005 90002 You should mail your application, including full payment of the user fee, at least 45 days before the date you need to submit Form 6166. We will contact you after 30 days if there will be a delay in processing your application. You can call (267) 941-1000 (not a toll-free number) and select the U.S. residency option if you have questions regarding your application. 90003 90002 90017 Early submission for a current year certification. 90018 90003 90002 The IRS can not accept an early submission for a current year Form 6166 that has a postmark date before December 1 of the prior year. Requests received with a postmark date earlier than December 1 will be returned to the sender. For example, a Form 6166 request for 2019: 90003 90022 90023 90002 Received with a postmark date before December 1, 2018, can not be processed.90003 90026 90023 90002 Received with a postmark date on or after December 1, 2018, can be processed with the appropriate documentation. 90003 90026 90031 90002 90003 90002 90003 90004 User Fee 90005 90002 Form 8802 application (s) will not be processed until the non-refundable user fee is paid. The user fee is for the number of applications submitted, not the number of certifications requested. 90003 90002 The user fee for all applications postmarked before December 1, 2018, is $ 85.User fees for Form 8802 applications postmarked on or after December 1, 2018, vary based on the type of applicant. If you are sending your Form 8802 by fax, see 90041 Fax 90042 under 90041 Electronic Payment 90042, later. Be sure to include the appropriate user fee for your applicant status or the IRS will reject the application. 90003 90002 90017 Requests by individual applicants. 90018 90003 90002 The user fee for a request by an individual applicant is $ 85 per Form 8802, regardless of the number of countries for which certification is requested or the number of tax year (s) to which the certification applies.For this purpose, an individual applicant means an individual who is a citizen of the United States or a resident thereof, within the meaning of section 7701 (b) (1) (A) of the Internal Revenue Code. 90003 90002 90017 Requests by applicants other than individuals. 90018 90003 90002 The user fee for an application by each non-individual applicant is $ 185 per Form 8802, if postmarked on or after December 1, 2018. If postmarked before December 1, 2018, the user fee is $ 85. 90003 90002 90003 90004 Fiscally transparent entities.90005 90002 A partnership, S corporation, grantor trust, or other fiscally transparent entity pays a single $ 185 user fee per Form 8802 application with respect to all Forms 6166 issued under its employer identification number (EIN), notwithstanding that the IRS will verify the tax status of each of the partners, owners, or beneficiaries of the entity who have consented to the request for certification. 90003 90002 90003 90004 Custodial accounts. 90005 90002 A custodian requesting certification on behalf of an account holder pays a user fee for each account holder taxpayer identification number (TIN).The custodian will pay a user fee of $ 85 or $ 185, depending on whether that account holder is an individual or a non-individual applicant. 90003 90002 90017 Multiple requests. 90018 90003 90002 Because an applicant must pay the user fee of either $ 85 or $ 185 for each separate Form 8802 submitted, the IRS encourages each applicant to include all Form 6166 requests on a single Form 8802 (separate for individual and non-individual) to avoid multiple user fee charges. 90003 90002 90017 Additional request.90018 90003 90002 Additional requests for Form 6166 submitted on a separate Form 8802, following the procedures established under 90041 Additional Requests 90042, later, will require the payment of the applicable user fee. 90003 90002 90017 3-year procedure. 90018 90003 90002 You are required to pay the applicable user fee for each Form 8802 application submitted under the 3-year procedure. See 90041 Certification Under the 3-Year Procedure 90042, later. 90003 90002 90003 90004 Method of Payment 90005 90002 Payment of the user fee can be by check, money order, or electronic payment.90003 90002 90003 90002 Form 8802 must be accompanied by a check or money order in U.S. dollars, payable to the United States Treasury, in the appropriate amount. Do not submit foreign checks. Do not send cash. 90003 90002 90017 Multiple Forms 8802. 90018 90003 90002 If you are submitting multiple Forms 8802, you can submit a single check or money order payment to cover the aggregate amount of the user fee for all Forms 8802. No more than 200 Forms 8802 can be associated with one check or money order.90003 90108 Note. 90109 90002 If you pay by check, it will be converted into an electronic funds transfer (EFT). This means we will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours, and will be shown on your regular account statement. You will not receive your original check back. We will destroy your original check, but we will keep a copy of it. If the IRS can not process the EFT for technical reasons, you authorize us to process the copy of the check.90003 90002 90003 90004 Electronic Payment (e-payment) 90005 90002 You can access the electronic payment page at the Pay.gov website. Go to Pay.gov, and enter «IRS Certs User Fee» in the search box. At the «IRS Certs» topic, click the «Continue to the Form» button. Follow the on-screen prompts, and enter the required information when requested. 90003 90002 The user fee website requires the entry of the following information. 90003 90022 90023 90002 Applicant’s name.90003 90026 90023 90002 Applicant’s TIN or EIN. 90003 90026 90023 90002 Submitter’s name (name of person or entity submitting the payment). 90003 90026 90023 90002 Contact email address. 90003 90026 90023 90002 Contact phone number. 90003 90026 90023 90002 Number of Form (s) 8802 submitted. 90003 90026 90023 90002 Payment amount. 90003 90026 90023 90002 Selection of bank account (Automatic Clearing House (ACH)) or debit or credit card, which will open a window for account information.90003 90026 90031 90002 90003 90002 Once the IRS processes your electronic payment, you will receive an electronic payment confirmation number for the transaction. Enter the electronic payment confirmation number on page 1 of Form 8802 before you submit the application. You can use either the Agency Tracking ID or the Pay.gov ID as the electronic payment confirmation number. Either one is acceptable. If you make an electronic payment covering multiple Forms 8802, write the same electronic payment confirmation number on each form.The IRS will not process Form 8802 if the application does not include the electronic payment confirmation number. 90003 90002 90003 90004 Supplemental User Fee Payment 90005 90002 If the U.S. Residency Certification Unit contacts you to make a supplemental payment, you can use the electronic payment page at the Pay.gov website (discussed earlier) to make the payment. Click the «Supplement Payment» checkbox at the input screen. 90003 90002 90003 90004 Where To File 90005 90002 The method by which you can submit Form 8802 to the IRS depends upon how you choose to pay the user fee.90003 90002 90003 90004 Payment by Check or Money Order 90005 90002 If you are paying the user fee by check or money order, send the payment, Form 8802, and all required attachments to: 90003 90176 Internal Revenue Service 90177 P.O. Box 71052 90177 Philadelphia, PA 19176-6052 90179 90002 90177 Or, by private delivery service to: 90003 90176 Internal Revenue Service 90177 2970 Market Street 90177 BLN # 3-E08.123 90177 Philadelphia, PA 19104-5016 90179 90002 90003 90002 90003 90004 Electronic Payment 90005 90002 After you have received your electronic payment confirmation number, and entered it on page 1 of Form 8802, you can submit Form 8802 and all required attachments by mail, private delivery service, or fax (see below for limitations on the use of faxed transmissions ).90003 90002 If you are paying the user fee by e-payment, send Form 8802 and all required attachments to: 90003 90176 Department of the Treasury 90177 Internal Revenue Service 90177 Philadelphia, PA 19255-0625 90179 90002 90177 Or, by private delivery service to: 90003 90176 Internal Revenue Service 90177 2970 Market Street 90177 BLN # 3-E08.123 90177 Philadelphia, PA 19104-5016 90179 90002 90003 90002 90017 Fax. 90018 90003 90002 You can fax up to 10 Forms 8802 (including all required attachments) for a maximum of 100 pages to the fax numbers below.You must use a fax cover sheet stating the number of pages included in the transmission. 90003 90002 The following fax numbers are available. 90003 90022 90023 90002 (877) 824-9110 (within the United States only, toll free). 90003 90026 90023 90002 (304) 707-9792 (inside or outside the United States, not toll free). 