User Manual - Akutbutiken.se
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1. User Manual Electronic Lung Ventilator SPENCER 170 1 GENERAL I NFORMATI ON 1 1 MANUFACTURER Spencer Italia S r l is known all over the world for the production of lung ventilators Our experience customer satisfaction and technology level guarantee the quality of the supplied devices 1 2 CUSTOMER SERVI CE CENTRE For any need regarding use maintenance and spare parts request the Customer is requested to contact the manufacturer or authorised Service Centre specifying the data shown on the label See paragraph 3 5 1 3 CERTIFI CATION Spencer electronic ventilators are realised according to relevant Council Directives 1 4 GUARANTEE Fill and send the specific form to activate the guarantee rt See paragraph 8 2 1 5 STRUCTURE OF USER MANUAL The Customer is advised to read this Manual carefully as the correct use of the device represents the basis of the Customer Manufacturer relationship Spencer Italia S r l Life Support Page 2 21 User Manual Electronic Lung Ventilator SPENCER 170 1 5 1 Object This Manual is intended to give the Customer all necessary information to allow correct use and maintenance of the device It includes information concerning technical aspects operating conditions maintenance safety and replacement parts gt Operators must read this Manual carefully before any action is undertaken Should questions arise regarding the use or care of this produc2. Spencer Italia S r l Life Support Page 16 21 User Manual Electronic Lung Ventilator SPENCER 170 6 3 SERVI CE REQUEST Contact the manufacturer for any information concerning use installation maintenance etc The contacted manufacturer should ask questions clearly with reference to this manual and to the instructions enumerated within 6 4 DEMOLITION In case of demolition of the device it is necessary to separate the plastic pieces from the electronic components which will be collected separately according to the laws in force Concerning the metallic pieces of the device the steel pieces have to be divided from the metallic ones to execute efficient materials recycling 7 REPLACEMENT PARTS 7 1 ORDERI NG SPARES cS Only an authorised technician can perform repairing operations Therefore it is recommended to call the Technical Assistance Centre of the Manufacturer which is at disposal with skilled people appropriate implements and tools and original spares EE To execute the spares orders below mentioned please follow the instructions enumerated in the paragraph 1 2 7 2 LIST OF REPLACEMENT PARTS DESCRI PTI ON Polycarbonate panel ITALIAN EV12170A Pressure condition type K4 for ventilators Spencer Italia S r l Life Support Page 17 21 User Manual Electronic Lung Ventilator SPENCER 170 DESCRI PTI ON Power cable for electronic ventila
3. User Manual Electronic Lung Ventilator SPENCER 170 5 2 OPERATING INSTRUCTION To use correctly and safely the product follow the instructions below mentioned after connecting it with the electric net See par 4 3 Connect ventilator to gas supply by automatic outlet Connect patient circuit and non rebreathing valve Switch ON the device l position on the switch Select frequency Select minute volume the ventilator can supply an air oxygen mixture from 2 to 20 l min in multiples of 2 litres Check that pressure gage pointer is on 0 In every moment the attendant can visualise the patient airway real pressure monitored by the pressure gage on the front panel When device is on it automatically operates in CONTROLLED VENTILATION MODE the gas supply starts Medical gas is supplied to the patient at intervals depending on the frequency value set by the control knob Current gas volume supplied at every respiratory act depends on the minute volume set on the front panel by the control knob it can be estimated dividing set volume by frequency To make selection easier and suggest values on the minute volume and frequency control knobs ICS bands of different colours are used BLUE band child frequency 20 30 litres minute 2 6 GREEN band adult frequency 10 20 litres minute 6 14 Is AIR MIX NO AIR MIX selection depends on patient s needs AIR MIX low oxygen concentration Is suggest
