Кислородный концентратор nuvo lite mark 5 инструкция

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Mark 5 Nuvo Lite — кислородный концентратор премиум компакт-класса

Устройство Mark 5 Nuvo Lite из линейки товаров американского бренда Nidek оптимально подойдет для оксигенотерапии на дому. Благодаря данному прибору лечение кислородной недостаточности является максимально простым и удобным для пациента. Преимуществом данной модели является минимальный вес, составляющий всего 13,6 кг. Корпус устройства снабжен ручкой и колесами, поэтому его перемещение не представляет сложности даже для пациентов зрелого возраста или людей с ограниченной подвижностью.
Компактный прибор занимает мало места, поэтому Mark 5 Nuvo Lite без труда устанавливается не только в помещении, но и в салоне медицинского транспорта. Аппарат отличается простотой настройки, а уровень шума при работе не создает неудобств. При этом модель является очень производительной, благодаря чему может успешно использоваться для профилактического лечения и оказания срочной медицинской помощи.

Экономичность и легкость в обслуживании

Достоинством концентратора Mark 5 Nuvo Lite является простота сервисного обслуживания. При регулярном применении прибора замена фильтра предварительной очистки производится всего один раз в год.
В целях повышения эффективности кислородной терапии устройство оборудовано трехступенчатой системой фильтрации воздуха, благодаря чему происходит не только повышение содержания кислорода, но и бактериальная очистка воздуха.
Также Mark 5 Nuvo Lite снабжен диагностическим модулем для непрерывного контроля содержания кислорода. При изменении показателей срабатывает световой и звуковой индикатор.

Применение устройства

Концентратор кислорода «Марк 5 НУВО Лайт» компактный и высокопроизводительный прибор.
«Марк 5 Нуво Лайт» используется очень широко:

• Для организации лечения на дому с целью продолжительной кислородной терапии.
• В медицинских учреждениях, при проведении мер неотложной помощи.
• При проведении процедур профилактической кислородотерапии.
• Предназначен для длительной кислородотерапии на дому, в больничных и поликлинических условиях.
• Расходомер с регулятором потока кислорода от 0, 125 до 5 л/мин. (12 положений регулятора потока)
• При максимальном потоке 5 л/мин концентрация кислорода составляет более 90%.
• Круглосуточная работа в течение 24 часов.
• Звуковые предупреждения и оптические индикаторы.
• Счетчик проработанного времени (в часах).

В спортивных клубах и учреждениях санаторно-курортного типа прибор можно использовать для приготовления кислородных коктейлей.

ТЕХНИЧЕСКИЕ ХАРАКТЕРИСТИКИ Марк 5 НУВО Лайт

Ресурс	до 30 000 часов
Электропитание	220/230В ~50Гц 1,55А
Поток кислорода	от 0,125 до 5 литров в минуту (л/мин)
Концентрация кислорода в процентах	от 0,125 до 5 л/мин 90% (+6,5%/3%)
Максимальное давление кислорода на выходе	50,0 кПа (7,0 psig)
Подсчет проработанного времени	Счетчик времени (в часах)
Уровень шума	менее < 45 ДБ
Мощность	максимум 290 Вт
Принадлежности	Увлажнитель кислорода Канюля носовая с трубкой Маска кислородная с трубкой
Эксплуатация при температуре и влажности	от 5°С до 40°С, от 40% до 95%
Условия хранения Температура:	от 40°С до 70°С Влажность: от 10% до 100%
Вес Нетто	14,5 кг
Вес Брутто	16 кг
Упаковка Марк 5 нуво лайт	Картонная коробка с полиуретановыми вставками
Габаритные размеры	585 мм (в) х 360 мм (ш) х 230 мм (г)
Габаритные размеры упаковки	660 мм (в) х 480 мм (ш) х 340 мм (г)
Соответствие европейским директивам и стандартам	93/42 EEC, IEC606012, EN60601+A1+A2, ISO8359:1996, ISO9001: 2000/ISO13485:2003
Классификация устройства	класс II, тип B
Гарантия	3 года

Комплектация

Комплектация Nidek Марк 5 нуво лайт

Концентратор кислорода Nidek Mark 5 Nuvo Lite 1 шт

Удлинительная кислородная трубка 10 м. 1шт.

