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504-2056A 51

APPENDIX A

Product Safety, Transportation and

Disposal of Recommended Batteries

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Содержание Pneupac babyPAC 100

Страница 1: ...miths medical family of companies 2006 PN 504 2056A Issue 6 10 2006 Smiths Medical International Ltd Bramingham Business Park Enterprise Way Luton LU3 4BU England Tel 44 0 1582 430000 Fax 44 0 1582 430001 Email info smiths medical com Website www smiths medical com ...

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Страница 3: ...ECTION 3 SET UP AND FUNCTIONAL CHECK 23 a Set Up 23 b Functional Check 23 SECTION 4 OPERATION 27 a User s Skill 27 b Setting of Ventilator 27 i General 27 ii Ventilating Patient Refer to Table 1 page 25 27 c Humidification 28 d Manual Ventilation 29 e Gas Usage 29 f Use with MRI MR Compatibility 29 SECTION 5 CARE CLEANING STERILISATION 31 a Care 31 b Cleaning 31 c Disinfection 32 d Sterilisation 3...

Страница 4: ...on and Disposal of Lithium Batteries 53 Appendix B Calibration accuracies and deviations due to change in ambient conditions 59 Appendix C Cleaning and inspection log 63 Smiths Medical International Ltd reserves the right to make changes without notice which may affect the information contained in this manual Additional copies of this User s Manual can be obtained from Smiths Medical International...

Страница 5: ...ific operational requirements of the babyPAC ventilator The babyPAC ventilator is intended only for use in transport and emergency situations where the patient is being constantly monitored by the carer The integrated alarm unit is intended to alert the carer to changes in the patient s ventilation but it cannot ensure that the patient s blood gases are maintained at the required level Therefore p...

Страница 6: ...ls may be used but if these circuits have higher compliance ventilatory performance may be compromised Corrugated disposable hoses are not recommended for this reason 7 Warning Provision of Accessories Ancillaries and Spares for CE marked products Section 2 e 6 d 7 The babyPAC ventilators described in this manual carry a CE mark to certify that they have been manufactured to conform to the require...

Страница 7: ...t connector These procedures are the minimum required in safeguarding against projectile risks or altered performance due to the inadvertent addition of magnetically attracted parts or changed compatibility conditions 15 Warning Use in Extreme Environments Appendix B Although use of this ventilator outside the environmental conditions specified in this manual will not directly lead to a safety haz...

Страница 8: ...chanical ventilation problems or decreases in gas exchange always ensure that there are no blockages in the breathin system If a blockage is found immediately replace the breathing system or HME filter To prevent such problems occuring filters and HME s shiould be routinely replaced in accordance with the manufacturer s instructions 19 WARNING Exhalation Valve Diaphragm Fitment Section 5 f To avoi...

Страница 9: ...s See Appendix A 4 Use In Confined Spaces Section 3 b 13 If the babyPAC ventilator is mounted within a very confined space care should be taken to ensure that the fresh gas intake port is supplied with air that is not contaminated by the expired gas released from the expiratory valve as this will affect the delivered oxygen concentration If necessary a short length of 10mm bore soft tubing can be ...

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Страница 11: ...on The babyPAC ventilator consists of a control module with a conventional Y patient circuit See Fig 1a page 10 It is a gas powered time cycled pressure generator which depends solely on the pressure of the supply gas for its operation The model described in this manual additionally incorporates an integrated electronic pressure alarm unit which becomes operational during CMV modes It alerts the u...

Страница 12: ...e CPAP function This function is also automatically introduced during the expiratory phase whenever IMV is selected The exhalation valve is mounted on the ventilator output manifold and consists of a twist to remove housing and a silicone rubber valve element Both items can be autoclaved for sterilisation see section 5 d babyPAC ventilators have been supplied which are suitable for ventilating pat...

Страница 13: ...504 2056A 13 b Controls and Features See Figs 1a 1b 22 19 20 25 10 8 1a 4 17 18 7 9 14 1b 11a 12 26 6 16 3 21 5 2 11b 6a Figure 1a 23 15 13 24 Figure 1b ...

Страница 14: ...vailable as a compressed supply gas then a concentration range of 45 approx 100 oxygen concentration is possible The air dilution is obtained by entraining atmospheric air Because of this the minimum oxygen concentration setting approximately 45 on the white scale with oxygen only as a supply is the most economic setting in terms of gas usage If both oxygen and air are connected as gas sources the...

Страница 15: ...min to the breathing system and excess gas is vented to atmosphere at the exhalation valve The breathing system pressure is maintained at the constant pressure as set by the CPAP pressure control and is continuously displayed on the pressure manometer In the CMV ACTIVE PEEP position the ventilator operates as described under CMV PEEP but the ventilator flow in the patient circuit is maintained thr...