4. 12V A To avoid hypercapnia effects DO NOT USE 100 oxygen for protracted ventilation the device is provided with a special mixer switch to change mixed oxygen air at 60 or 100 3 4 SAFETY SYSTEMS The device is provided with the following safety systems Mechanical overpressure valve Maximum limits of device pressure 60mbar Overpressure valve on the patient valve non rebreathing The valve when positioned on INFANT limits maximum pressure to 25mbar Spontaneous breathing When the ventilator is off or gas supplying is interrupted the patient can breathe spontaneously The device is provided with an independent power supply alarm 9V battery This acoustic and visible alarm signals intermittently the condition of discharged battery The said alarm functions even if the switch of the device is turned OFF Spencer Italia S r l Life Support Page 8 21 User Manual Electronic Lung Ventilator SPENCER 170 3 5 LABELLING E A Labels on the ventilator must not be removed or covered identification FEEDING Identification of CONNECTION electric characteristics Identification Identification MEDI CAL GAS MEDICAL GAS FUSE THA BATTERY BATTERY 12W Spencer Italia S r l Life Support Page 9 21 User Manual Electronic Lung Ventilator SPENCER 170 4 INSTALLATION 4 1 HANDLING AND STORAGE Before effecting transportation of the device ensure
5. reduction of the compliance the ventilator will react with a rise of respiratory pressure at a constant volume Overpressure valve test After assembling and connecting the device to the relevant sources you can execute the following test Close the patient outlet with the palm of a hand and rotate the pressure limit knob to verify the lancet excursion on the manometer 5 3 FUNCTIONING MODES CONTROLLED Breathing PPV This functioning mode is selected automatically by the device when it is turned on It consists in supplying to the patient packets of medical mix regularly at intervals of standard duration as per the frequency selection When operating in this mode the relationship between the duration of the inhalation phase and the duration of the exhalation phase is constantly 1 to 2 5 4 END OF USE After using the device it is necessary to Turn the switch to the OFF position Interrupt oxygen supply 5 5 ALARMS IS Any alarm signal corresponds to an abnormal functioning condition which demands the intervention of the operator As follows are the various abnormal situations which may determine the activation of alarms and the relevant corrective actions the operator must carry out to solve the matter DI SCHARGED I NTERNAL BATTERY Type of signal intermittent visual and acoustic Meaning the internal battery needs recharging Correction connect the ventilator to an external feeding source in compliance with th
6. that the indications of the table below have been followed packaging is adequate and risks of bumping or falling during transportation are minimised IL Preserve the original packaging for possible future handling Is Damages to the device caused by handling are NOT covered by guarantee Repairs or replacement of damaged components are at Customer s expense In case of prolonged periods of inactivity and or before transportation Switch in OFF position Take out the power lead Check the internal battery and if necessary re charge it In case of long inactivity besides the above mentioned recommendations the device must be stored with the precautions relevant to the place and time of stocking Store the device in a closed place Keep it from stress and impacts En Protect device from humidity as well as excessive thermal excursions El par 2 4 Avoid contact with corrosive substances 4 2 PREPARATI ON IG Put the device on a flat surface i e shelf trolley gt If put on an ambulance the ventilator must be fixed correctly using the apposite threaded holes with threaded screws diam 6 A The operations of preparation below listed must be carried out and checked before every use To check Result required Corrugated Tube Must be whole and connected Non rebreathing valve correctly RESPIRATORY SYSTEM pe vas OverpressureTest See section 5 2 VentilationT est The respirator ventilates Press ON functio