Маска кислородная 1шт.

Канюля кислородная, трубка 1.8м. 1 шт

Увлажнитель кислорода 1 шт

Фильтр грубой очистки 1 шт

Фильр тонкой очитки, оригинал для Mark 5 Nuvo Lite 1 шт

Инструкция по эксплуатации 1 шт

Гарантийный талон 1 шт

Документы

Инструкция по эксплуатации

Руководство по эксплуатации mark 5 nuvo lite инструкция

Техзадание

Техническое задание на Кислородный концентратор Mark 5 nuvo lite

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Комплект поставки:
Концентратор кислорода 1 шт.
Удлинительная кислородная трубка 10 м. 1шт.
Маска кислородная 1шт.
Канюля кислородная, трубка 1.8м. 1 шт.
Увлажнитель кислорода 1 шт.
Фильтр грубой очистки 1 шт.
Фильтр тонкой очитки 1 шт.
Инструкция по эксплуатации 1 шт.
Гарантийный талон 1 шт.

Наименование товара, товарный знак	Концентратор кислорода Mark 5 Nuvo Lite
Наименование страны происхождения товара	Соединенные Штаты Америки, ОКСМ: USA, 840
Описание требований	Наличие функции или величина параметра
Назначение	Для длительной кислородотерапии
Счетчик проработанного времени (в часах)	наличие
Звуковые предупреждения, оптические индикаторы	наличие
Оптические индикаторы	наличие
Уровень шума	37 Дб
Максимальное давление кислорода на выходе	50,0 кПа
Поток кислорода в диапазоне	от 0,125 л/мин до 5 л/мин (12 позиций переключателя)
Концентрация кислорода	90-95%
Электропитание	220В, 50Гц, 1,55А
Потребляемая электрическая мощность	290 Вт
Габаритные размеры	580 мм (высота) х 350 мм (ширина) х 220 мм (глубина)
Размеры в упаковке	660 мм (в) х 480 мм (ш) х 340 мм (г)
Масса, нетто	13,6 кг
Масса, брутто	16 кг
Упаковка	Картонная коробка
Колесики для передвижения	4 шт. вмонтированы в корпус
Классификация устройства	класс II, тип B
Гарантия производителя	3 года

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Nidek Medical Products, Inc®

Mark5 Nuvo® [M5C5] Oxygen

Concentrator Service Manual

Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Birmingham, Alabama 35217 USA

Telephone: (205) 856-7200 • 24-Hour Fax: (205) 856-0533

Nidek Medical is a trademark of Nidek Medical Products, Inc.

Mark5 Nuvo® and M5C5 are registered trademarks of Nidek Medical Products, Inc.

Section 6.0

Troubleshooting

Appendices

●the electrical installation of the corresponding premises complies with appropriate regulations and codes,

●the device is used in accordance with the instructions for its use.

If the replacement parts used for periodic servicing by an approved technician do not comply with the manufacturer’s specifications, the manufacturer is absolved of all liability in the event of an incident.

Do not open the equipment when it is powered on: risk of electrocution.

This device complies with the requirements of the FDA Quality System Regulation and EU Directive 93/42/EEC, but its operation may be affected by the use in the surrounding area of appliances such as diathermy, high frequency electro-surgical instruments, defibrillators, short wave treatment appliances, cell-phones, CB devices and other portables, microwave ovens, induction hot plates or remote control toys, and more generally, by electromagnetic interference exceeding the levels specified in standard IEC(EN) 60601-1-2.

