SPENCER 202 Electronic pulmonary ventilator User's Manual
Contents
1. C 003 The product is compliant with the specifications of the Directive 93 42 CEE Type B device a Keep in a cool and dry place A Functioning temperature Fuse Storage temperature Battery Device with isolation class II Information to the users in compliancy with comma 13 of the Italian Legislative Decree n 151 of 25 July 2005 Fulfilment of the Directives 2002 95 CE 2002 96 CE and 2003 108 CE regarding Reduction of the use of dangerous substances in electric and electronic equipments and the disposal of their wastes Information for end user as indicated in Art 22 of the Law Decree n 188 20 11 08 regarding the implementation of the Directive 2006 66 CE regarding batteries accumulators and their disposal which annuls the Directive 91 157 CEE gt Bet lf IP22 Grade of protection IP22 EMC Electromagnetic compatibility 1 4 SERVICING REQUESTS For any information regarding the use maintenance and installation please contact the Spencer Customer Care Service on tel 0039 0521 541111 fax 0039 0521 541222 e mail info spencer it or write to Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY 1 5 DEMOLITION Follow the current regulations Information to the users in compliancy with comma 13 of the Italian Legislative Decree n 151 of 25 July 2005 Fulfilment of the Directives K 2002 95 CE 2002 96 CE and 2003 108 CE regarding Reduction of the use of dangerous substances in electric a2. Signal visual and acoustic Meaning the source of medical gas has insufficient pressure and or capacity Correction verify the line and source of feeding Alarm inhibition On the front panel on the dedicated alarm section there are two buttons reset alarms and acoustic exclusion which inhibit the alarm signals Reset alarms cancels any selected alarms and must be activated once the cause for the alarm has been removed in order to avoid that the signal remains active Acoustic excluded inhibits for about one minute thirty seconds the acoustic signal in order to permit corrective interventions in better conditions The signal of discharged battery and the absence of medical gas are not influenced by the activation of the above commands The relevant signals are turned off only when the cause which activated them is removed The apnoea alarm can be removed not only by activating the reset alarms and acoustic exclusion buttons but also from the moment the patient starts spontaneously breathing again 4 6 TROUBLESHOOTING PROBLEM CAUSE REMEDY The ventilator is not connected to a compressed Connect the ventilator to a medical gas sup gas source oxygen or medical gas plying source The oxygen bottle is empty Replace with another bottle that is full and fill 10 Gas supply alarm The patient cannot exhale the empty one The pressure or the erogation capacity are not Check the adapter performance correct lower than 2 5 bar
3. OX08000A Fuse 1 Ampere EV30090E Alkaline battery 9 V PP3 OX07005A Tube connector diameter 7 M 1 8 OX07006A Cylindrical tube connector diameter 7 M 1 4 G OX05013A Outlet for oxygen connection UNI 9507 OX90007A Ring clamp 11 13 11 12 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 Spencer continually strives to reach the perfection of all items sold We therefore hope you will understand if we reserve the right at any time to modify the shape equipment lay out or technical aspects that are herein described Copyright Spencer Italia S r l All rights reserved No part of this document can be photocopied reproduced or translated into another language without the written approval of Spencer Italia S r l
4. Patient valve is not in correct position or is Check the fixing of the valve or replace it damaged Corrugated tube not connected or connected badly Connect the corrugated tube adequately Minimum pressure alarm _ gt 1 _ Corrugated tube faulty or not sealed properly Replace the corrugated tube The non rebreathing valve is not adequately Adequately connect the non rebreathing valve connected after sterilisation to the tube and or to the mask and corrugated tube mask compromising good holding Low Paw pressure of the airways Inferior alarm limiter lower than PEEP Set to 5 mbar under the maximum pressure of l the airways PROBLEM CAUSE REMEDY Obstructed airways Remove dentures effect bronco aspiration suction Bent corrugated tube Ensure that there are no bending or obstruc tions MAAU pipsu aahi The patient is not hyperextended Hyperextend or position the Guedel or Berman cannula Superior alarm limiter set to a value that is too Set to 10 mbar above the maximum value of high the airways pressure The internal battery has less than 5 minutes of Use an external battery or connect to electricity Battery is flat autonomy left power recharge the internal battery immedia tely see par 4 3 2 5 MAINTENANCE AND CLEANING eee 5 1 CLEANING The operations below described must be executed after each use of the SPENCER 202 Switch off the pulmonary ventilator Isolate it from the pow