7. with a 2 hour self powered electric feeding system after two hours external power feeding is necessary this will automatically recharge the internal system The user interface is in the front control panel realised in abrasive and common medical substances resistant material The front panel has clear and intuitive graphics and the case sleeve protects the control buttons On the right hand side there is a flange with connections for the pressurised oxygen and the supply of medical mix for the patient The wide range of volumes and respiratory frequencies of the SPENCER 170 and the monitoring system for patient safety allows for its use with both adult and paediatric patients 2 2 MAIN COMPONENTS The device is composed of the following main components Frontal panel control All the control devices to operate the ventilator are lodged in this panel Electronic control board Effects the integrated control of all respiratory functions and of the main parameters of respiration Pneumatic block of gas mixing The pressurised gas in entry is sent to the mixing block of the device thanks to a flow cutting valve controlled by the electronic check When turned off any flowing pressurised gas cannot be supplied into the device as it is blocked by the closed off electro valve 2 3 DIMENSIONS AND WEI GHT Weight accessories included kg 4 300 2 4 ENVIRONMENTAL CONDITIONS During handling and During operation storage Temp
8. ER Tolerance 20 70 mbar Range from 20 to 10 mbar 2 mbar Range from 10 to 70 mbar 5 mbar MAXIMUM DEVIATION OF SET VALUES Medical gas flow 1 litre Frequency 1 bpm Note The ventilator does not monitor the oxygen concentration mechanical mixing Unless otherwise specified the parameters are expressed in ATPD Ambient temperature and pressure Spencer Italia S r l Life Support Page 5 21 User Manual Electronic Lung Ventilator SPENCER 170 2 5 1 STANDARDS APPLIED e EN 60601 1 1990 Al 1993 A2 1995 A12 1993 A13 1996 correction specs July 1994 IEC 601 1 2 EN 60601 1 2 EN 794 3 1998 89 336 EC 92 31 EC 2 6 PNEUMATIC DRAWING SCHEMA ay VENTILATOR POLMOMNARI SPENCER 170 SPENCER 190 SPENCER 202 LEGENDA F Serpe O AA z 2 lino fo premene Prefer ole wre de Pages don pardo rapido y de Fralimprr funa piein r amp Foner ier A i La T Eieirel rado a dr id ME E ee eee Mweka ch func oe gt f porian peice risa liisi A Pi Walei di a oe Pi PI cient ia PE Heciapora akai parao Miscelatore gas T hoario TA oria CEA gt riain de ars aro 7 con Venturi At talado at erario SST Bos Pare radio iso Drees Die tree m pre P7 Cenis ceed dl oe mima lt J Equipegplamenta interno anparecchio 2 7 ACCESSORIES Device includes the following accessories PATIENT CIRCUIT Composed of atoxic hose 22mm non rebreathing
9. User Manual ELECTRONIC LUNG VENTILATOR PACE VE ADA ii TN 70 m MA p CEH E H aia LETTET VEH Lay BERAAT lady SPENCER 170 cod EV01170A SPENCER ITALIA S r l LIFE SUPPORT Strada Cavi 7 43044 Collecchio PR ITALIA Tel 0039 0521 541111 Fax 0039 0521 541222 User Manual Electronic Lung Ventilator SPENCER 170 1 GENERAL INFORMATION 1 1 Manufacturer 1 2 Customer Service Centre 1 3 Certification 1 4 Guarantee 1 5 Structure of User Manual 1 5 1 Object 1 5 2 Preservation 1 5 3 Used symbols 2 DEVICE DESCRIPTION 2 1 Operating principle 2 2 Main components 2 3 Dimension and weight 2 4 Environmental conditions 2 5 Technical data 2 5 1 Standards applied 2 6 Pneumatic drawing 2 7 Accessories 2 8 Electromagnetic environment 3 SAFETY 3 1 General warnings 3 2 Intended use 3 3 Contra indications and undesirable effects 3 4 Safety systems 3 5 Labelling 4 INSTALLATION 4 1 Handling and storage 4 2 Arrangement 4 3 Electric Feeding 4 4 Compressed gas feeding 5 OPERATION 5 1 Front control panel 5 2 Start UP 5 3 Functioning Modes 5 4 End of Use 5 5 Alarms 5 6 Troubleshooting chart 6 MAINTENANCE 6 1 Cleaning 6 2 General revision 6 3 Service request 6 4 Demolition 7 REPLACEMENT PARTS 7 1 Ordering Spares 7 2 List of replacement parts 8 ATTACHMENTS 8 1 Declaration of Conformance 8 2 Guarantee form Spencer Italia S r l Life Support Page 1 21
10. e been modified deleted taken off or in any way made illegible This warranty is not valid when the product is used in a way that is non compliant with the prescriptions indicated in the user s instructions The following are excluded from the warranty Any interventions for periodical maintenance and repairing or replacement of parts subject to normal wear and tear Any adaptation or change made to the product to strengthen its performance beyond the one described in the instructions of use and maintenance manual without previous authorisation in writing from Spencer Italia s r l All the costs for technical assistance or for any transport from the Client s premises to the Servicing Centre Laboratory and vice versa as well as any relevant risks Damages caused by Improper use including but not limited to a the use of the product for different purposes to the ones expected or the failed observation of the Spencer Italia s r l instructions of correct use and maintenance and b installation or use of the product non compliant with the technical and safety standards in force in the Country in which the product is used Any repairing carried out by unauthorised personnel or by the Client him herself Any accidents lightning floods fires wrong ventilation or other causes non imputable to Spencer Italia s r l Faults of the plants or devices the product is connected fixed to This warranty does not affect the buyer s rights