1.0Introduction

1.1Home Service Provider Responsibility

All Home Service Providers of the Nidek Medical Mark5 Nuvo® Oxygen Concentrator must assume responsibilities for handling, operational check-out, patient instruction, and maintenance. These responsibilities are outlined below and throughout this manual.

WARNING

Mark5 Nuvo units must not be used for or with any life-supporting or life sustaining applications. Patients unable to communicate discomfort while using this device may require additional monitoring. Advise patients to immediately notify their Home Service Provider(s) and/or physician(s) in case of an alarm or any discomfort.

As a Home Service Provider, you must do all of the following:

●Inspect the condition of each Mark5 Nuvo® unit immediately upon delivery to your business location. Note any sign of damage, external or internal, on the delivery receipt, and report it directly to both the freight company and Nidek Medical Products, Inc. immediately.

●Check the operation of each Mark5 Nuvo® before delivery to a patient.

Always operate the unit for a reasonable length of time and check that the oxygen concentration level is within specifications as referred to in Section 2.4. Test the battery and power disconnect alarm as described in Section 2.3 of this manual.

●Deliver Mark5 Nuvo® units only to patients authorized by a physician’s prescription. The Mark5 Nuvo® must not be used as a life-supporting or life sustaining device. A backup supply of oxygen must be available.

●Instruct patients how to use the Mark5 Nuvo® in conjunction with the

Patient Manual.

●Instruct patients to notify their physicians and/or Home Service Providers if they experience any signs of discomfort.

●Instruct each patient how to perform routine maintenance of the cabinet air filter and how to check the alarm system battery. (Refer to Section 3.2.)

Be available to service each patient at any time. Maintain the Mark5 Nuvo® in accordance with Section 4.0.

Repair components and replace parts only as outlined in this manual. Use only Nidek Medical parts for replacement in Mark5 Nuvo® Oxygen Concentrators.

●Refer to the Mark5 Nuvo® Product Warranty if parts replacement is required within the warranty period.

1.2Important Notice and Symbol Explanations

As you read the manual, pay special attention to the WARNING, CAUTION, and NOTE messages. They identify safety guidelines or other important information as follows:

The following harmonized symbols (pictograms), used for non-English language countries, will be located on the exterior of the Mark5 Nuvo® unit:

Read the accompanying documents; particularly the patient operating guide.

Store, ship and use the device in an upright condition.

No smoking within five feet of this device, oxygen-carrying tubing, or accessories.

Indicates an alarm signal.

delivers up to 95% oxygen concentration at flow rates from 1 to 5 l/min. The remaining constituents of the product gas stream are nitrogen and argon, both of which are part of the air we breathe, are inert and are completely safe.

2.2Operational Check

Nidek Medical runs each device through a burn in period and tests every Mark5 Nuvo® Oxygen Concentrator thoroughly after manufacture before releasing for shipment. As the home service provider, it is your responsibility to perform the following test to ensure that no damage occurred in shipping or handling.

1.Open and inspect all concentrator cartons upon receipt. Unpack each unit and remove it from its carton. Inspect the unit itself for damage. If the exterior of the carton is damaged, or the unit itself is damaged, note it on the freight bill signed by the driver.

●Before plugging the unit into the wall outlet, actuate the I/0

(ON/OFF) switch to the I (ON) position and note that the audible alarm sounds continuously. (See Section 2.3). Move the switch to the 0 (OFF) position.

2.Plug in the power cord of the unit, and set the I/0 (ON/OFF) switch to the I (ON) position. Check to see that the following occurs:

●The compressor runs, listen for the sound.

●Exhaust air flows out of the bottom of the unit.

●OPTIONAL for Units Equipped with Oxygen Concentration Status

Indicator (OCSI): The OCSI green light remains off until the oxygen concentration reaches 85% ± 3% (82% ± 2% for 50 Hz units) (approximately two minutes).

3.Turn the flow meter adjustment knob counterclockwise until it stops (wide open). The flow meter should register in excess of 5.5 liters/min. If not, refer to Section 5.8 to adjust the product regulator.