5. ventilation must be immediately re established manually ex Spencer B life manual resuscitation bag in order to maintain vital life support If necessary they can be used with a PEEP valve and reservoir bag for the enri chment with oxygen When the device is being used the assistance of qualified staff must be guaranteed The device has seals If they have been removed or tampered with the manufacturer declines any responsibility for the product and for its correct func tioning and for any consequent damage that may occur to the device Before turning on the pulmonary ventilator the battery must be put under charge for at least 12 hours The use of the device with power source and environmental conditions different from those indicated compromises the safety of operating In the fol lowing table are some of the abnormalities that could occur under these conditions Excessive power feeding current The fuse burns Low power feeding current The battery does not recharge Excessive environmental temperature Problems with the sealing membranes Gas leaks Excursions of the set flow Low environmental temperature Possible presence of condensation occurring when the ventilator is returned to a higher temperature The device must be used in a ventilated environment A minimum of charge must always be maintained in the battery 2 3 CONTRAINDICATIONS AND SIDE EFFECTS Do not use the SPENCER 202 pulmonary ventilator in neonatal clinics 0 18 months and in
6. 12 Vdc source or with 220 V transformer With a fully charged battery in good condition the ventilator can function for about two hours With low batteries or battery in bad A condition it may function for a shorter time If the device remains unused for over 3 months the battery must be recharged The device must not be left under charging for more than the time indicated If the battery is allowed to become flat and or if the device is left attached to the source the life of the battery will be considerably reduced 4 3 3 External 12 Vdc source An external source may be used in emergency situations or during the use of the ventilator on ambulances and or helicopters Use only electric connection cable code EV20010A The free end of the cable must be correctly connected with the direct current plug Connection specifications Red or brown wire on positive pole White wire on negative pole Shielding on negative pole Insert the connector on the ventilator side The device indicates the connection with the net through the Ext source LED 4 3 4 Emergency electrical feeding through a supplementary battery Do not put the spare battery on the device It must be placed as far as possible from the inlet air filter of the ventilator 4 4 FEEDING COMPRESSED GAS Use oxygen central system or oxygen tank with pressure regulator or compressed medical air with an entrance pressure from 3 5 bar 0 5 bar and a minimum capacity of 140 L min
7. 4 5 FUNCTIONING 4 5 1 Front control panel Fig D NO AIR MIX Low pressure alarm Manovacuumeter luminous AIR MIX selection or disconnection LED composed of 21 LED in switch with Trigger selection knob knob green colour and 3 in yellow protection from 0 to 12 mbar colour which turn on when the pressure reaches 60 65 70 Ea Maximum pressure mbar a value which requires Airway pressure limit alarm selection the operator s attention o selection knob from 20 to knob Visualises the values of mini 60 mbar mum and maximum pressure and trigger set by the operator coc NO AIR MIX TRIGGER LOW FRESS HIGH PRESS E s mbar mbar AENT 20 16 12 8 4 1 0 40 50 60 70 PRESSURE LIMIT TaS i ei inde FI O2 AIR WAY PRESSURE mbar APNEA Alarms LED HIGH PRESS _ ALARM X LOW PRESS Hea GAS SUPPLY Em E E EXT SOURCE 0 f p ON CHARGE LOW BAT MINUTE VOLUME FREQUENCY SE fa bpm ADULT Minute volume Frequency OFF switch hold selection knob selection knob IDES See LED for battery Colour code OM condition and feeding screening Alarms management button Exclusion of the acoustic alarm LED test with pressure for 2 sec 4 5 2 Operating instructions When turning on the device the microprocessor automatically switches the ventilator to the default controlled mode and checks the acoustic alarm inhibiting it for about 30 seconds detailing any information on the front panel in the dedicated alar
8. concentrations with a single gas sour ce complete with mechanical and electronic safety devices which supervise over some of the principal respiratory parameters The SPENCER 202 pul monary ventilator is portable with a two hour self powered electric energy system after two hours external power feeding is necessary this will auto matically recharge the internal system SPENCER 202 has two operating modes automatically changed by the software and a series of warning lights connected to an audible signal which permits rapid identification of any dysfunctions The user interface is in the front control panel made in a material which is scratch proof and resistant to common medical substances The front panel has clear and intuitive graphics and the operating buttons are pro tected to avoid accidental functioning 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 202 and the monitoring system for patient safety permits its use for both adult and paediatric patients The device can carry out the following functions Substitute the breathing functions in those patients who do not breathe spontaneously controlled ventilation Assist those patients whose breathing functions are irregularly altered and anyway insufficient automatic breathing system The switch from one mode to another is automatically mana