11. e specifications provided in paragraph 4 3 I NSUFFI CI ENT FEEDI NG GAS OR PRESSURE Type of signal acoustic Meaning the feeding of medical gas has insufficient pressure and or capacity Correction verify the line and source of feeding Spencer Italia S r l Life Support Page 14 21 User Manual Electronic Lung Ventilator SPENCER 170 5 6 TROUBLESHOOTING CHART gt AAA The ventilator is not connected to Gas Supply a compressed gas source oxygen or medical gas Connect the ventilator to a medical gas source The oxygen bottle is empty ae full cylinder and refill Clean in regulators where it is already possible to replace the filter the regulator or replace it The patient cannot ala Check the fixing of the valve or replace exhale it The non rebreathing valve is Re assembling of the not adequately connected after Adequately connect the N R valve to non rebreathing valve sterilisation to the tube and or the mask and corrugated tube mask compromising good holding The pressure regulator is obstructed Use an external battery or connect to The internal battery is nearly electricity power recharge the internal exhausted battery immediately see recharge battery Dead Battery Spencer Italia S r l Life Support Page 15 21 User Manual Electronic Lung Ventilator SPENCER 170 6 MAINTENANCE 6 1 CLEANING A ILS The operations below d
12. e the external feeding 12V DC please do the following Use only cable EV20010A The free end must be perfectly connected with the ground outlet Brown wire on Blue wire on e Insert the connector dedicated on the ventilator side The device indicates the connection with the net through the EXTERNAL FEEDING led Emergency electrical feeding through a supplementary battery A Do not put the additional battery on the device It must be placed as far as possible from the air entering filter of the ventilator 4 4 FEEDI NG GAS COMPRESSED Is Use oxygen central system or oxygen tank with pressure regulator or compressed air with an entrance pressure from 3 up to 4 5 bar and a minimum capacity of 60 It min Spencer Italia S r l Life Support Page 11 21 User Manual Electronic Lung Ventilator SPENCER 170 5 OPERATION 5 1 FRONT CONTROL PANEL Bourdon pressure gage scale 20 mbar 70 mbar intervals 10 mbar FREQUENCY selection with zero deflection lancet screw knob accessible to the operator used for screening pressure in the patient airways AIRMIX NO AIRMIX Switch ON OFF switch PRESSIONE VIE AEREE Egra EAT SGARIGA FAME INCARCA Y ou AUM ere ADULTO B and colour code MINUTE VOLUME selection knob Led for battery condition and feeding screening AIRWAY PRESSURE LIMIT selection knob Spencer Italia S r l Life Support Page 12 21
13. ed for a medium long use and when there is a small oxygen bottle NO AI R MI X high oxygen concentration Is absolutely necessary in case of air pollution gt A It is absolutely necessary to regulate first the ventilator volume and then pressure because a late volume regulation l min would bring to an immediate change of the pressure limit After choosing volume ventilation keep closed with the palm of the hand the exit outlet of the patient valve where is normally inserted the mask and regulate then the pressure limit with the apposite knob Hyperextend the head and seek after inserting an oral pharynx cannula in the patient s mouth with an apposite manoeuvre in order to guarantee clearness of the airways Place the ventilation mask on the mouth and on the nose of the patient checking the adhesion of the soft part of the mask on the patient s face for a good holding system Selection method of the volume minute knob through trips prevents from value changing during functioning in case of accidental touch Spencer Italia S r l Life Support Page 13 21 User Manual Electronic Lung Ventilator SPENCER 170 gt In case of intubation leave the ventilation mask of the patient valve Insert in the free hose the endo tracheal tube with its connector Resistance of the airways due to obstructions or external cardiac massaging does not cause a variation of the respiratory volume frequency In case of
