U.S. patent application number 14/915671 was filed with the patent office on 2016-07-14 for incubator with a noise muffling mechanism and method thereof.
The applicant listed for this patent is ASPECT IMAGING LTD.. Invention is credited to Uri RAPOPORT.
Application Number | 20160199241 14/915671 |
Document ID | / |
Family ID | 51799128 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199241 |
Kind Code |
A1 |
RAPOPORT; Uri |
July 14, 2016 |
INCUBATOR WITH A NOISE MUFFLING MECHANISM AND METHOD THEREOF
Abstract
A noise-attenuating neonate incubator (NANI) comprising sound
attenuating module (SAM) configured to decrease the ratio,
(AmpRatt_i), of the sound's amplitude at a time, t_i, to a
reference amplitude, to a critical amplitude ratio value of said
sound measured over a predetermined time, At, (AmpR.sub.QV.DELTA.t)
or less. The SAM comprises passive noise attenuating, active noise
attenuating or both. A method for sound attenuating a neonate
incubator, characterized by: (a) obtaining a noise-attenuating
neonate incubator (NANI) comprising sound attenuating module (SAM)
configured to decrease AmpRatt_i to AmpR.sub.QV.DELTA.t or less;
(b) accommodating said neonate in said NANI; and, (c) attenuating
said noise by said at least one SAM, thereby changing the sound
signature.
Inventors: |
RAPOPORT; Uri; (Moshav Ben
Shemen, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ASPECT IMAGING LTD. |
Shoham |
|
IL |
|
|
Family ID: |
51799128 |
Appl. No.: |
14/915671 |
Filed: |
September 2, 2014 |
PCT Filed: |
September 2, 2014 |
PCT NO: |
PCT/IL2014/050785 |
371 Date: |
March 1, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61872793 |
Sep 2, 2013 |
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61879154 |
Sep 18, 2013 |
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61893959 |
Oct 22, 2013 |
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61902236 |
Nov 10, 2013 |
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61902314 |
Nov 11, 2013 |
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Current U.S.
Class: |
600/22 |
Current CPC
Class: |
G10K 11/20 20130101;
A61G 2203/46 20130101; A61F 2007/0054 20130101; A61F 2007/0057
20130101; A61F 2007/0093 20130101; G10K 2210/118 20130101; A61F
2007/0095 20130101; G10K 11/175 20130101; G10K 2210/3224 20130101;
A61M 2205/0233 20130101; A61M 16/0003 20140204; G01H 3/14 20130101;
G10K 11/162 20130101; G10K 2210/3223 20130101; A61M 16/105
20130101; A61B 2503/045 20130101; A61G 11/00 20130101; A61G 11/009
20130101; A61G 2203/70 20130101; A61G 2210/50 20130101; A61F
2007/0055 20130101; A61G 2203/44 20130101; G10K 2210/129 20130101;
G10K 2210/509 20130101; A61F 7/0053 20130101; A61M 2016/0027
20130101; A61G 2203/30 20130101; A61M 2205/3633 20130101; G10K
2210/301 20130101; G10K 11/168 20130101; G10K 11/172 20130101; A61G
2203/36 20130101; A61F 2007/006 20130101; A61M 16/161 20140204;
A61G 2200/14 20130101; A61B 5/0555 20130101; G10K 2210/116
20130101; A61M 2205/42 20130101 |
International
Class: |
A61G 11/00 20060101
A61G011/00; G10K 11/175 20060101 G10K011/175 |
Claims
1. A noise-attenuating neonate incubator (NANI) comprising sound
attenuating module (SAM) configured to decrease the sound amplitude
ratio at time, t.sub.i, (AmpRat.sub.ti) to a critical amplitude
ratio value of the sound measured over a predetermined time,
.DELTA.t, (AmpR.sub.QV.DELTA.t) or less, wherein said sound
attenuating module (SAM) comprises: a. at least one sound sensor in
communication with a computer readable medium (CRM), configured for
continuously sampling said sound amplitude ratio at time t.sub.i
(AmpRat.sub.ti) within said incubator; b. at least one CRM for
storing said critical amplitude ratio value of said sound measured
over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t) and,
said sound amplitude ratio at time, t.sub.i (AmpRat.sub.ti); and,
c. at least one sound attenuator in communication with said CRM for
decreasing said sound amplitude ratio at time, t.sub.i; wherein a
plurality of said sound sensors providing feedback signals at time
t.sub.i to said CRM (AmpRat.sub.ti); said CRM configured to
instruct said sound attenuator, if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, to operate such that
AmpRat.sub.ti<AmpR.sub.QV.DELTA.t; further wherein said SAM,
said incubator, or both are made of MRI safe materials.
