Автоклав midmark ultraclave m11 инструкция на русском

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Руководство пользователя парового стерилизатора midmark M11

Рис. 18. Тестовый цикл.jpg

Применяется к моделям:
М9/М11/М3
КК1-01
КС3(Р)-01
КС6(Р)-01

Примечание: В этих инструкциях описаны основные процедуры запуска. Для получения всей технической информации и руководств пользователя посетите нашу техническую библиотеку по адресу техническая библиотека.midmark.com

Паровой стерилизатор M9 / M11

Значок заметкиОповещение об оборудовании
Используйте дистиллированную воду или воду, которая соответствует требованиям по чистоте воды, указанным в руководстве пользователя. Несоблюдение этого требования может привести к неисправности стерилизатора и/или преждевременному выходу из строя из-за чрезмерной коррозии.

Очистка.
A) Вымойте наружную часть стерилизатора в соответствии с процедурой вашего учреждения для поверхностей, контактирующих с больными, при этом обратите внимание на следующее: (Для дезинфекции устройства используйте только четвертичные дезинфицирующие средства. Окрашивание, точечная коррозия, обесцвечивание или размягчение могут возникнуть, если на основе фенола, йодофора или глутарового альдегида дезинфицирующее средство используется на пластиковых поверхностях устройства.Кроме того, использование спирта или аэрозольного чистящего/дезинфицирующего средства, содержащего значительное количество спирта в формуле, может повредить лицевую панель).
Б) Отожмите лишний раствор с ткани.
C) Используя мягкую ткань, протрите все внешние поверхности.
D) Следуйте инструкциям, прилагаемым к чистящему/дезинфицирующему средству, относительно ополаскивания и сушки внешних поверхностей.
E) Осмотрите прокладки на предмет возможных повреждений.
F) Очистите прокладки и сопрягаемые поверхности с помощьюamp ткань.
G) Вымойте лотки, штатив, пластину и внутреннюю часть камеры с использованием мягкого мыла или Speed-Clean и дистиллированной воды или воды, которая соответствует указанным спецификациям чистоты воды.

Рис. 1. Очистка.JPG

Проверьте фильтры.
Визуально проверьте, чтобы сетки фильтров были на месте как сзади, так и снизу камеры стерилизатора.

Рис. 2. Проверить фильтры.JPG

Значок заметки Оповещение об оборудовании
Установите подставку для лотка / пластину так, чтобы конец пластины был наклонен к задней части камеры.
Не допускайте контакта пластины с датчиком уровня воды.

Установите стойку/тарелку для лотков и лотки.
A) Вставьте решетку для лотка в пластину для лотка.
B) Поместите заднюю часть пластины лотка в камеру.
C) Нажмите на подставку для лотка, скользя в камеру.
D) Поместите лотки в прорези стойки для лотков.

Рис. 3 Предупреждение об оборудовании.JPG

Заполните резервуар.
A) Откройте дверь в блок.
B) Заливайте дистиллированную воду в заливное отверстие до тех пор, пока уровень воды не достигнет верхней части метки уровня заполнения на трубке указателя уровня воды.

Рис. 4. Заполнить резервуар.JPG

Значок заметкиОповещение об оборудовании
Используйте дистиллированную воду или воду, которая соответствует требованиям по чистоте воды, указанным в руководстве пользователя. Несоблюдение этого требования может привести к неисправности стерилизатора и/или преждевременному выходу из строя из-за чрезмерной коррозии.

Подключите шнур питания.
A) Вставьте шнур питания в розетку на задней панели стерилизатора.
B) Вставьте шнур питания в правильно поляризованную и заземленную розетку, рассчитанную как минимум на 15 ampс. Рекомендуется специальный контур, используемый только для стерилизатора.
C) M9/M9D и M11 не оснащены выключателем, дисплей работает при очень малом энергопотреблении. (бывшийample: дисплей микроволновой печи)
Примечание. При подключении питания на дисплее появятся показанные сообщения.

Внимание
Для моделей M9-04x / M11-04x режим пользовательских настроек позволяет пользователю установить желаемую единицу измерения и настроить часы. См. раздел «Настройки пользователя» в руководстве пользователя.

Рис. 5. Подсоедините кабель питания.JPG

* На этих экранах отображается общее количество циклов, выполненных устройством, номер модели (M9/M9D или M11), номер версии программного обеспечения, серийный номер, а модели M9/M11-04X также отображают дату и время.

Цикл тестирования
Запустите тестовый цикл, чтобы убедиться, что ваша система работает правильно.

Значок заметкиОповещение об оборудовании
Стерилизатор не будет работать, если дверца не будет закрыта и заперта должным образом.
Закройте и защелкните дверь.
A) Поднимите дверную ручку, затем закройте дверь.
B) Нажимая на дверь, сдвиньте дверную ручку вниз, чтобы защелкнуть защелку.

Рис. 6. Тестовый цикл.JPG

Выберите цикл.
Нажмите нужную кнопку цикла на панели дисплея.

Квалификационное тестирование
Ваш стерилизатор должен быть протестирован после установки стерилизатора, неисправности, перемещения, капитального ремонта и после сбоя в процессе стерилизации. Перед вводом стерилизатора в эксплуатацию необходимо провести квалификационные испытания. Если используется несколько типов циклов, например, «Пакеты» и «Упаковки», следует квалифицировать каждый тип цикла. Квалификационное тестирование должно включать как минимум один биологический индикатор (BI) (иногда называемый тестом на споры) и один химический индикатор (CI). Тестовый пакет следует поместить на нижний лоток рядом с дверью камеры и проводить с предметами, которые обычно обрабатываются и которые считаются наиболее сложными для стерилизации. Дополнительные предметы следует поместить в камеру вместе с биологическим индикатором и химическим индикатором, чтобы камера была полностью загружена (не превышайте максимальную вместимость, указанную в таблицах в разделе «Рекомендации по загрузке» в этом руководстве). Один тестовый прогон для каждого испытанного типа цикла с отрицательными результатами BI и соответствующими показаниями всех физических мониторов и химических индикаторов, демонстрирующих полную стерилизацию, обеспечивают подтверждение того, что стерилизатор был правильно установлен (или переустановлен после перемещения) или отремонтирован до спецификации изготовителя и что он будет эффективно функционировать на объекте, на котором он установлен. Все предметы, обработанные во время квалификационных испытаний, должны быть помещены на карантин до получения результатов биологических испытаний.

Стерилизатор М3

Очистка.
A) Вымойте устройство в соответствии с процедурой вашего учреждения для поверхностей, контактирующих с больными, с учетом следующего: (Для дезинфекции устройства используйте только четвертичные дезинфицирующие средства. При использовании дезинфицирующих средств на основе фенола, йодофора или глутарового альдегида на пластике могут возникнуть пятна, ямки, обесцвечивание или размягчение. поверхности устройства.Кроме того, использование спирта или аэрозольного чистящего/дезинфицирующего средства, содержащего значительное количество спирта, может повредить лицевую панель.).
Б) Отожмите лишний раствор с ткани.
C) Используя мягкую ткань, протрите все внешние поверхности.
D) Следуйте инструкциям, прилагаемым к чистящему/дезинфицирующему средству, относительно ополаскивания и сушки внешних поверхностей.
E) Промойте прокладку и сопрягаемую поверхность с помощьюamp ткань.
F) Осмотрите прокладку на наличие повреждений.
G) При необходимости замените прокладку.
H) Визуально проверьте, чтобы сетка фильтра камеры была на месте.

Рис. 7. Стерилизатор M3.JPG

Внимание
Внешний конденсационный бак не требуется, если M3 подключен к системе термического восстановления Vista Cool с прямым сливом.

Значок заметки Оповещение об оборудовании
Шланг бака должен быть правильно подсоединен (и не перекручен). Неправильное подключение приведет к утечке воды/пара или неисправности стерилизатора, если поток воды в резервуар ограничен.

Рис. 8. Стерилизатор M3.JPG

Подсоедините емкость для конденсата.
A) Если подключен, отсоедините шнур питания стерилизатора.
B) Вставьте шланг бака в компрессионный фитинг на крышке. Затяните гайку. (Если шаг B затруднен – см. ПРИМЕЧАНИЕ.)
C) Подсоедините шланг резервуара к задней части стерилизатора.
D) Заполните емкость для конденсата водопроводной водой до отметки минимального уровня воды.
E) Закрепите крышку на баке для конденсата, совместив выступы, и поверните крышку по часовой стрелке, чтобы зафиксировать.