14. erature from 20 to 60 from 10 to 40 Humidity rel from 10 to 100 from 15 to 95 Atmospheric Pressure from 50 kPa to 106 kPa from 70 kPa to 110 kPa Spencer Italia S r l Life Support Page 4 21 User Manual Electronic Lung Ventilator SPENCER 170 2 5 TECHNICAL DATA ELECTRIC VALUES Electric power feeding Connection to external tension stabilised at 12V DC ChargingTension max 14 V Absorption of current max 244 mA at 12V continuous current 2 93 W FUSES External Feeding 12V 1A INTERNAL BATTERY Functioning time average 120 minutes Recharging time 8 hours Functioning time after signalling of discharged battery 5 min Internal Volume of the Patient Circuit tubes 351 cm MEDI CAL GAS Oxygen centralised plant or tank with pressure regulator Entry pressure from 2 5 to 4 bar Minimum Capacity 60 It min PRESSURES Piima 70 mbar AA 20 mbar P w max maximum ensured through pressure limiter max 10 Bar in entry an 3 Bar VENTILATION Minute Volume from 2 to 20 It min Volume released measurable volume minutes frequency Frequency from 5 to 30 bpm The medical gas flow is not influenced by pressure dry Oxygen concentration 60 100 LE 1 2 Pressure sub atmospheric negative in the exhaling phase not available MANOVACCUUMET
15. escribed must be executed after each use of the device Switch OFF the ventilator Isolate the device from the feeding source net if connected e Disassemble the NON REBREATHING valve e Disassemble the PEEP valve where present Control any presence and remove any residuals in proximity of the connection with the patient circuit Autoclave the non rebreathing valve and substitute the patient circuit I On request a re usable patient circuit can be provided autoclavable After operating the necessary operations of cleaning sterilisation the NON REBREATHING and PEEP where present must be reassembled reconnect the device to the feeding source if necessary gt The external cleaning of the device can be effected to ensure compatibility with the materials with use of apposite disinfectants for surfaces as indicated in the table below PRODUCTS WHICH CANNOT BE PRODUCTS WHICH CAN BE USED USED EE Disinfecting with aldehydes Compounds liberating halogens Disinfecting with alcohol Strong organic acids A Quaternaric ammonic compounds Compounds liberating oxygen 6 2 GENERAL REVISION The ventilator must undergo general revision carried out by skilled and authorised people every 2 years When general revision occurs the following are checked The ventilation parameters frequency volume manovacuumeter The alarms The system holding The battery and the recharging circuit for the battery
16. established in the current national laws in force or the client s rights towards the supplier deriving from the Sales Contract Any expenses and risks of transport from and to the servicing centres mentioned are at the buyer s charge The manufacturer is not responsible for direct or indirect damages of any nature to people or things for the improper use of the product or for the impossibility of use of the product during the time needed for repair For any controversy deriving from the interpretation and or interpretation of this warranty it is of exclusive competence of the judicial authority of the place of origin of the manufacturer to intervene The products must be repaired only at the manufacturer s premises or at an authorised laboratory The faulty product must be accompanied by The under reported form entirely filled in at the purchase moment Enclosed form entirely filled in please send it to SPENCER ITALIA S r l Strada Cavi 7 43044 COLLECCHIO PR ITALIA A document or proof of purchase Spencer Italia S r l reserves the right to contest the validity of the Guarantee form if it results from unbiased checks that the product did work for a long before the purchasing date It is recommended to read the instructions of use carefully before contacting Spencer Italia or its authorised Sellers PRIVACY WARRANTY According to the Art 10 of the 675 96 law we inform You that Your details are kept in our computer archives and are u
