Spencer Italia S.r.l. Str. Cavi n°7 43044 Collecchio (PR) ITALY
tel. +39 0521 541111 fax +39 0521 541222 e-mail: info@spencer.it
www.spencer.it
We hereby declare that the ELECTRONIC
LUNG VENTILATOR MOD.190,
conforms with the 93/42/CEE “Medical
Device” directive
Guarantee of Quality system for the production and
the final control of the products certified by the
notifying body TÜV product service GMBH.
Instruction and Maintenance Manual
ELECTRONIC LUNG
VENTILATOR MODEL 190
INDEX
General Informations pag. 2
Warnings pag. 3
Appliance Description pag. 4
Operation Instructions pag. 6
Functioning pag. 8
Maintenance pag. 10
Accessories and Replacement Partspag. 11
SP/06/028/IU
REV. 8 18/04/07
2
AIM AND CONTENTS
The aim of this manual is to supply all the information necessary so that the client, apart from attaining an adequate use of the appliance, 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.
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.
SYMBOLS USED
1.1
1 GENERAL INFORMATION
Thank you for choosing a Spencer product
1.3
1.2
1.4
DEMOLITION
WARNINGS FOR THE CORRECT DEMOLITION OF THE PRODUCT ACCORDING TO THE EUROPEAN DIRECTIVE 2002/96/EC:
At the end of its lifetime the product may not be demolished together with other urban refusals.
It should be delivered to specialized differentiated collection centres, named by the local authorities, or to the distributor in case a new item is bought. Demolishing the pro-
duct separately, it is possible to avoid any negative influences to the environment and human health, caused by an incorrect demolition of dangerous substances contai-
ned by electric and electronic devices or the devices themselves. It makes it possible as well to save important amounts of energy and other resources. In order to point
out the obligation of demolition separately medical devices, on the product itself you will find a sign of a crossed mobile trashcan.
We remind you that, in case of abusive demolition of these refusals, endorsements are provided, as written in the European Directive 2002/96/EC (approved in Italy by
Dlgs 25 July 2005, n. 151).
1.5
1.6 LABELLING
The labels shown can be found on the device and may not be removed or covered. In order to speed up assistance, please always indicate or communicate the serial
number (SN) you find on the label.
SERVICING REQUESTS
For any information regarding the correct interpretation of the instructions, use, maintenance, installation, please contact the Spencer Customer Service on 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.
SYMBOL MEANING
Warning, consult the users manual
Mark: in compliance with 93/42/CEE directive
Type B device
Conserve in a cool and dry place
Temperature for use
Fuse
Stocking temperature
Battery
Device with isolation class 2
Warnings for the corretc demolition of the product
according to the European Directive 2002/96/EC
T/ 1A
GENERAL WARNINGS
-Before carrying out any kind of operation on the product, the operator must carefully read the enclosed instructions, paying particular attention to the correct safety pre-
cautions and to the procedures to be followed for installation and for correct use.
-In 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. Carry out the prescribed maintenance in order to keep the appliance in good condition and to guarantee correct functioning and a long life.
-In the case of any abnormalities or damage to the appliance, which could jeopardize the functioning, and the safety, the appliance must be immediately removed from ser-
vice.
-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 eventual injuries caused by the appliance itself.
-Whoever modifies or has modified, prepares or has 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 hazards that can arise as the result of contact with blood or body fluids.
-Handle with care.
SPECIFIC WARNINGS
-If at any time the device does not operate properly, take it out of service immediately and contact the Customer Service Centre. Ensure to have a manual resuscitator avai-
lable to guarantee continuous ventilation (for example B-life, in case PEEP or oxygen are requested: B-LIFE with reservoir).
-The presence of trained personnel must be guaranteed during the use of the device.
