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1. Introduction

The SLE2000 is a constant flow, time cycle, and pressure limited neonatal ventilator
with patient triggering.

Main features are that it has no expiratory valve but uses a reverse flow of mixed gas
that is injected from the exhaust manifold into the expiratory limb of the patient circuit.
This flow of gas has the effect of compressing 5 LPM humidified gas into the patient
ET tube.

The advantage of this system is that there is no expiratory resistance due to valves or
diaphragms, therefore no inadvertent PEEP is generated.

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Содержание 2000

Страница 1: ...Issue 11 SLE 2000 Ventilator User manual Infant Ventilator ...

Страница 2: ...n sle co uk E mail s should be addressed to the Service Manager Web site www sle co uk All rights reserved No part of this publication may be reproduced stored in any retrieval system or transmitted in any form or by any means electronic mechanical photocopy recording or otherwise without prior permission of SLE Copyright SLE 16 12 2014 Manual UM17 Issue 11 SLE Part Nº N2000 11 ...

Страница 3: ...ssure Display 20 8 5 CMV Mode 21 8 6 PTV Mode 21 8 7 SIMV Mode 22 8 8 Alarm Test 23 8 8 1 Low CPAP 23 8 8 2 High and Cycle Fail Alarm 23 8 8 3 Leak and Block Alarms 24 8 8 4 Mains failure alarm 24 8 8 5 O2 Blender Alarm 25 8 9 Condition of O2 Cell 25 8 10 Completing Functional Testing 25 8 11 Basic Set Up 26 8 12 To Use the SLE2000 in CPAP Mode 27 8 12 1 Manual breaths in CPAP mode 27 8 13 To Use ...

Страница 4: ...arm 40 10 0 8 Low CPAP Alarm 41 10 0 9 O2 Blender Alarm 41 10 0 10 Alarm Mute 41 10 0 11 Alarm Volume 41 10 0 12 Alarm Verification 41 11 Auxiliary Output 42 12 Rear Panel 43 13 Patient Circuit Connection 44 14 Filter Systems 46 14 1 Bacterial filter SLE Part Nº N2029 Autoclavable 46 14 2 Bacterial filter SLE Part Nº N2587 Single use 46 14 2 1 Precautions when using bacterial filter N2587 46 15 Cl...

Страница 5: ...tilation 57 20 2 Displays 57 20 3 Controls 58 20 4 Alarms 59 20 5 Air and Oxygen Supplies 59 20 5 1 Oxygen supply 59 20 5 2 Air supply 59 20 6 Power Dimensions etc 60 21 Consumables and Accessories for SLE 2000 61 22 Ordering Information 63 23 Technical Bulletins 64 ...

Страница 6: ...NTILATOR FAILURE TO DO SO COULD LEAD TO INJURY OR DEATH 1 PERFORM THE FUNCTIONAL TESTS PAGE 19 THIS SHOULD TAKE NO MORE THAN 20 MINUTES 2 SETUP THE SLE2000 IN THE CHOSEN MODE PAGE 26 3 THE SLE2000 IS READY FOR USE FOR MORE INFORMATION SEE TECHNICAL SECTION PAGE 32 FOR TROUBLE SHOOTING SEE TROUBLESHOOTING CHART PAGE 51 ...

Страница 7: ...atory valve but uses a reverse flow of mixed gas that is injected from the exhaust manifold into the expiratory limb of the patient circuit This flow of gas has the effect of compressing 5 LPM humidified gas into the patient ET tube The advantage of this system is that there is no expiratory resistance due to valves or diaphragms therefore no inadvertent PEEP is generated ...

Страница 8: ...ressure PIP To avoid the possibility of gas dilution these regulators are supplied with the same oxygen concentration as the Fresh Gas supply The front nozzle is used to generate an opposing flow to the Fresh Gas in the exhalation block and thus create CPAP The rear nozzle is used to generate the peak inspiratory pressure in the same way supplying constant pressures at all breathing rates The PIP ...

Страница 9: ...ntil all necessary repairs and or maintenance have been completed and a factory authorised service representative has certified that the equipment is fit and ready for use This equipment its accessories or component parts should not be modified The use of non approved parts or accessories will invalidate the warranty The owner user of this equipment shall have the sole responsibility and liability...