90003 90026 90031 90002 90003 90002 90003 90004 Non-individual user fee. 90005 90002 For purposes of determining whether you are required to pay the new $ 185 user fee for non-individual applicants, Forms 8802 will be treated as postmarked before December 1, 2018, if the IRS receives Form 8802 with a valid electronic payment confirmation number by fax at one of the above phone numbers before December 1, 2018.If your faxed Form 8802 is received on or after December 1, 2018, you will be required to pay the $ 185 user fee for non-individual applicants, if applicable. 90003 90002 90003 90004 Who Is Eligible for Form 6166 90005 90002 In general, under an income tax treaty, an individual or entity is a resident of the United States if the individual or entity is subject to U.S. tax by reason of residence, citizenship, place of incorporation, or other similar criteria. U.S. residents are subject to tax in the United States on their worldwide income.An entity may be considered subject to tax on its worldwide income even if it is statutorily exempt from tax, such as a pension fund or charity. Similarly, individuals are considered subject to tax even if their income is less than the amount that would require that they file an income tax return. 90003 90002 In general, the IRS will issue Form 6166 only when it can verify that for the year for which certification is requested one of the following applies. 90003 90022 90023 90002 You filed an appropriate income tax return (for example, Form 1120 for a domestic corporation), 90003 90026 90023 90002 In the case of a certification year for which a return is not yet due, you filed a return for the most recent year for which a return was due, or 90003 90026 90023 90002 You are not required to file an income tax return for the tax period on which certification will be based and other documentation is provided.90003 90026 90031 90002 90003 90002 90003 90004 Who Is Not Eligible for Form 6166 90005 90002 In general, you are not eligible for Form 6166 if, for the tax period for which your Form 6166 is based, any of the following applies. 90003 90022 90023 90002 You did not file a required U.S. return. 90003 90026 90023 90002 You filed a return as a nonresident (including Form 1040NR, Form 1040NR-EZ, Form 1120-F, Form 1120-FSC, or any of the U.S. possession tax forms).90003 90026 90023 90002 You are a dual resident individual who has made (or intends to make), pursuant to the tie-breaker provision within an applicable treaty, a determination that you are not a resident of the United States and are a resident of the other treaty country . For more information and examples, see Regulations section 301.7701 (b) -7. 90003 90026 90023 90002 You are a fiscally transparent entity organized in the United States (that is, a domestic partnership, domestic grantor trust, or domestic LLC disregarded as an entity separate from its owner) and you do not have any U.S. partners, beneficiaries, or owners. 90003 90026 90023 90002 The entity requesting certification is an exempt organization that is not organized in the United States. 90003 90026 90023 90002 The entity requesting certification is a trust that is part of an employee benefit plan during the employee benefit plan’s first year of existence, and it is not administered by a qualified custodian bank, as defined in 17 CFR 275.206 (4) -2 (d ) (6) (i). 90003 90026 90031 90002 90003 90002 90003 90004 Special Rules 90005 90002 90003 90004 Certification Under the 3-Year Procedure 90005 90002 Estates, employee benefit plans / trusts, and exempt organizations (lines 4d, 4g, and 4h) can submit a Form 8802 that covers up to a 3-year period (the current year and the following two tax years).If you request certification under this procedure, you must submit a Form 8802 for each year, but in years 2 and 3 you only need to attach a copy of the year 1 Form 8802 (including the penalties of perjury statement), provided there are no material changes to the information entered on the Form 8802 in year 1. 90003 90002 90307 90003 90002 90003 90002 Certification will not be issued to a trust that is part of an employee benefit plan during the employee benefit plan’s first year of existence, unless it is administered by a qualified custodian bank, as defined in 17 CFR 275.206 (4) -2 (d) (6) (i). 90003 90108 Note. 90109 90002 If you choose to use the 3-year procedure, write «Filed Under the 3-Year Procedure» at the top of page 1 of the Form (s) 8802 filed for each year. 90003 90002 You can not use this procedure if there is a material change of fact (including name or permanent address) with respect to the estate, employee benefit plan / trust, or exempt organization during the period for which the certification is requested. 90003 90002 90017 First year. 90018 90003 90002 In the first year for which a certification is requested under this procedure, you must submit a completed Form 8802, signed and dated by the applicant, with the current year entered on line 7.Attach Form 2848, Power of Attorney and Declaration of Representative, or Form 8821, Taxpayer Information Authorization, as applicable, to Form 8802. Form 2848 or Form 8821 must apply to all of the years for which certification is requested. For the rules relating to Forms 2848 and 8821, including the 3-year procedure, see 90041 Line 3b. Third Party Appointee’s Information, 90042 later. 90003 90002 In year 1, a penalties of perjury statement is required stating that the applicant is a U.S.resident and will continue to be so through the current tax year and the following two tax years. See Table 2 for the penalties of perjury statement for the 3-year procedure that you must enter on line 10 of Form 8802 or attach to the form. 90003 90002 90017 Second year. 90018 90003 90002 In the second year for which certification is requested under this procedure, you must submit a completed Form 8802 requesting certification for year 2 with a copy of the year 1 Form 8802 (including the penalties of perjury statement) and Form 2848 or Form 8821 attached , as applicable.90003 90002 Enter the current year on line 7. A penalties of perjury statement and signature are not required on the Form 8802 filed in year 2. However, you must enter «See attached year 1 Form 8802 filed under the 3-year procedure» on line 10. 90003 90002 90017 Third year. 90018 90003 90002 In the third year for which certification is requested under this procedure, you must submit a completed Form 8802 requesting certification for year 3 and attach a copy of the year 1 Form 8802 (including the penalties of perjury statement) and Form 2848 or Form 8821 attached, as applicable.90003 90002 Enter the current year on line 7. A penalties of perjury statement and signature are not required on the Form 8802 filed in year 3. However, you must enter «See attached year 1 Form 8802 filed under the 3-year procedure» on line 10. 90003 90002 90003 90004 Form 8802 Filed Before Return Posted by the IRS 90005 90002 If your return has not been posted by the IRS by the time you file Form 8802, you will receive a request to provide a signed copy of your most recent return.If you recently filed your return, it may take less time to process your application if you include a copy of the income tax return with your Form 8802. Write «COPY — do not process» on the tax return. 90003 90002 90003 90004 Individuals With Residency Outside the United States 90005 90002 If you are in any of the following categories for the current or prior tax year for which you request certification, you must submit a statement and documentation, as described below, with Form 8802.90003 90357 90023 90002 You are a resident under the internal law of both the United States and the treaty country for which you are requesting certification (you are a dual resident). 90003 90026 90023 90002 You are a lawful permanent resident (green card holder) of the United States or U.S. citizen who filed Form 2555. 90003 90026 90023 90002 You are a bona fide resident of a U.S. possession. 90003 90026 90370 90002 90003 90002 If you are a dual resident described in category 1, above, your request may be denied unless you submit evidence to establish that you are a resident of the United States under the tie-breaker provision in the residence article of the treaty with the country for which you are requesting certification.90003 90002 If you are described in category 2 or 3, attach a statement and documentation to establish why you believe you should be entitled to certification as a resident of the United States for purposes of the relevant treaty. Under many U.S. treaties, U.S. citizens or green card holders who do not have a substantial presence, permanent home, or habitual abode in the United States during the tax year are not entitled to treaty benefits. U.S. citizens or green card holders who reside outside the United States must examine the specific treaty to determine if they are eligible for treaty benefits and U.S. residency certification. See 90041 Exceptions 90042, later. 