9. keep a log book regarding the operations carried out on the device 5 2 2 Special servicing 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 regar ding 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 The device if used as indicated in the following instruction manual has an average life span of 5 years The life span can be expanded only fol lowing a general revision of the product that must be carried out by the manufacturer or by a centre authorised by the manufacturer 16 ACCESSORIES AND SPARE PARTS 6 1 ACCESSORIES EV60030C EVX 30 PEEP valve autoclavable EV60032C EVX 32 PEEP valve disposable EV20008A Electric connection cable 150 cm EV20009A Electric connection cable 250 cm EV20010A Electric connection cable 40 cm EV20011A Electric connection cable 200 cm 6 2 SPARE PARTS EV00106A Patient circuit complete with antibacterial filter EV50020A Patient circuit tube in PVC diameter 22x120 cm EV50021A Straight connection 22 M 15 F for patient circuit EV50011K Non rebreathing valve in polycarbonate EV50025E Patient circuit tube in silicone diameter 22x120 cm EV50110K Disposable resuscitation filter latex free
10. patients with un drained pneumothorax Do not use the device in presence of inflammable or anaesthetic gases Do not use the device if it is connected to an SPS charger or other transformer 220 V 12 V To avoid hypercapmia effects do not use 100 oxygen for protracted ventilation the device is provided with a special mixer switch to select mixed oxygen air at 60 or 100 2 4 SAFETY SYSTEMS The device is provided with the following safety systems Mechanical overpressure safety valve The maximum limit of device pressure is 60 mbar This value is imposed by the manufacturer The user can reach the maximum level by use of the regulation knob Spontaneous breathing When the pulmonary ventilator is off or gas or electrical supply is interrupted the patient can breathe spontaneously The device is provided with an independent power supply alarm 9 V battery This acoustic and visible alarm signals the low battery condition This alarm functions even if the device is turned off with the switch in the O position The device is provided with an acoustic alarm which functions when the machine is turned on if the incoming medical gas input is interrupted DESCRIPTION OF PRODUCT 3 1 INTENDED USE SPENCER 202 is a breathing control assistance device which comprehends the emerging trends in the field of automatic respirators It is a volumetric type device with electrical control of the respiratory functions capable of supplying medical gas at two different
11. EV60202A Porta Vent 202 Rucksack version of resuscitation system 3 4 TECHNICAL DATA Width 330 mm Height 180 mm Depth 175 mm Weight accessories included 3 5 kg Isolation class II Grade of protection IP22 Electric source connection to external tension stabilised at 12 Vdc Charging tension maximum 14 V Absorption of current maximum 249 mA Absorption of current at 12 Vdc 2 98 W FUSES eee External powered 12 V 1A Functioning time average 2h Recharging time 12 h Functioning time after signalling of low battery 5 min Internal volume of the patient circuit tubes 351 cms Input pressure central system or tank with pressure regulator 3 5 bar 0 5 bar Minimum capacity 140 L min Minute volume from 2 to 20 L min Volume delivered measurable volume minutes frequency Ventilation Frequency from 5 to 40 BpM Oxygen concentration 60 or 100 I E Ratio 1 2 Pressure Sub atmospheric negative in the exhaling phase Not available Tolerance da 20 a 70 mbar Range from 20 to 10 mbar 2 mbar Range from 10 to 70 mbar 5 mbar Medical gas flow 15 Frequency 1BpM Note The medical gas flow is not influenced by pressure The ventilator does not monitor the oxygen concentration mechanical mixing Unless otherwise specified the parameters are expressed in ATPD Ambient Temperature and Pressure Dry 3 5 ENVIRONMENTAL CONDITIONS STORAGE AND TRANSPORT FUNCTIONING Environmental temperature from 10 to 60 C from 0 to 40 C Relative humidity fr
12. SPENCER 202 Electronic pulmonary ventilator Directive 93 42 CEE Medical Devices the final control of the products certified by the This appliance conforms with the Guarantee of Quality system for the production and E notifying body T V S D Product Service GmbH INDEX General Information page 2 Operating Instruction page 6 Warnings page 3 Maintenance and Cleaning page 11 Description of Product page 4 Accessories and Spare parts page 11 Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY tel 0039 0521 541111 fax 0039 0521 541222 e mail info spencer it First edition 1998 REV 11 26 06 13 www Spencer it Thank you for choosing a Spencer product 1 GENERAL INFORMATION eee 1 1 AIM AND CONTENTS The aim of this manual is to supply all the information necessary so that the client will not only attain adequate use of the appliance he will also be capable of using the instrument in the most autonomous and secure way possible This includes information regarding technical aspects functioning maintenance spare parts and safety 1 2 CONSERVATION OF THE INSTRUCTION MANUAL The instruction and maintenance manual must be kept with the product inside the specially provided container and above all away from any substances or liquids which could compromise perfect legibility 1 3 SYMBOLS USED SYMBOL MEANING A General or specific warning pH See instructions for use SN Serial number Product code