Страница 10: ...LE 2100 or of SpO2 or Pt02 PtCO2 will dependably alert the medical team to an alarm situation not the monitoring of pressures 6 When the ventilator is being used on a patient a suitably trained person must be in attendance at all times to take prompt action should an alarm or other indication of a problem occur 7 The ventilator functional tests must be carried out each time the SLE 2000 is used on...

Страница 11: ...nebulizers and other delivery systems e g NO with the ventilator in High Alarm or gas leak condition the patient can receive inaccurate mixtures 20 If the SLE 2000 Infant Ventilator is adversely affected by equipment emitting electromagnetic interference then that equipment should be switched off or removed from the vicinity of the 2000 Conversely if the 2000 is the source of such interference to ...

Страница 12: ...ental Fibroplasia Retinopathy of prematurity The minimum patient monitoring requirements for Ventilation are 1 ECG heart rate 2 Chest wall movement 3 Blood pressure continuous intravascular regular intermittent measurements 4 Transcutaneous carbon dioxide intravascular carbon dioxide regular intermittent arterial capillary samples 5 Regular arterial and transcutaneous blood gas monitoring 6 Regula...

Страница 13: ... Positive Airway Pressure O2 Oxygen C Degrees Celsius PTV Patient Triggered Ventilation F Degrees Fahrenheit PIP Peak Inspiratory Pressure EMC Electromagnetic Compatibility PEEP Positive End Expiratory Pressure ET Endotracheal psi Pounds per Square Inch FIO2 Fractional Concentration of Inspired Oxygen SaO2 Saturated oxygen Hz Hertz SIMV Synchronised Intermittent Mandatory Ventilation I E Inspirato...

Страница 14: ...g Current Attention consult accompanying documents Conformance mark and notified body registration Type B IEC601 1 protection against electric shock I On power connection to the mains O Off power disconnected from the mains Rotate clockwise to increase anticlockwise to decrease 0120 ...

Страница 15: ...Page 15 of 66 ...

Страница 16: ...Ventilator Description The SLE 2000 consists of two linked modules Electronic and Pneumatic 7 1 Front Panel Electronic Module Pneumatic Module 28 1 2 3 4 5 7 9 12 13 14 17 18 19 20 21 22 24 25 26 10 27 6 8 11 15 23 16 ...

Страница 17: ... patient circuit line 7 I E RATIO digital display Displays from 9 9 1 to 1 9 9 calculated from BPM and Insp time 8 LEAK LED s audible alarm Indicates problems within the patient circuit line 9 MAX MEAN MIN switch with digital PRESSURE display Selects and displays Max Mean or Min airway pressures 10 FIO2 digital display Accurately displays the O2 as set by the Air Oxygen Blender 11 TRIGGER BACK UP ...

Страница 18: ...e Approximate indication of the pressure above PEEP which will be delivered to the patient in CMV PTV SIMV or manual breath modes 22 CPAP PEEP regulator Sets CPAP level in the circuit range is 0 to 15 cmH2O nominal 23 ALARM RESET Pushbutton Resets audible and visual alarms 24 Fresh Gas Port 5LPM blended gas supply to patient ventilator powered up 1LPM blended gas supply to patient ventilator OFF 2...

Страница 19: ... to a suitably rated and grounded electrical power source Connect SLE approved patient circuit with test lung to the ventilator For further information see page 44 or instructions supplied with patient circuit 8 1 Pressure Regulators and Gauges Check the CPAP PEEP regulator by turning the control from minimum to maximum making sure the large gauge reads between 0 and greater than 15 Check the INSP...

Страница 20: ...further three seconds all the digital displays show a sequence of numbers from O to 9 before returning to their normal state Note Block LED does not come on during this sequence 8 4 Pressure Display Set CPAP PEEP regulator to give 10 cmH2O on the pressure display with the pressure display selector switch in the MIN position Set the INSP pressure to 40 cmH2O Set the INSP Time to 0 5min Ensure that ...

Страница 21: ...t the BPM Rate to 60 Set the INSP TIME to 0 50 Ensure that The ventilator is cycling I E Ratio display reading 1 1 With the pressure switch check that the mean reads approximately 20 and the peak reads approximately 40 on the LED 8 6 PTV Mode Set BPM rate to 20 in CMV mode Advance the mode switch to PTV Set the PTV Sensitivity control to 1 Ensure that Ventilator should continue to cycle BPM displa...