2. The NANI of claim 1, wherein said sensor is further in
communication with a selected from a group consisting of: at least
one indicator, at least one user interface, at least one alarm
system, at least one CPU, and any combination thereof.
3. The NANI of claim 1, wherein said CRM is configured to control
said sound attenuator according to one or more parameters selected
from a group consisting of: parameters received by means of said at
least one sensor, parameters inputted through a user interface,
parameters received from neonate medical equipment, and any
combination thereof.
4. The NANI of claim 1, wherein said sound attenuator comprises an
active sound masking system, configured to emit at least one
acoustical sound signal, by means of at least one acoustical
sound-speaker.
5. (canceled)
6. The NANI of claim 1, wherein said sound attenuator comprises a
reactive acoustical device, configured to cancel or reduce said
noise by means of a destructive interference generated by a
selected from a group consisting of: at least one transducer, at
least one speaker, and any combination thereof.
7. The NANI of claim 1, wherein said SAM is configured to
differentiate at least one predefined sound from background noise,
and attenuate a selected from a group consisting of: said
background noise, said at least one predefined noise, and any
combination thereof.
8. The NANI of claim 1, wherein said CRM is configured to store at
least one sound characteristic selected from a group consisting of:
sound levels, tone, overtone composition, reverberations, sound
frequency, sound wavelength, sound wave amplitude, sound wave
speed, sound wave direction, sound wave energy, sound wave phase,
sound wave shape, sound wave envelope, sound timbre, and any
combination thereof.
9. (canceled)
10. (canceled)
11. The NANI of claim 1, wherein said SAM is configured to
attenuate said noise by a selected from a group consisting of:
reduce sound levels, reduce sound reflections, reduce sound
reverberation, create sound diffusion, mask sound, cancel sound,
change the sound signature, and any combination thereof.
12. The NANI of claim 1, wherein said SAM is configured to change
at least one sound characteristic selected from a group consisting
of: sound levels, tone, overtone composition, reverberations, sound
frequency, sound wavelength, sound wave amplitude, sound wave
speed, sound wave direction, sound wave energy, sound wave phase,
sound wave shape, sound wave envelope, sound timbre, and any
combination thereof, thereby generating a different sound
signature.
13. (canceled)
14. The NANI of claim 1, wherein said SAM comprises at least one
means selected from a group consisting of: active sound attenuating
means, passive sound attenuating means, hybrid sound attenuating
means, and any combination thereof.
15. The NANI of claim 14, wherein said at least one passive sound
attenuating means is selected from a group consisting of: at least
one sound absorptive material, at least one resonator, at least one
sound shield, at least one bass trap, at least one sound baffle, at
least one diffuser, at least one insulation padding, at least one
sound reflector, at least one sound muffler (SM), and any
combination thereof.
16. The NANI of claim 15, wherein said SAM comprises at least one
sound muffler (SM) comprising at least one cylindered conduit,
having at least one length (l) and at least one width (w); said
cylinder comprising at least one air inlet, and at least one air
outlet; further wherein said SM is configured such as that sound
exiting at least one air outlet is of a different sound signature
than sound entering at least one air inlet.
17. The NANI of claim 16, wherein said SM comprises at least a
first cylinder, and at least a second cylinder, connected
therebetween, said connection comprises at least one opening
configured to permit a fluid communication therebetween.
18. The NANI of claim 16, wherein said at least one cylinder width
(w) is selected from a group consisting of: width (w) is equal
along said length (l), is differential along said length (l) or any
combination thereof.
19. The NANI of claim 16, wherein said SM comprises a plurality of
n cylinders, having said length (l).sub.1- . . . n and said width
(w).sub.1- . . . n of said each cylinder, are selected from a group
consisting of: (l).sub.1=(l).sub.n, (l).sub.1>(l).sub.n,
(l).sub.1<(l).sub.n, (l).sub.1.noteq.(l).sub.n,
(w).sub.1=(w).sub.n, (w).sub.1>(w).sub.n,
(w).sub.1<(w).sub.n, (w).sub.1.noteq.(w).sub.n, and any
combination thereof.
