Spencer 170 NXT User Manual
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Spencer 170 NXT User Manual

Electronic lung ventilator
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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
www.spencer.it
|
SPENCER ITALIA SRL
– Via Provinciale n° 12 – 43038 Sala Baganza (PR) - Italy
support.spencer.it
- e-mail:
info@spencer.it
Quality System EN ISO 9001 – EN ISO 13485
Electronic lung ventilator
| service:
service@spencer.it
User manual
Spencer 170 NXT
|Ph./Tel. +39.0521.541111
1

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Summary of Contents for Spencer 170 NXT

  • Page 1 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...

  • Page 2: Table Of Contents

    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 non valgono sempre identiche regole. Per questa ragione possono esserci differenze fra quanto qui descritto ed i prodotti consegnati.

  • Page 3: Models

    3. REFERENCES STANDARD As Distributor or final User of the products manufactured and/or sold by Spencer Italia S.r.l., it’s strictly required to know the law dispositions applied in the Country of destination of the goods, applicable to the supplied devices (including the regulations about technical specifications and/or safety requirements.

  • Page 4: Symbols

    4.3 SYMBOLS Symbol Meaning See instructions for use Do not lubricate Lot number Product code Serial number Product compliant with the Medical device directive 93/42/CE 0123 The device must be used before the date indicated on the package (Accessories) Protection against electric shock. Class II Type BF applied part Alternating current Direct current...

  • Page 5: Warranty And Support

     Those who modified or have modified, prepare or have prepared the Spencer Italia S.r.l. medical appliances in such way that they no longer serve the purpose for which they were intended, must satisfy the valid conditions for the first introduction into the market.
  • Page 6 Maintenance/Cleaning Spencer Italia S.r.l. declines any liability for any damage, direct or indirect, which is a result of an improper use of the device and its replacement parts and/or of any repairs made by someone other than the Manufacturer, which employs authorized internal and external trained technicians;...

  • Page 7: Specific Warnings

     If disposable accessories are used, use only once and for only one patient. Do not wash or sterilize after use. Reuse may cause cross- infection. Some symbols contained in this manual refers to the standard accessories included in the purchased device. ...

  • Page 8: Requirements Of Operators

    Requirements of operators Spencer 170 is a device intended for professional use only. Each operator must be trained in their use and maintenance of good operating conditions. Do not allow untrained people to assist in the use of the product, as this may cause injury to themselves or others.

  • Page 9: Residual Risk

    Risks arising from prolonged use, are closely linked to the side effects of NIV.  The reuse of unsterilized patient circuits, involves risks of infection for patients and operators. 8. TECHNICAL DATA AND COMPONENTS Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without prior notice. Technical data DIMENSIONALS Width...

  • Page 10: Components

    I/E Ratio High pressure alarm with frequency <20 bpm 60 mbar ± 5% High pressure alarm with frequency >20 bpm 25 mbar ± 5% Valve Filter Breathing tube 2,5 cmH O espiraz. Respiratory resistance 2,5 cmH 0,12 cmH O a 30l/min 1,73 cmH O inspiraz.

  • Page 11: Pneumatic Diagram

    If opening of the case of the device or any other type of unauthorized modification will be found, the warranty would be voided and Spencer Italia will not have any liability related to the functionality and use of the product.
  • Page 12 Guide and Manufacturer's Declaration The 170 ventilator is intended for use in the electromagnetic environment specified below. The customer and / or user of the ventilator 170 must ensure that the device is used in such environment. IMMUNITY TEST Conformity level Guida all’ambiente elettromagnetico Floors should be wood, concrete or ceramic tile.
  • Page 13 Recommended separation distances between portable and mobile communications equipment and the ventilator 170. The 170 ventilator is intended for use in an electromagnetic environment in which radiated RF disturbance is controlled. The customer or the user of the 170 ventilator may prevent electromagnetic interference by maintaining a minimum distance between the communications equipment radio frequency (RF) Portable and mobile equipment (transmitters) and the 170 ventilator, as described below and in accordance with the maximum output power of the communication device Maximum output power rating...

  • Page 14: Start-Up

    The device must be connected to electrical power supply and to a source of medical gas having the following characteristics: Power supply Medical gas supply Voltage 12 V/DC Pressure From 280 to 600 kPa (-15% + 25%) Needed Current > 1A Flow >...

  • Page 15: Functional Characteristics

    Once the tests are carried out, is necessary to:  Turn off the Spencer 170 by pressing the button “O” for about 2 seconds  Break off the medical gas supply If the device is working properly and the conditions above are met, it can be considered ready for use; otherwise put the device out of service and contact the manufacturer.

  • Page 16: Instruction For Use

    For their use, the pulmonary ventilators require fundamental accessories that make up the patient circuit, which includes in the assembly order the Mask, Patient valve, straight fit, antibacterial filter, corrugated tube. Spencer 170 includes Component Description Straight fit 22/15 Allows the connection between the filter and the patient valve Corrugated tube Canalizes the medical gas flow and connects the devices of the patient circuit.

  • Page 17: Ventilation Modes

    11.4 Ventilation modes CMV ventilation mode This mode is the only one available on 170 and is selected by default when the unit is turned on. It consist in the erogation of the medical gas to the patient according to the parameters set with the adjustment knobs. With this mode, the inspiratory and expiratory time ratio is constantly 1:2.
  • Page 18 Technical high priority alarms GAS SUPPLY Alarm specification 10 sequences of sound pulses spaced 2,5 seconds and dedicated led flashing two times per second Reason of activation The pressure of the pneumatic supply is low Possible causes of activation 1 – The gas supply doesn’t have adequate performances for this device 2 –...

  • Page 19: Cleaning And Maintenance

    To guarantee the traceability of the products and to protect the procedures of maintenance and assistence of Yours devices, Spencer has made available the ASSTEC portal http://service.spencer.it/asstec/login.aspx, which will allow you to view 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.
  • Page 20 12.2.3 Fuse replacement Spencer 170 uses two fuses type F1L250V (Fusibile Fast 5x20mm 1A). The manufacturer assumes no liability related to the use of spare parts not meeting the specifications provided. The fuse is a protection mean for the device, which interrupts the flow of current to the ventilator if it exceeds the maximum value acceptable the device.
  • Page 21 High pressure alarm Test 2: Connect the device to the pneumatic supply. Set the minute volume at the lower value Set the pressure limit at 60 mbar Set the frequency lower than 20 bpm Turn on the device Close with one hand the port used to connect the breathing tube making sure it is completely obstructed. Gradually increase the volume minute until the alarm is activated.

  • Page 22: Periodic Maintenance

    For any operations that are not carried out directly by the manufacturer but by an authorised centre, we have to underline that a report regarding all operations carried out must be requested. This will permit both Spencer Italia S.r.l. and the end user to keep a log book regarding the operations carried out on the device.

  • Page 23: Troubleshooting

    13. TROUBLESHOOTING PROBLEM CAUSE SOLUTION The device is not connected to a medical gas Connect the device to a medical gas supply supply Replace with a new tank and prepare the old one for filling Medical gas alarm The oxygen tank is exhausted procedures The delivered pressure is not sufficient (less than Verify the distribution system , or verify the performance of the...

  • Page 24: Modalità Di Rientro Per Riparazione

    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.

  • Page 25: Demolition

    16. DEMOLITION The components of the patient circuit, when no longer suitable for use, if they haven’t been contaminated by any particular agents, they can be disposed of as normal solid waste, otherwise follow the current regulations for demolition. WARNINGS FOR THE CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 2012/19/EU WEEE: At the end of his life, the product must not be disposed as household waste.

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