Страница 22: ...ieve correct operation Note The BPM display will show patient effort detected each minute 8 7 SIMV Mode Advance the mode switch to SIMV Ensure that The ventilator continues to cycle The BPM display shows set rate Gently squeeze and release the test lung to simulate patient breathing Ensure that The ventilator continues to cycle at the set rate but synchronised with the pressure from test lung Set ...

Страница 23: ...Cycle Fail Alarm Set the PIP alarm control to 30 cmH2O Set the Pressure display switch to PEAK Advance the mode switch to CMV The ventilator will start to cycle Adjust the Inspiratory pressure regulator to give a pressure of 30 cmH2O on the pressure LED display The ventilator is ready for the High and Cycle Fail Alarm tests Decrease the PIP alarm control to 20 cmH2O This will trigger the HIGH visu...

Страница 24: ...PEEP regulator to 10 cmH2O 8 8 3 Leak and Block Alarms Remove the hose from the FRESH GAS TO PATIENT port The LEAK visual and audible alarm will be initiated Place a finger over the FRESH GAS TO PATIENT port The BLOCK visual and audible alarm will be initiated Replace the hose to cancel the alarms 8 8 4 Mains failure alarm Do not turn the mode switch to off Disconnect mains power by switching off ...

Страница 25: ...1 If the reading does not reach 100 then the cell requires adjustment To adjust the O2 cell reading set blender control to 100 Disconnect air supply hose from the wall socket and allow 3 minutes before adjusting control on rear panel See Rear Panel on page 43 for position of control If unable to set 100 O2 Cell must be replaced Ignore any blender alarms during this adjustment 8 10 Completing Funct...

Страница 26: ...d patient circuit should be used with this equipment Step 2 Set up the humidifier to manufacturer s instructions Step 3 Set the following ventilator conditions Set the mode switch to OFF Set all the pressure regulators to minimum Set the Pressure display switch to MIN Set the CPAP alarm control to 5 cmH2O and the PIP alarm control to 60 cmH2O Step 4 Select mode of ventilation to CPAP The ventilato...

Страница 27: ... of ignition away when oxygen is in use Do not use oil or grease on oxygen fittings or where oxygen is used 8 12 To Use the SLE2000 in CPAP Mode As in steps 1 to 5 plus a Increase CPAP PEEP pressure to required level These Controls are lockable Push to lock Pull to unlock Pressure will be indicated on the digital display b Set the CPAP alarm to the required level 8 12 1 Manual breaths in CPAP mode...

Страница 28: ... rate e Set the pressure display switch to PEAK and increase the INSP PRESSURE regulator to the desired level This is indicated on the digital pressure display f Set the PIP alarm to required level Press RESET to clear the alarms LOW CPAP is activated if pressure falls below setting HIGH will activate if PIP setting is exceeded by more than 4 cms It will also open a pressure relief valve and activ...

Страница 29: ...R BACK UP light extinguishing The weaker the patient the higher the sensitivity required After 60 seconds with an update every 60 seconds the BPM LED display will indicate the number of patient initiated breaths that were delivered in the preceding minute Care should be taken not to set the PTV sensitivity too high as it could self trigger Note on the set up for PTV If currently ventilating a pati...

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Страница 31: ...Page 31 of 66 ...

Страница 32: ...9 1 2 System Fail LED Lights if main microprocessor system or other electronic circuitry fails See section on alarms page 39 9 1 3 CPAP Mode FlO2 mean and min airway pressure digital displays The Manual Breath pushbutton and associated with it the High Low Failure to Cycle and Fresh Gas alarms Also activated is the INSP Time control for maual breath The time of this breath and pressure must be pre...

Страница 33: ...vered in the preceding minute In this mode inspiratory times of less than 0 4 seconds are recommended In PTV mode the BPM display will show only patient initiated breaths To check back up rate it is necessary to change the mode switch temporarily to CMV To enable an audible back up bleep hold the Reset button in during the automatic test mode on power up Note PTV has a default of 12 breaths per mi...

