Spencer 170 NXT Скачать руководство пользователя страница 1 | Manualshive

Страница: 1 / 25

Spencer 170 NXT Скачать руководство пользователя страница 1

1

User manual

Spencer 170 NXT

Electronic lung ventilator

0123 Class IIb Medical Device, compliant with the Medical device directive 93/42/CE

Warning

The information contained in this manual is subject to change without notice.

The Diagrams are inserted only for reference and may vary slightly from the actual device.
Spencer Italia S.r.l. assumes no responsibility for any errors contained herein or for damage, accidents or consequences connected with the supply,
performance or use of this manual

Prima emissione:

1998

Rev. 3:

21/05/2019

SPENCER ITALIA SRL

– Via Provinciale n° 12 – 43038 Sala Baganza (PR) - Italy

support.spencer.it

- e-mail:

[email protected]

| service:

[email protected]

|Ph./Tel. +39.0521.541111

Quality System EN ISO 9001 – EN ISO 13485

1
2
3
...
»

Содержание 170 NXT

Страница 1: ...d may vary slightly from the actual device Spencer Italia S r l assumes no responsibility for any errors contained herein or for damage accidents or consequences connected with the supply performance or use of this manual Prima emissione 1998 Rev 3 21 05 2019 SPENCER ITALIA SRL Via Provinciale n 12 43038 Sala Baganza PR Italy www spencer it support spencer it e mail info spencer it service service...

Страница 2: ...ESHOOTING 23 13 1 Modalità di rientro per riparazione 24 13 1 How to return for servicing 24 14 ACCESSORIES 24 15 SPARE PARTS 24 16 DEMOLITION 25 Avvertenza Le informazioni contenute in questo documento sono soggette a modifica senza preavviso e sono da intendersi come impegno da parte della Spencer Italia S r l con riserva di modifiche I prodotti Spencer vengono esportati in molti paesi nei quali...

Страница 3: ...sts Regulation 10 Uniform provisions concerning the approval of vehicles with regard to electromagnetic compatibility 4 INTRODUCTION 4 1 Use of the Manual This manual is intended to provide to the health care operator all the necessary information for its safe and appropriate use as well as adequate maintenance of the device Note this Manual is an integral part of the device therefore it must be k...

Страница 4: ...ep in a cool and dry place IP34 Protection of enclosures for electrical devices First digit protection against ingress of particulate greater than 2 5 mm diameter Second digit Protected against splashing water from all directions Warning for the correct disposal of the product according to the European Directive 2012 19 UE External power supply Internal power supply I ON O OFF AUDIO PAUSED Non ion...

Страница 5: ... will be made available to the competent Authorities and or manufacturer if requested In the absence of such documentation sanctions will be applied Do not allow any untrained person to help during the use of the product because they could cause damage to themselves or to others Note Spencer Italia S r l is always at your disposal to organise product training Installers training The installer of t...

Страница 6: ...end of life of the product and must be made available to the competent authorities and or the Manufacturer if requested The cleaning scheduled for reusable products must be performed in accordance to the directions provided by the Manufacturer in the User Manual in order to avoid the risk of cross infections due to the presence of secretions and or residuals The device and all of its components if...

Страница 7: ...s or wrong measurement of ventilation parameters Portable RF communications equipments should be used no closer than 30 cm from any part of the device including cables Otherwise the performance of the device could be compromised In order to maintain the essential performance and basic safety of the device is essential to check before and after each use the integrity of the electrical connections a...

Страница 8: ...erapy For the use of the ventilator a specialized doctor must be present The doctor will be able to determine if the technical specifications of the device makes it suitable to be used on a specific patient and will be the sole responsible for the definition and setting of the ventilation parameters Do not use the device in presence of inflammable substances and anesthetics The device is not inten...

Страница 9: ...leakage decreasing the effectiveness of the ventilation therapy or leading to improper operation of alarms The artificial ventilation can have side effects In order to identify the hazards associated with the use of the device related to the clinical conditions of the patient its essential the presence of an expert doctor who can evaluate the actual benefits provided by the artificial ventilation ...

Страница 10: ...tion according to IEC 60601 1 Classe II if externally powered Internally powered if operating with internal battery Classification applied part Breathing tube filter connector valve mask BF Enclosure protection according to IEC 60529 IP44 Protected against ingress of particles with diameter greater than 12mm Protected against splashing water from all directions 8 2 Components N Description Materia...

Страница 11: ...y would be voided and Spencer Italia will not have any liability related to the functionality and use of the product The pneumatic circuit can be modified or implemented without prior notice 9 INSTALLATION AND START UP 9 1 Installation Warning The device is shipped with unplugged battery Connect the buttery before the start up The installation of the device is a critical step to ensure a proper op...