17. fuse cuts out Low power feeding current The battery is not recharged Problems with the holding membranes Excessive environmental temperature Gas leaks Excursions of the set flow Possible presence of condense at the moment when Low environmental temperature the ventilator is brought to higher temperatures again Spencer Italia S r l Life Support Page 7 21 User Manual Electronic Lung Ventilator SPENCER 170 3 2 INTENDED USE The device substitutes the breathing functions in those patients who are not able to breathe spontaneously controlled ventilation The following list shows the optimal ventilation parameters PATIENT RESP FREQUENCY CORRENT VOLUME MINUTE VOLUME Adult 10 20 atti min 10 12 ml Kg TVXFR Child until 5Kg 35 40 atti min 10 15 ml Kg TVXFR Child over 5Kg 30 35 atti min 10 15 ml Kg TVXFR For childrens weighing below 5 kg you ought to carry out pressure ventilation observing thorax excursion and avoiding to overcome a pressure of 30 35 mbar The device was designed for use on emergency rescue vehicles i e ambulances helicopters 3 3 CONTRA I NDI CATIONS AND UNDESIRABLE EFFECTS A DO NOT USE the ventilator in neonatal clinics and in patients with pneumothorax A DO NOT USE ventilator in presence of inflammable substances and anaesthetics A DO NOT USE the device if it is connected to an SPS charger or other transformer 220V
18. i President Warning The information contained in this document may be modified without previous notice and should be considered as an engagement from Spencer Italia S r l Spencer Italia S r l Life Support Page 19 21 User Manual Electronic Lung Ventilator SPENCER 170 8 2 GUARANTEE FORM 10 Dear Client thank you very much for purchasing a Spencer product we are certain you will be satisfied with its quality Spencer Italia srl guarantees the product against manufacturing or materials faults for 12 TWELVE MONTHS starting from the date of purchase In case that any manufacturing or materials faults are found during the above stated period of time Spencer s Authorised Sellers or Spencer itself will take care of the repairing or replacement of the product and of any faulty parts within the terms and conditions below listed without any charges for the costs of manpower and of any spare parts Conditions This warranty does not cover costs and or damages and or faults caused by manumission changes or adaptations made to the product without previous written authorisation released by Spencer Italia s r l in order to be compliant with the technical and national or local safety standards that are in force in different Countries from the ones for which the product was originally designed and manufactured This warranty is not valid when the indication of model and serial number shown on the product hav
19. ning mode The respirator ventilates ELECTRIC POWER SUPPLY CONTROLLED A Ensure the availability of a mechanical manual ventilation system i e auto expansible insufflator Spencer Italia S r l Life Support Page 10 21 User Manual Electronic Lung Ventilator SPENCER 170 4 3 ELECTRIC FEEDI NG Connection with the electric net In order to connect the device with the electric net Q tension value indicated on the tension selector must correspond to the net tension Connect the feeder SPS with the lung ventilator through the specific connector and then insert the SPS plug in an electric outlet with a grounding perfectly installed installed following norms VDE 0100 or equivalent national rules the device indicates the connection with the net through the EXTERNAL FEEDING led CONTROL OF I NTERNAL BATTERY RECHARGE The emergency battery embedded recharges automatically during normal functioning of the device connected with feeding 12V CC or with tension 220V Before turning the ventilator on it is necessary to test the battery and if requested to recharge it With a charged battery or in good conditions the ventilator may function two hours With discharged battery or in bad conditions it may function for a shorter time External feeding 12V DC The external feeding may be used in emergency situations or during the use of the ventilator on ambulances and or helicopters In order to us
20. sed by our firm only for the sending of administrative commercial and promotional materials relevant to our activities We inform you moreover that in conformity with Art 13 of the law you have a right to know update delete and change your details or to object their use if treated in violation of the law Spencer Italia S r l Life Support Page 20 21 User Manual Electronic Lung Ventilator SPENCER 170 Thank you for choosing http www spencer it Copyright Spencer Italia S r l All rights reserved Rev 3 01 23 12 1999 GUARANTEE Article Code A Lot Purchasing date Serial Buyer sa Stamp and sign GUARANTEE Article Code N Lot Purchasing date i Serial Buyer sa Stamp and sign Fill in and send the pre cut part to SPENCER ITALIA S r l STRADA CAVI 7 43044 COLLECCHIO PR Spencer Italia S r l Life Support Page 21 21