Страница 34: ...he ventilator mode switch from the OFF position to SIMV and during the initial ventilator system check when the digital displays run the their numerical check the RESET button is held in This will enable the audible bleep until the ventilator is switched OFF again The ventilator will only supply one breath during each time period set by the BPM rate So the total number of breaths delivered either ...

Страница 35: ...solution 0 02 secs 0 01 0 3 secs 126 250 BPM range setting resolution 0 01 secs 9 1 9 I E Ratio This appears on a four digit LED display and is calculated from the settings of the BPM and the INSP TIME controls If the BPM and the INSP TIMES are set so that the l E ratio exceeds 9 9 1 or 1 9 9 the display will show four dashes This will also occur in the PTV Mode 9 1 10 Oxygen FlO2 Indication of th...

Страница 36: ...tapered as indicated This is a Locking Toggle Switch Pull toggle lever to release The ventilator should be set to a square waveform for breathing rates above 60 BPM 9 1 14 Manual Breath The manual breath push button functions in the CPAP CMV and PTV modes with the High pressure and Failure to Cycle alarms operative The duration of the Manual Breath is controlled by the INSP TIME setting Manual Bre...

Страница 37: ...l pressure transducers 9 2 2 Removable Exhalation Block N2190 Can be removed easily for cleaning by lowering side panel 9 2 3 Fresh Gas Port The Fresh Gas port supplies 5 LPM of the blended gas via the humidifier to the patient inspiratory port on the ET connector when the ventilator is switched on Pressure release valve ...

Страница 38: ...e PIP SYSTEM DRIVING PRESSURE This guage shows the pressure above CPAP PEEP 9 2 5 O2 Blender FlO2 The oxygen blender controls the amount of oxygen available in the fresh gas supply The blender is monitored separately by an internal analyser and displayed on the FlO2 digital display There is an option Option 3 for a blended gas output connected on the side of the unit Note This output provides up t...

Страница 39: ...hing the ventilator off Other hardware system checks are incorporated such as the monitoring of the solenoid driver circuitry If the solenoid driver fails to operate when the processor has initiated a solenoid valve closure or opening SOL will appear in the BPM display window All the front panel potentiometers are frequently checked for continuity If a defect is found then HELP appears in the l E ...

Страница 40: ...relief valve will be activated 10 0 5 Adjustable Alarm Two controls on the front panel control the settings for HIGH CYCLE FAIL and LOW alarms 10 0 6 High Alarm Should the airway pressure exceed the PIP alarm setting by more than 4 cms audible and visual alarms will be activated a system leak will be introduced to vent excessive pressure and the fresh gas supply will be cut off HIGH pressure alarm...

Страница 41: ...d will sound when the pressure difference between the supply gasses is greater than 30psi indicating a possible gas supply failure 10 0 10 Alarm Mute This button will mute the audible alarms of PATIENT GAS FAILURES CYCLE FAIL LOW PRESSURE and HIGH PRESSURE for a period of 60 seconds but can be reset by the RESET push button providing no alarm condition exists 10 0 11 Alarm Volume The main high fre...

Страница 42: ...ket is not in use Analogue signal outputs are available at the rear of the electronics module on the 7 pin DIN connector Auxiliary O P Buffered airway pressure Pin 1 1 7 volts corresponding to 0 to 60 cmH2O FIO2 Pin 2 0 4 volts corresponding to 0 to 100 Common ground Pin 3 All other pins must be left unconnected SLE reserve the right to use these pins for other uses Only SLE approved equipment may...

Страница 43: ...ILTERS REGULARLY SEE USER MANUAL DANGER EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANAESTHETICS THIS EQUIPMENT SHOULD ONLY BE USED BY SUITABLY TRAINED AND CLINICALLY AUTHORISED PERSONNEL SLE 232 SELSDON ROAD SOUTH CROYDON SURREY CR2 6PL U K TYPE Nº SERIAL Nº SUPPY V Hz POWER A CLASS TYPE Auxiliary Output Connector FuseHolders FI02 100 Adjustment Tool Range switch Alarm Sounder Runnin...

Страница 44: ...PLY LINE Take the main patient circuit and fit the blue tube with the large connector to the humidifier outlet Plug the electrical connector into the humidifier heated wire supply 3 EXPIRATORY SUPPLY LINE Take the clear tube with the large connector and fit to the exhalation port of the ventilator Position water trap in an upright position at the lowest point in the circuit limb 4 PROXIMAL AIRWAY ...