90003 90002 If you are described in category 2 and are claiming treaty benefits under a provision applicable to payments received in consideration of teaching or research activities, see Table 2 for the penalties of perjury statement you must either enter on line 10 of Form 8802 or attach to the form. 90003 90002 90003 90002 You do not need to attach the additional statement or documentation requested if you: 90003 90022 90023 90002 Are a U.S. citizen or green card holder; and 90003 90026 90023 90002 Are requesting certification only for Bangladesh, Bulgaria, Cyprus, Hungary, Iceland, India, Kazakhstan, Malta, New Zealand, Russia, South Africa, Sri Lanka, or Ukraine; and 90003 90026 90023 90002 The country for which you are requesting certification and your country of residence are not the same. 90003 90026 90031 90002 90003 90002 90003 90004 Form 1116, Foreign Tax Credit 90005 90002 If you have filed or intend to file a Form 1116 claiming either a foreign tax credit amount in excess of $ 5,000 U.S. or a foreign tax credit for any amount of foreign earned income for the tax period for which certification is requested, you must submit evidence that you were (or will be if the request relates to a current year) a resident of the United States and that the foreign taxes paid were not imposed because you were a resident of the foreign country. 90003 90002 In addition, individuals who have already filed their federal income tax return must submit a copy of it, including any information return (s) relating to income, such as Form W-2 or Form 1099, along with the Form 1116.Your request for U.S. residency certification may be denied if you do not submit the additional materials. 90003 90002 90003 90004 United Kingdom 90005 90002 If you are applying for relief at source from United Kingdom (U.K.) income tax or filing a claim for repayment of U.K. income tax, you may need to complete a U.K. certification form (US-Individual 2002 or US-Company) in addition to Form 8802. For copies of these forms, contact HM Revenue and Customs. 90003 90022 90023 90002 On the Internet at 90177 www.hmrc.gov.uk, enter «US Double Taxation» in the search box, and scroll down to the link for the Form US-Individual 2002 or Form US-Company. 90003 90026 90023 90002 Telephone at: 44-135-535-9022 if calling from outside the U.K., or 0300-200-3300 if calling from the U.K. 90003 90026 90031 90002 90003 90002 Send the completed U.K. form to the IRS with your completed Form 8802. 90003 .90000 Online Technical Writing: Instructions 90001 90002 The focus for this chapter is one of the most important of all uses of technical writing-instructions. As you know, 90003 instructions 90004 are those step-by-step explanations of how to do something: how to build, operate, repair, or maintain things. 90005 90002 Be sure to check out the examples. 90005 90008 Writing Instructions 90009 90002 One of the most common and one of the most important uses of technical writing is instructions-those step-by-step explanations of how to do things: assemble something, operate something, repair something, or do routine maintenance on something.But for something seemingly so easy and intuitive, instructions are some of the worst-written documents you can find. Like me, you’ve probably had many infuriating experiences with badly written instructions. What follows in this chapter may not be a fool-proof, goof-proof guide to writing instructions, but it will show you what professionals consider the best techniques. 90005 90002 Ultimately, good instruction writing requires: 90005 90014 90015 Clear, simple writing 90016 90015 A thorough understanding of the procedure in all its technical detail 90016 90015 Your ability to put yourself in the place of the reader, the person trying to use your instructions 90016 90015 Your ability to visualize the procedure in great detail and to capture that awareness on paper 90016 90015 Finally, your willingness to go that extra distance and test your instructions on the kind of person you wrote them for.90016 90025 90002 By now, you’ve probably studied headings, lists, and special notices-writing a set of instructions with these tools probably seems obvious. Just break the discussion out into numbered vertical lists and throw in some special notices at the obvious points and you’re done! Well, not quite, but that’s a great start. This chapter explores some of the features of instructions that can make them more complex. You can in turn use these considerations to plan your own instructions.90005 90008 Some Preliminaries 90009 90002 At the beginning of a project to write instructions, it’s important to determine the structure or characteristics of the particular procedure you are going to write about. 90005 90002 Audience and situation. Early in the process, define the audience and situation of your instructions. Remember that defining an audience means defining its level of familiarity with the topic as well as other such details. See the discussion of audiences and steps to use in defining audiences.90005 90002 Most importantly, if you are in a writing course, you’ll need to write a description of your audience and attach that to your instructions. This will enable your instructor to assess your instructions in terms of their rightness for the intended audience. And remember too that in a technical-writing course it is preferable to write for nonspecialist audiences-much more of a challenge to you as a writer. 90005 90002 Number of tasks. How many tasks are there in the procedure you are writing about? Let’s use the term 90003 procedure 90004 to refer to the whole set of activities your instructions are intended to discuss.A 90003 task 90004 is a semi-independent group of actions within the procedure: for example, setting the clock on a microwave oven is one task in the big overall procedure of operating a microwave oven. 90005 90002 A simple procedure like changing the oil in a car contains only one task; there are no semi-independent groupings of activities. A more complex procedure like using a microwave oven contains plenty of such semi-independent tasks: setting the clock; setting the power level; using the timer; cleaning and maintaining the microwave, among others.(The instructions on using a camera are organized by tasks.) 90005 90002 Some instructions have only a single task, but have many steps within that single task. For example, imagine a set of instructions for assembling a kids ‘swing set. In my own experience, there were more than a 130 steps! That can be a bit daunting. A good approach is to group similar and related steps into phases, and start renumbering the steps at each new phase. A 90003 phase 90004 then is a group of similar steps within a single-task procedure.In the swing-set example, setting up the frame would be a phase; anchoring the thing in the ground would be another; assembling the box swing would be still another. 90005 90002 Best approach to the step-by-step discussion. Another consideration, which maybe you can not determine early on, is how to focus your instructions. For most instructions, you can focus on tasks, or you can focus on tools (or features of tools). 90005 Use task orientation. Focus on the tasks your readers want to perform; use how to or -ing phrasing on headings.90002 In a 90003 task approach 90004 (also known as task orientation) to instructions on using a phone-answering service, you’d have these sections: 90005 90014 90015 recording your greeting 90016 90015 playing back your messages 90016 90015 saving your messages 90016 90015 forwarding your messages 90016 90015 deleting your messages, and so on 90016 90025 90002 These are tasks-the typical things we’d want to do with the machine.For further discussion, see the chapter on task analysis. 90005 90002 On the other hand, in a 90003 tools approach 90004 to instructions on using a photocopier, there would be these unlikely sections: 90005 90014 90015 copy button 90016 90015 cancel button 90016 90015 enlarge / reduce button 90016 90015 collate / staple button 90016 90015 copy-size button, and so on 90016 90025 90002 If you designed a set of instructions on this plan, you’d write steps for using each button or feature of the photocopier.Instructions using this tools approach are hard to make work. Sometimes, the name of the button does not quite match the task it is associated with; sometimes you have to use more than just the one button to accomplish the task. Still, there can be times when the tools / feature approach may be preferable. 90005 90002 Groupings of tasks. Listing tasks may not be all that you need to do. There may be so many tasks that you must group them so that readers can find individual ones more easily.For example, the following are common task groupings in instructions: 90005 90088 90015 unpacking and setup tasks 90016 90015 installing and customizing tasks 90016 90015 basic operating tasks 90016 90015 routine maintenance tasks 90016 90015 troubleshooting tasks; and so on 90016 90099 90008 Common Sections in Instructions 90009 90002 The following is a review of the sections you’ll commonly find in instructions. Do not assume that each one of them 90003 must 90004 be in the actual instructions you write, nor that they have to be in the order presented here, nor that these are the only sections possible in a set of instructions.90005 90002 As you read the following on common sections in instructions, check out the example instructions. 