21. t that are not covered clearly in this manual contact customer service representatives 1 5 2 Preservation This User Manual must be stored near the product protected from anything which could compromise its integrity and legibility 1 5 3 Used symbols SYMBOL MEANING NOTES Indicates a danger also with risk A DANGER of death for users Indicates a warning note about key function or useful information ts WARNING Pay maximum attention to text blocks marked by this symbol The user is requested to measure D OBSERVATI ON a value to control a signal User is requested to verify the proper position of an element Q QUESTI ON before operating a function User is requested to look up the EE CONSULTATI ON Manual before operating a function In case of particular operating fa conditions or faults a mechanical REGULATION or electric calibration could be required Spencer Italia S r l Life Support Page 3 21 User Manual Electronic Lung Ventilator SPENCER 170 2 DEVICE DESCRIPTION 2 1 OPERATING PRI NCI PLE Spencer 170 is a breathing control assistance device which comprehends some of the emerging trends in the field of automatic respirators It is an electronically controlled device and works as a flow intermittent pneumatic unit time cicled able to supply medical gas at two different concentrations with the same gas energy source The device is portable
22. tor CM 150 EV20008A Plug 12V mod MAGIC for power cable EV20012A Silicon breathing gas hose diam 22x120cm EV50020E KOMPAK bag EV50100A Aluminium bracket for KOMPAK EV50101A As the assistance interventions are performed only and exclusively by Spencer Italia S r l or by authorised Centres the list of the replacement parts is enumerated only to inform the buyer or the user Spencer Italia S r l Life Support Page 18 21 User Manual Electronic Lung Ventilator SPENCER 170 8 ATTACHMENTS 8 1 DECLARATI ON OF CONFORMITY DECLARATION OF CONFORMITY C 0123 Manufacturer Spencer Italia S r l Life Support Address Str Cavi 7 43044 Collecchio PR ITALIA Product ELETTRONIC LUNG VENTILATOR Model Code SPENCER 170 EV01170A We hereby declare that the above mentioned products meet the provisions of 93 42 EEC Council Directive MDD Classification according to Council Directive 93 42 CEE Annex IX Ilb Application from the Annex I1 3 according to Council Directive 93 42 CEE Notified Body TUV PRODUCT SERVICE We hereby declare that the above mentioned products meet the provisions of EN 60601 1 Medical Electric Devices Safety General Laws IEC 601 1 2 EN 60601 1 2 EN 794 3 Medical Electric Equipment Lung ventilators 89 336 CEE 93 68 CEE Magnetic Electric Compatibility Place date Sala Baganza 15 06 98 Sign and position si Pizzi Spadoni Luig
23. valve and a quick connection inlet 12 V FEEDING CABLE 2 8 ELECTROMAGNETI C ENVIRONMENT The device is realised to operate correctly in an electromagnetic environment It has successfully passed all the electromagnetic tests required by Harmonised Standards by the Notifying Body see Declaration of Conformity Spencer Italia S r l Life Support Page 6 21 User Manual Electronic Lung Ventilator SPENCER 170 3 SAFETY 3 1 GENERAL WARNINGS gt Operators have to read this Manual carefully paying special attention to safety precautions and operating instructions Use the device only as prescribed in this Manual Never alter or modify ts A it modification can cause unpredictable consequences and in this case Spencer declines all responsibilities If at any time the device does not operate properly take it out of Ls A service immediately and contact the Customer Service Centre Ensure to have a manual resuscitator available to guarantee continuous ventilation gt A Ensure to execute periodically all preparation and maintenance operations described in this Manual gt A Do not operate without proper training The utilisation of the ventilator in power feeding and environmental Is A conditions different from the indicated ones compromises the safety of operating find as follows some of these conditions CONDITIONS Verifiable problem Excessive power feeding current The
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