Страница 45: ...G Two ports are provided for dual temperature probes one in the connector on the humidifier outlet next to the heated wire inlet and a second port in the ET Manifold ITEM 5 STERILISING Maximum Temperature 134 C Dismantle circuit parts and water container for cleaning Steam autoclave only at a recommended temperature of 121 C for 20 minutes Allow 15 minutes dry time and return to ambient temperatur...

Страница 46: ...aturated steam at 134ºC 277ºF Allowable variation of temperature of 3ºC at 220kPa 32psi with a minimum holding time of 3 minutes or 121ºC 248ºF Allowable variation of temperature of 3ºC at 96kPa 14 1psi with a minimum holding time of 15 minutes The filter can be autocalved a maximum of 25 times within its anticipated service life of 12 months For other makes of bacterial filter please refer to man...

Страница 47: ...in its original box Remove the protective film from the LCD screen Clean disinfect and sterilize in accordance with the instructions in section 15 2 Remove the inlet air and O2 gas port caps Retain for future use 15 2 Cleaning and disinfection of an in service ventilator The table 1 outlines the areas of the ventilator which can be uniquely cleaned disinfected and sterilized Before cleaning or dis...

Страница 48: ...ally discard and replace with a new silencer 15 3 Cleaning method Note Cleaning is an essential prerequisite to disinfection and sterilization Ventilator For cleaning use three clean disposable absorbent non shedding cloths Wipe clean with the first cloth using a hand hot water mild general purpose detergent solution as prescribed by the appropriate hospital authority Do not overload the cloth wit...

Страница 49: ...ed to dry thoroughly before sterilization 15 5 Sterilization method The silencer SLE part Nº N2186 and exhalation block SLE part Nº N2190 must be sterilized between use on patients The ventilator cannot be sterilized The exhalation block must be cleaned as an essential prerequisite to sterilization Autoclave with pure dry saturated steam at 134ºC 277ºF Allowable variation of temperature of 3ºC at ...

Страница 50: ... is changed 2 Check the running time meter on the rear of the ventilator to see if preventative maintenance or overhaul is due Arrange if necessary 3 It is the users responsibility to ensure that the ventilator is maintained in accordance with the service programme Preventative maintenance 6 monthly Overhaul 10 000 hours or 24 monthly ...

Страница 51: ...vice Manual Block Alarm audible visual Fresh gas filter blocked Fresh gas restrictor blocked Replace filter Replace circuit Blender Alarm audible when both gases connected Alarm shuttle sticking Either Air or O2 gas has failed Air O2 differential pressure exceeded Remove both gases from supply and re connect O2 first If this does not work disconnect and then connect the Air first Consult SLE train...

Страница 52: ...anual or SLE trained Engineer System Fail audible visual Component failure As above CPAP Unable to set desired pressure Faulty patient circuit Incorrectly assembled patient circuit Exhalation block located incorrectly Regulator cap is in LOCKED position Seized regulator control CPAP nozzle blocked Replace circuit Reassemble as per drawing supplied with circuit Relocate the block assembly Pull regu...

Страница 53: ...ble as per drawing supplied with circuit Relocate the block assembly Pull regulator cap out to release from locked status Consult SLE trained Engineer Consult SLE trained Engineer Reset alarm setting Drain tube HELP message Displayed in I E window System failure Consult SLE trained Engineer SOL message displayed in BPM window System failure Consult SLE trained Engineer Varying pressures Check for ...

Страница 54: ...ning all dust from interior of the unit Visual inspection and replacement where necessary of all tubing electrical wiring connectors crimps screws nuts hardware and checking the general condition of all other internal components and assemblies Inspection of the mains failure battery holder for corrosion and replacement of the battery Pneumatic and Electronic testing and where necessary calibration...

Страница 55: ... sounders Mode wave shape frequency range and pressure range switches Pressure relief valves A service manual including circuit diagrams descriptions of operations parts lists etc is available for use by qualified engineers who have been trained by SLE on this product Contact your distributor for further information SLE can offer an exchange service for the complete pneumatic module ...