Внимание
Если трубу трудно установить.
A) Снимите компрессионную гайку и два феррула.
B) Установите гайку и наконечники на шланг бака, как показано на рисунке.
(Большие и маленькие наконечники должны располагаться, как показано на рисунке)
C) Вставьте шланг в штуцер бака, затем затяните гайку.

Подсоедините емкость для конденсата – продолжение.
F) Поместите бак на ровную поверхность, предпочтительно ниже стерилизатора, но ни в коем случае не выше опорной поверхности стерилизатора.
G) Подсоедините штекер датчика.
H) Вставьте шнур питания в розетку на задней панели стерилизатора.
I) Вставьте шнур питания в правильно поляризованную и заземленную розетку, рассчитанную как минимум на 15 ampс. Рекомендуется специальный контур, используемый только для стерилизатора.

Рис. 9. Подсоедините бак для конденсата.JPG

Внимание
Оформление.
Поддерживайте зазор не менее 6 дюймов над конденсатором для надлежащей вентиляции пара. В случае помещения в шкаф опорная поверхность и окружающие поверхности должны быть защищены водостойким материалом (например, пластиком, ламинатом, нержавеющей сталью и т. д.). Если устройство помещено в шкаф, рекомендуется вентилировать дверь, чтобы избежать перегрева, накопления влаги и потенциального повреждения внутренней части шкафа.

Заполните резервуар.
Залейте один (1) галлон дистиллированной воды в заливное отверстие.
Не заливайте выше нижней кромки заливного отверстия.

Рис. 10. Заполнить резервуар.JPG

Значок заметки Оповещение об оборудовании

Используйте дистиллированную воду или воду, которая соответствует требованиям по чистоте воды, указанным в руководстве пользователя. Несоблюдение этого требования может привести к неисправности стерилизатора и/или преждевременному выходу из строя из-за чрезмерной коррозии.

Выключатель
Для работы стерилизатора выключатель питания должен быть включен (I).

Рис. 11. Выключатель питания.JPG

Заполнение водяного насоса
Переведите стерилизатор в режим пользовательской диагностики, чтобы заполнить водяной насос.

Чтобы активировать режим диагностики пользователя.
A) Выключите питание (O).
Б) Нажмите и удерживайте кнопку кнопка.
C) Включите выключатель питания ( I ).
Г) Нажмите кнопку кнопку, когда на дисплее отображается «ДИАГНОСТИКА ПОЛЬЗОВАТЕЛЯ».

Для заполнения насоса стерилизатора.
А) Переведите устройство в режим пользовательской диагностики.
Б) Нажмите кнопку кнопку, чтобы начать процесс заливки насоса.
Устройство автоматически выполнит предварительно запрограммированный цикл заполнения…
• Закрытие дверцы стерилизатора.
• Нагрев котла.
• Циклическое включение и выключение насоса до тех пор, пока насос не будет заполнен.
По завершении во 2-й строке дисплея отобразится «ЗАПРАВКА ЗАВЕРШЕНА».
В) Нажмите кнопку кнопку, чтобы вернуться в меню диагностики пользователя.
D) Поверните выключатель питания в положение OFF (O), чтобы выйти из пользовательского режима диагностики.

Цикл тестирования
Запустите тестовый цикл, чтобы убедиться, что ваша система работает правильно.

Выберите цикл.
Нажмите нужную кнопку цикла на панели дисплея.

Квалификационное тестирование
Ваш стерилизатор должен быть протестирован после установки стерилизатора, неисправности, перемещения, капитального ремонта и после сбоя в процессе стерилизации. Перед вводом стерилизатора в эксплуатацию необходимо провести квалификационные испытания. Если используется несколько типов циклов, например, «Пакеты» и «Низкотемпературный», каждый тип цикла должен быть квалифицирован. Квалификационное тестирование должно включать как минимум один биологический индикатор (BI) (иногда называемый тестом на споры) и один химический индикатор (CI). Тестовый пакет следует поместить рядом с передней частью лотка и проводить с предметами, которые обычно обрабатываются и которые считаются наиболее сложными для стерилизации. Дополнительные предметы следует поместить в камеру вместе с биологическим индикатором и химическим индикатором, чтобы камера была полностью загружена (не превышайте максимальную вместимость, указанную в таблицах в разделе «Рекомендации по загрузке» в этом руководстве). Один тестовый прогон для каждого испытанного типа цикла с отрицательными результатами BI и соответствующими показаниями всех физических мониторов и химических индикаторов, демонстрирующих полную стерилизацию, обеспечивают подтверждение того, что стерилизатор был правильно установлен (или переустановлен после перемещения) или отремонтирован до спецификации изготовителя и что он будет эффективно функционировать на объекте, на котором он установлен. Все предметы, обработанные во время квалификационных испытаний, должны быть помещены на карантин до получения результатов биологических испытаний.

Рис. 12. Квалификационное тестирование.JPG

Установки QuickClean™

Закройте сливной клапан.
Убедитесь, что сливной клапан находится в закрытом положении.

Рис. 13. Закройте сливной клапан.JPG

Перед использованием QuickClean™

A) Очистите устройство и протрите бак. «Очистите, протерев рекламойamp намыльной тряпкой и прополоскать».
Б) Налейте воду в ванну так, чтобы она доходила до датчика уровня жидкости, но не превышала максимальный уровень заполнения. Соблюдайте рекомендации моющего средства по температуре воды. Эффективность очистки может быть гарантирована только в том случае, если температура воды составляет не менее 70 F.
C) Добавьте необходимую дозу чистящего средства. Следуйте рекомендациям производителей чистящих средств и инструментов в отношении допустимых чистящих средств и концентраций.
Чтобы учесть размер резервуара, округлите количество чистящего средства до ближайшего значения 1 унция/галлон, 10 мл/л или 10 грамм/л.
D) Включите машину с помощью выключателя на задней панели устройства, прямо над кабелем питания. После этого переключатель загорится.
E) Запустите цикл дегазации.

Подключение шнура питания.

A) Подключите шнур питания к разъему основного питания, расположенному на задней панели устройства.
B) Убедитесь, что ультразвуковая ванна QuickClean™ подключена к полностью заземленной розетке на 115 В переменного тока.

Рис. 14. Подключение шнура питания.JPG

Рис. 15. Подключение шнура питания.JPG

Цикл Дега

Рис. 16. Цикл дегазации.jpg

Дегазировать

  • Цикл дегазации обеспечивает оптимальную ультразвуковую активность за счет удаления газов, присутствующих в обычной водопроводной воде.
  • Время, необходимое для дегазации жидкости, зависит от количества газа, присутствующего в жидкости, и количества воды в баке.
  • Рекомендуется период дегазации от 5 до 10 минут.
  • Во время цикла дегазации вы увидите пузырьки газа, образующиеся внутри ультразвуковой ванны и медленно поднимающиеся на поверхность, когда вы больше не увидите, как эти пузырьки выходят на поверхность, вы можете завершить цикл дегазации.

Запуск цикла Дега.
A) Когда устройство включено, когда вы меняете раствор или когда жидкость падает ниже датчика уровня воды, вы получаете возможность дегазировать свой ультразвуковой датчик.
B) Перед началом цикла дегазации удалите все инструменты и убедитесь, что устройство заполнено жидкостью и необходимой дозой чистящего раствора.
C) Установите крышку на ультразвуковой блок.
D) Выберите верхнюю < YES, чтобы начать цикл дегазации. На экране ниже отобразится
E) Как только все пузырьки выйдут на поверхность, цикл дегазации будет завершен.
F) Нажмите  стрелку влево SKIP, чтобы завершить цикл дегазации. Ваш цикл дегазации НЕ остановится автоматически после завершения дегазации.

Рис. 17. Цикл дегазации.jpg

Цикл тестирования
Запустите тестовый цикл, выполнив тест «Foil», чтобы убедиться, что ваша система работает правильно.

Выполните тест «Фольга».
Назначение: Используется для определения эффективности ультразвуковой очистки.

  • Рекомендуется ежеквартально тестировать ультразвуковой очиститель, чтобы убедиться, что он работает должным образом.
  • Тестирование следует также проводить всякий раз, когда есть подозрение на ухудшение характеристик очистителя.
  • Этот тест с использованием фольги относительно прост в выполнении и обеспечит постоянную запись для будущей сравнительной оценки производительности ультразвуковых очистителей.

Примечание: Инструкции по тестированию фольги можно найти в Руководстве пользователя.