Страница 16: ...e alarm 25 is provided to signal that the limitation pressure has been achieved and that gas loss is occurring through this valve This control should always be set above the set inspiratory pressure but below the pressure that is considered the safe maximum for the patient being ventilated The pneumatically operated alarm is backed up by a high priority electronically generated audible and visual ...

Страница 17: ...ed with adequate pressure they show white for the oxygen supply or black and white for the air supply respectively The babyPAC ventilator will operate to specification on oxygen only giving an output of 45 approx 100 oxygen concentration air only 21 oxygen concentration output or oxygen and air 21 70 oxygen concentration output Any visible red on the alarm for a required gas indicates that the res...

Страница 18: ...n installed in the ventilator it produces no noticeable effect Only this battery should be used when the babyPAC 100 is used as an MR Compatible ventilator It must be noted that no battery of this type commercially available is completely free of ferrous content and so it must never be removed from the battery compartment of the ventilator in the presence of a magnetic field The battery is retaine...

Страница 19: ...aning by means of the knurled diameter as described in section 5 b ii 19 Supply Gas Inlet Connection s Two connectors are provided for the supply of pressurised oxygen and air respectively As standard these are non interchangeable proprietary permanent connectors that require a spanner for disconnecting or connecting the supply hoses User connectable gas specific connections in compliance with mos...

Страница 20: ...as only oxygen or air The green LED illuminates 3 times every 30 seconds whenever the ventilator is operating on a single gas supply If one of the gases fails the audible alarm will also sound until muted section 2 c item11 e Mounting Options The babyPAC ventilator has been designed to be mounted and carried with a wide range of options examples of which are shown in Fig 2 It may be mounted with i...

Страница 21: ...ke port to duct in fresh air Figure 2d Figure 2e f Accessories i Instant Action Case An Instant Action carrying case can be supplied which is specially designed to carry a babyPAC ventilator a D sized gas cylinder and a wide range of accessories It enables a comprehensive set of pulmonary ventilation equipment to be carried for immediate action at the scene of an emergency Fig 3 shows the general ...

Страница 22: ...esigned to reduce the pressure of high pressure gas cylinders from 137 200 x100kPa 137 200 bar to 400kPa 4 bar as required by the babyPAC ventilator It will deliver flow in excess of 60 L min at this nominal pressure Pin index or other standard inlet connectors are available for air or oxygen The regulator is equipped with a protected contents gauge and a gas specific quick release outlet connecto...

Страница 23: ... the babyPAC Accessories and Spare Parts List can be used with the ventilator provided the same inlet connection is specified b Functional Check The following procedure should be followed when first setting up the ventilator to check that it has been assembled correctly and is operating safely It should be repeated periodically as specified under Maintenance 1 Set the ventilator controls as follow...

Страница 24: ...h priority electronic audible alarm will also sound Check that the unit cycles regularly about every 3 seconds NOTE After the 60 second initial silenced period the electronic audible alarm will operate if an alarm condition persists This sound can be silenced for 60 seconds by a single depression of the silencing button If the alarm condition continues beyond this silencing period a second depress...

Страница 25: ...hould not be used until a more thorough check has been completed WARNING Before changing gas cylinders turn off the cylinder valve and then switch on the ventilator After one or two cycles the ventilator will stop and it is then safe to unclamp the pin index yoke without a sudden release of pressure PRECAUTION It is recommended that the valve on the gas cylinder is turned off after use to ensure t...

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Страница 27: ... hose s probe to gas supply ies 2 Slowly turn on gas supply ies if relevant 3 Check that the visual alarm s for supply gas failure has changed from red to white oxygen black and white air 4 Set the function selection switch to CMV PEEP 5 Check that the alarm indicators flash in sequence and that the alarm sounds to indicate correct function 6 Set ventilation parameters to suit the patient 7 Briefl...

Страница 28: ... Humidification There is no provision in the standard babyPAC patient circuit for a heated water humidifier because of the problems these present during the transportation of patients If humidification is considered necessary then the use of alternative means such as HMEs is recommended These should comply with EN ISO 9360 WARNING If a Heat Moisture Exchanger HME filter is used and the patient is ...

Страница 29: ...pplied and with minimum setting on oxygen concentration scale white selected In this setting 2 3rds of the gas flow in the patient circuit during the inspiratory phase is ambient air and the compressed gas usage will be most economical As the oxygen concentration is increased towards 100 oxygen supply only or 70 with oxygen and air supplies so the gas usage will rise to approximately double that a...