13. be intact and correctly con Non rebreathing valve nected Overpressure test See paragraph 4 5 2 Operating instructions Face mask Ventilation test Anti batteric filter Straight connector ELECTRIC POWER SUPPLY Press on switch I The respirator ventilates A Ensure the availability of a mechanical manual ventilation system i e resuscitation bag Spencer B life Before using the device check the correct functioning of the alarm LED by applying pressure at least 2 sec on the acoustic turnoff button During the test the LED lights up and the buzzer will sound The device must be used in a ventilated environment 4 3 ELECTRIC SOURCE 4 3 1 Control of alarms battery 9 V The 9 V alarms battery should be regularly checked or replaced depending on its use Through digital tester verify that the voltage of the 9 V battery is not lower than 10 The correct polarity for the reintegration of the 9 V battery is guaranteed by the seat of the battery holder and symbols indicated For older versions Kompak and Porta Vent exercise care and reassemble the fan frame without excessive force on the rear M6 allen 4 3 2 First charge of the internal battery The SPENCER 202 pulmonary ventilator is powered by a rechargeable battery A new battery is never completely charged It will be charged completely only if left under charge it for 24 hours non stop before first use The battery recharges automatically during normal functioning of the device connected to the
14. eaning the pressure in the patient circuit does not reach the minimum value expected during the inhalation phase Cause 1 the patient circuit is not connected to the patient Correction 1 re effect the connection Cause 2 there is no medical gas Correction 2 check that the medical gas alarm is not on verify the connection with the power source verify the condition of the power source Cause 3 the minute volume selected is insufficient the patient manifests a breathing rate superior to the machine erogation Correction 3 adapt the minute volume to the patient s needs Software fault Signal intermittent visual all LEDs on and acoustic Meaning an error in the execution of the software program occurred a RAM fault occurred general malfunctioning of the microprocessor occurred Correction send the lung ventilator back to the manufacturer Apnoea Signal visual and acoustic Meaning the device did not automatically wait for voluntary inhalation of the patient Cause 1 the connection between patient and device was interrupted Correction 1 re effect the connection Cause 2 the patient stopped breathing spontaneously Correction 2 verify that controlled breathing is automatic Battery Signal intermittent visual and acoustic Meaning the internal battery needs recharging Correction connect the ventilator to an external feeding source in compliance with the specifications provided in paragraph 4 3 Electric Source Medical gas
15. ed ventilation Start halfway through the exhaling phase it extends for the duration of the whole exhaling phase Any attempt of the patient to inhale sufficient amounts of product in this interval determines the start of a new breathing act and the consequent delivery of medical gas flow Attempts to inspire made outside this interval are not accepted anticipated attempts because they could be caused by transitional situations in the patient circuit and could simulate voluntary breathing late attempts as they could not show since the machine switches automatically to controlled mode if the maximum limiter of wait is exceeded thus inhibiting any attempt to inhale except for the final part of the exhaling phase In case of exceeded maximum pause period the apnoea situation is signalled visually and acoustically The alarm remains active until accep tance on the part of the respirator of an attempted inhalation valid as from the patient or until the alarm cancelling button Reset alarms is pres sed This functioning mode guarantees prompt intervention of the machine in case spontaneous breathing of the patient stops but also allows for an easy adaptation of the patient as it permits variations in the breathing frequency of up to 50 increase or decrease It is important though that the breathing frequency selected is as close as possible to the natural breathing of the patient The intervention of the apnoea alarm means that the selected frequency is too