20-23. (canceled)
24. The NANI of claim 1, wherein said SAM comprises at least one
sound reflector configured to direct said noise to a selected from
a group consisting of: at least one absorptive surface, at least
one sound diffuser, at least one sound baffle, at least one
reflective surface, at least one resonator, at least one sound
shield, a location directed away from said neonate, and any
combination thereof.
25-29. (canceled)
30. The NANI of claim 1, wherein said incubator further comprises
at least one conduit having at least one SAM configured to muffle
the sound passing through said conduit.
31-34. (canceled)
35. The NANI of claim 1, wherein said NANI is at least temporarily
accommodated in a cart comprising a mobile base, interconnected to
said incubator by at least one support pillar.
36. The NANI of claim 35, wherein said cart further comprises at
least one SAM.
37. The NANI of claim 36, wherein said SAM is connected to a
selected from a group consisting of said incubator, said cart base,
said pillar, and any combination thereof.
38-42. (canceled)
Description
FIELD OF THE INVENTION
[0001] The present invention generally pertains to a medical
device, preferably a neonate incubator, with a noise muffling
mechanism and to method thereof.
BACKGROUND OF THE INVENTION
[0002] The medical environment is characterized by many noise
generating elements. The major benefits of making a quiet medical
product are that soothing sounds, or absence thereof, lead to
greater patient acceptance, patient compliance and, and reduces
health risks for both the patient and the medical/technical
personal. Further, a quiet medical environment lowers the
disturbances to the medical staff, leading to less mistakes in
caregiving.
[0003] The effect on the patient from the noisy surroundings can
range from disturbing to harmful depending on the noise generating
device. Patients may experience discomfort, anxiety, and temporary
to permanent hearing damage. Acoustic noise may pose a particular
problem to specific patient groups. For example, patients with
psychiatric disorders may become confused or suffer from increased
anxiety because of exposure to loud noise. Sedated patients may
experience discomfort in association with high noise levels.
[0004] Neonates and babies are another group of patients that are
especially sensitive to sound disturbances. As reviewed in Ranganna
R., Bustani P., "Reducing noise on the neonatal unit", Infant,
2011; 7(1):25-28, noise can have a harmful effect on the heart rate
and oxygen saturations of the neonate. Further noise changes the
sleep and awake cycles of the neonates therefore alters feeding
patterns.
[0005] The sound levels, especially at low frequencies, within a
modern incubator may reach levels that are likely to be harmful to
the developing newborn. Much of the noise is at low frequencies and
thus difficult to reduce by conventional means. Therefore, advanced
forms of noise control are needed to address, see e.g., Marik et
al., Pediatr Crit Care Med. 2012 November; 13(6):685-9. The noise
in an incubator can result for example from the circulation of air,
and/or engines, pumps, and ventilators supporting various life
supporting mechanisms. Many noises are even amplified within an
incubator, such as the noise generated by CPAP (continuous positive
airway pressure) because of the closed space.
[0006] In addition, various noise types corrupts infants analyzing
devices, such as Electrocardiography (ECG). As described in J.
Mahil and T. Sree Renga Raja "Hybrid swarm algorithm for the
suppression of incubator interference in premature infants ECG", J.
Applied Sciences, Engineering and Technology 6 (16):2931-2935,
2013, where a learning algorithm is described for interference
noise cancelling techniques for filtering the ECG signal.
[0007] Another example of a noise generating medical device is a
Magnetic Resonance Imaging device. An MRI utilizes strong magnetic
fields and radio waves to form images of the body. The MRI's
magnetic field is created by running electrical current through an
electromagnet. An MRI is noisy because when the current is switched
on, the force on the coil comprising the electromagnet goes from
zero to huge in just milliseconds, causing the coil to expand
slightly, which makes a loud "click." When the MRI generates an
image, the current is switched on and off rapidly. The result is a
rapid-fire clicking noise, which is amplified by the enclosed space
in which the patient lies. Other noise sources in the MRI facility
are Patient comfort fans and cryogen reclamation systems associated
with superconducting magnets of MR systems. Acoustic noise produced
by these subsidiary systems is considerably less than that caused
by gradient magnetic fields, but contributes to the overall
discomfort of the patient. RF hearing is another noise generated by
the magnetic resonance device during scanning. This occurs when the
human head is subjected to pulsed radiofrequency (RF) radiation at
certain frequencies, an audible sound perceived as a click, buzz,
chirp, or knocking noise may be heard. This acoustic phenomenon is
referred to as "RF hearing", "RF sound" or "microwave hearing",
believed to originate from thermo-elastic expansion over a brief
time period in the tissues of the head. With specific reference to
the operation of MR scanners, RF hearing has been found to be
associated with frequencies ranging from 2.4- to 170-MHz, as is
usually masked by other noise generating means.