Рис. 18. Тестовый цикл.jpg

Испытательная установка из фольги, погруженная в водный раствор

© 2020 Корпорация Мидмарк | 60 Виста Драйв Версаль, Огайо 45380 США | 1.800.643.6275 | 1.937.526.3662 | midmark.com

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Installation

& Operation

Manual

Go To Table Of Contents

M11 UltraClave™

Steam Sterilizer

To purchase a printed copy of this manual,

click on the «Place Order» button below.

Place Order

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M1

1 UltraClave

®

Important

Information

Page 2

Installation

Page 4

Description

Page 6

Components

Overview

Page 8

Controls &

Indicators

Page 9

Operation

Page 11

Operator

Maintenance

Page 20

Calling For

Service

Page 28

Specifications

Page 29

Limited

Warranty

Page 29

Style L

Go To Table Of Contents

Owner’s Product Identification

(information that you will need to provide for servicing — key information is highlighted)

Date of Purchase Serial Number

Name of Owner / Facility / Department

Name of Authorized Dealer

Address of Authorized Dealer

Model Number

Telephone # of Authorized Dealer

MODEL AND SERIAL

NUMBER LOCATION

MODEL NUMBER

SERIAL NUMBER

MA439101

CONTENTS

IMPORTANT INFORMATION ………………………………………………………………………………………….. 2

Scope and Purpose of This Manual ………………………………………………………………………….. 2

Intended Use of Product………………………………………………………………………………………….. 2

Safety Instructions………………………………………………………………………………………………….. 2

Explanation of Safety Symbols and Notes …………………………………………………………………. 3

Transportation and Storage Conditions ……………………………………………………………………… 3

INSTALLATION……………………………………………………………………………………………………………… 4

Location Requirements For Sterilizer ………………………………………………………………………… 4

Re-Location Requirements For Sterilizer …………………………………………………………………… 5

Electrical Requirements ………………………………………………………………………………………….. 6

DESCRIPTION………………………………………………………………………………………………………………. 6

Operational Features………………………………………………………………………………………………. 6

Mechanical Features ………………………………………………………………………………………………. 7

Safety Features ……………………………………………………………………………………………………… 7

COMPONENTS OVERVIEW …………………………………………………………………………………………… 8

CONTROLS & INDICATORS ………………………………………………………………………………………….. 9

OPERATION ……………………………………………………………………………………………………………….. 11

Recommended Steam Sterilization Monitoring Program ……………………………………………. 12

Sterilizer Preparation Before Operation……………………………………………………………………. 12

Cleaning Instruments ……………………………………………………………………………………………. 13

Guidelines For Loading Trays …………………………………………………………………………………. 14

Operation…………………………………………………………………………………………………………….. 16

Standard Cycle Parameters …………………………………………………………………………………… 19

List of Authorized Accessories ……………………………………………………………………………….. 19

OPERATOR MAINTENANCE ……………………………………………………………………………………….. 20

Daily …………………………………………………………………………………………………………………… 20

Weekly………………………………………………………………………………………………………………… 20

Monthly……………………………………………………………………………………………………………….. 20

Quarterly …………………………………………………………………………………………………………….. 23

Toubleshooting Guide……………………………………………………………………………………………. 24

Error Code Guide …………………………………………………………………………………………………. 26

CALLING FOR SERVICE ……………………………………………………………………………………………… 28

SPECIFICATIONS ……………………………………………………………………………………………………….. 29

LIMITED WARRANTY ………………………………………………………………………………………………….. 29

PRINTER INSTALLATION AND OPERATION …………………………………………………………………. 30

Installing the Printer ……………………………………………………………………………………………… 31

Operating the Printer …………………………………………………………………………………………….. 34

Inserting the Paper Roll…………………………………………………………………………………………. 34

About the Cartridge Ribbon……………………………………………………………………………………. 35

Installing a New Cartridge Ribbon…………………………………………………………………………… 36

Removing the Paper Roll……………………………………………………………………………………….. 37

Power Up Message ………………………………………………………………………………………………. 37

Printer Tape Description ………………………………………………………………………………………… 37

Important

Information

Return To Table Of Contents

IMPORTANT INFORMATION

Scope and Purpose of This Manual

This manual provides complete instructions for the installation, operation, and normal care of the M11 UltraClave™ Steam Sterilizer. It is intended that this manual be used by all personnel operating the sterilizer or performing operator level maintenance. No repair information is included in this manual as no repairs are authorized at the operator level.

Intended Use of Product

The M11 Ultraclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat stable and moisture stable, reusable equipment. Dental handpieces can be sterilized in the M11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters on page 19 in this manual for detailed information.

Safety Instructions

The primary concern of Midmark is that this equipment is operated and maintained with the safety of the patient and staff in mind. To assure safer and more reliable operation:

• Read and understand this manual before attempting to install or operate the sterilizer.

• Assure that appropriate personnel are informed on the contents of this manual; this is the responsibility of the purchaser.

• Assure that this manual is located near the sterilizer, or if possible, permanently affixed to the sterilizer.

2

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Explanation of Safety Symbols and Notes

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. The DANGER symbol is limited to the most extreme situations.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices.

EQUIPMENT ALERT

Indicates an imminently or potentially hazardous situation which, if not avoided, will or may result in serious, moderate, or minor equipment damage.

NOTE

Amplifies an operating procedure, practice, or condition.

Transportation and Storage Conditions

EQUIPMENT ALERT

The water must be drained from the unit’s reservoir before transporting or storing at 0°C (32°F) or below. Also, the unit should be allowed to reach room temperature before operating. Failure to do so could result in damage to unit.

• Ambient Temperature Range: ….. -40°C to +70°C (-40°F to 158°F)

• Relative Humidity …………………… 10% to 90% (non-condensing)

• Atmospheric Pressure ……………. 500hPa to 1060hPa (0.49atm to 1.05atm)

Important

Information

3

Installation

Return To Table Of Contents

INSTALLATION

Location Requirements For Sterilizer

DANGER

Do not operate this sterilizer in areas where flammable anesthetics are used or stored. An explosion could occur, causing personal injury.

Adherence to the following recommendations for location of the sterilizer will contribute to optimum performance of the unit:

F

E

B

D

C

A

MA439500

Support Surface (A) — Sterilizer must be placed on a level surface to ensure that the chamber will fill correctly. Improper water level in the chamber could cause a sterilizer malfunction.

Support Surface Material (B) — Formica, stainless steel, or other water and heat resistant material. Heat from bottom of sterilizer could reach 71°C (160° F) on the support surfaces for short periods of time.

4

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Support Surface Depth (C) — Support surface should be approximately 533 mm

(21 in) deep. Allow at least 51 mm (2 in) clearance behind the sterilizer for air circulation.

Distance To Side Wall (D) — If the sterilizer is located next to side walls, there should be no less than 51 mm (2 in) clearance between the side of the sterilizer and the wall.

Distance Above Sterilizer (E) — If the sterilizer is to be located beneath wall cabinets or shelves, the underside of the cabinets or shelves should be at least 584 mm (23 in) above the support surface, to provide access to the top inspection cover and to allow for changing the printer paper roll.

Overhang (F) — If the sterilizer is to be located beneath an overhang, the underside of the overhang should project no further than 381 mm (15 in) over the rear of the sterilizer.

Location On Support Surface — The front of the sterilizer should be located near the front of the support surface so water can be easily drained from the tube into a container.

Neighboring Materials and Equipment — If the sterilizer will be operated in continuous cycles, locate the sterilizer where excessive emission of steam will not damage materials or equipment in the surrounding area.

Re-Location Requirements For Sterilizer

1. Disconnect power cord from the electrical outlet and allow sterilizer to cool.

2. Drain water from reservoir or take care not to tip the sterilizer, which will allow water to spill from reservoir.

Installation

5

Installation

Description

Return To Table Of Contents

Electrical Requirements

WARNING

Use 220 — 240 VAC, 50/60 HZ alternating current only for 230

VAC models and 90 — 110 VAC, 50/60 HZ alternating current only for 100 VAC models. Failure to do so could result in electrical shock to personnel and will result in damage to sterilizer.

Do not use this sterilizer in an explosive or oxygen-enriched atmosphere. Failure to do so could result in serious personal injury or death.

NOTE

Grounding reliability can only be achieved if this unit is connected to a matching three-pronged, grounded, isolated, correctly polarized receptacle.

The electrical rating for the 230 VAC unit is 230 VAC, 50/60 Hz, 10 amps. The electrical rating for the 120 VAC unit is 120 VAC, 60 Hz, 15 amps. The electrical rating for the 100 VAC unit is 100 VAC, 50/60 Hz, 20 amps. The three-pronged grounding plug on the sterilizer power cord must be plugged into a matching three-pronged, grounded, isolated, correctly polarized receptacle. Check the serial number label on the back panel of the sterilizer to verify the voltage rating for the unit.