16. ent and human health which could otherwise be caused by inappropriate waste handling of the battery The recycling of the materials will help to conserve natu ral resources At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office your household waste disposal service or the shop where you purchased the product 1 6 LABELLING The serial number as indicated below can be found on each appliance and must not be removed or covered In order to facilitate assistance please indicate or communicate the serial number SN on the label Lateral panel Fuse identification Sn THA Medical gas output g p GAS OUTPUT Feeding connector identification ae identification AO classi TYPEB EMC Spencer Italia s r l Str Cavi 7 43044 Collecchio PR ITALY Tel 39 0521 SANTI Feu 9052 54120 Medical t eee DRIVING OXYGEN INPUT edical gas Inpu 3 5bar 0 5bar min 140 1 min identification ELETRONIC LUNG VENTILATOR mod 202 DO NOT USE NEAR FLAMMABLE GASES OR ANESTHETICS Rear panel Alarm battery 9 V Rechargeable battery 12 V 2 2 3 AH Fig B 2 WARNINGS SS 2 1 GENERAL WARNING Before carrying out any kind of operation on the appliance the operator must carefully read the enclosed instructions paying particular attention to the correct safety precautions and
17. er source net if connected Disassemble the non rebreathing valve Disassemble the PEEP valve if present Autoclave the mask and substitute the patient circuit supplied with antibacterial filter On request a re usable autoclavable patient circuit can be provided After operating the necessary operations of cleaning sterilisation the non rebreathing and PEEP valve if present must be reassembled recon nect the device to power if necessary The external cleaning of the device should be carried out ensuring compatibility of the constructions materials with appropriate surfaces disin fectants as indicated in the table below Disinfecting with aldehydes Compounds releasing halogens Disinfecting with alcohol Strong organic acids Quaternary ammonia compounds Compounds releasing oxygen Trichloroethylene 5 2 MAINTENANCE 5 2 1 Precautionary Maintenance The person responsible for every day maintenance can only substitute the spare parts indicated on paragraph 6 2 Spare Parts All other substi tutions or repairs can be carried out only by the manufacturer or by a centre authorised by the manufacturer The device must be serviced by the manufacturer or by an authorised centre every year For any operations that are not carried out directly by the manufacturer but by an authorised centre we have to underline that a report regar ding all operations carried out must be requested This will permit both Spencer Italia S r l and the end user to
18. ged by the microprocessor under certain conditions The following list shows the optimal ventilation parameters RESPIRATORY FREQUENCY RF Adult 10 20 breaths min 10 12 ml kg TV x RF Child up to 15 kg 40 breaths min 10 15 ml kg TV x RF Child over 15 kg 30 35 breaths min 10 15 ml kg TV x RF The device has been designed for use on road ambulances 3 2 MAIN COMPONENTS The main functional components of the device are the following Front control panel All the commands and functional selectors are positioned here Manufactured in anti scratch polycarbonate Electronic control board Operates the integrated control of all respiratory functions and of the main parameters of respiration Electro pneumatic circuit for gas mixing and erogation The pressurised gas in entry is sent to the mixing block thanks to a flow cutting valve that is electronically controlled Patient circuit It is made up of a corrugated PVC tube Spencer Mask size 4 face mask autoclavable non rebreathing valve in polycarbonate straight connec tor and anti batteric filter 100 cm Oxygen connecting tube For connection of the lung ventilator to a source of oxygen 12 V Connecting cable It can be connected to the cigarette lighter socket for the 12V source or to a transformer with the following characteristics inlet source 220 230 Vac 50 60Hz outlet 4 V 0 8 Ampere 3 3 MODELS EV01202A Spencer 202 Electronic pulmonary ventilator EV02202A Kompak 202 Resuscitation system
19. high and the patient cannot maintain the rhythm of the device Assisted ventilation IPPV with trigger This function ensures that flowing volumes are of fixed duration and they are erogated to the patient These volumes can be set by means of the frequency knob and of the minute volume intervals following the patient s natural breathing rhythm The inhaling and exhaling ratio depend on the characteristics of the patient s natural breathing however can be corrected using the frequency knob which in this circumstance determi nes the duration of the inhaling phase only The duration of the inhaling phase is calculated dividing by 3 the duration of the whole breathing act E g Frequency F 10 breaths min Inhalation INS 60 3 F 2 sec F 5 INS 60 3 5 4 sec F 20 INS 60 3 20 1 sec The flow volume erogated by the patient at each inhalation is calculated dividing the volume minute set on the knob positioned bottom right of the front panel by the number of acts per minute set on the frequency knob Trigger The trigger is a special device able to synchronise the insufflation with the beginning of spontaneous inhalation of the patient The ventilation supporting technique is normally employed on patients who are able to sustain inhalation work at brief intervals The patient s effort to produce spontaneous breathing generates inside the respirator a negative pressure which triggers rapidly the insufflation thank to the trigger mechan