90005 90002 90109 Schematic view of instructions. Remember that this is a typical or common model for the contents and organization-many others are possible. 90005 90002 Introduction. Plan the introduction to your instructions carefully. Make sure it does any of the following things (but not necessarily in this order) that apply to your particular instructions: 90005 90014 90015 Indicate the specific tasks or procedure to be explained as well as the scope of coverage (what 90003 will not 90004 be covered).90016 90015 Indicate what the audience needs in terms of knowledge and background to understand the instructions. 90016 90015 Give a general idea of ​​the procedure and what it accomplishes. 90016 90015 Indicate the conditions when these instructions should (or should not) be used. 90016 90015 Give an overview of the contents of the instructions. 90016 90025 90002 See the section on introductions for further discussion. 90005 90002 General warning, caution, danger notices.Instructions often must alert readers to the possibility of ruining their equipment, screwing up the procedure, and hurting themselves. Also, instructions must often emphasize key points or exceptions. For these situations, you use special notices-note, warning, caution, and danger notices. Notice how these special notices are used in the example instructions listed above. 90005 90002 Technical background or theory. At the beginning of certain kinds of instructions (after the introduction, of course), you may need a discussion of background related to the procedure.For certain instructions, this background is critical-otherwise, the steps in the procedure make no sense. For example, you may have had some experience with those software applets in which you define your own colors by nudging red, green, and blue slider bars around. To really understand what you’re doing, you need to have some background on color. Similarly, you can imagine that, for certain instructions using cameras, some theory might be needed as well. 90005 90002 Equipment and supplies.Notice that most instructions include a list of the things you need to gather before you start the procedure. This includes 90003 equipment 90004, the tools you use in the procedure (such as mixing bowls, spoons, bread pans, hammers, drills, and saws) and 90003 supplies 90004, the things that are consumed in the procedure (such as wood, paint , oil, flour, and nails). In instructions, these typically are listed either in a simple vertical list or in a two-column list. Use the two-column list if you need to add some specifications to some or all of the items-for example, brand names, sizes, amounts, types, model numbers, and so on.90005 90002 Discussion of the steps. When you get to the actual writing of the steps, there are several things to keep in mind: (1) the structure and format of those steps, (2) supplementary information that might be needed, and (3) the point of view and general writing style. 90005 90002 Structure and format. Normally, we imagine a set of instructions as being formatted as vertical numbered lists. And most are in fact. Normally, you format your actual step-by-step instructions this way.There are some variations, however, as well as some other considerations: 90005 90014 90015 90003 Fixed-order steps 90004 are steps that must be performed in the order presented. For example, if you are changing the oil in a car, draining the oil is a step that 90003 must 90004 come before putting the new oil. These are numbered lists (usually, vertical numbered lists). 90016 90015 90003 Variable-order steps 90004 are steps that can be performed in practically any order.Good examples are those troubleshooting guides that tell you to check this, check that where you are trying to fix something. You can do these kinds of steps in practically any order. With this type, the bulleted list is the appropriate format. 90016 90015 90003 Alternate steps 90004 are those in which two or more ways to accomplish the same thing are presented. Alternate steps are also used when various conditions might exist. Use bulleted lists with this type, with OR inserted between the alternatives, or the lead-in indicating that alternatives are about to be presented.90016 90015 90003 Nested steps 90004. In some cases, individual steps within a procedure can be rather complex in their own right and need to be broken down into substeps. In this case, you indent further and sequence the substeps as a, b, c, and so on. 90016 90015 90003 «Stepless» instructions 90004. And finally there exist instructions that really can not use numbered vertical list and that do little if any straightforward instructional-style directing of the reader.Some situations must be so generalized or so variable that steps can not be stated. 90016 90025 90002 See the chapter on lists for the style and format of these possibilities. 90005 90002 Supplementary discussion. Often, it is not enough simply to tell readers to do this or to do that. They need additional explanatory information such as how the thing should look before and after the step; why they should care about doing this step; what mechanical principle is behind what they are doing; even more micro-level explanation of the step-discussion of the specific actions that make up the step.90005 90002 The problem with supplementary discussion, however, is that it can hide the actual step. You want the actual step-the specific actions the reader is to take-to stand out. You do not want it all buried in a heap of words. There are at least two techniques to avoid this problem: you can split the instruction from the supplement into separate paragraphs; or you can bold the instruction. 90005 90002 90109 Bolding actual user steps in instructions. Bold text helps distinguish the actual action from the supplementary information.90005 Avoid telegraphic writing-omitting «understood» articles (the, a, an). True, robots write that way, but we do not have to.) 90002 Writing style. The way you actually write instructions, sentence by sentence, may seem contradictory to what previous writing classes have taught you. However, notice how «real-world» instructions are written-they use a lot of imperative (command, or direct-address) kinds of writing; they use a lot of «you.» That’s entirely appropriate.You want to get in your reader’s face, get her or his full attention. For that reason, instruction-style sentences sound like these: «Now, press the Pause button on the front panel to stop the display temporarily» and «You should be careful not to …» 90005 90002 A particular problem involves use of the passive voice in instructions. For some weird reason, some instructions sound like this: «The Pause button should be depressed in order to stop the display temporarily.» Not only are we worried about the Pause button’s mental health, but we wonder who’s supposed to depress the thing (are you talkin ‘to me?).Or consider this example: «The Timer button is then set to 3:00.» Again, as the person following these instructions, you might miss this; you might think it is simply a reference to some existing state, or you might wonder, «Are they talking to me?» Almost as bad is using the third person: «The user should then press the Pause button.» Again, it’s the old double-take: you look around the room and wonder, «Who me?» (For more detail, see passive-voice problem.) 90005 90002 Another of the typical problems with writing style in instructions is that people seem to want to leave out articles: «Press Pause button on front panel to stop display of information temporarily» or «Earthperson, please provide address of nearest pizza restaurant.»Why do we do this? Do we all secretly want to be robots? Anyway, be sure to include all articles (90003 a 90004, 90003 an 90004, 90003 the 90004) and other such words that we’d normally use in instructions. 90005 90008 Graphics in Instructions 90009 90002 Probably more so than in any other form of writing (except maybe for comic books), graphics are crucial to instructions. Sometimes, words simply can not explain the step. Illustrations are often critical to readers ‘ability to visualize what they are supposed to do.90005 90002 In a technical writing course, instructions may require you to include illustrations or other kinds of graphics-whatever would normally be used in the instructions. The problem of course may be that you do not have access to graphics that would be suitable for your particular instructions, and that you do not feel wildly confident in your artistic abilities. There are ways to overcome these problems! Take a look at the suggestions in graphics. In that chapter, you’ll see not only suggestions for creating graphics, but also requirements on their format.90005 90008 Format in Instructions 90009 90002 Headings. In your instructions, make good use of headings. Normally, you’d want headings for any background section you might have, the equipment and supplies section, a general heading for the actual instructions section, and subheadings for the individual tasks or phases within that section. Take a look at the examples at the beginning of this chapter. See headings for common requirements. 