DESCRIPTION

Operational Features

The M11 UltraClave™ sterilizers . . .

• will begin a sterilization program cycle when a sterilization program is selected, the door is closed and fully latched, and the START switch is pressed.

• will automatically fill the chamber with water to the correct level once the

START switch is pressed.

• begin the cycle time countdown only after the proper pressure and temperature have been reached.

• automatically exhaust the steam pressure from the chamber and open the door slightly to facilitate drying upon completion of the sterilization phase.

• automatically starts a 30 minute drying phase. Items that do not require drying may be removed any time after the sterilization phase is complete. Ste-

rility of unwrapped items and moist wrappings is compromised on exposure to a non-sterile environment.

• will signal the operator that the drying phase and therefore the sterilization

6

Return To Table Of Contents

program cycle is complete by sounding five audible “beeps”. The sterilizer may be switched to standby at this time or restarted if additional sterilization programs are desired.

Mechanical Features

The M11UltraClave™ sterilizers . . .

• have a tray rack which can hold two small and two large trays. The tray rack can be removed for periodic cleaning of the chamber, tray plate, tray rack, and filter.

• have an optional printer which provides a permanent record of actual exposure times and temperatures.

• have a removable power supply cord (100 and 230 VAC units only).

• have a two gaskets in the door; a dam gasket and a door gasket which can easily be replaced by operator in seconds.

Safety Features

The M11UltraClave™ sterilizers . . .

• have a

door stop

which prevents the door from opening fully if there is a slight residual pressure in the chamber when the door handle is operated.

The door stop also retains the door in a partially open position during the drying cycle.

• have a

door closed switch

which is used to signal the sterilizer that the door is completely closed. This switch is activated just as the door becomes fully closed. An audible signal will sound and the “Door Ajar” light will flash if the door is not fully closed.

• have a

water low indicator

which signals the operator if there is insufficient water to fill the chamber to the proper level. An audible signal will sound and the “Water Low” light will flash if the reservoir needs to be refilled with water.

• have their

chamber temperature monitored

during a cycle to prevent an overheat condition. If chamber temperature reaches or exceeds 146°C

(295°F), power to the sterilizer is cut off.

• have a

pressure relief valve

which opens to provide backup protection to reduce chamber pressure in the event that the chamber steam pressure exceeds the allowable limit. Released steam is directed out of the bottom of the unit’s cabinet. An access cover is located on the top cover for relief valve operational checks.

• have a

fault detection circuit

which monitors all functions of the sterilizer during a cycle. If a fault occurs during a cycle, the sterilizer monitoring circuitry will stop the cycle, sound an audible signal, and light a flashing error lamp.

Installation

Description

7

Components

Overview

Return To Table Of Contents

COMPONENTS OVERVIEW

The illustration below shows the location of the sterilizer’s major components and the chart below provides their descriptive name.

1

8

3

6

2

4

5

7

MA439900

1. Access Cover

2. Reservoir Lid

3. Printer (Optional)

4. Level Indicator / Reservoir

Drain Tube

DESCRIPTION OF COMPONENTS

5. Door and Dam Gaskets

6. Display / Control Pad

7. Wire Tray Rack and Tray Plate

8. Pressure Relief Valve

8

Return To Table Of Contents

CONTROLS & INDICATORS

The following illustrations show the location of the sterilizer’s controls and indicators and the chart on the following pages describes their function.

1

3 4

5 6 7 8 9

TEMP (

°

F) TIME (MIN : SECONDS)

FILLING STERILIZING DRYING COMPLETE WATER LOW DOOR AJAR ERROR

PRESSURE (PSI)

2

UNWRAPPED POUCHES LIQUIDS PACKS

10

11

18

12

13

START STOP ON/STANDBY

14

15

16

17

Components

Overview

Controls &

Indicators

20

19

MA439400

9

Controls &

Indicators

Return To Table Of Contents

4

5

6

2

3

Ref.

1

7

8

9

10

11

12

13

Control Function

Temperature / Time display

Pressure display

FILLING indicator

ERROR indicator alternately indicates cycle temperature and exposure time when a cycle is selected. During a cycle, the cycle time remaining is displayed.

indicates current chamber pressure during a cycle.

illuminates when the chamber is being filled with water at the beginning of a cycle.

STERILIZING indicator illuminates during the heat up and sterilization phases of a cycle.

DRYING indicator

COMPLETE indicator illuminates during the drying phase of a cycle.

illuminates when a cycle is complete, indicating that the sterilized goods may be removed at this point.

WATER LOW indicator indicator flashes (and a beep sounds) when the water level is too low in the reservoir to initiate a cycle.

DOOR AJAR indicator indicator flashes (and a beep sounds) when the door is not completely latched.

indicator flashes (and a beep sounds) when a cycle is terminated before completion.

UNWRAPPED button

POUCHES button

LIQUIDS button

PACKS button

NOTE: a corresponding error code is displayed on the Temperature / Time display any time an error occurs. See Error Code Guide for a detailed explanation of each error code.

when pressed, selects a program cycle designed to process unwrapped instruments at 132°C (270°F) for 3 minutes with a 30 minute drying cycle following the sterilization phase.

when pressed, selects a program cycle designed to process instruments and dental handpieces in combination paper / plastic sterilization pouches or wrapped instruments at 132°C (270°F) for 15 minutes with a 30 minute drying cycle following the sterilization phase.

when pressed, selects a program cycle designed to process non-volatile liquids at

121°C (250°F) for 30 minutes.

when pressed, selects a program cycle designed to process packs of instruments at

121°C (250°F) for 30 minutes with a 30 minute drying cycle following the sterilization phase.

10

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Ref.

14

15

16

17

18

19

20

Control

START button

STOP button

ON / STANDBY button

Printer

Door Handle

Level Indicator / Reservoir Drain Tube

Fill opening

Function

when pressed, initiates the program cycle that has been selected.

when pressed, terminates the program cycle currently in progress.

when pressed, turns the sterilizer ON or into

STANDBY mode. If the ON / STANDBY button is pressed during a cycle, the program cycle is aborted. In Standby mode, all program buttons and indicator lights are locked out to prevent accidental program initiation.

The printer (optional equipment) can be used on all models to provide a permanent record of the time, temperature, and pressure reached during a cycle. Refer to the Printer section later in this manual for detailed information on printer features and operation.

used to open or latch the door. The door handle is raised to unlatch the door and lowered to latch the door.

indicates the water level in the reservoir. Also, the tube may be detached from its clips and used to drain the reservoir quickly and easily into a suitable container.

allows distilled or demineralized water to be poured into the reservoir from the front of the unit (with door in open position).

OPERATION

DANGER

Do not use this sterilizer in an explosive or oxygen-rich atmosphere, or where flammable anesthetics are stored. To do so could result in an explosion or fire.

If the sterilizer malfunctions, immediately unplug sterilizer. If the sterilizer continues to malfunction, call for service; do not attempt to repair the sterilizer yourself.

EQUIPMENT ALERT

For optimal sterilizer performance, allow the sterilizer to reach room temperature before operating.

Controls &

Indicators

Operation

11

Operation

Return To Table Of Contents

Recommended Steam Sterilization Monitoring Program

Physical monitors (temperature and pressure measuring devices) can be used to help detect failures in sterilizer function. The sterilizer notifies the user if sterilization conditions fall outside of established limits. It is recommended that the

Printer Accessory be used to create a record of each load’s actual cycle time, temperature, and pressure.

Process monitors, such as biological indicators and chemical indicators, should be included in each sterilization cycle. The process monitors detect whether the cycle parameters were delivered. Process monitors cannot establish that a processed item is actually sterile. If the monitors detect a failure, the user must determine the source of the failure. Failures could result from improper packaging, loading, or sterilizer malfunction. Follow the process monitor manufacturer’s instructions for proper selection, storage, use, and interpretation of their devices.

Follow the appropriate agency (state dental or medical board) for sterilization monitoring guidelines for your office. Additional information can also be obtained from CDC, AAMI, OSAP, and ADA regarding monitoring programs or other sterilization issues.

Sterilizer Preparation Before Operation

EQUIPMENT ALERT

Check the serial number label (1) on the back panel of the sterilizer to verify the voltage rating for the unit. Failure to do so could result in damage to the unit.

1. Locate the sterilizer and plug in its power cord in accordance with the Installation instructions contained earlier in this manual.