Страница 12: ... near any part of the appliance including cables etc and should be kept at a distance never less than the recommended and calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 0 583x P d 1 2 x P da 80Mhz a 800MHz d 2 3 x P da 800Mhz a 2 7 GHz where P is the maximum rated power output of the transmitter in watts W according to the transmitter ...

Страница 13: ...and reflection from structures objects and people Guide and Manufacturer s Declaration Immunity to proximity fields from RF wireless communications equipment Test frequency MHz Modulation Immunity level V m 385 Pulse modulation 1 at 18Hz 27 450 FM 2 5Hz deviation 1kHz sine 28 710 Pulse modulation 1 at 217Hz 9 745 Pulse modulation 1 at 217Hz 9 780 Pulse modulation 1 at 217Hz 9 810 Pulse modulation ...

Страница 14: ...ion on a flat floor Drill two holes on the surface for the screws Choose screws of appropriate length according to the installation surface Tighten the screws until a safe fix is reached Make sure the screws are fully seated If they are not perfectly coupled with the surfaces is necessary to choose shorter ones or if the distance between the screw and the surface is reduced apply washers 9 2 Start...

Страница 15: ... AIR MIX selector Allows to choose whether to use the medical gas delivered by the medical gas supply system at 100 NO AIR MIX or at 60 AIR MIX mixing it with air taken from the environment in which is placed the device F ON OFF switch Turn on the device by pressing the I button turn it off by pressing the O button G Alarm LED section Provide visual feedback regarding the activated alarms or their...

Страница 16: ...his LED To disconnect the device from the pneumatic supply push the outer plastic part of the socket in axial direction while pulling out the probe 11 2 Turn on the device Turn on the device by pressing on the button identified with the symbol I The device will perform an autodiagnostic test by turning on all LEDs for about 1 second and emitting 3 short sounds When this test is concluded the devic...

Страница 17: ...ously If connected to the external power supply and the battery is not fully charged the charging will automatically start and the white led next to the symbol will light Flashing of the white led next to the symbol identifies a particular condition that do not allow to charge the battery See par 11 6 The real pressure in the patient circuit is always shown on the manovacuometer placed on the fron...

Страница 18: ...s of activation 1 The battery has a remaining autonomy of about 10 minutes Action to take 1 Connect the device to the external power source as soon as possible Technical medium priority alarms LOW BATT Alarm specification 3 sequences of sound pulses spaced 2 5 seconds and dedicated yellow led flashing one time every two seconds Reason of activation The primary battery has reached a charge level th...

Страница 19: ...the data of the products owned or on the market to monitor and update the plans of periodic reviews to view and manage extraordinary maintenances Routine maintenance of the device must be carried out by operators in possession of specific qualifications trained and experienced in the use and maintenance of the device The operator must always wear adequate personal protection such as gloves and mas...

Страница 20: ...must be replaced every year 12 2 4 Battery replacement The annual maintenance of the device requires among other activities provided by the manufacturer the replacement of all batteries If is necessary to replace the batteries before the annual revision follow these instructions Verify that the device is turned off and disconnected from the power supply Using a coin or a screwdriver open the batte...

Страница 21: ...uito descritte devono essere effettuate prima di ogni utilizzo dell apparecchio To check Required result RESPIRATORY SYSTEM Corrugated Tube Non rebreathing valve PEEP valve if present Face mask Ventilation test Disposable filter Connection All components have to be in good conditions and correctly connected The device or its components must be correctly cleaned or replaced ELECTRIC POWER SUPPLY Tu...

Страница 22: ... Spencer Italia S r l and the end user to keep a log book regarding the operations carried out on the device 12 4 EXTRAORDINARY maintenance Only the manufacturer or centres with written authorisation are authorised to complete any special servicing operations For any operations that are not carried out directly by the manufacturer but by an authorised centre we have to underline that a report rega...

Страница 23: ...e battery The fuse is blown Replace the fuse as described in the manual The device is not working Low voltage has caused the block of the microprocessor Verify the voltage of the power supply Turn off the device and turn on again If the problem persists contact a Service center Turning on the device it does not start the controlled ventilation Failure to electrical or pneumatic supplies or a failu...

Страница 24: ...d Request to specify the defect in order to carry out the repair in the shortest possible time It therefore requires to carefully read the instructions to avoid compromising the device with inappropriate use It requires you to specify the kind of fault to give way to the technical Spencer Italy S r l to judge whether the fault falls into the category of warranty 14 ACCESSORIES Standard equipment E...

Страница 25: ...waste Can be taken to special recycling centers provided by local government or return it to the dealer on purchase of a new device of the same type and used for the same functions Dispose of the product separately avoids possible negative consequences for the environment and human health resulting from inappropriate disposal and allows to recover the materials in order to obtain significant savin...

Отзывы:

Нет отзывов