90005 90002 Lists. Similarly, instructions typically make heavy use of lists, particularly numbered vertical lists for the actual step-by-step explanations.Simple vertical lists or two-column lists are usually good for the equipment and supplies section. In-sentence lists are good whenever you give an overview of things to come. See lists for common requirements. 90005 90002 Special notices. In instructions, you must alert readers to possibilities in which they may damage their equipment, waste supplies, cause the entire procedure to fail, injure themselves or others-even seriously or fatally. Companies have been sued for lack of these special notices, for poorly written special notices, or for special notices that were out of place.See special notices for a complete discussion of the proper use of these special notices as well as their format and placement within instructions. 90005 90002 90109 90109 Indentation of notices in instructions. In the first example, notice how the notice is indented to the 90003 text 90004 of the preceding step. In the second example, notice that the severe notice is placed at the beginning before any of the steps. 90005 90002 Number, abbreviations, and symbols.Instructions also use plenty of numbers, abbreviations, and symbols. For guidelines on these areas. 90005 90008 Revision Checklist for Instructions 90009 90002 As you reread and revise your instructions, watch out for problems such as the following: 90005 90014 90015 Make sure you provide real instructions-explanations of how to build, operate, or repair something. 90016 90015 Write a good introduction-in it, indicate the exact procedure to be explained, indicate audience requirements, and provide an overview of contents.90016 90015 Make sure that you use the various types of lists wherever appropriate. In particular, use numbered vertical lists for sequential steps. 90016 90015 Use headings to mark off all the main sections and subheadings for subsections. (Remember that no heading «Introduction» is needed between the title and the first paragraph. Remember not to use first-level headings in this assignment; start with the second level.) 90016 90015 Use special notices as appropriate.90016 90015 Make sure you use the style and format for all headings, lists, special notices, and graphics as presented in these chapters. If that’s a problem, get in touch with your instructor. 90016 90015 Use graphics to illustrate any key actions or objects. 90016 90015 Provide additional supplementary explanation of the steps as necessary. 90016 90015 Remember to create a section listing equipment and supplies, if necessary. 90016 90025 90002 I would appreciate your thoughts, reactions, criticism regarding this chapter: your response- 90003 David McMurrey 90004.90005 .90000 User Manual Template and Guide to Create Your Own Manual in 15 Steps 90001 90002 Step 1 Getting General Knowledge on the User Manual Template 90003 90004 Before actually using the User Manual Template and the other tools that I developed for Philip, I wanted to make sure we have the same starting point. I provided him with some general information about user instructions and with some good examples of existing user manuals. 90005 90004 I have listed this information below. 90005 90008 90009 What is the definition of a user manual? 90010 90011 90004 A user manual is a technical communication document intended to give assistance to people on how to use a product.A good user manual assists users on how to use a product safely, healthily and effectively. 90005 90004 Other names, or other forms of a user manual, might be: 90005 90016 90017 User guide 90018 90017 Technical documentation 90018 90017 Instruction manual 90018 90017 Operational manual 90018 90017 Training manual 90018 90017 Quick Start Guide 90018 90017 Installation manual 90018 90017 Maintenance manual 90018 90017 Software manual 90018 90035 90004 Besides the primary goal of a user manual (to assist a user), secondary goals could be creating a better user experience and meeting legal requirements.90005 90004 A user manual consists of textual visual information (illustrations, screenshots, tables etc.) to assist the user in completing specific tasks. 90005 90004 The user plays the central role when drawing up a user manual. A well-drafted user manual only provides that information that is relevant for the intended user of the product. 90005 90004 The user manual should contain both procedural information (step-by-step instructions) and conceptual information (information the user needs in order to understand procedural information).90005 90004 A good user manual is concise and uses jargon-free language. A good user manual should answer HOW and WHAT questions. They should contain information about what happens if a task is not done correctly. 90005 90004 In some cases, a product is intended to be used by different types of users. Typical user types are the end-user, installer, maintenance engineer and operator. Each user type needs a different approach in terms of language to be used, the tone of voice and provided conceptual information.90005 90008 90009 What information should be in a user manual? 90010 90011 90004 Different kind of products need a user manual. A product can be a system, tool, device, an instrument, a piece of software or an app. Depending on the type of product, a user manual might include things as: 90005 90016 90017 Product name 90018 90017 Model or type number 90018 90017 Intended use 90018 90017 Features / accessories 90018 90017 Description of the main product elements 90018 90017 Description of the user interface 90018 90017 Safety warnings 90018 90017 Installation instructions 90018 90017 Description of how to use / operate the product 90018 90017 Troubleshooting section and instructions on how to solve problems 90018 90017 Maintenance information 90018 90017 Repair information 90018 90017 Information on disposal of the product and packaging 90018 90017 Technical specifications 90018 90017 Table of content 90018 90017 Index 90018 90017 Glossary 90018 90017 Warranty information 90018 90017 Contact details 90018 90035 90008 90009 Using a user manual template 90010 90011 90004 The main tool that I developed in order to help Philip draw up his user manual is a User Manual Template.The template contains all the information and more from the list above. It complies with the requirements for his product. 90005 90004 The User Manual Template can be used for creating your manual for your system, tool, device, instrument, or for creating an installation manual, software manual, operational manual, maintenance manual or training manual. 90005 90004 Based on the first template for Philip, we have developed templates for the following product groups: 90005 90008 90009 What formats does a user manual have? 90010 90011 90004 User manuals can be provided in either a paper format or as an electronic document (PDF or placed online or on-device in HTML).The user manual template is an MS Word document that can be printed or placed online. 90005 90004 User manuals can be created using a variety of tools. Each tool has its own advantages and disadvantages. I will mention the most common tools below: 90005 90112 90113 90114 90115 90116 90115 90009 Advantages 90010 90116 90115 90009 Disadvantages 90010 90116 90125 90126 90127 90114 90115 90009 Word 90010 90116 90115 Easy to learn 90134 User manual template can be set up easily 90116 90115 Less suitable for large documents 90134 No reuse of content possible 90116 90125 90114 90115 90009 Indesign 90010 90116 90115 High degree of design freedom 90116 90115 Content changes may require many extra DTP hours 90116 90125 90114 90115 90009 CMS (technical authoring & publishing solutions) 90010 90116 90115 Reuse of content 90134 All in one solution 90134 Omni-platform publications 90134 Contains default user manual templates 90116 90115 High learning curve 90116 90125 90163 90164 90008 90009 User manual examples 90010 90011 90004 While drafting a user manual with help of the User Manual Template, it can be handy to have some good examples.Through the following links you can download a user manual sample for documentation: 90005 90004 90172 90173 90005 90002 Step 2 Identify the User (s) of Your User Manual Template 90003 90004 Ok, so now Philip has some basic knowledge about user manuals. Let’s dive into the details and actions. 