EQUIPMENT ALERT

Use only distilled or demineralized water. Normal tap water contains minerals, especially chlorides, which have corrosive effects on stainless steel. Failure to use distilled or demineralized water may cause serious deterioration and premature failure of the stainless steel chamber which could result in serious injury or death.

12

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2. Open the door and pour distilled or demineralized water into the fill opening (2) until the water level found in the Level Indicator

Tube (3) is at the top of the red / green fill level label (4).

3. If the unit has a printer (optional equipment), turn the printer to

ON.

Cleaning Instruments

3

2

1

DANGER

Clean and dry instruments before putting them into the sterilizer. Incomplete and improper cleaning of instruments will impede sterilization and will result in unsterile instruments which could lead to personal injury or death.

4

1. Clean instruments in accordance with instrument manufacturers’ and OSHA’s recommendations.

MA440000

2. Thoroughly wash instruments to remove gross debris (either mechanically or using an ultrasonic cleaner).

3. Rinse instruments thoroughly.

4. Dry instruments.

Operation

13

Operation

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Guidelines For Loading Trays

Sterilizer loading is critical to effective sterilization.

Protective coverings designed to be used in steam sterilization processes should be used to help ensure that items retain sterility until used. A proper load for a sterilizer is determined by the number of items to be sterilized, their characteristics, and how they are prepared and positioned within the sterilizer. A single large item may be the maximum load for that type of item while the maximum load for very small items may contain hundreds of items. Large and small items can be included in the same load. The sterilization process will be effective if items are properly prepared and positioned, so they get adequate contact with steam for the correct amount of time.

The M11 sterilizers are equipped with two large and two small trays to maximize the number of items that can be processed at one time and provide separation for better steam flow and penetration. Four properly loaded trays, as noted in the chart on page 15 (two large and two small), is the maximum load for the

M11 sterilizers.

General Guidelines

• Sterilize jointed instruments in an open position.

• Place all containers so the opening allows steam to enter and air to leave the container (containers are usually positioned on their side or with the opening tilted slightly down).

• Pouch or wrap items to preserve sterility after processing. Use only protective coverings designed and recommended for use with steam sterilization.

• Do not wrap items too tightly. Steam penetration will be affected if an item has excessive wrapping.

• Do not stack trays on one another. Using Midmark’s standard tray rack and trays provides proper tray spacing.

• Position loads on trays with appropriate space between items. Adequate space is required between items to allow proper steam flow and drying.

• Place unwrapped items on a towel or absorbent paper.

• Vented liquid containers should not be filled to more than 75% of their capacity to allow for fluid expansion and to prevent overflow. Depending on the user’s desired results, many different container styles may be acceptable. Careful consideration of the liquid to be sterilized should guide the user in selection and use of appropriate containers and closures. Always consult the liquid and/or container manufacturer for information on sterilization.

Not recommended for sterilization of liquids intended for direct patient contact.

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Loads Including Dental Handpieces and/or Instruments

NOTE

Dental handpieces should only be sterilized when placed in a pouch and in the POUCHES cycle. Only one handpiece should be placed in each pouch.

The maximum M11 load shall be nine handpieces (in the pouch rack) and 75 instruments. Other combinations of fewer handpieces and items can be processed in a single load if that allows for efficient sterilization. If a load surpasses these limits, we recommend dividing the load and running multiple cycles. Listed below are the maximum recommended loads for each tray:

Load Type

Solid Items

Handpieces

Liquids (

)

Packs (

‡)

Maximum Capacities

M11 Large /

Deep Tray

45 instruments — 1224 grams (2.7 lbs.) or

9 in rack or

30 instruments — 816 grams (1.8 lbs.) or

9 in rack or

3 — 198 ml (6.76 oz) containers or

4,424.5 cu. cm up to

5.0 cm thick (270 cu. in. up to 2 in. thick)

M11 Small Tray

2 — 198 ml (6.76 oz) containers or

3,195.5 cu. cm up to

5.0 cm thick (195 cu. in. up to 2 in. thick)

Sterilizer Total

150 instruments — 4.1 kg (9.0 lbs) or

9 handpieces in rack and 75 instruments or

3 — 198 ml (6.76 oz) containers or

15,240 cu. cm up to

5.0 cm thick (930 cu. in. up to 2 in. thick)

Not recommended for sterilization of liquids intended for direct patient contact.

Packs to have a minimum of 1/4 in. (6.3 mm) space between each other and away from all sterilizer surfaces.

Operation

15

Operation

Operation

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WARNING

Do not use this sterilizer in an explosive or oxygen-rich atmosphere, or where flammable anesthetics are stored. To do so could result in an explosion or fire.

Do not use this sterilizer for sterilizing volatile substances or for any purpose other than its intended design. Burns and toxic or explosive conditions could result.

Clean and dry instruments before putting them into the sterilizer.

Incomplete and improper cleaning of instruments will impede sterilization and will result in unsterile instruments which could lead to personal injury or death.

If the sterilizer malfunctions, immediately unplug sterilizer. If the sterilizer continues to malfunction, call for service; do not attempt to repair the sterilizer yourself.

Do not force door handle at any time. Chamber pressure may cause door to open with extreme force. If the door handle does not move freely, allow unit to cool and depressurize for 40 minutes before opening door. Failure to adhere could result in serious personal injury or death.

EQUIPMENT ALERT

Do not use toweling or packaging which may contain chlorine bleach residue. Doing so could result in trays and/or chamber rusting or discoloring. In extreme cases, the life of the chamber may be significantly shortened.

NOTE

Use sterility monitors with each sterilization load. Also, if a sterilizing cycle is terminated prematurely, reprocess the instruments to ensure the sterility of the load.

Refer to the following steps for a detailed description of the program operating procedures:

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hide

3 5 6 8 9

TEMP (

°

F) TIME (MIN : SECONDS)

FILLING STERILIZING DRYING COMPLETE WATER LOW DOOR AJAR ERROR

PRESSURE (PSI)

START STOP ON/STANDBY UNWRAPPED POUCHES LIQUIDS PACKS

7

2

4

1

MA439200

1. Press the ON / STANDBY button (1).

• The Selector / Indicator panel turns on (displays will illuminate).

• The Program Indicator lamps (2) flash until a sterilization program is selected.

NOTE

Before operating the sterilizer, be sure the door handle is completely depressed (latched). If the handle is not fully latched, the sterilizer will alert the operator with an audible beep and will not start until the door handle is latched.

2. Close and latch the door; the sterilizer will not operate unless the door is closed.

EQUIPMENT ALERT

Processing goods using an incorrect sterilization program could result in unsterile goods and may damage instruments. Consult with your supply manufacturer for specific sterilization instructions.

3. Select a sterilization program in accordance with the Standard Cycle

Parameters (see table later in this manual).

• The Temperature / Time display (3) displays the selected program’s parameters alternately.

• If an incorrect program selection is made, select the correct program cycle by pressing the correct program cycle button (2).

4. Press the START button (4).

Operation

17

Operation

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• The sterilizer automatically begins processing its sterilization load.

• The FILLING lamp (5) illuminates and the chamber automatically fills to the correct level.

• The STERILIZING lamp (6) illuminates, indicating that the sterilizer is in the heating and sterilization phase of the selected cycle.

• When the correct temperature (3) and pressure (7) are reached, the sterilizer begins its time countdown. The selected exposure time and temperature are maintained throughout the sterilization phase.

• When the exposure time is complete, the sterilizer vents the chamber of all steam and water back into the reservoir tank.

WARNING

Keep clear when the door is ready to open. Five series of three audible beeps will be heard prior to partial door opening. Leave door in this position until steam dissipates. Failure to do so could result in severe burns from steam being released.

• When venting is complete and the pressure inside the chamber is reduced to zero, the sterilizer signals the operator with five series of three audible beeps, warning the operator that the sterilizer door is opening.

• The door opens, the DRYING lamp (8) illuminates, and the sterilizer begins a 30 minute drying phase (unless Liquids cycle was selected).

CAUTION

The processed load and metal inner surfaces will be hot at the completion of the drying phase. Avoid contact. Failure to do so could result in serious burns.

NOTE

The sterility of wrapped or packed instruments cannot be ensured unless the wrapped or packed instruments are allowed to dry fully.

• Leave the sterilization load in the chamber to dry or remove the sterilization load from the chamber if drying is not necessary.

• When the 30 minute drying phase is complete, the sterilizer signals the operator that the drying phase is complete with five series of three audible beeps and the COMPLETE lamp (9) illuminates to indicate that the program cycle is complete.