-Before turning on the unit, charge the battery for at least 12 hours
-The utilisation of the ventilator in power feeding and environmental conditions different from the indicated ones, compromises the safety of operating; find as follows some
of these conditions:
2 WARNINGS
2.1
2.2
2.3
CONDITIONS Verifiable problem
Excessive power feeding current The fuse cuts out
Low power feeding current The battery is not recharged
Excessive environmental temperature Problems with the holding membranes
Gas leaks
Excursions of the set flow
Low environmental temperature Possible presence of condensation (at the moment when
the ventilator is brought to higher temperatures again)
CONTRA-INDICATIONS AND UNDESIRABLE EFFECTS
- DO NOT USE the ventilator in neonatal clinics (0-18 months) and in patients with pneumothorax.
- DO NOT USE ventilator in presence of inflammable substances and anaesthetics.
- DO NOT USE the device if it is connected to an SPS charger or other transformer 220V/12V.
- 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%).
The device must be used in a ventilated environment.
3
LATERAL PANEL
FUSE IDENTIFICATION FEEDING
IDENTIFICATION
MEDICAL GAS
ENTRANCE
IDENTIFICATION
MEDICAL GAS EXIT
IDENTIFICATION
REAR PANEL
BATTERY
Rechargeable battery
12v 1,8 Ah-S
9 V alarm battery
4
3 DESCRIPTION OF PRODUCT
3.1
Spencer 190 is a breathing control/assistance device, which comprehends some of the emerging trends in the field of automatic respirators.
It is a volumetric device, which electrically controls breathing functions. It can erogate two different concentrations of medical gas by means of just one feeding gas. The
Spencer 190 ventilator is equipped with safety mechanical and electronical devices able to control some of the main breathing parameters.
It is an electronically controlled device and works as a flow intermittent pneumatic unit, time-cycled, able to supply medical gas at two different concentrations with the same
gas energy source.
The device is portable with a 2-hour self-powered electric feeding system: after two hours external power feeding is necessary, this will automatically recharge the internal
system.
It works in three different modes, which can be selected by the user and has a series of luminous signals paired with an acoustic alarm, that allows rapid recognition of
anomalous situations and functioning.
The user interface is in the front control panel realised in abrasive material that is resistant to common medical substances.. The front panel has clear and intuitive graph-
ics 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 gas for
the patient.
The wide range of volumes and respiratory frequencies of the SPENCER 190 and the monitoring system for patient safety allows for its use with both adult and paediatric
patients.
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 CURRENT
VOLUME MINUTE
VOLUME
Adult 10-20 breaths per min 10-12 ml/Kg TVxFR
Child (until 15Kg) 40 breaths per min. 10-15 ml/Kg TVxFR
Child (over 15Kg) 30-35 breaths per min. 10-15 ml/Kg TVxFR
SAFETY SYSTEMS
The device is provided with the following safety systems:
Mechanical overpressure valve
Maximum limits of device pressure 70mbar.
This value is set up by the manufacturer, by moving the pressure-limit knob the user can set a value up to the maximum threshold.
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. This battery needs to be checked periodically.
The device is equipped with an acoustic alarm for absence of medical gas in entry, when it is turned on.
2.4
The device can carry out the following functions:
- substitute the breathing functions in those patients, who do not breathe spontaneously (controlled ventilation)
- assist the breathing functions in those patients whose natural functions are insufficient (assisted ventilation)
- assist those patients whose breathing functions are irregularly altered and anyway insufficient (automatic breathing system)
The passage from one mode to another is managed automatically by the microprocessor when certain situations occur.
The device was designed for use on emergency rescue vehicles (i.e. ambulances, helicopters).
3.1.1 3MODELS
Electronic lung ventilator Mod. 190
Electronic lung ventilator Mod. 190 KOMPAK with oxygen bottle and adapter
Electronic lung ventilator Mod. 190 KOMPAK without oxygen bottle and adapter
Electronic lung ventilator Mod. 190 with Porta Vent Backpack
3.3 TECHNICAL DATA
Width mm 330
Height mm 180
Depth mm 175
Weight (accessories included) kg 5,3
3.2 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.