[0008] Various types of acoustic noise are produced during the
operation of an MR system. Problems associated with acoustic noise
for patients and healthcare professionals include annoyance, verbal
communication difficulties, heightened anxiety, temporary hearing
loss and, also, the potential for permanent hearing impairment.
Currently, patients are given headphones and ear plugs in order to
illuminate at least partially their acoustic noise exposure. These
passive means of noise protection may have the limitation of
hampering verbal communication with patients during the operation
of the MR system. Additionally, standard earplugs are often too
large for the ear canal of adolescents and infants Importantly,
passive noise control devices provide non-uniform noise attenuation
over the hearing range. While high frequencies may be well
attenuated, attenuation is often poor at low frequencies. This is
problematic because, for certain pulse sequences, the low frequency
range is where the peak MR imaging-related acoustic noise is
generated. Active noise cancellation means are known in the art to
significantly reduce in the level of acoustic noise. This is
achieved by introducing "anti-phase noise" to a particular source
that interferes destructively with the noise source and built into
headphones. The anti-noise system involves a continuous feedback
loop with continuous sampling of the sounds in the noise
environment so that the surrounding noise is attenuated. These
mechanisms require adaptation to each different noise generating
device and pose another device to be installed over the patient, in
an already complicated and tensioned environment.
[0009] It is thus still a long felt need to provide an effective,
safe, medical environment for patients within a medical device,
eliminating the need for the patient to be further connected to
additional devices, and mechanisms during medical examinations with
a noise generating device. This device will effectively reduce
equipment derived noise and sound reverberation and/or reflection.
Further the device disclosed in the present invention can function
to reduce the transfer of sound to the patient accommodating
volume.
SUMMARY OF THE INVENTION
[0010] The present invention provides a noise-attenuating neonate
incubator (NANI) comprising sound attenuating module (SAM)
configured to decrease the sound amplitude ratio at time, t.sub.i,
(AmpRat.sub.ti) to a critical amplitude ratio value of the sound
measured over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t)
or less, wherein the sound attenuating module (SAM) comprises: (a)
at least one sound sensor in communication with the CRM, configured
for continuously sampling the sound amplitude ratio at time t.sub.i
(AmpRat.sub.ti) within the incubator; (b) at least one CRM for
storing the critical amplitude ratio value of the sound measured
over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t) and, the
sound amplitude ratio at time, t.sub.i, (AmpRat.sub.ti); and, (c)
at least one sound attenuator in communication with the CRM for
decreasing the sound amplitude ratio at time, (AmpRat.sub.ti), if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, such that
AmpRat.sub.ti<AmpRat.sub.QV.DELTA.t; wherein the critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, AmpRat.sub.QV.DELTA.t<about 178.8.sub..DELTA.t.
It is another object of the current invention to disclose the NANI
defined in any of the above, wherein the sensor is further in
communication with a selected from a group consisting of: at least
one indicator, at least one user interface, at least one alarm
system, at least one CPU, and any combination thereof.
[0011] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the CRM is configured
to control the sound attenuator according to a selected from a
group consisting of: parameters received by means of at least one
sensor, parameters inputted through a user interface, parameters
received from neonate medical equipment, and any combination
thereof.
[0012] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the sound attenuator
comprises an active sound masking system, configured to emit at
least one acoustical sound signal, by means of at least one
acoustical sound-speaker.
[0013] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least one
acoustical sound signal is selected from a group consisting of:
white noise, pink noise, grey noise, brownian noise, blue noise,
violet noise, and any combination thereof.
[0014] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the sound attenuator
comprises a reactive acoustical device, configured to cancel or
reduce the noise by means of a destructive interference generated
by a selected from a group consisting of: at least one transducer,
at least one speaker, and any combination thereof.
[0015] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is configured
to differentiate at least one predefined sound from background
noise, and attenuate a selected from a group consisting of: the
background noise, at least one predefined noise, and any
combination thereof.
[0016] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the CRM is configured
to store at least one sound characteristic selected from a group
consisting of: sound levels, tone, overtone composition,
reverberations, sound frequency, sound wavelength, sound wave
amplitude, sound wave speed, sound wave direction, sound wave
energy, sound wave phase, sound wave shape, sound wave envelope,
sound timbre, and any combination thereof.