• Remove the sterilizer load from the chamber.

5. Press the ON / STANDBY button (1) to return the sterilizer to the STANDBY mode

or

if additional sterilization program cycles are desired, restart the sterilizer at this time.

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Standard Cycle Parameters

The following table lists the standard cycle parameters for the four different types of sterilizer loads (follow state and federal guidelines regarding sterilization of single use devices and instruments).

Standard Cycle Parameters

CYCLE TEMP / PRES-

SURE/TIME (minimums)

Unwrapped 132°C (270°F) /

186 kPa (27 psi) for 3 minutes

Pouches 132°C (270°F) /

186 kPa (27 psi) for 15 minutes

Liquids 121°C (250°F) /

104 kPa (15 psi) for 30 minutes

Packs 121°C (250°F) /

104 kPa (15 psi) for 30 minutes

ITEMS TO BE STERILIZED

(Always consult the item manufacturer’s recommendations for sterilization.)

Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C

(270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment.

Instruments and dental handpieces.

Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C

(270°F) for 15 minutes.

Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions.

Not recommended for sterilization of liquids intended for direct patient contact.

Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at

121°C (250°F) for 30 minutes.

List of Authorized Accessories

Listed below are the accessories which are authorized for use with this sterilizer:

Accessory Name Order Number

• Printer Accessory 9A155001

• Speedclean, 1 case (12 bottles) 002-0396-01

• Speedclean, 1 bottle 002-0396-00

Operation

19

Operator

Maintenance

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• M11 Sterilizer Deep Tray

• Sterilizer Pouch Rack

• M11 Horizontal Cassette Rack

• M11 Vertical Cassette Rack

9A225001

9A226001

9A215001

9A215002

OPERATOR MAINTENANCE

It is the responsibility of the user to establish a periodic maintenance procedure to assure correct operation of the equipment and reliable sterilization of the loads. Contact your local distributor or representative to develop a program for planned maintenance.

Daily

1. Clean External Surfaces — Wipe with a soft dry cloth and wash occasionally with a damp cloth and mild soap or detergent.

WARNING

Make sure that the unit is cool when cleaning the door gasket and any mating surfaces. Failure to do so could result in serious burns to hands.

2. Clean Sterilizer Door Gasket — Clean door gasket and mating surface with a damp cloth. Examine gasket for possible damage that could prevent a good sealing surface.

Weekly

EQUIPMENT ALERT

Do not use abrasive or bleaching agents in the chamber (i.e. steel wool, scouring powder, bleach, etc.). Also, never use a wire brush. If these materials are used, possible damage to the metal surfaces of the chamber and other components could result.

1. Clean Chamber and Trays — The sterilizing chamber and instrument trays should be cleaned weekly. First, drain the water from the reservoir. A drain tube is located on the front of the unit for draining. Wash the inside of the chamber and the trays with mild soap or Speed-Clean and distilled or demineralized water. Refill the reservoir with distilled or demineralized water.

Monthly

1. Flush the System — To protect the intricate parts of the unit, the system must be flushed once a month with Speed Clean Sterilizer Cleaner:

20

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(a) Drain reservoir and fill with clean, distilled water then add one ounce of

Speed Clean Sterilizer Cleaner to a cool chamber.

(b) Run one 30 minute cycle (PACKS) at 121°C (250°F). Instruments must not be sterilized while cleaning the sterilizer.

(c) Drain reservoir fill with clean distilled or demineralized water and run one

3 minute cycle (UNWRAPPED) at 132°C (270°F).

(d) Drain reservoir and allow sterilizer to cool to room temperature. Remove the trays, tray rack (1), and the tray plate (2).

This is accomplished by grasping the tray rack (1) on both sides in the front and gently pulling outward. The tray rack and tray plate should slide out of the chamber together.

2

1

(e) Wipe out the inside of the chamber being careful not to damage the heater element or the temperature and level sensor components. Wipe off the trays, tray rack, and tray plate.

30

°

A

3

MA439000

(f) Re-install the tray rack (1) and tray plate (2) in the chamber as follows:

Position the two rear posts of tray rack in rack holes (A) of tray plate.

Then, hold front end of tray rack at approximately a 30° angle from the tray plate. Then, insert rear end of tray rack and tray plate as an assembly in chamber (3). Push tray rack and tray plate into chamber completely. Re-install the trays.

(g) Refill the reservoir with clean distilled or demineralized water.

2. Perform Pressure Relief Valve Check — The pressure relief valve must be checked each month by a qualified person to be sure that the relief valve is functioning properly:

Operator

Maintenance

21

Operator

Maintenance

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(a) Remove the top inspection cover (1).

(b) Select the UNWRAPPED cycle and

START the cycle.

1

A

WARNING

The pressure relief valve will be hot. Do not use bare hands to pull wire ring; use a screwdriver or rod. Failure to do so will result in burns to hands. Also, steam will be vented from under the rear of the sterilizer. To keep from being burned, place a steam barrier (a rolled up towel around the bottom of the sterilizer.

2

MA438900

(c) When the “heat up” portion of the cycle is complete and the elapsed time is being counted down on the display panel, pull upward on wire ring (A) of pressure relief valve (2) with a screwdriver for approximately 3 seconds; steam should discharge freely from beneath the rear of the unit.

NOTE

If the pressure relief valve does not close completely when the wire ring is released, pull the wire ring again and release it quickly so the valve snaps back into position. Do this until the valve seats properly.

(d) Release the wire ring of pressure relief valve (2). The steam should vent out of the pressure relief valve until the wire ring is released. When the wire ring is released, the valve should seat, stopping the release of steam.

(e) Press STOP to prevent the unit from overheating.

(f) If excessive force is required to open pressure relief valve (2) or pressure relief valve will not reseat properly, the pressure relief valve must be replaced (See Calling For Service later in this manual).

(g) Install top inspection cover (1).

22

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3. Cleaning Chamber Filter:

(a) Before performing this procedure, make sure that the sterilizer has cooled to room temperature.

(b) Open the sterilizer door and remove all trays, tray rack, and tray plate from the chamber. Locate the chamber filter (1) on the bottom of the chamber.

1

NOTE

If the filter cannot be cleaned effectively, the filter must be replaced.

MA438800

(c) Grasp the filter (1) and gently pull upwards while twisting slightly (a pair of pliers may be used if filter is stuck). The filter may be cleaned with mild soap and distilled or demineralized water. A small stiff bristled brush or ultrasonic cleaner may be helpful to remove foreign objects from the filter surface. Rinse the filter with distilled or demineralized water.

EQUIPMENT ALERT

Do not operate the sterilizer without the filter in place. Doing so could result in the sterilizer malfunctioning.

(d) Replace the filter (1) by inserting the filter into the hole in the chamber bottom and pressing downwards while twisting slightly.

Quarterly

1. Remove and Clean Door Gasket — the door gasket and dam gasket must be removed and checked and the gasket housing channel must be cleaned as follows:

Operator

Maintenance

23

Operator

Maintenance

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(a) Open sterilizer door. Then, remove dam gasket (1) and door gasket (2) from door (3).

(b) Clean the gaskets (1 and 2) with a mild detergent and inspect the gaskets for cracks, cuts, shrinkage, or swelling. Replace gaskets if necessary.

3

(c) Clean the gasket housing channel (A) with a solution of mild soap and distilled or demineralized water. A small brush (not wire brush) may be used to aid the cleaning.

(d) Press the door gasket (2) into the channel (A). Then, install dam gasket (1).

(e) Run one cycle to seat the gaskets properly.

Troubleshooting Guide

A

1

2

MA438700

Use the following table to assist in correcting minor problems with the sterilizer.

Troubleshooting Guide

Problem Possible Cause

WATER LOW lamp in on.

not enough water in reservoir tank to fill chamber.

DOOR AJAR lamp is on.

Chamber door is not fully closed and / or latched.

ERROR lamp is on.

_

Steam is escaping from the pressure relief valve.

pressure relief valve was not properly reseated after pressure relief valve inspection

Solution

add distilled or demineralized water to reservoir tank.

Close the door properly and make sure the door is fully latched.

See Error Code Guide for a detailed explanation

Reseat the pressure relief valve (see Perform Pressure

Relief Valve Check under

Monthly maintenance in this manual).

24

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Problem

Sterilization failure evidence from process monitor (chemical indicator, biological indicator, etc.)

Door gasket leaks.

Packs not dry

Troubleshooting Guide — (Continued)

Possible Cause

sterilization conditions were not present at the location of the indicator.

insufficient air removal, low temperature, or low pressure.

indicator is out of date, is inappropriate for sterilizer cycle, or has malfunctioned.

door gasket is damaged or dirty.

sterilizer is not level.

sterilizer is overloaded.

chamber filter is clogged.