Electro-pneumatic gas mixing and erogation circuit
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 pres-
surised gas cannot be supplied into the device, as it is blocked by the closed off electro-valve.
ELECTROMAGNETIC 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).
STANDARDS APPLIED
·EN 60601-1+ A1 (1993) + A2 (1995) + A12 (1993) +A13 (1996) + correction specs (july 1994)
·IEC 601-1-2 (EN 60601-1-2)
·EN 794-3
·89/336/CEE
·92/31/CEE
3.4 ENVIRONMENTAL CONDITIONS
5
TECHNICAL CHARACTERISTICS
Isolation Class II
Grade of protection Type B
ELECTRIC VALUES
Electric power feeding Connection to external tension stabilised at 12V DC
ChargingTension max 14 V
Absorption of current max 223 mA
at 12V continuous current 2.67 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 cm3
MEDICAL GAS (Oxygen)
(centralised plant or tank with pressure regulator) Entry pressure 3,5 bar ± 0,5 bar
Minimum capacity 60 lt/min
VENTILATION
Minute Volume from 2 to 20 lt/min
Volume released (measurable) From 0,4 lt to 0,5 lt
Frequency from 5 to 40 bpm
Oxygen concentration 60% - 100%
I:E ratio 1 : 2
Pressure (sub-atmospheric) negative in the exhaling phase Not available
MANOVACCUUMETER -20 +70 mbar
Tolerance (Range da -20 a +10 mbar) 2 mbar
Tolerance (Range da +10 a 70 mbar) 5 mbar
MAXIMUM DEVIATION OF SET VALUES
Medical gas flow ± 15%
Frequency ± 1 bpm
Note:
The medical gas flow is not influenced by pressure.The ventilator does not monitor the oxygen concentration (mechanical mixing). Unless otherwise speci-
fied the parameters are expressed in ATPD (Ambient, temperature and pressure,dry)
During handling and storage During operation
Temperature from - 10° to + 60° from 0° to + 40°
Relative humidity from 10 % to 100 % from 15 % to 95 %
Atmospheric Pressure from 50 kPa to 106 kPa from 70 kPa to 110 kPa
3.5
3.6
4 IOPERATING INSTRUCTIONS
4.1 HANDLING AND STORAGE
Before effecting transportation of the device ensure that: the indications of the table below have been followed, packaging is adequate and risks of bumping or falling during
transportation are minimised. Preserve the original packaging for possible future handling. Damages to the device caused by handling are NOT covered by the warranty.
Repairs or replacement of damaged components are at Customer's expense
6
3.7 PNEUMATIC DRAWING
In case of prolongued periods of inactivity and/or before transportation
Switch to 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
·Protect device from humidity as well as excessive thermal excursions
·Avoid contact with corrosive substances.
PREPARATION
- Put the device on a flat surface (i.e. shelf, trolley)
- If put on an ambulance, the ventilator must be fixed correctly, using the apposite threaded holes, with threaded screws diam. 6.
- It is possible to fix the ventilator on a bar or rail with the apposite hooks.
The operations of preparation below listed must be carried out and checked before every use:
4.2
To check Result required
RESPIRATORY SYSTEM
-Corrugated Tube
-Non-rebreathing valve
-Peep valve
-Mask
-VentilationTest
-All components have to be in one piece
and connected correctly.
-See section 5.2
ELECTRIC POWER SUPPLY-Press ON, functioning mode:
CONTROLLED The respirator ventilates and the mode
indicator turns on.
Ensure the availability of a mechanical/manual ventilation system (i.e. self-expanding insufflator)
Before using the device assure the correct functioning of the alarm L.E.D.'s by pressing the "L.E.D. test" button (all LED's must turn on and the buzzer must
produce a sound)
The device must be used in a ventilated environment.