4 Perform an oxygen concentration test, as described in Section 2.4.

2.3Alarm System

The Mark5 Nuvo® Oxygen Concentrator is equipped with a battery-powered alarm system, which sounds a continuous and loud alarm when a power failure occurs or when one or more cycle variables are not within specification. It sounds an alarm if the high or low pressure indicators are activated or if the optional OCSI detects lower than predetermined levels of oxygen concentration. The alarm remains on until you correct the alarm condition or you set the I/0 (ON/OFF) switch to the 0 (OFF) position. Refer to Section 6.0 for a list of probable alarm causes,

2.3.1 Battery Test

The Mark5 Nuvo® battery can be checked by observing that the continuous alarm sounds when the I/0 (ON/OFF) switch is moved to the I (ON) position when the unit is unplugged from the wall outlet.

2.3.2 Power Failure Alarm Test

To test the power failure alarm, perform the following actions:

Unplug the power cord from the wall outlet, and set the I/0 (ON/OFF) switch to the I (ON) position.

This should immediately activate the audible alarm. If it does not, refer to the troubleshooting chart in Section 6.0 of this manual.

2.4Oxygen Concentration Test and Specification

To ensure that the output of oxygen from the device is within specification, you must perform an oxygen concentration test. Test the unit upon delivery to a patient and at periodic intervals. Home Service Providers, based on their expertise and documentation, may establish and implement their own plans for checking oxygen concentration. The interval established may be longer or shorter than 90 days, which is Nidek Medical’s default time period for providers who do not choose to establish their own plan.

1.If an oxygen humidifier bottle is used, remove it from the oxygen outlet.

2.Connect a calibrated oxygen concentration analyzer to the oxygen outlet.

3.Set the I/0 (ON/OFF) power switch to the I (ON) position. (It takes approximately five minutes for the oxygen concentration to stabilize.) Take oxygen concentration readings over a period of several minutes to reduce any cyclic variations

4.Verify that the product flow rate delivered by the unit matches the patient’s prescription and does not exceed the capacity of the unit.

5.Disconnect the oxygen analyzer, and reconnect the humidifier bottle (if used) and any other equipment / accessories that may be required.

6.Adjust the flow meter adjustment knob to the prescribed flow rate.

NOTE

Do not measure oxygen concentration output after the product stream passes through a humidifier bottle, erroneous readings will result and your oxygen concentration measuring device might be damaged.

Nidek Medical Mark5 Nuvo® Concentration Specifications

3.0Patient Instructions

3.1General Instructions

It is important that patients thoroughly understand how to operate the Nidek Medical Mark5 Nuvo® unit. This enables proper treatment as prescribed by a qualified, licensed physician. You must explain that the purpose of this therapy is to alleviate symptoms. If patients experience any discomfort or the unit alarms, they must notify their Home Service Provider and/or physician immediately. You, as the Home Service Provider, are responsible to see that each patient receives the Patient Manual. Explain each step in the operation of the unit to the patient in reference to this manual.

3.2Routine Maintenance by the Patient

To ensure accurate output and efficient operation of the unit, the patient must perform two simple routine maintenance tasks:

•Clean the cabinet air filter

•Check the alarm system battery

3.2.1Cleaning the Cabinet Air Filter

NOTE:

The patient must clean this filter weekly, as described below. The filter may require daily cleaning if the Mark5 Nuvo® unit operates in a harsh environment such as a house heated by wood, kerosene, or oil, or one with excessive cigarette smoke.

1Remove the dirty cabinet air filter from the back of the Mark5 Nuvo® unit.

2Wash the dirty filter in warm water with household detergent, and rinse.

3Use a soft absorbent towel to remove excess water.

4Reinstall the clean air filter on the grille in the back of the unit.

3.2.2 Checking the Alarm System Battery

See Procedure described in Paragraph 2.3.1

4.0Home Service Provider Maintenance

4.1Routine Maintenance

The Mark5 Nuvo® unit has two filters and a 9-volt battery that require scheduled maintenance and replacement.