90005 90004 When you want to write a manual that helps your user to solve problems, you first need to define who your user is. This can be done by creating a user profile, also named a persona.90005 90004 With a persona, you make some reasonable assumptions about the characteristics of your user. This is not only useful for creating your user instructions, but it is an essential element at the start of the development of any product! As an educated industrial design engineer, this is how we started all our design assignments. 90005 90004 When checking the ISOVOX website, I did not even find a clear description of their intended users. That’s why I asked Philip to define his users and answer questions like: 90005 90016 90017 Who is the user of your product? 90018 90017 Is the product used professionally or mainly privately? 90018 90017 What other technical experiences do they have? What describes the user? 90018 90035 90004 I have created a template that contains the questions.I asked Philip to fill out the template. 90005 90004 You can use the template yourself to determine who your user is. Please note that the second tab also contains Philip’s answers, so you have an example of how the sheet could be used. 90005 90004 Action: Use the template to describe your user (s). 90005 90004 I am a HUGE fan of visualizing things. So if you want to take defining your user one step further, I would suggest you visualise your user in the form of a persona. When creating a persona you are giving your user a name, age et cetera, so it becomes a real person that represents your user.90005 90004 I did this for Philip. This is the result: 90005 90004 90204 90005 90004 Action: Create a visualization of your user 90005 90004 If you want to know more about defining your audience and creating personas: 90005 90004 https://www.nngroup.com/articles/persona/ 90134 http://www.astauthors.co.uk/aboutast/articles/determiningyouraudience.php 90134 https://www.smashingmagazine.com/2014/08/ a-closer-look-at-personas-part-1/90134 https://www.prismnet.com/~hcexres/textbook/aud.html 90005 90002 Step 3 Creating Topics for Your User’s Problems 90003 90004 Start with identifying the problems that your user (s) might encounter during the lifecycle of the product and that s / he wants to solve.Typical problems might include: installing the product, using the product, using the product safely, maintaining the product and disposing of the product. 90005 90004 If the problem is too complex, you could break it down into chunks. 90005 90004 I asked Philip to identify the problems and solutions that his user might encounter during the product lifecycle. In order to do so, I created another template for Philip. In the left column of the Lifecycle tab, the stages of a product’s lifecycle are mentioned.These are derived from the international standard for user instructions, the IEC 82079. Our user manual templates are compliant with this standard. 90005 90004 On the Lifecycle [ISOVOX] tab you see how Philip adjusted the lifecycle to his own product. 90005 90004 Action: Use this template and the instructions on the first tab to identify the problems your user might have during the lifecycle of your product and present their solutions. 90005 90004 If you want to know more about defining your user’s problems and creating topics: 90005 90004 90230 90005 90002 Step 4 Define the Structure of the User Manual Template 90003 90004 Philip has now identified the problems a user might have with his product during its lifecycle and he has now thought of the solution to solve the problem.In other words: Philip has defined the topics for his user manual. Each topic can only be about one specific subject, has an identifiable purpose, and must be able to stand alone. 90005 90004 A topic should give the answer to only one user’s question. A user wants to solve one problem at a time. When a user has solved the problem, he / she will go and solve the next problem. 90005 90004 A topic will become a section in the user manual. It can be a chapter or a (sub-) paragraph. As soon as a user is looking for an answer to his problem, he will use the table of contents to find out how to navigate to that answer.90005 90004 I asked Philip to structure the topics and define their place in the user manual, by assigning a certain topic to a specific chapter or (sub-) paragraph. The result can be seen on the ToC [ISOVOX] tab. 90005 90004 Action: To define the structure of your user manual: 90005 90244 90017 Copy the content from the 90009 Lifecycle [product name] tab 90010 to the 90009 ToC [product name] tab 90010. 90018 90017 On the 90009 ToC [product name] tab 90010, replace 90009 product name 90010 with your own product name.90018 90017 Add a column to the left. Name it ‘Section’. 90018 90017 If applicable, organize your sections logically. 90018 90017 Determine what topics will become chapters by adding chapter numbers. Start numbering PREPARATION PRODUCT FOR USE with number 4. We will add some more chapters in the next step. 90018 90017 Determine what topics will become paragraphs by adding the section numbers. 90018 90017 Determine what topics will become sub-paragraphs by adding the subsection numbers.90018 90267 90004 You have now created the Table of Contents (ToC). The ToC is the outline of your user manual. Later we will add some more topics / sections, like the Introduction, Safety Information etc., so do not worry about adding that now. 90005 90002 Step 5 Create Meaningful Headings 90003 90004 Each topic in the user manual gets its own heading. The headings are the (sub-) titles that precede the actual text. They appear in the ToC, so the user can navigate to the needed information.90005 90004 So, Philip has just created the (sub-) titles for his topics. 90005 90004 Because the ToC entries play such an important role in helping your user find their way, and to help them skip what is NOT important, they need a bit more attention. 90005 90004 Basically, you should try and work with three levels of headings: first-, second- and third-level headings. 90005 90004 The first-level heading describes what the entire chapter or section is about (e.g. INSTALLATION OF THE PRODUCT).The second-level headings should use the ‘how what’ style of phrasing (e.g. 90281 How to Assemble the Product 90282 and 90281 How to Do the Electrical Installation 90282). A third-level heading uses noun-phrases (e.g. 90281 Packaging contents 90282 and 90281 Tools to be used 90282). 90005 90004 I asked Philip to redirect his headings and to take notice of the following general guidelines: 90005 90016 90017 Use the structure as shown above for the first, second and third level heading.90018 90017 Make sure the headings are self-explanatory. The heading 90281 Making Pancakes 90282 is much more user-oriented than 90281 Using the MagicCook5000 90282. 90018 90017 Make sure that the heading covers the full topic. If the section covers the maintenance and repair of a product, the heading 90281 Maintenance 90282 would be incomplete. 90018 90017 If possible, try to omit articles at the beginning of headings 90018 90035 90004 Action: Write new headings for your ToC entries.90005 90004 Philips’s ToC with meaningful headings can be found on the 90009 ToC w. Meaningful Headings tab 90010. 90005 90002 Step 6 Determine the Legal Content 90003 90004 Dependent on the market where your product is placed in or put into service, and dependent on the product group your product belongs to, specific legislation applies to your product. 90005 90004 In general, the legislation requires that your product is ‘safe’ and therefore gives general safety requirements your product should meet.90005 90004 These requirements also include requirements on the content of your user manual and safety instructions. 90005 90004 In order to sell your product in a specific market, you should make sure that your user manual complies with these requirements. 90005 90004 These two articles below will tell you how you can find out exactly which legislation applies to your product for the European and U.S. market and what the requirements are for your user manual. Pro tip: when there is a Declaration of Conformity available already, you can find the applicable directives in there.90005 90004 Philip did not need to conduct these steps, as the template he used already contained the legal content as required by the relevant directives. 90005 90004 For his product, it means that the following information is required for the user manual for his product: 90005 90004 EU (relevant CE marking directives: LVD, EMC, RoHS, WEEE, REACH): 90005 90016 90017 The user manual should be translated to the language (s) of the country where the product is sold. 90018 90017 The user manual should describe the intended use of the product.90018 90017 The user manual should describe the reasonably foreseen unintended use of the product. 