Страница 56: ...PSI pound per square inch b at 4 oC c at 0 oC PSIa k Pascal bar cmH2Ob mmHgc PSI 1 000 6 8947 6 8947 x 10 2 70 308 51 715 k Pascal 0 14504 1 000 10 000 x 10 3 10 1973 7 5006 bar 14 5 100 1 000 1019 73 750 06 cmH2O 1 42237 x 10 2 0 09806 9 806 x 10 4 1 000 0 7355 mmHg 1 9337 x 10 2 0 13332 1 3332 x 10 3 1 3595 1 000 ...

Страница 57: ...cates power on SYSTEM FAIL Indicates main processor system fail TRIGGER BACK UP Indicates a machine delivered breath if patient fails to trigger ventilator during back up time window MAX MEAN MIN indicates which value is being displayed on the 7 segment pressure display MUTE Indicates that the mute function is active Alarm LED s LOW CPAP warning of the pressure dropping below the LOW CPAP alarm li...

Страница 58: ...min exp time 0 12 Pressure Display Switch MAX MEAN MIN Pressure Wave Switch Slow or Fast rise Manual Breath Pushbutton Alarm Mute and Reset Pushbuttons Mute active for 60 seconds approx Trigger Sensitivity Control Range 2ml 0 5 sec max To 10ml 0 5sec min Using SLE N2188 patient circuit Pressure alarm setting controls LOW CPAP 5 to 15cmH2O PIP 10 to 60 cmH2O Pressure controls INSPIRATORY CPAP PEEP ...

Страница 59: ... with medical grade compressed air and oxygen 20 5 1 Oxygen supply The SLE2000 requires a supply of pure oxygen between 3 to 5 bar 20 5 2 Air supply The SLE2000 requires a supply of medical grade compressed air to ISO8573 1 Class 1 4 1 minimum level of filtration between 3 to 5 bar Recommended level of filtration is class 1 1 1 Description of Class 1 4 1 1 particle size of 0 1 microns 4 Pressure d...

Страница 60: ...mplies with CE DECLARATION OF CONFORMITY IEC 601 1 and 601 2 12 1988 BS 5724 Part 1 and section 2 12 1990 EMC Medical device 601 1 2 Patient Circuit Required Model N2188 Single use or variant Model N2200 Re usable or variant Transport and storage conditions Temperature 20 to 50 C for not longer than 2 5 months Humidity 15 to 90 non condensing for not longer than 2 5 months Atmospheric pressure 500...

Страница 61: ... Circuits for use with above Box of 30 Other configurations available N3557 MR557 Heater Adapter for use with above single use patient circuits chambers N3340 MR340 Re usable chamber for use with above N2391 Re Usable Patient Circuit for use with above N2200 Re Usable Patient Circuit Accessory Kit N3558 MR558 Heater Adapter for use with above re usable patient circuits chambers N3170 MR170 Pole Cl...

Страница 62: ... filter single use Inlet Outlet 15mm female or 22mm male Tapered Connections N2186 Silencer fitted to rear of exhalation block N2035 O2 complete 4 metres length N2199 Air hose 4 bar complete 4 metres length N2006 11 User Manual for SLE2000 N2000 00 Service Manual for SLE2000 N2002 01 User Manual for SLE2000 on CD ROM N2002 Service Manual for SLE2000 on CD ROM ...

Страница 63: ...ed Ventilator without humidifier SLE 2000 Z2202 As above but for Rail mounted Ventilator without humidifier State voltage required OPTIONS Option 1 ref N2200 Reusable circuit start up kit Part No N2200 Option 3 ref Z0003 Auxiliary 0 15 LPM Blended Output State operation required Air Compressors AD 3600 ref L0035 Suitable for 1 Ventilator AD 2000 ref L0030 Suitable for 2 Ventilators ...

Страница 64: ... 990603 Removal of hour counter from electrical chassis TB 000201 New versions of control software TB 000801 Ventilator firmware revision list TB 040301 CPU Boards for serial Nº E0108 Y0963 to Y0975 TB 040401 V0226 potentiometer design change Any of the above technical bulletins can be obtained by contacting the SLE Service Department ...

Страница 65: ...Page 65 of 66 SLE reserves the right to make changes without prior notice in equipment publications and prices as may be deemed necessary or desirable ...

Страница 66: ...0120 ...

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