Страница 30: ...parts and accessories MRI should be added as a suffix to the order code of each part ordered See Section 7 WARNING The normal routine of checking the ventilator system for magnetic attraction should be followed whenever the equipment is taken into an MR environment to ensure that magnetic parts have not been added to the system inadvertently It is also recommended that every time a patient is posi...

Страница 31: ...t by immersion in any fluid Do not allow any oil or grease to come into contact with the module or in particular with the input and output fittings because of the potential fire risk when oxygen is being used ii Exhalation Valve The exhalation valve can be disassembled for cleaning by unscrewing the body of the 22 15mm taper connector The knurled portion assists the grip during this operation Once...

Страница 32: ...ch as distortion hardening cracking or poor fit of mating parts Before putting the system back into service the functional check described in Section 3 b should be carried out f Exhalation valve removal cleaning re assembly procedure This section describes the removal cleaning re assembly procedure for an Exhalation valve Diaphragm Part No 510 3043 This procedure will enable the prolonged continuo...

Страница 33: ...omponents that are damaged or worn see Equipment Required section WARNING To avoid the risk of the exhalation valve diaphragm remaining depressed against the valve housing and resulting in continuous pressure loss from the patient circuit avoid depressing the center of the diaphragm during fitment Following the replacement procedure ensure that the center of the diaphragm is is not depressed and a...

Страница 34: ...onal check Functional Check WARNING Any deviations observed in the functional check should be reported immediately to your supplier or an authorised service engineer and the ventilator should not be used until a more thorough check has been completed The functional check should be carried out to validate that the assembly procedure has been sucessfully completed and the unit is operating safely as...

Страница 35: ...ending upon the intensity of use Normally this would be not more often than once every 6 months but at least once every 2 years c Changing of battery The specified batteries will give several years of service under normal use conditions but to avoid the need to locate a spare battery whilst the ventilator is in field service it is recommended that the battery is replaced as a matter of routine at ...

Страница 36: ... devices therefore at the user s discretion the ventilation can be continued whilst replacing the battery providing there are no hazards associated with battery replacement eg MRI environment flammable environment static sensitive areas etc d Servicing If the babyPAC ventilator shows a malfunction during operation or testing or if its performance is measured to be outside the tolerance stated in t...

Страница 37: ...l Module 510A1960 Gas cylinders Oxygen D size 365L Full W6837 CE Empty W6838 CE Compact C size 230L Full W6833 CE Empty W6834 CE Oxygen 500 A162CE Air 500 A162CE Z28 Regulator Pin Index Cylinder Connection with gas specific outlet Oxygen brass body 500 A162CE Z52 Regulators for use with incubators 500 A162 Z41 CE 500 A162 Z44 CE alarmPAC AP20H CE Mounting Clamp for Medical Rail 30 35mm 500 A4843 C...

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Страница 39: ...19 Valve 20 in conjunction with bleed 21 sets the PEEP pressure level on valve 17 and so once valve 18 has switched the patient pressure will drop down to the PEEP level and the patient will exhale During the inspiratory phase the flow amplifier valve 11 supplies oxygen to the mixer control valve 12 to ensure that the required oxygen flow is supplied to the mixer 9 The mixer draws in the required ...

Страница 40: ...a medium priority audible alarm if one of the supply pressures drops to a level where the indicator shows red The inflation pressure detector is a pressure switch which senses the pressure at the outlet connector of the ventilator An output signal is given to the alarm control unit whenever the inflation pressure is greater that 10 x100 Pa The signal is used to determine if the pressure has passed...

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Страница 43: ...ygen Concentration 45 approx to 100 with oxygen only as supply 21 to 70 with oxygen and air supplies Audible High Pressure Alarm 12 80 x100Pa 12 80 cmH2O with pressure limiting VBS Inspiratory Resistance 2 x100Pa 5 L min 4 5 x100Pa 15 L min Expiratory Resistance 2 x100Pa 5 L min 4 5 x100Pa 15 L min Compliance 4 5 mL kPa Internal volume 150 mL Duration of Gas Supply 1 60 min L cylinder capacity 200...

Страница 44: ...rs for connection and disconnection User connections conforming to certain National and International Standards available as options Input Hoses Standard 2 metre long 3mm bore with probes to BS5682 for oxygen and air Colour coded to BS1319 and ISO32 as standard oxygen white air black with white bands Dimensions 92H x 250W x 162D mm Weight 3 75 kg excluding hoses and patient circuit Threaded Bushes...

Страница 45: ...d Transport Ventilators The unit follows the International Standard for alarm sounds and indication ISO 9703 Electrical Safety to IEC 601 1 Internally powered Type B equipment EMC to EN60601 1 2 c Accuracies The accuracies to which the ventilation parameters of the babyPAC ventilator are factory calibrated and how these are affected by operating and ambient conditions are tabulated in Appendix B ...