To ensure that the output of oxygen from the unit is within specification, you must perform an oxygen concentration test. Test the unit upon delivery to a patient and at periodic intervals. Home Service Providers, based on their expertise and documentation, may establish and implement their own practices for checking oxygen concentration. Consult Nidek Medical’s Service and Maintenance Log (A- 15) for the recommended intervals for testing.

Nidek Medical does not require preventive maintenance on the concentrator. You do not need to perform any maintenance as long as the Mark5 Nuvo® unit remains within specifications at the prescribed flow rate. (Refer to Section 2.4)

Cabinet Air Filter

The external cabinet air filter is located on the back of the unit, You can easily remove it by hand. Instruct the patient to clean this filter weekly. (Refer to Section 3.2.1.)

NOTE

The filter may require more frequent cleaning if the Mark5 Nuvo® unit operates in a harsh environment such as a house heated by wood, kerosene, or oil, or one with excessive cooking, cigarette smoke or atmospheric dust.

4.1.2 Final Product Filter Replacement

The final product filter does not require periodic replacement; it needs to be replaced only if it restricts oxygen flow. It is suggested that it be replaced whenever the sieve module is repaired or replaced and after the compressor is rebuilt.

1.Set the I/0 (ON/OFF) switch to the 0 (OFF) position, and unplug the power cord.

2.Remove the cabinet back to locate the final product filter.

NOTE: Observe the position of the filter before removal.

3.Separate the silicone tubing from both sides of the filter.

4.Install the new filter with the inlet side in the same position as before. Push the tubing together so that it overlaps the barbs of the final product filter

5.2.5 Caster Replacement

The casters are a push in type that does not require any fastener. Lay the device on its back to access the casters from the bottom. Pull them straight out away from the bottom.

5.3Compressor

The compressor is the pump within the oxygen concentrator that supplies air to the separation process performed by the sieve beds. The pressure generated by the compressor forces oxygen to flow out of the top of the sieve columns.

The compressor is the likely cause of two potential specific problems:

a.An insufficient amount of air is supplied to the process, and

b.An excessive sound level.

● Air Supply

Compressor output refers to how much compressed air the compressor can produce. This depends upon the model of the compressor, length of stroke, piston diameter, speed of rotation and condition of seals. The cup seals form the seal between the piston and the cylinder wall. As the cup seals wear, the output begins to gradually decrease. This reduction in compressor output results in less air, and thus less oxygen, entering the sieve beds. Therefore, the production of oxygen decreases.

Because this drop in oxygen production occurs over a long period of time, preventive maintenance on the compressor is not required.

You can continue a patient’s therapy on the Mark5 Nuvo® unit as long as the oxygen concentration level at the prescribed liter flow rate is within Nidek Medical’s specification limits. Refer to Section 2.4.

Restrictor

Air

Filter

● Sound Level

The sound level is largely determined by the condition of the compressor’s bearings.

There are four bearings located within the compressor that allow the inner components of the compressor to rotate. If the bearings wear to the point that they become loose and noisy, the compressor becomes noticeably loud and needs servicing. The life of a compressor is determined primarily by its operating temperature. It is extremely important that the cabinet air filters are cleaned and replaced as required.

5.3.1 Compressor Replacement

Remove Compressor Assembly

To remove the compressor assembly for exchange, follow the steps listed below:

1.Set the unit’s I/0 (ON/OFF) switch to the 0 (OFF) position, and unplug the power cord.

2.Remove the cabinet back and front.

3.Disconnect the suction tube.

4.Disconnect the two compressor power cable leads and the two leads to the capacitor at the inline connector.

5.Remove the three screws that connect the compressor plate to the base of the unit, lift and slide out the compressor assembly.

6.Remove compressor from the plate by removing the four compressor bolts.

7.Remove tie wrap from compressor plate wiring harness.

8.Remove the heat exchanger tubing and fittings.