1、w- 3 A-A-54444 65 = 9999974 0062166 8 r A-A-54 4 4 4 19 July 1991 a e AMSC N/A FSC 6530 DISTRIBUTION STATEMENT A: distribution is unlimited. Approved for public release; COMMERCIAL ITEM DESCRIPTION VENTILATOR, VOLUME, PORTABLE The General Services Administration has authorized the use of this Commer
2、cial Item Description This Commercial Item Description covers a self-contained, portable volume ventilator which operates on 11-30 volts DC and also on 110/230 volts AC, 50-400 Hz when used with the separate AC power supply furnished. Salient Characteristics: The portable volume ventilator containin
3、g time cycling, pressure limiting, constant flow, and microprocessor (CPU) control shall be suitable for use in hospitals, ambulances, fields, and in military aeromedical aircraft. It shall be suitable for providing controlled ventilations to the non- breathing patient and for assisting ventilations
4、 to the spontaneously breathing patient. The ventilator shall be a self-contained apparatus except for a compressed gas source and shall contain at least the following: a control/display panel; internal battery; battery recharge circuit; EMI/RFI suppression circuitry; valve to select flow of gas; al
5、arms; and chart depicting tidal volume by gas flow/inspiratory time. The apparatus with above mentioned items shall be self-contained and have its own separate carrying case with condensed operating instructions marked directly on the case or on a label attached to the case. the specified Operating
6、and Maintenance Manuals. The case shall be a semi-rigid plastic or corrosion-resistant metal material with integral carrying handle, and shall have a hinged, clear door to protect the operator controls of the control/display panel from inadvertent contact and provide splash protection. These instruc
7、tions are in addition to Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54444 65 9999974 0062Lb7 T = A-A-54 4 4 4 The internal battery shall be a rechargeable 12 volt battery. Two batteries wired to provide 12 volts is acceptable. The ventilator
8、 battery shall be rechargeable from any of the following inputs: 11 to 30 volts DC, positive or negative ground; and nominal. 110/230 volts AC, 50-400 Hz, single phase. A totally depleted internal battery shall be capable of being fully recharged within 24 hours from any of the voltages cited. The v
9、entilator apparatus shall include a patient valve with a removable PEEP valve (attached), all tubing and connectors required for complete ventilator system operation, a separate AC power supply with power cord assembly, and operating/maintenance manuals. All of the above, including the case containi
10、ng the ventilator, shall be contained in a carry-all, semi-rigid carrying case. The apparatus shall have a separate AC power supply. power supply shall contain an Input Voltage selector switch to allow selection of either 110-125 volts, 50-400 Hz, single phase service or nominal 220-250 volts AC, 50
11、-400 Hz, single phase service. electromagnetic interference/radio frequency interference requirements. relieved line cord, at least 6 feet long, consisting of SJT- type wire with a minimum rating of 18/3 AWG, and terminating in a 3 conductor male hospital-grade plug. The output cable of this supply
12、shall be at least 4 feet long and terminate in a suitable, non-shorting type plug to interface with the ventilator apparatus. The power supply output voltage shall be within the range of acceptance of the ventilator apparatus described herein. The AC This supply shall conform with the It shall also
13、contain an appropriately strain- The ventilator shall be operational from the 12 volt internal battery and from external DC sources of 11-30 volts including, vehicle generating system rated 120 amperes at 14 volts; 120 amp-hour heavy duty 12 volt battery, and aircraft 28 volt generating system. It s
14、hall operate from these external voltages irrespective of ground polarity (positive or negative). Additionally, the ventilator apparatus shall be operational from external AC power sources of 110/230 volts, 50-400 Hz, single phase when connected to the separate AC power supply furnished. It shall al
15、so be operational during battery recharge. 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-0. .i A-A-54444 65 9999974 0062Lb8 L A-A- 5 4 4 4 4 A vehicle power cord assembly shall be provided approximately 6 feet long, having a vehicle cigar lighter
16、 plug on one end and a ventilator plug on the other end. An aircraft DC power cord assembly shall be provided approximately 6 feet long, having one free end (no plug) and a ventilator plug on the other end. Alternately, the vehicle power cord and/or aircraft power cord assemblies may be permanently
17、attached to the ventilator. The ventilator apparatus shall automatically perform a complete functional self-check prior to the commencement of operation. ventilator apparatus to ambient barometric pressure. It shall also provide a means to calibrate the The ventilator shall have a minimum operating