20. ism The effort or negative pressure necessary to set off the trigger mechanism can be regulated and increased progressively in order to aid and prompt the patient towards breathing spontaneously re educating and training the breathing muscles The range of regulation goes from 0 to 12 mbar 4 5 4 Alarms Any alarm signal corresponds to an abnormal functioning condition which demands the intervention of the operator Following are the various abnormal situations which may determine the activation of alarms with the relevant corrective actions the operator must carry out to resolve them Maximum pressure selected by user Signal visual and acoustic with the interruption of the medical gas Meaning exceeded superior safety limit of the patient circuit pressure Cause 1 the minute volume selected is too high Correction 1 decrease the minute volume selected Cause 2 the connection tube is squashed Correction 2 free the connection and put it in a safe condition Cause 3 the minute volume selected is correct but the internal resistance of the patient in certain conditions may cause intervention of an alarm Correction 3 position the pressure limiter at a lower level so that the patient circuit can be discharged without alarm intervention Cause 4 the pressure limiter does not work correctly Correction 4 send the device back to the manufacturer for a maintenance check Minimum pressure selected by user Signal visual and acoustic M
21. lume and then pressure because if the volume was to be regulated after the pressure it would cause an immediate change of the pressure limit After choosing volume ventilation use the palm of the hand to keep the outlet of the patient valve where the mask normally is attached and then regulate the pressure limit with the knob Hyperextend the head and check the passage of the air by inserting an oral pharynx cannula or Guedel cannula in the patient s mouth with the usual manoeuvre 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 tight fitting Selection method of the minute volume knob step selector prevents undesired value changing during functioning in case of accidental touch If the patient is intubated remove the ventilation mask of the patient valve Insert the free adapter the endotracheal tube with its own connector Resistance of the patient airways due to obstructions or to external cardiac massage do not involve a frequency and respiratory volume modifi cation In case of lung compliance reduction the ventilator reacts with an increase of the respiratory pressure at a constant volume When use of the SPENCER 202 terminates it is necessary to Press the off button O for 2 seconds Interrupt oxygen supply by closing the valve on the oxygen tank or by disconnecting the oxygen tube connection 4 5 3 Functioning modes Assisted controll
22. m section Erogation of medical gas to the patient starts in cycles at regular intervals in correspondence with the relevant frequency selected by the command The current volume of mix sent to each breathing act is detected in the following way read the set value on the minute volume button and divide it by the set fre quency The real pressure of the patient circuit is always monitored by the luminous manovacuumeter on the front panel For the duration of functioning the microprocessor regulates the cyclical erogation of medical gas and verifies the state of some parameters of breathing moreover it signals the exceeding of safety limits activating depending on the case the acoustic and or luminous signals The different functioning modes are described in the next paragraph 5 3 Functioning modes Apnoea will be detected by the device only if the patient after one or more spontaneous inspirations situation which automatically activates the assisted functional mode interrupts breathing during the breathing cycle 8 seconds In this case the lung ventilator activates the luminous acoustic signal of apnoea and commutes automatically in controlled erogated mix at fixed frequency it turns on the luminous signal of apnoea Should the patient start to breathe naturally the device will automatically go back to assisted controlled mode and cancel any alarm signals which are still active A It is essential to regulate first the ventilator vo