Страница 46: ...of the Inspiratory Time to the Expiratory Time Lung Compliance Volume added per unit pressure increase when is added to a human or artificial lung Muting Causing the cessation of a sounding auditory alarm by the deliberate action of a second depression of the silencing button The muting is reset when either the condition which caused the alarm is removed or the ventilator is switched off MRI Magne...

Страница 47: ...sses through the alarm whenever the pressure in the ventilation breathing system exceeds the setting of the pressure relief valve as set by the high inflation pressure alarm control Air Intake Fresh Gas Intake Port where entrainment air is taken in prior to blending with supply gas and feeding to patient O2 Chemical symbol for oxygen Qmax Maximum Flow Requirement This symbol denotes the maximum fl...

Страница 48: ...me alarm signals are given if a constant positive pressure greater than 10 x100Pa is detected for 8 seconds or more If the constant positive pressure alarm has been muted then the flashing of this alarm decreases to a burst of 3 flashes every 8 seconds Cycle Indicator This green light flashes once for 1 10th second every time the patient inflation pressure rises through the pre set threshold press...

Страница 49: ...st lungs with the relief valve and high pressure alarms just operating during of the inspiratory phase Inspiratory and expiratory times frequency inflation pressure and peak inflation pressure were continuously monitored by remote measurement ii Projectile Risk At no point along the axis of the magnetic field did the ventilators present a projectile risk but for a distance of about 15 cm around th...

Страница 50: ...and values The maximum gradient value used at this position was 13 3mT 566396Hz EPI alternates from high positive gradient to high negative gradient in 452μs giving a switching rate of 29 43T s 1253Hz μs This process is repeated after 214μs with the polarity switching again This was run continuously whilst observing the ventilator No effect due to magnetic field switching could be detected vi Effe...

Страница 51: ...504 2056A 51 APPENDIX A Product Safety Transportation and Disposal of Recommended Batteries ...

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Страница 53: ...igorously with water producing flammable hydrogen gas which can cause a fire PRECAUTIONS FOR STORAGE Batteries should be stored at temperatures between 10 C and 25 C with relative humidity not exceeding 65 To maximise shelf life excessive temperature cycling and storage at temperatures greater than 25 C should be avoided Storage of lithium batteries at lower temperatures is possible providing care...

Страница 54: ...ontains not more than 1 gram of lithium or lithium alloy 2 Each battery contains not more than an aggregate quantity of 2 grams of lithium or lithium alloy 3 Cells are separated so as to prevent short circuit 4 Batteries are separated so as to prevent short circuit and are packed in strong packaging except when installed in electronic devices 5 If a battery contains more than 1 gram of lithium or ...

Страница 55: ...osal of the lithium batteries recommended in this manual is not regulated by European Community Directive 91 157 EEC on Batteries and Accumulators Containing Certain Dangerous Substances However individual countries may also establish regulations that cover the disposal of waste batteries These may be more stringent that EC requirements Thus local regulatory authorities should be contacted for the...

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Страница 57: ...504 2056A 57 APPENDIX B Calibration accuracies and deviations due to change in ambient conditions ...

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Страница 59: ...sec 0 015 sec 0 07 sec See Tables 3 4 below See Tables 3 4 below TE min 0 02 sec 0 01 sec 0 015 sec 0 07 sec See Tables 3 4 below See Tables 3 4 below TI max 0 sec 0 22 sec 0 025 sec 0 19 sec See Tables 3 4 below See Tables 3 4 below TE max 0 24 sec 0 74 sec 0 25 sec 1 0 sec See Tables 3 4 below See Tables 3 4 below TE IMV max 2 0 sec 2 0 sec 2 0 sec 2 0 sec 7 8 Peak Pressure 2 x100Pa 3 x100Pa 1 5...

Страница 60: ... E time 0 11 0 15 0 50 I E time 0 08 0 10 0 35 I E time 0 05 0 07 0 25 I E time 0 1 0 1 Table 4 Frequency Accuracies Setting Frequency range using I E service limits Inspiration Expiration Nominal Frequency Maximum Minimum 2 00 4 00 10 00 12 50 8 33 1 00 2 00 20 00 25 00 16 67 0 75 2 00 21 82 27 27 18 18 0 50 1 00 40 00 50 00 33 33 0 35 0 75 54 55 68 18 45 45 0 25 0 50 80 00 109 09 63 16 ...

Страница 61: ...504 2056A 61 APPENDIX C Cleaning and inspection ...

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Страница 63: ...504 2056A 63 Appendix C Cleaning and inspection log Contents Complete Cleanliness Checked Functional Performance Check section 3 b Cylinder contents Date Signature Comments ...

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