Solution

reload the sterilizer in accordance with Guidelines for Loading Trays. If the problem recurs, take the unit out of service and contact an authorized service representative (see

Calling For Service later in this manual).

take the unit out of service and contact an authorized service representative (see

Calling For Service later in this manual).

use an indicator, appropriate for the load and cycle selected, from a fresh supply that has been stored properly. Contact the indicator manufacturer for additional information on proper selection, use, storage, and potential misapplication or malfunction.

allow sterilizer to cool; then clean or replace door gasket (see Remove and

Clean Door Gasket under

Quarterly maintenance in this manual).

level the sterilizer.

reload the sterilizer in accordance with Guidelines for Loading Trays. If the problem recurs, take the unit out of service and contact an authorized service representative (see

Calling For Service later in this manual).

allow sterilizer to cool; then clean or replace filter (see

Cleaning Chamber Filter under Monthly maintenance in this manual).

Operator

Maintenance

25

Operator

Maintenance

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Problem

Troubleshooting Guide — (Continued)

Possible Cause

sterilizer is not level input voltage is too low.

Solution

level the sterilizer.

have a qualified electrician connect sterilizer to a separate (dedicated) circuit with proper voltage level.

Error Code Guide

Use the following table to determine the meaning of an error code and assist in correcting minor problems with the sterilizer.

Error Code Guide

Problem

Error Code 1

(power interruption to sterilizer)

Possible Cause

unit powered up for first time.

power was interrupted by power outage.

overheat switch was activated.

_

Solution

press ON / STANDBY button and then continue normal operation.

press ON / STANDBY button and then continue normal operation.

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

restart sterilizer after unit stops beeping.

Error Code 2

(STOP button pushed during cycle)

Error Code 3

(ON / STANDBY button pushed during cycle)

Error Code 4

(door ajar during cycle)

_ restart sterilizer after unit stops beeping.

Door was opened during cycle.

door switch not functioning properly.

restart sterilizer after unit stops beeping.

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

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Problem

Error Code 5

(excessive pressure)

Error Code 6

(excessive temperature)

Error Code 7

(pressure low during cycle)

Error Code Guide — (Continued)

Possible Cause

sterilizer overloaded with gauze or linen packs.

Unit is out of calibration or bellows is not functioning properly.

unit is out of calibration.

leaking door gasket.

internal leak in unit plumbing.

Solution

reload the sterilizer in accordance with Guidelines for Loading Trays. If the problem recurs, take the unit out of service and contact an authorized service representative (see

Calling For Service later in this manual).

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

allow sterilizer to cool; then clean or replace door gasket (see Remove and

Clean Door Gasket under

Quarterly maintenance in this manual).

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

Error Code 8

(door malfunction) door did not open at end of cycle.

make sure the tray rack is pushed all the way back into the chamber and is not making contact with door.

Operator

Maintenance

27

Operator

Maintenance

Calling For

Service

Return To Table Of Contents

Problem

Error Code 9

(door malfunction)

Error Code 10, 11, 12

(hardware / software error)

Error Code Guide — (Continued)

Possible Cause

door switch out of adjustment or is malfunctioning.

door did not pop open at end of cycle. Unit may be out of calibration.

Hardware is malfunctioning or software is corrupt.

Solution

contact an authorized service representative (see

Calling For Service later in this manual). DO NOT

OPERATE STERILIZER

AGAIN UNTIL SERVICED.

Rerun cycle to ensure dryness of load.

Sterilization cannot be ensured unless door opens, allowing the load to dry completely before handling.

Do not attempt to operate sterilizer again if error reoccurs. Contact an authorized service representative (see Calling

For Service later in this manual).

allow sterilizer to cool completely. Restart sterilizer. If unit has errors again, unplug unit and contact an authorized service representative (see

Calling For Service later in this manual).

Calling For Service

If you are having a problem or have a question, refer to the inside front cover of this manual and call your dealer. Make sure that you have the information that is highlighted on the inside front cover of this manual available. If you can’t resolve your question or problem with your dealer, call the following number:

Outside CE Union 1-800-Midmark (1-800-643-6275)

8:00 a.m until 5:00 p.m. (Eastern Standard Time in the U.S.)

Monday thru Friday, except for standard U.S. holidays.

Inside CE Union

33-2-430-517-76

Promotal

22, Rue De St. Denis

53500 Ernee, France

28

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SPECIFICATIONS

Physical Dimensions:

Overall Length …………………………… 559 mm (22 in)

Overall Width…………………………….. 457 mm (18 in)

Overall Height……………………………. 445 mm (17.5 in)

Counter Area…………………………….. 457 mm x 406 mm (18 x 16 in)

Chamber ………………………………….. 279 mm Diameter x 457 mm depth

(11 in Diameter x 18 in depth)

Large Trays (2) ………………………….. 381 mm x 152 mm x 25 mm

(15 in x 9 in x 1 in)

Small Trays (2) ………………………….. 381 mm x 152 mm x 25 mm

(15 in x 6 in x 1 in)

Weight:

Empty Reservoir………………………… 45 Kgs (95 lbs)

With Shipping Carton …………………. 48 kgs (105 lbs)

Water Reservoir Capacity …………. Approximately 4.54 Liters to Full Mark

(1.2 gallons)

Electrical Requirements:

NOTE: A separate (dedicated) circuit is recommended for this sterilizer. The sterilizer should not be connected into an electrical circuit with other appliances or equipment unless the circuit is rated for the additional load.

100 VAC, 50/60 Hz Model …………… 20 AMP Circuit, Single Phase

120 VAC, 60 Hz Model ……………….. 15 AMP Circuit, Single Phase

220-240 VAC, 50/60 Hz Model …….. 10 AMP Circuit, Single Phase

Maximum Power Consumption:

100 VAC, 50/60 Hz Model …………… 1425 Watts, 14.2 A @ 100V

120 VAC, 60 Hz Model ……………….. 1425 Watts, 11.9 A @ 120 V

220-240 VAC, 50/60 Hz Model …….. 1500 Watts, 6.3 A @ 240 V

Chamber Pressure at

132°C (270°F) …………………………… 215 kPa (31 psi)

Safety Valve Setting …………………. 276 kPa (40 psi)

Certifications …………………………… ISO-9001 Certified

LIMITED WARRANTY

SCOPE OF WARRANTY

Midmark Corporation (“Midmark”) warrants to the original purchaser its new Alternate Care products and components (except for components not warranted under

“Exclusions”) manufactured by Midmark to be free from defects in material and workmanship under normal use and service. Midmark’s obligation under this warranty is limited to the repair or replacement, at Midmark’s option, of the parts or the

Operator

Maintenance

Calling For

Service

Specifications

Limited

Warranty

29

Limited

Warranty

30

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products the defects of which are reported to Midmark within the applicable warranty period and which, upon examination by Midmark, prove to be defective.

APPLICABLE WARRANTY PERIOD

The applicable warranty period, measured from the date of delivery to the original user, shall be one (1) year for all warranted products and components.

EXCLUSIONS

This warranty does not cover and Midmark shall not be liable for the following: (1) repairs and replacements because of misuse, abuse, negligence, alteration, accident, freight damage, or tampering; (2) products which are not installed, used, and properly cleaned as required in the Midmark “Installation” and or “Installation / Operation Manual for this applicable product. (3) products considered to be of a consumable nature; (4) accessories or parts not manufactured by Midmark; (5) charges by anyone for adjustments, repairs, replacement parts, installation, or other work performed upon or in connection with such products which is not expressly authorized in writing in advance by Midmark.

EXCLUSIVE REMEDY

Midmark’s only obligation under this warranty is the repair or replacement of defective parts. Midmark shall not be liable for any direct, special, indirect, incidental, exemplary, or consequential damages or delay, including, but not limited to, damages for loss of profits or loss of use.

NO AUTHORIZATION

No person or firm is authorized to create for Midmark any other obligation or liability in connection with the products.

THIS WARRANTY IS MIDMARK’S ONLY WARRANTY AND IS IN LIEU OF ALL

OTHER WARRANTIES, EXPRESS OR IMPLIED. MIDMARK MAKES NO

IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY WARRANTIES OF

MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. THIS

WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE

PARTS.

SF-1487 REV. A1

PRINTER INSTALLATION AND OPERATION

The printer is an optional add-on that some units may have. The printer may be purchased as an accessory at a later date and installed.