[0017] The present invention provides a noise-attenuating neonate
incubator (NANI) comprising sound attenuating module (SAM)
configured to decrease the sound's amplitude ratio at time,
(AmpRat.sub.ti) to a critical amplitude ratio value of the sound
measured over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t)
or less.
[0018] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is configured
to attenuate the noise in a predefined sound characteristic.
[0019] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is configured
to attenuate the noise by a selected from a group consisting of:
reduce the sound levels, reduce sound reflections, reduce sound
reverberation, create sound diffusion, mask sound, cancel sound,
change the sound signature, and any combination thereof.
[0020] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is configured
to change at least one sound characteristic selected from a group
consisting of: sound levels, tone, overtone composition,
reverberations, sound frequency, sound wavelength, sound wave
amplitude, sound wave speed, sound wave direction, sound wave
energy, sound wave phase, sound wave shape, sound wave envelope,
sound timbre, and any combination thereof, thereby generating a
different sound signature.
[0021] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the sound signature
is selected from a group consisting of: configurable by the user,
predefined, automatically adjustable in reference to the neonate's
life parameters, and any combination thereof.
[0022] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM comprising at
least one means selected from group consisting of: active sound
attenuating means, passive sound attenuating means, hybrid sound
attenuating means, and any combination thereof.
[0023] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least one passive
sound attenuating means is selected from a group consisting of: at
least one sound absorptive material, at least one resonator, at
least one sound shield, at least one bass trap, at least one sound
baffle, at least one diffuser, at least one insulation padding, at
least one sound reflector, at least one sound muffler (SM), and any
combination thereof.
[0024] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM comprising at
least one sound muffler (SM) comprising at least one cylindered
conduit, having at least one length (l) and at least one width (w);
the cylinder comprising at least one air inlet, and at least one
air outlet; further wherein the SM is configured such as that sound
exiting at least one air outlet is of a different sound signature
than sound entering at least one air inlet.
[0025] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SM comprises at
least a first cylinder, and at least a second cylinder, connected
therebetween, the connection comprises at least one opening
configured to permit a fluid communication therebetween.
[0026] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least one cylinder
width (w) is selected from a group consisting of: width (w) is
equal along the length (l), is differential along the length (l) or
any combination thereof.
[0027] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SM comprises a
plurality of n cylinders, having the length (l).sub.1- . . . n and
the width (w).sub.1- . . . n of the each cylinder, are selected
from a group consisting of: (l).sub.1=(l).sub.n,
(l).sub.1>(l).sub.n, (l).sub.1<(l).sub.n,
(l).sub.1.noteq.(l).sub.n, (w).sub.1=(w).sub.n,
(w).sub.1>(w).sub.n, (w).sub.1<(w).sub.n,
(w).sub.1.noteq.(w).sub.n, and any combination thereof.
[0028] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM comprises at
least one insulation padding configured to insulate the neonate
placement within the NANI; further wherein the insulation comprises
at least one opening configured to permit access to within the
NANI.
[0029] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least a portion of
the insulation comprises a material selected from a group
consisting of: thermo insulating material, sealing material, foam
material, fire retardant materials, at least partially transparent
material and any combination thereof.
[0030] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM comprises at
least one sound shield comprising at least a portion of a material
selected from a group consisting of: at least one insulating
material, at least one sealing material, at least one sound
absorbent material, at least one vibration absorbing material, and
any combination thereof.
[0031] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is a modular
component reversibly attachable to the incubator.
[0032] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM comprises at
least one sound reflector configured to direct the noise to a
selected from a group consisting of: at least one absorptive
surface, at least one sound diffuser, at least one sound baffle, at
least one reflective surface, at least one resonator, at least one
sound shield, a location directed away from the neonate, and any
combination thereof.
[0033] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least a portion of
the SAM comprises n layers; further wherein each of the n layers
comprising an inner side towards the neonate, and an opposite outer
side facing away from the neonate.
[0034] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein each of the n layers
comprising a predefined Noise Reduction Coefficient (NRC) value,
Sound Transmission Class (STC) value, or both; further wherein the
NRC value, STC value, or both, can be equal or different for the
each of one of n layers.