4.3 ELECTRIC FEEDING
Connection with the power line
In order to connect the device with the power line:
- The tension value indicated on the tension selector must correspond to the line tension
- Connect the feeder SPS with the lung ventilator through the specific connector and then insert the SPS plug in an electric outlet with grounding perfectly installed ( fol-
lowing norms VDE 0100 or equivalent national rules), the device indicates the connection to power through the "EXTERNAL FEEDING" L.E.D.
CONTROL OF INTERNAL BATTERY RECHARGE
The unit is powered by a rechargeable battery. A new battery is never completely charged. It will be charged only if you charge it for 24 hours non stop before using it.
The battery, recharges automatically during normal functioning of the device connected with feeding 12V CC or with tension 220V.
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 short-
er 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 use the external feeding 12V DC please do the following:
·Use only the special cable EV20010A.
·The free end must be perfectly connected with the ground outlet
Connection specifications: Red wire on + (positive pole)
White wire on - (negative pole)
Shielding on - (negative pole)
·Insert the cable into the dedicated connector on the side of the ventilator.
The device indicates the connection to the power through the "EXTERNAL FEEDING" L.E.D.
Emergency electrical feeding through a supplementary battery
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.
FEEDING COMPRESSED GAS
Use oxygen (central system or oxygen tank with pressure regulator) or compressed air with an entrance pressure from 3,5 bar ± 0,5 bar and a minimum capacity of 60
lt./min.
5.1
5 OPERATION
FRONT CONTROL PANEL
Alarm management
buttons
ALARMS Display Bourdon pressure gauge used
for screening pressure in the
patient airways
ZERO regu-
lation
FREQUENCY selection
knob
ON/OFF Buttons
(hold for 2 sec.) Knob for mechanical limitation of
selectable pressure from 20 mbar to
70 mbar
7
FUNCTIONS display and
respiratory cycle
MINUTE VOLUME
selection knob
AIRMIX/NO AIR-
MIX
switch
4.4
TRIGGER selection knob
(0 mbar / -12 mbar)
Functioning mode
selection buttons:
CONTROLLED,
ASSISTED,
ASSISTED/CON-
TROLLED
OPERATING INSTRUCTIONS
When turning on the device, the microprocessor, after a quick functional self test, 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 alarm section. Erogation of medical gas to the patient starts
in cycles at regular intervals, in correspondance 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 "volume/minute" button and divide it by the set frequency.
At any time the operator can see the situation by observing the luminous writings on the front panel of the device. Particularly the functioning modes are visualised, the
breathing phases, spontaneous inspiration of the patient and any alarm situations. The real pressure of the patient circuit is always monitored by the luminous manovacu-
umeter on the front panel.
For each breathing act, the electronic controlling device sets off a luminous display that visualises, in sync with the real time passing, the various phases of the breathing
act. If the functioning modes set by the electronic controlling device are not adequate for the patient in question when the machine is turned on, then the operator can select
a different mode, using the select buttons on the front panel.
The different functioning modes are described in the next paragraph.
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 sig-
nals the exceeding of safety limits activating, depending on the case, the acoustic and/or luminous signals.
The device detects the apnoea situation only if "assisted" or "assisted/controlled" mode is selected. Precisely, if in the "assisted/controlled" mode the patient does not show
any spontaneous breathing functions within the lapse of time between the theoretical term of the breathing act, it activates the luminous/acoustic signal of apnoea and com-
mutes automatically to "controlled" (erogation mix at fixed frequency), tuning 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.
5.2
8
It is absolutely necessary to regulate first the ventilator volume and then pressure, because a late volume regulation (lt/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 the mask is
normally inserted), then regulate the pressure limit with the apposite knob.
Hyperextend the head and seek, after inserting an oral-pharynx cannula in the patient's mouth following the correct manoeuvre, in order to guarantee clear-
ness 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 it is accidentally knocked.