90018 90017 If applicable, non-compliance in residential areas should be mentioned. 90018 90017 The type, batch or serial number or other element allowing the product’s identification should be mentioned on the product. If the product is too small this can be placed in the user manual. 90018 90017 The name, registered trade name or registered trademark and the postal address should be mentioned on the product.If the product is too small this can be placed in the user manual. 90018 90017 A risk analysis should be conducted to determine the residual risks related to the use of the product. Safety information shall be provided in order to inform the user of measures to be taken. 90018 90017 WEEE information shall be included 90018 90017 Information on packaging waste shall be included. 90018 90035 90004 Besides this legislation, there also is an international standard for user manuals, the IEC 82079-1: 2012.This standard has been harmonised in the EU. Compliance with harmonised standards provides a presumption of conformity with the corresponding legislation! 90005 90004 The user manual template complies with this standard. 90005 90004 I have also created an IEC 82079 checklist that can be used to double check that your user manual complies with this standard. 90005 90004 In order to create an internationally compliant user manual, you should always make sure your manual meets the EU, US and 80279 requirements.90005 90004 Action: To determine the legal requirements on your user manual: 90005 90244 90017 Follow steps 1-2 from the EU compliance and / or steps 1-6 from the US compliance articles to determine the legal framework for your instructions. 90018 90017 Study the IEC 82079 checklist to ensure your manual complies with the 82079 standard. 90018 90267 90002 Step 7 Download and Prepare the User Manual Template 90003 90004 Now Philip can start the actual creation of his user manual. 90005 90004 I asked him to adjust the table of contents of the template according to his own table of contents.Without removing and mandatory elements of course … 90005 90004 90134 Do you remember from step 4 that I asked to start the numbering of the sections with chapter 4? Once you download the user manual template doc yourself, you will see that a few standard chapters have been added, as well as some appendices. 90005 90004 Action: To adjust the user manual template: 90005 90004 If you want to work with the free template: 90005 90244 90017 Download the free user manual template Word 2013 or 2007 90018 90017 Change the section headings according to your own ToC.90281 90009 Notice! 90010 90282 Do not adjust the Table of Contents. The table of contents can be updated automatically once you have adjusted the section headings. 90018 90017 Add the mandatory content as determined in step 6 of your manual. 90018 90017 If applicable, modify sections 1-3 and the appendices according to your own needs. 90018 90267 90004 Or use one of our paid templates that contain all mandatory content, like Philip did: 90005 90002 Step 8 Create the Content for Your User Manual Template 90003 90008 90009 Write the Intended Use 90010 90011 90004 The purpose of your product, or better: the intended use, is the heart of a user manual and forms the basis of ensuring the safe and healthy use of the product.90005 90004 The way the intended use is described also determines your liability and affects the further contents of the user manual. 90005 90004 The most legislation requires you to include a description of the intended use in the user instructions. 90005 90004 The international standard for user instructions, the IEC 82079-1, provides the following definition for the intended use: 90005 90004 90281 An exhaustive range of functions or foreseen applications defined and designed by the supplier of the product 90282 90005 90004 By describing the intended use you determine the safe envelope of the product.And once you have determined the intended use, you can focus on providing only those safety and user instructions for how to use the product within the given envelope. 90005 90004 Additionally, to the intended use, many more standards, directives and regulations also require you to include a description of the reasonably foreseeable misuse. 90005 90004 For example, the reasonably foreseeable misuse of an aggressive detergent could be the use of it in a food processing environment. 90005 90004 Paying too little attention to describing the reasonably foreseeable misuse will affect a company’s liability.90005 90004 Product liability laws / regulation hold a manufacturer liable for a defective product. If the defectiveness of a product needs to be determined, all circumstances will be taken into account. That includes the reasonably foreseeable use of the product. 90005 90004 The description of the intended use determines which instructions are given in the rest of the manual. For example, if a cooling system is only used for cooling certain medications, then only these procedures need to be described.90005 90004 When it could reasonably be foreseen that the cooling system may be used as a system to cool organs, this should be described in the instructions. By doing so, you, as the manufacturer, will limit your liability and you can focus on only describing how to use the system to cool medicines. 90005 90004 Action: write the intended use and the reasonably foreseeable misuse of your product. 90005 90004 90432 90134 Figure 1. Reasonably foreseeable misuse? 90005 90008 90009 Write the safety warnings based on the risk analysis 90010 90011 90004 Even though the intended use has now been clearly defined, this does not mean that using a product is completely without any risks.90005 90004 To identify the hazards that come with the use of a product, you can conduct a risk analysis. A risk analysis can also be mandatory for certain product groups, such as low-voltage equipment, toys, machinery and equipment for use in explosive atmospheres. 90005 90004 Standards, like the ISO 12100, have been developed on how to conduct a risk analysis. The ISO 12100 also gives a method for taking mitigation measures: the Three-Step Method. According to this method, there is the following hierarchy of risk-reducing measures: 90005 90244 90017 Inherently safe design measures 90018 90017 Safeguarding and complementary protective measures 90018 90017 Information for use 90018 90267 90004 This means that the user guide should warn of any residual risks related to the use of the product.This is done with safety warnings. 90005 90004 A good safety warning describes the nature of a hazardous situation, the consequences of not avoiding a hazardous situation and the method (s) for avoiding it. 90005 90004 To indicate the degree of hazard that may be encountered by the user, the signal words «Danger», «Warning» and «Caution» should be used. 90005 90004 Have a look at the following safety messages: 90005 90004 90009 WARNING! 90010 Rotating parts. Risk of serious injuries. Keep hands clear.Lockout / Tagout before servicing. 90005 90004 Then you want to warn the user where a hazardous situation might be encountered. The ANSI Z535.6 standard describes the following locations in the user manual where this could be: 90005 90016 90017 Grouped in a separate chapter. 90018 90017 In the first part of the specific section: 90134 90472 90018 90035 90004 1. Do this. 90134 2. Do that. 90009 WARNING! 90010 This is embedded safety messages. General text general text general text.90134 3. Do this. 90005 90016 90017 In the Preface any supplemental directives can be placed, such as 90281 Read all instructions before use 90282 or 90281 Keep these instructions for future reference 90282 can be placed in the introduction of a user manual. 90018 90035 90004 In the EU, depending on the kind of product, it might be allowed to provide only the safety information in printed form and the rest of the information online. 90005 90004 In order to help Philip create and place a safety message, I have created another template.90005 90004 Action: conduct a risk analysis and craft your safety messages using this template. 90005 90008 90009 Create all other content 90010 90011 90004 Now I asked Philip to create all other content, such as the procedures, technical specs and legal information. 90005 90004 I gave the following tips: 90005 90016 90017 Exclude unnecessary material to avoid information overload (for example sales promotion, extensive repetition etc). 90018 90017 Make sure terms are familiar to the user, technical features and terms are well explained and use terms consistently.90018 90017 Describe any prerequisites that should be met before the actual instructions start. This may also be describing special tools or space for maintenance and repair. 90018 90017 Provide conceptual information when information is necessary for adequate understanding and execution of tasks. 90018 90017 Always write topic based. 90018 90017 Use a bold typeface for all product elements. 