18、temperature range from minus 4OF to plus 115OF, from all power sources cited including the internal rechargeable battery. minimum long-term storage temperature range shall be from 50F to 80F. The The unit shall be provided with a self-contained patient valve. The patient valve shall be reusable, aut
19、oclavable, and transparent. It shall be fabricated from material(s) compatible-for-use in environments of 100 percent oxygen. The patient valve shall include at least: combination 15mm (female)/22mm (male) patient connection port: anti-asphyxiation/demand valve inlet port; exhalation port with remov
20、able PEEP (positive end expiratory pressure) .valve (attached); and pressure transducer adapter. The patient valve shall be configured to allow the ventilator apparatus to detect spontaneous inhalation efforts, and allow the ventilator to trigger at predetermined negative pressure thresholds, in con
21、junction with synchronized assist and synchronized intermittent mandatory ventilation modes of operation. a gas inlet port; The apparatus shall also include a PEEP monitoring circuit, which when activated, enables the user to automatically monitor PEEP performance or manually program the apparatus f
22、or a specific PEEP value. 3 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54444 65 9999974 00b21b9 3 s A-A- 54 4 4 4 The ventilator shall be provided with connecting tubing (with connectors) for attachment between the output connector of ventil
23、ator apparatus and gas inlet of patient valve; between the transducer input of ventilator apparatus and pressure transducer port of patient valve: and between gas input connector of ventilator apparatus and gas source of 50 psi. The unit shall have an input to accept 100 percent oxygen, medical-grad
24、e air, or blended air/oxygen mixtures from an external blender with a nominal rating of 50 psi. The ventilator shall have a gas-efficient patient circuit and not require purging of exhaled gas accumulations. The ventilator shall have a flow rate variable from O to at least 100 liters per minute (LPM
25、). The unit shall have a ventilator rate adjustable from at least 1 to 150 ventilations per minute with a minimum resolution of 1 ventilation per minute (plus or minus 1 digit on the display panel). Inspiratory times shall be adjustable from at least.0.1 to 3.0 seconds (as limited by the ventilator
26、rate setting) with a minimum resolution of 0.1 seconds (plus or minus 1 digit on the display panel). Inspiratory pressure (pressure limiting) shall be monitored and limited to a default maximum of 100 cmH20. It shall be adjustable over the entire high pressure alam setting range. The ventilator appa
27、ratus shall provide a means by which to vent excess pressures away from the patient without disruption of the inspiratory time cycle. The apparatus shall include a redundant means by which to inhibit gas flow to the patient in the event of CPU failure or CPU detected malfunction. During such occurre
28、nces, the ventilator apparatus shall cause the patient valve to default into a non-inspiration condition. During inverse I:E ratio alarm conditions, the ventilator apparatus shall cause the patient valve to default into a non-inspiration condition. 4 Provided by IHSNot for ResaleNo reproduction or n
29、etworking permitted without license from IHS-,-,-A-A-54444 65 9999974 0062370 T A-A-54 4 4 4 A sigh circuit shall be included, which when activated, shall provide a ventilator breath equivalent to 150 percent of the inspiratory time setting (truncated to a maximum of 3 seconds) once every 7 minutes
30、or 100 breaths, whichever occurs first. The synchronized assist and synchronized intermittent mandatory ventilation modes shall include an adjustable trigger level sensitivity to activate ventilator controlled breaths. The trigger level sensitivity range shall be adjustable to at least minus 8 cmJ32
31、0. Trigger level sensitivities shall not be absolute values but values relative to positive end expiratory pressure (PEEP). The ventilator shall have a manual trigger circuit. When its activating switch is depressed, the manual trigger shall permit a continuous flow of gas (at the flow control setti
32、ng) until released. normal ventilator operation and in the event of microprocessor (CPU) failure. When the manual trigger is released the ventilator shall resynchronize for automatic operation by initiating one exhalation period before resuming timed breaths. The manual trigger shall be operable dur
33、ing The unit shall have controls and indicators functionally grouped to facilitate operator usage. A digital bar graph shall be included consisting of at least 20 distinct bars. The bar graph shall provide a means by which to continuously display airway pressure. The range of this graph shall be at