In case of intubation, take the ventilation mask off the patient valve, and 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 reduction of the
compliance, the ventilator will react with a rise of respiratory pressure at a constant volume.
FUNCTIONING MODES
ASSISTED/CONTROLLED Breathing
Starting from halfway the exhaling phase, breathing extends for the duration of the whole exhaling phase. Any attempt of the patient to inhale sufficient amounts of prod-
uct in this interval determines the start of a new breathing act and the consequent erogation of medical gas flow.
Attempts to inspire effected 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 time of wait, the APNOEA situation is signalled visually and acoustically.
The alarm remains active until acceptance on the part of the respirator of an attempted inhalation valid as from the patient or until the alarm cancelling button "RESET
ALARMS" is pressed.
Any time the respirator considers as valid the inhalation attempt of the patient, it is signalled by means of the luminous display "SPONTANEOUS" underneath the graph-
ics of the inhaling phase.
This functioning mode guarantees prompt intervention of the machine in case spontaneous breathing of the patient stops, and allows for an easy adaptation of the
patient in that the breathing frequency can vary up to 50% increasing or decreasing.
NOTE
It is important though that the breathing frequency selected is the closest to the natural breathing of the patient.
In order to make a precise selection, besides the physiological data and direct observation of the patient, it is useful to use the shape of the wave generated every time
the patient breathes in on the functions monitor.
The selection can be considered optimal when it will be able to illuminate completely by means of the wave shape and during a single breathing act, without setting of
the apnoea condition. A wave shape which cannot complete its cycle when turning on the machine means that the frequency value selected is too low. Consequently,
the patient is discomforted and the I/E ratio is altered significantly. In fact, the ratio is calculated at I/E=1/2 and the volume/minute of mix erogated increases proportional-
ly.
Should the apnoea alarm go off, it means that the value of frequency selected is too high and that the patient cannot keep up with the rhythm of the machine.
CONTROLLED Breathing (IPPV)
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.
ASSISTED Breathing (IPPV with TRIGGER)
This functioning mode can be selected by activating the "assisted" button.
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 volume/minute intervals, following the patient's natural breathing rhythm.
The aperture of the inhalation valve is regulated by pressure; it is necessary that the patient creates depression for the breathing flow erogation to start.
The inhaling and exhaling ratio depends on the characteristics of the patient's natural breathing, however can be corrected using the frequency knob, which determines
the duration of the inhaling phase only, in this circumstance.
The duration of the inhaling phase is calculated dividing by 3 the duration of the whole breathing act.
5.3
E.g.: frequency F = 10 acts/min.
inhalation INS = 60 / 3 * F = 2 sec.
F=5 INS=60/3*5=4 sec.
F=20 INS=60/3*20=1 sec.
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
mechanism.
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 mbar to -12 mbar.
5.4 END OF USE
After using the device it is necessary to:
· Turn the switch to the OFF position
· Interrupt oxygen supply
ALARMS
Any alarm signal corresponds to an abnormal functioning condition, which demands the intervention of the operator.
MAX ALARM PRESSURE
Type of signal: visual and acoustic
Meaning: exceeded superior safety limit of the patient circuit pressure
Cause n.1: the volume/minute selected is too high
Correction: decrease the volume/minute selected
Cause n.2: the connection tube is crushed
Correction: free the connection and put it in a safe condition
Cause n.3: the volume/minute selected is correct but the internal resistance of the patient in certain conditions may cause intervention of an alarm Correction: position
the pressure limiter on a level inferior to the way the patient circuit can be discharged without alarm intervention.