23. nd electronic equipments and the disposal of their wastes The crossed dustbin symbol applied on the product or on it s packaging indicates that the item should be disposed of separately The correct disposal of the item when use has terminated is defined and organised by the manufacturer The end user who has to proceed with disposal must therefore contact the manufacturer and follow the system and procedures the manufacturer has organised for the separate collection treatment and disposal at end of life The correct separate collection of the out of use device which will permit recycling treatment and destruction in an ecologically friendly manner and will contribute to avoiding possible negative effects on the environment and for health while privileging the reuse and or recycling of the collected waste com ponents Please note that the owner will be subject to administrative sanctions in case of unauthorised disposal of the item Information for end user as indicated in Art 22 of the Law Decree n 188 20 11 08 regarding the implementation of the Directive 2006 66 CE regarding batteries accumulators and their disposal which annuls the Directive 91 157 CEE DISPOSAL OF WASTE BATTERIES This symbol on the battery or on the packaging indicates that the battery provided with this product shall not be treated as household waste By ensuring these batteries are disposed of correctly you will help prevent potentially negative consequences for the environm
24. om 10 to 100 from 15 to 95 Atmosferic pressure from 50 to 106 kPa from 70 to 110 kPa 3 6 ELECTROMAGNETIC ENVIRONMENT The SPENCER 202 pulmonary ventilator is created to operate correctly in an electromagnetic environment It has successfully passed all the electromagnetic tests stipulated in Harmonised Standards by the Notifying Body see Declaration of Conformity 3 7 STANDARDS APPLIED EN 60601 1 A1 A2 A12 A13 corrigenda July 1994 IEC 601 1 2 EN 60601 1 2 EN 794 3 89 336 CEE 92 31 CEE 3 8 PNEUMATIC DRAWING Inside equipment High pressure source High pressure gauge High pressure adapter Quick coupling input Low pressure adapter Pressure switch Electrovalve with 2 N C outputs Flow regulator with fixed capacity 9 Venturi system 10 No return valve 11 Aspiration air filter 12 Capacity selection knob 13 Overpressure release with no return valve 14 Overpressure release valve 15 Low pressure erogation manometer 16 Pressure switch 17 Outlet with no return valve 4 OPERATING INSTRUCTIONS eee 4 1 TRANSPORT AND STORAGE Before transporting the appliance make sure that it is correctly packaged ensuring also that there are no risks of shocks bumps or falls during the transport itself Keep the original packaging for use in case of any further transport Damage to the appliance caused during transport and handling is not cove red by the guarantee Repairs or replacement of the damaged parts are the resp
25. onsibility of the client The appliance must be stored in a dry place free from humidity In case of prolonged periods of inactivity or before transportation 1 Switch is in off position O 2 Unplug the power lead 3 Check the charge status of the internal battery and re charge it if necessary In case of long inactivity in addition to these recommendations the device must be stored with the precautions relevant to the place and time of stocking Store the pulmonary ventilator in a closed place aS See SS Keep it from stress and impacts Protect it from humidity as well as excessive thermal excursions Avoid contact with corrosive substances 4 2 PREPARATION On receipt of the product Remove the packaging and display the material so that all components are visible Check that all the components pieces on the accompanying list are present The appliance must be checked before every use so as to reveal any working abnormalities and or damage caused by transport and or storage Put the pulmonary ventilator on a flat surface i e shelf trolley If used on an ambulance the device must be fixed correctly using the purpose made threaded holes with diameter 6 threaded screws It is possible to fix the pulmonary ventilator on a rail with the purpose made hooks A The operations of preparation listed below must be carried out and checked before every use To check Result required RESPIRATORY SYSTEM Corrugated tube All components must
26. to the procedures to be followed for installation and for correct use In the case of any doubts as to the correct interpretation of the instructions please contact Spencer Italia S r l for any necessary clarifications Regularly check the appliance In the case of any abnormalities or damage to the appliance which could jeopardize the functioning and the safety the appliance must be immedia tely removed from service Do not alter or modify in any way the appliance any such interference could cause malfunctions and injury to the patient and or rescuer The appliance must not in any way be tampered with In such cases all responsibility will be denied for any malfunctions or injuries caused by the appliance itself Those who modify or have modified prepare or have prepared medical appliances in such a way that they no longer serve the purpose for which they were intended or no longer supply the intended service must satisfy the valid conditions for the introduction onto the market Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise as the result of contact with blood or body fluids Handle with care 2 2 SPECIFIC WARNINGS The product must be used by trained personnel only If any failure or incorrect functioning of the device is detected it must be immediately substituted with a similar item so that the rescue procedures are guaranteed without any interruption If another lung ventilator is not available
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