34、least minus 10 to plus 100 cmH20. The ventilator shall have a digital readout, consisting of at least 3 digits. This readout will furnish numeric data pertinent to airway conditions, control settings, alarms and calibration. The digital readout shall become activated whenever airway pressure, peak a
35、irway pressure, mean airway pressure and PEEP pressure display switches are depressed. It shall activate whenever the ventilator rate, inspiratory time, low airway pressure alarm and high airway pressure alarm control settings are adjusted or their respective display switches are depressed. The digi
36、tal readout shall also activate at Ilpower upt1 displaying the current settings for ventilator rate, inspiratory time, low and high pressure alarms. It shall activate to warn of CPU failure, an operator attempt to set inverse I:E ratio (inspiratory time greater than expiratory time), and detection o
37、f incorrect 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54444 b5 9999974 OOb2II7L II A-A-54 4 4 4 pressure transducer calibration. The digital readout shall be designed to activate at any time and incorporate a battery power saver which sha
38、ll self-blank after approximately 3- seconds. All controls, having a capability to activate the digital display shall have visual indicators which indicate the control function or airway condition being displayed. The indicator shall remain illuminated until the digital display self-blanks. The unit
39、 shall have a visual indicator which illuminates when sigh control is activated. A visual indicator which illuminates when the synchronized assist or synchronized intermittent mandatory ventilation modes are activated shall be provided. Additional indicators which denote the presence of operating po
40、wer and/or connection to live external power sources shall be provided, The ventilator shall contain a pleurality of alarm circuits. Alarms shall provide both audible and visual indications. For operator convenience and safety, certain alarms shall incorporate audible muting, automatic reset, automa
41、tic reactivation and mute overrides as described. Alarms such as CPU failure, inverse I:E and pressure transducer calibration shall not be mutable. A new alarm occurrence shall override any pre-existing mute condition(s). Each of these alarms shall automatically reset when the alarm condition no lon
42、ger exists and reactivate should the condition present itself again. The unit shall have as a minimum, alarms which monitor the internal battery, external power, high and low airway pressure conditions, disconnect, apnea, PEEP, CPU failure, inverse I:E ratio and pressure transducer calibration. The
43、apparatus shall have a battery alarm that will activate when conditions indicative of low battery charge or shorted battery are sensed. operable from external power regardless of battery charge status. Battery alarm conditions shall be capable of being audibly muted for 5-minute periods. The ventila
44、tor apparatus shall be 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-r: A-A-54444 65 9999974 0062372 3 A-A-54444 The ventilator shall have an external power alarm that shall activate when a low external voltage condition is sensed. It shall also
45、activate when no external voltage is sensed and a power source plug is connected to the ventilator apparatus. When the external power alarm activates, the ventilator apparatus shall immediately begin operation from its internal batteries. The external power alarm shall be mutable, and remain muted,
46、until the internal battery alarm activates. Thereafter, the mute period shall last for 5-minute periods. O The ventilator shall have high pressure alarm settings that are adjustable from 15 to 100 cmH20 (100 shall be equivalent to IIOFFtt) with a minimum resolution of 1 cmH20 (plus or minus 1 digit
47、on the display panel). The unit shall have a high pressure alarm that shall operate in conjunction with the high pressure alarm control setting. It shall be mutable for 30 second periods. The apparatus shall have low pressure alarm settings that are adjustable from ltOFFtt to 50 cmH20 with a minimum
48、 resolution of lcm2H2O (plus or minus 1 digit on the display panel). A low pressure alarm that shall operate in conjunction with the low pressure alarm control setting shall be provided. It shall also detect the absence of breathing gas(es) and activate when the pressure transducer fails to detect a
49、 pressure rise in the patient circuit during ventilator delivered breaths. It shall be mutable for 30 second periods. The ventilator shall have a disconnect alarm that shall operate when the pressure transducer fails to detect a pressure rise in the patient circuit during ventilator delivered breaths. The disconnect alarm shall be mutable for 30-second periods. The PEEP alarm shall activate when the CPU fails to ascertain PEEP pressure. The PEEP alarm shall be m