Cause n.4: the pressure limiter does not work correctly
Correction: send the device back to the manufacturer for a maintenance check
MIN PRESSURE ALARM
Type of signal: visual and acoustic
Meaning: the pressure in the patient circuit does not reach the minimum value expected during the inhalation phase
Cause n.1: the patient circuit is not connected to the patient
Correction: re-effect the connection
Cause n.2: there is no medical gas
Correction: check that the medical gas alarm is not on; verify the connection with the feeding source; verify the condition of the feeding source
Cause n.3: the volume/minute selected is insufficient: the patient manifests a breathing will superior to the machine erogation Correction: adapt the volume/minute to the
patient's needs
SOFTWARE FAULT ALARM
Type of signal: intermittent visual (all l.e.d.s 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 Ventilator back to the manufacturer
APNOEA
Type of signal: visual and acoustic
Meaning: the machine did not automatically wait for voluntary inhalation of the patient
Cause n.1: the connection between patient and device was interrupted
Correction: re-effect the connection
Cause n.2: the patient stopped breathing spontaneously
Correction: verify that controlled breathing is automatic
DISCHARGED INTERNAL 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 the specifications provided in paragraph 4.3
9
5.5
INSUFFICIENT FEEDING 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
TROUBLESHOOTING CHART
5.6 PROBLEM CAUSE SOLUTION
Gas Supply The ventilator is not connected to a compressed gas source
(oxygen or medical gas) Connect the ventilator to a medical gas supplying source
Gas Supply The oxygen bottle is empty Replace with another bottle that is full and fill the empty one
Gas Supply The pressure or the erogation capacity are not correct (lower
than 2,5 bar) Check the adapter performance
The patient cannot exhale Patient valve Check the fixing of the valve or replace it
Low PAWThe corrugated tube is not connected
or connected in a bad way Adequately connect the corrugaed tube
Low PAW Non compatible corrugated tube or damaged tube Replace the corrugated tube
Low PAW The "non rebreathing" valve is not adequately connected
(after sterilisation) to the tube and/or mask compromising
good holding
Adequately connect the "N.R." valve to the mask and corru-
gated tube
APNOEA No spontaneous breathing Digit mode ASS/CONTR or CONTR
High PAWObstructed Airways Remove the Bronchoinspiratingprosthesis
High PAW Bent corrugated tube Ensure that there are no bending or obstructions
High PAW The patient is not hyperextended Hyperextend or position the Guedel or Berman cannula
High PAW Superior alarm limiter set to a value that is too high Set to 10 mbar above the maximum value of the airway pres-
sure
Dead Battery The internal battery has less than 5 minutes of life left Use an external battery or connect to electricity power;
recharge the internal battery
immediately (see recharge battery)
10
CLEANING
The operations below described must be executed after each use of the device.
Switch OFF the ventilator
Isolate the device from the feeding source/net (if connected)
Disassemble the NON REBREATHING valve
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
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).
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:
6 MAINTENANCE
6.1
PRODUCTS WHICH CAN BE USED PRODUCTS WHICH CANNOT BE USED
Disinfecting with aldehydes Compounds releasing halogens
Disinfecting with alcohol Strong organic acids
Quaternaric hammonia compounds Compounds releasing oxygen
Trichloroethylene
MAINTENANCE
6.2.1Precautionary Maintenance
The person who carries out the precautionary maintenance of the appliance (user in person, manufacturer/supplier or a third party) has to guarantee the following basic
requirements:
-Technical knowledge of the appliance, of the periodic maintenance procedures as described in these instructions;
-Use of technical personnel in possession of specific qualifications and training in the maintenance operations of the appliance in question;
-Use of components/replacement parts/accessories that are either original or approved by the supplier, in such a way as to carry out every operation without causing alter-
ations or modifications to the appliance;
-Possession of the checklist of operations carried out on the appliance;
-Guarantee complete adherence to the instructions of the 93/42/CEE Directive also regarding the obligation towards the manufacturer to allow the aforementioned an
after sales care and traceability of the appliance when requested.
6.2.2 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
- pressure
- alarms
- system holding
- battery, the feeding battery's recharging circuit, the alarm battery.
