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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.
First edition:
1998
Rev. 12:
09/03/2015
www.spencer.it
|
Spencer 170/ Kompak 170/ Portavent 170
SPENCER ITALIA SRL
support.spencer.it
- e-mail:
info@spencer.it
Quality System EN ISO 9001 – EN ISO 13485
Electronic pulmonary ventilator
– Strada Cavi n° 7 – 43044 Collecchio (PR) - Italy
| service:
service@spencer.it
Manuale d'uso utente
|Ph./Tel. +39.0521.541111
1
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Summary of Contents for Spencer Spencer 170
- 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.
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Page 2: Table Of Contents
Warning The information contained in this document could be modified without any warning and is not to be intended as a commitment on behalf of Spencer Italia S.r.l. Spencer products are exported to many countries and the same identical regulations are not always valid. For this reason there could be differences between the description here described and the product actually delivered. -
Page 3: Models
Is not indicated for use with newborns. The device substitutes temporarily the breathing functions in those patients who are not able to breathe spontaneously. Spencer 170 is intended to be installed inside a medical vehicle; Kompak and Portavent are transportable systems, with a time of use strictly related to the battery life time and to the autonomy of the medical gas supply. -
Page 4: Symbols
4.3 SYMBOLS Symbol Meaning General or specific warnings See instructions for use Do not lubricate Lot number Product code Serial number Prodotto conforme ai requisiti previsti nella Direttiva 93/42/CEE 0123 The device must be used before the date indicated on the package (Accessories) Protection against electric shock Class II B Type device Alternating current... -
Page 5: Warranty And Support
The suitability of the user to use the product may be attested by the records of training, where the names of those trained, of the trainers, dates and place are Indicated. This register which certifies the eligibility of the operators to use the Spencer device must be kept for a period of 10 years after the disposal of the device itself. -
Page 6: Regulatory Requirements
Spencer Italia S.r.l. disclaims any liability for any damage, direct or indirect, that is the result of incorrect repairs or use of products made by Spencer Italia S.r.l. Repairs must necessarily be carried out by an authorized Spencer Italia service centre, which in using original spare parts will provide a quality repair service in strict accordance with the technical specifications given by the manufacturer. -
Page 7: Specific Warnings
The device must always be accompanied by a replacement unit and/or by a manual ventilation system to ensure the possibility to intervene on the patient in any case. Use of Spencer manual resuscitators is suggested. If connected to the 220V main supply by an adapter, is necessary that its features are like described in this manual, has passed the test for electromagnetic compatibility according to EN 60601-1-2 and electrical safety according to IEC 60601-1 and IEC 62353 reporting the specific marking, and does not affect the electrical safety and electromagnetic parameters of the ventilator. -
Page 8: Requirements Of Operators
6.1 Requirements of operators Spencer 170 and its variants Kompak and Portavent, are devices 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: Technical Data And Components
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 295 mm Height 155 mm Depth 165 mm Weight 3,68 kg Patient circuit weight 242 g... -
Page 10: Components
Components N° Description Material N° Description Material Led battery status, charge Integrated in the PC panel Power connector Al/Steel/Nichel/Nylon and power supply Pressure adjustment knob Medical gas output Anodized Aluminum Volume/minute adjustment Medical gas inlet Brass knob Frequency adjustment knob Battery compartment Lever selection Air Mix/No 9V backup battery... -
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 - Electromagnetic Immunity (EN60601-1-2: 2007) The 170 ventilator is intended for use in the electromagnetic environment specified below. The customer and / or end user of the 170 ventilator must ensure that the equipment is used in such environment. LEVEL OF CEI EN 60601 IMMUNITY TEST Level of conformity...
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Page 13: Start - Up
Select the breathing frequency Select the volume/minute (Spencer 170 can deliver a mixture of air/oxygen from 2 to 20 l/min). Verify that the pressure gauge is on zero position. Test the overpressure valve in the following way: Close with the palm of one hand the patient outlet and turn the pressure limiting knob. -
Page 14: Functional Characteristics
Necessary for the connection to the power source 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... -
Page 15: Instructions For Use
11. INSTRUCTIONS FOR USE 11.1 Principle of operation When turning on the device, the electronics predisposes the device to operate in the mode described as “controlled”. Starts the cyclical delivery of medical gas that is sent to the patient at regular intervals according to the frequency set by the operator. The real pressure in the patient circuit is always monitored by the manovacuometer placed on the front panel. -
Page 16: Cleaning And Maintenance
Failure to carry out the correct cleaning routine could increase the risk of cross infection, due to presence of body fluids and/or residuals. The operator must always wear adequate personal protection such as gloves and mask, etc. during all checking and cleaning procedures. The described operations must be performed after each use of Spencer 170. Turn off the device ... - Page 17 12.2.3 Fuse replacing Spencer 170 uses a fuse type F1L250V (Fuse 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.
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Page 18: Periodic Maintenance
Please note that you must do the cleaning as described in this manual and verify functionality before and after each use. Spencer Italia S.r.l. declines any responsibility for the improper functioning or damages caused to the patient or user by the use of devices not subject to routine maintenance and will void the warranty and the compliance to the Medical Device Directive 93/42/CEE. -
Page 19: Troubleshooting
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... -
Page 20: Accessories
SPENCER MASK – POLYS. AUTOCL. BLACK FACE MASK SZ.4 RM20805A SPENCER MASK – POLYS. AUTOCL. BLACK FACE MASK SZ.5 RM20810B SPENCER MASK – KIT 4 SIZES POLYS. AUTOCL. BLACK FACE MASKS SC60014E 10G wall bracket for ventilators EV50104E Wall bracket for Kompak...
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