90018 90017 Indicate when you want to add an image for better understanding later. 90018 90017 Make sure words and phrases are not too complicated or over-sophisticated.90018 90017 Use simple / standardized and short phrases: one sentence-one command. 90018 90017 Do not put too much information into one sentence. 90018 90017 Use the direct active voice and assertive commands. 90018 90017 Use words like nouns and verbs consistently to avoid ambiguity. 90018 90017 To write better instructions, use the Principles of Minimalism in Technical Communication and Simplified Technical English. 90018 90035 90004 Action: create all other content for your user manual.90005 90004 Again, for most product groups there are paid templates available which might make the work easier. These templates contain all legal texts, mandatory disposal information, copyright statements and comply with the IEC 82079 standard on user instructions. 90005 90008 90009 Place the safety warnings in the right position 90010 90011 90004 When using the template for crafting the safety messages, I asked Philip to indicate whether a safety message is a supplemental directive, or should be placed as a grouped, section or embedded safety message.90005 90004 Now all text has been created, the safety messages can be placed in the right place. 90005 90004 Action: place all safety messages in the right location in the user manual. 90005 90002 Step 9 Add Navigation to Your User Manual Template 90003 90004 A user manual should give assistance to people by providing information about how to use a product. Finding the right information that solves the user’s problem should take as little time as possible. 90005 90004 The crafting of meaningful headings is one of the tools that aid users in finding information.However, there are several other tools to help the user finding the information he / she wants, such as: 90005 90016 90017 Table of contents 90018 90017 Page numbering 90018 90017 Index 90018 90035 90004 I asked Philip to update the table of contents and add page numbering and an index. 90005 90004 Action: Add or update your table of contents, page numbering and index. 90005 90002 Step 10 Have Your User Manual Reviewed 90003 90004 Philip has now created the draft version of his user manual, using the user manual template.We call this version the 90281 textual content design 90282. 90005 90004 As Philip has a business partner and a developer with in-depth technical product knowledge, I asked Philip to let them review the work so far. 90005 90004 Both his business partner and the developer provided feedback. Philip used this feedback to optimize the user manual. 90005 90004 Action: Send the draft version of the user manual to anyone within your team who might be able to deliver feedback. Ask them to combine all feedback into one document before sending it back to you.This stimulates discussion of your team members and prevents disagreement at a later stage. 90005 90002 Step 11 Create the Images 90003 90004 Once the user manual has been reviewed and optimized, the texts are more or less definite. This means that any images can now be created and added to the content. 90005 90004 The reason to wait until the texts are ready is that creating or editing images can be time-consuming. As images should support, replace, or augment text, you want to wait to create them until the texts are final.90005 90004 Images in user manuals may include illustrations, photos, screenshots, tables, diagrams and schematics. 90005 90004 There are many great tools that can help you create your images, such as: 90005 90004 90586 90005 90004 I advised Philip not to use photos as a cheap alternative for illustrations. Often, photos are not as informative because they contain too much information. Besides that, photos can make a user manual look messy. 90005 90004 For that reason, Philip used Google Sketchup to create his illustrations.90005 90004 Action: Create the images for your user manual. 90005 90004 If you want to know more about creating images: 90005 90004 90597 90005 90002 Step 12 Final Check of the User Manual Template 90003 90004 Before we start making it look nice and translate the content, we want to be sure that the content is complete. 90005 90004 In order to do so, I asked Philip to use a checklist. 90005 90004 Action: l make sure that your user manual complies with all relevant requirements from the IEC 82079-1 діє до: 2012 by using this checklist.90005 90002 Step 13 Design Your User Manual Template 90003 90004 A well-designed manual contributes to a better brand and user experience. 90005 90004 You can adjust the User Manual Template in MS Word by adding a company logo and adjust the font, colours et cetera, but that might have limitations. 90005 90004 When you know how to work with Adobe Indesign, or are willing to learn to work with it, this will offer you much greater design possibilities. 90005 90004 I created this template in Indesign and asked Philip to adjust it to match his brand identity.90005 90004 90618 90005 90004 Action: Adjust the User Manual Template to fit your brand identity, or download the InDesign user manual template and adjust it. 90005 90002 Step 14 DTP Works 90003 90004 DTP stands for Desktop Publishing and Wikipedia describes it as ‘the creation of documents using page layout skills on a personal computer primarily for print’. 90005 90004 Philip now has both the content of his user manual (Word file) and the user manual template (InDesign file). The content needs to be put into the InDesign template.This is called Desktop Publishing. 90005 90004 Action: place the content from your Word file into the Indesign template. If you decided not to use the InDesign template but stuck to the Word file, then you can skip this step. 90005 90002 Step 15 Translate and Publish your User Manuals 90003 90004 Depending on the market in which you are going to sell your product, you might need to translate the user manual. 90005 90004 Some general tips: 90005 90016 90017 Look for a translator with similar experience.This could be a translator who is experienced in translating technical content, with similar products or with translating user manuals. 90018 90017 If you need to translate to several languages, working with a translation agency might save you lots of time. 90018 90017 Ask the translator or agency about their quality procedures and who is going to revise the text after translation. 90018 90017 As you know your product best and who your audience is, it might be a good idea to provide the translator or agency a glossary or a list with the terminology that you want to use.90018 90017 Look for a translator who can work directly in your Word or InDesign file or find an agency that can do the DTP works as well. Alternatively, you can do this yourself, of course. 90018 90035 90004 As Philip will sell his product in both the US and EU, he decided to work with an agency. 90005 90004 Action: Find a translator or agency that fits your needs and have your user manual translated. 90005 90004 In general, a user manual should be available in a format that is easily accessible to the user.That can be printed, or used online or on-device. 90005 90004 As a user wants information at the moment he / she needs it and thus does not think in channels, the best approach would be to provide the instructions omni-platform. 90005 90004 In the European Union, for some product groups, it is still restricted to provide the user manual printed with the product. 90005 90004 However, as of April 2016, the instructions of many product groups may be delivered in a different format rather than in print.There is one exception, however. 90005 90004 Safety information shall still be delivered in paper form along with the product. Besides that, upon request from a consumer, a paper user manual should be made available to the consumer. 90005 90004 Philip decided to the following: 90005 90016 90017 He provides a printed full manual with the product, including the safety instructions. 90018 90017 He created a separate quick start guide to be provided with the product as well. 90018 90017 He placed a pdf version of the full manual online.90018 90017 He will create an online-help section on his website with the HTML version of the user manual. Here he can add videos as well. And by optimizing the HTML version for search engines he makes it easier for his user to find information for his user 90018 90035 90002 Conclusion 90003 90004 That’s all there is to it. That’s how Philip created a compliant user manual with help from the User Manuals Template and the other available tools that I provided. 90005 90004 The best part of all this is that you can get the same results as Philip did by following this step-by-step process on how to create a user manual.90005 90004 If you found this case study inspiring, I’d really appreciate if you would share Philip’s story on 90134 Facebook or Twitter, or leave a comment below. 90005 .