6.2.3 Servicing Maintenance
The person to whom the servicing of the appliance is entrusted must guarantee the following basic requirements:
-Adequate knowledge of the appliance, of its technical/construction features, of checks and final tests, of packaging, conservation and handling;
-Adequate knowledge of the technology used in the making of the appliance;
-Knowledge of the functions of the appliance, of any potential risks and of the probability of possible malfunctions or break-downs;
-To be in possession of all the instruments necessary for carrying out any kind of technical operation regarding servicing;
-To be in possession of original replacement parts or those authorized by the manufacturer;
-Specialized technical personnel trained by the manufacturer for the servicing of the appliance in question;
-Guarantee complete adherence to the instructions of the 93/42/CEE Directive also regarding the obligation towards the manufacturer to allow the aforementioned a post
sales care and traceability of the appliance when requested.
The device, if used as described in these instructions, has a lifetime of 6 years.
6.2
1
1
Display Card EV00192A
Microprocessor EV00191A
Power cable for electronic ventilator CM 250 EV20009A
Overpressure valve for ventilator EV00104B
Gas mixer for ventilator EV00105B
Complete microregulator EV01108A
Complete patient circuit for vent EV00106A
Joint, thread M 1/8 EV20220A
Joint, thread M 1/4 EV20226A
Connector rubber case diam.7 M 1/8 OX07005A
Connector rubber case diam.7 M 1/4 OX07004A
Automatic connector straight 6x4 M 1/8 EV30000A
Connector curved diam. 6x4 M 1/8 EV20300A
Driving air hose 25cm EV30010A
Driving air hose 100cm EV30020A
Polycarbonate non-rebreathing valve EV50011K
PVC breathing-gas hose diam.22x120cm EV50020A
Silicon breathing-gas hose diam.22x120cm EV50025E
"KOMPAK" bag EV50100A
Aluminium bracket for "KOMPAK" EV50101A
7 ACCESSORIES AND SPARE PARTS
SPARE PARTS
7.1
DESCRIPTION CODE
Polycarbonate panel ENGLISH EV13190A
Spare Battery EV30202A
Complete microregulator EV00108A
Manovacumeter for ventilators EV00107A
Electrovalve in brass for ventilators EV00110A
Pressure condition type "K4" for ventilators EV00112A
ON-OFF buttons EV00114A
L.E.D. alarms Card EV00193A
Unipolar exchanger 250V 10A EV00103A
Potentiometer 2,2K for vent. EV00119A
Potentiometer 22K for vent. EV00121A
Potentiometer 100K for vent. EV00120A
Fuse 1 Ampere for vent. OX08000A
Power cable for electronic ventilator CM 40 EV20010A
Power cable for electronic ventilator CM 150 EV20008A
Power cable for electronic ventilator CM 200 EV20011A
12
We remind you only qualified and authorized Technicians may perform repair works on the device.
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.
ACCESSORIES
Device includes the following accessories:
PATIENT CIRCUIT
(Composed of: atoxic hose Ø22mm, non-rebreathing valve and a quick connection inlet)
12 V FEEDING CABLE
Besides to the plug, for adaption to 12V feeding, this cable can be connected to a transformer with the following characteristics:
-Net feeding input 220/230 VAC 50/60Hz;
-14 V output 14 V - 0,8 Ampere.
7.2
Warning
The information contained in this document can be modified without warning and is not to be intended as a commitment on the part of Spencer Italia S.r.l.
Spencer Italia S.r.l. reserves the right to modify these instructions. Spencer products are exported to many countries in which the same identical regulations do not exist.
It is for this reason that there can be differences between the description and the actual product delivered. Spencer continuously improves all models of the products
sold, therefore hopes to have your understanding, by reserving the right to modify the shape, assembly, layout and technical aspects herein described, at any given
time.
© Copyright Spencer Italia S.r.l.
All rights reserved. No part of this document must be photocopied, reproduced or translated into another language without the written permission of Spencer Italia S.r.l.
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