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Installing the Printer

WARNING

Disconnect all electrical power to the unit before removing any of the unit’s covers/ shrouds or making any repairs to prevent the possibility of electrical shock. Failure to comply with these instructions could result in serious personal injury or death.

1. Unplug the power cord from wall outlet.

2. Remove top inspection cover (1) from top cover (2).

3

1

5

2

4

6

2

MA438400

3. Remove two screws (3) and printer cover plate (4) from top cover (2). Store the two screws and printer cover plate in the event that the printer is removed and these parts are needed again.

4. Remove two screws (5) from top cover (2).

5. Pull outward and down on the top edge of the right hand side panel (6) and remove right hand side panel from sterilizer.

Limited

Warranty

31

32

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6. Plug PCB printer harness (1) into PC board (2).

2

5

3

4

OFF ON/FEED

1

7. Route PCB printer harness (1) through harness clip (3) to prevent harness from contacting hot pressure relief valve.

8. Place the printer (4) on the top cover in the recessed area.

9. Connect PCB printer harness (1) into printer harness (5).

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10. Insert two tabs (A) of right hand side panel (1) into two slots (B) of base (2).

3

4

1

B

C

5

6

2

A

4

MA438600

11. Raise top edge of right hand side panel (1) into position under top cover (4) and secure using two screws (3).

12. Install top inspection cover (5) on top cover (4), making sure PCB printer harness (6) is routed into harness cutout (C) of top inspection cover.

13. Plug power cord into wall outlet.

33

34

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Operating the Printer

The paper feed switch on the printer is a rocker type switch.

Push the left side (A) of the rocker switch to toggle the printer ON and OFF. Push the right side (B) of the rocker switch to ON / FEED position to advance the paper.

When the printer is first turned on, it prints the word READY to assure the operator that its built in microprocessor is working properly. When turning the printer

OFF, wait at least 3 seconds before turning the printer back on.

OFF ON / FEED

A

OFF ON/FEED

B

MA439600

Inserting the Paper

Roll

1. Press the left side (A) of the switch to toggle the printer OFF (the lamp will go out).

2. Unroll 5 to 7.5 cm (2 to 3 in.) of paper (1).

3. Cut a straight edge on the paper (1) if it is torn or jagged; this will facilitate the entry of paper into the printer.

4. Slide the paper (1) into the slot (2) on the back of the printer; it will slide in 6.4 mm (1/4 in.) before it stops.

1

5. Press the left side (A) of the switch to toggle the printer ON (the lamp will turn on).

3

4

2

OFF ON / FEED

A

B

MA439700

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6. While holding the paper (1) in place, press the right side (B) of the switch to the ON / FEED position and hold. The printer will activate and a rubber roller will put the paper into the printer compartment. Continue to hold the switch down until the paper emerges from the top of the printer mechanism. Then, when 2.5 cm (1 in.) of paper has emerged from the top of the printer, release the switch.

7. Pull the paper (1) through the printer until 5 to 7.5 cm (2 to 3 in.) of paper is exposed.

8. Put the paper spindle (3) into the paper roll and place the roll with the spindle onto the grooves (4) at the back of the printer.

9. Turn the paper roll so as to take up the slack in the paper feeding to the printer. Make sure the roll of paper turns freely. If it does not turn freely, the paper will jam and possibly damage the printer mechanism.

About the Cartridge Ribbon

The printer takes a cartridge ribbon. When printing becomes faint or difficult to see, you should replace the cartridge. If the printer is used infrequently, the print impression sometimes becomes weak because the ribbon dries out. If the printed material is difficult to read and you suspect this is the cause of the problem, advance to a properly inked portion of the ribbon by pressing and holding the switch in the ON / FEED position for 3 seconds.

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Installing a New Cartridge Ribbon

1. Press the left side (A) of the rocker switch to toggle the printer OFF (the lamp will turn off).

2. Four small grooves (1) are embossed on the left and right side of the printer cover. With the index finger of each hand, press down gently on these grooves.

3. When the printer cover (1) is tilted up to a near-vertical position, you may lift it completely off.

4. Push down on the right side

(B) of the ribbon cartridge

(2) (marked PUSH) and remove the old ribbon cartridge.

3

2

1

B

A

EJECT

PUSH

NOTE

If ribbon ink gets on the printer plastic case, wipe it off immediately. Once it dries, it is difficult to remove.

MA439700

5. Install the new ribbon cartridge (2). Be sure the ribbon is inserted in front of the paper and the ribbon is flat against the paper. Press the ribbon cartridge

(2) downward until it snaps into place.

6. Turn the knob (3) on the ribbon cartridge (marked by an arrow) clockwise to stretch the ribbon so it is tight.

7. Replace the printer cover (1).

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Removing the Paper Roll

EQUIPMENT ALERT

Be sure to pull the paper out of the top of the printer (paper cutter side). Pulling the paper out of the back of the printer will damage the printer mechanism.

Before removing the paper roll, advance the paper about 2.5 cm (1 in.) beyond the paper cutter by pressing down and holding the switch to the ON / FEED position. Lift the paper roll away from the printer housing, and with a scissors, cut the paper roll feeding to the printer. Try to make the cut as straight as possible to facilitate the next reloading of the paper. Now, pull the remaining paper through the printer mechanism.

Power Up Message

When the printer is first turned on, it prints the word READY to assure the operator that its built in microprocessor is working properly. When turning the printer

OFF, wait at least 3 seconds before turning the printer back on.

Printer Tape Description

The printer will print the following information for each program cycle:

Set Temperature

Set Time

Run Number

Date: a blank line is printed so that the date can be recorded on the printer tape.

The printer will print the chamber temperature, the chamber pressure, and the time elapsed in two (2) minute increments during the heat up phase.

During the actual Sterilization Phase of the program cycle, the printer will record the chamber temperature, chamber pressure, and the time elapsed for each minute of the program cycle.

When the sterilizer has completed the Sterilization Phase of the program cycle, the printer will print the word VENT to show that the steam pressure was exhausted from the chamber.

When the sterilizer has completed the Drying Phase of the program cycle, the word COMPLETE will be printed to show that the sterilizer has completed the sterilization program cycle.

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The figure below shows an example of a typical printout of a program cycle:

Typical Printout of a Program Cycle

READY

BEGIN

SET TEMP:

SET TIME:

RUN #

DATE

HEAT UP

DEG

066

066

074

164

219

234

261

STERILIZE

PSI

00.0

00.0

00.0

00.0

04.1

09.4

22.6

273

272

272

272

272

272

273

273

274

273

DEG

272

272

273

274

273

273

30.1

30.0

30.1

30.4

30.4

30.7

31.0

30.8

31.0

30.7

PSI

30.2

30.7

31.3

31.0

30.7

30.4

VENT

COMPLETE

270F

015

001

006

007

008

009

010

011

012

013

014

015

MIN

000

001

002

003

004

005

MIN

000

002

004

006

008

010

012

TEMPERATURE

TIME

CYCLE NUMBER

HEAT UP

PHASE

STERILIZATION

PHASE

NOTES:

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39

40

NOTES:

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Midmark Corporation

60 Vista Drive

P.O. Box 286

Versailles, Ohio 45380-0286

937-526-3662

Fax 937-526-5542 midmark.com

003-1030-00 Rev. F (3/03)

17 мая 2023 01:00



Высокое кровяное давление является самым смертельным фактором риска для женщин во всем мире

Все женщины должны знать свое кровяное давление, чтобы предотвратить сердечные заболевания и инсульт, призвали кардиологи из Европейского общества кардиологов (ESC) во Всемирный день борьбы с гипертонией. Примерно каждая третья женщина во всем мире страдает гипертонией. Повышенное кровяное давление было названо самым важным фактором риска смерти у женщин во всем мире

15 мая 2023 01:00



Первый отечественный аппарат HIFU-терапии прошел регистрацию

Комплекс «ДИАТЕР-М», работа которого основана на использовании ультразвуковых волн высокой интенсивности предназначен для воздействия на ранние злокачественные и доброкачественные опухоли. Разработкой аппарата занималась группа ученых холдинга «Швабе» Госкорпорации Ростех и Санкт-Петербургского политехнического университета Петра Великого.

Все новости

Производитель: EMS

Страна: Швейцария

Паровой стерилизатор с сушкой.
Полный автомат.

Подтвержденная стерильность:

   Необходимый уровень стерильности по европейскому стандарту = 10 в степени –6
   Показатели, достигнутые автоклавами EMS (10 в степени –6), намного превышают европейскую норму.

Объем камеры UltraClave M11: 28 л.

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