[0035] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least 2 of the n
layers comprising a Noise Reduction Coefficient (NRC) value for
each of the n layers; where each of the layers comprising at least
one sound level S [dB] measured on the layer outer side, and at
least one first sound level S.sub.1 [dB], measured on the layer
inner side, having a dS.sub.1- . . . dSn, wherein dS of the SAM
equals S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0036] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein at least 2 of the n
layers comprising a Sound transmission class (STC) value for each
of the n layers; where each of the layers comprising at least one
sound level S [dB] measured on the layer outer side, and at least
one first sound level S.sub.1 [dB], measured the layer inner side,
having a dS.sub.1- . . . dSn, wherein dS of the SAM equals
S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0037] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM further
comprising: (a) a space, S.sub.1, between at least one of n layers
to the incubator, a space S.sub.n between each of the n layers, or
both; (a) STC.sub.1 (sound transmission class) value, measured for
the layers.sub.1-n; and, (c) mobilization means, connected to at
least one of the n layers, configured to mobilize at least one of
the n layers, having a space S.sub.1a, between at least one of n
layers to the incubator, a space S.sub.na between each of the n
layers, or both, and STC.sub.2 value measured for the
layers.sub.1-n; where S.sub.1<S.sub.1a, S.sub.n<S.sub.na, or
both, and where STC.sub.1<STC.sub.2.
[0038] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the incubator further
comprises at least one conduit having at least one SAM configured
to muffle the sound passing through the conduit.
[0039] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM, the
incubator, or both are made of MRI safe materials.
[0040] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the incubator further
comprises at least one sensor selected from a group consisting of:
sound level sensor, sound frequency sensor, sound direction sensor,
sound amplitude sensor, sound tone sensor, sound speed sensor,
sensor configured to sense life parameters of the neonate, and any
combination thereof.
[0041] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is configured
to reduce reverberation of sound, reflections of sound, or both
within the inner volume, by means of at least one selected from a
group consisting of; absorptive material, a sound baffle, a sound
diffuser, an active sound cancellation device and any combination
thereof.
[0042] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the NANI further
comprises at least one air inlet, air outlet, or both, configured
for the entry and/or exit of air; further wherein at least one air
inlet, outlet, or both further comprises at least one SAM.
[0043] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the NANI is at least
temporarily accommodated in a cart comprising a mobile base,
interconnected to the incubator by at least one support pillar.
[0044] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the cart further
comprises at least one SAM.
[0045] It is another object of the current invention to disclose
the NANI defined in any of the above, wherein the SAM is connected
to a selected from a group consisting of the incubator, the cart
base, the pillar, and any combination thereof.
[0046] The present invention provides a method for sound
attenuating a neonate incubator, characterized by: (a) obtaining a
noise-attenuating neonate incubator (NANI) comprising at least one
sound attenuating module (SAM) configured to decrease the sound's
amplitude ratio at time, t.sub.i. (AmpRat.sub.ti) to a critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, (AmpR.sub.QV.DELTA.t) or less; (b) accommodating
the neonate in the NANI; and, (c) attenuating the noise by at least
one SAM, thereby changing the sound signature.
[0047] It is another object of the current invention to disclose
the method as defined in any of the above, additionally comprising
the following steps: (a) obtaining the SAM further comprising: at
least one CRM, at least one sound sensor in communication with the
CRM, at least one sound attenuator in communication with the CRM;
(b) storing the critical amplitude ratio value of the sound
measured over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t)
and, the sound amplitude ratio at time, t.sub.i (AmpRat.sub.ti);
and, by means of the CRM; (c) continuously sampling the sound
amplitude ratio at time, AmpRat.sub.ti within the NANI, by means of
at least one sound sensor; and, (d) decreasing the sound amplitude
ratio at time, (AmpRat.sub.ti), if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, such that
AmpRat.sub.ti<AmpRat.sub.QV.DELTA.t; wherein the critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, AmpRat.sub.QV.DELTA.t<about 178.8.sub..DELTA.t,
by means of the sound attenuator. It is another object of the
current invention to disclose the method as defined in any of the
above, additionally comprising the step of further relaying
information from the sensor to a selected from a group consisting
of: at least one indicator, at least one user interface, at least
one alarm system, at least one CPU, and any combination
thereof.
[0048] It is another object of the current invention to disclose
the method as defined in any of the above, additionally comprising
the step of controlling the sound attenuator by means of the CRM
according to a selected from a group consisting of: parameters
received by means of at least one sensor, parameters inputted
through a user interface, parameters received from neonate medical
equipment, and any combination thereof.
[0049] The present invention provides a standard of care for sound
attenuating an incubator, comprising steps of: (a) obtaining a
noise-attenuating neonate incubator (NANI) comprising at least one
sound attenuating module (SAM) configured to decrease the sound's
amplitude ratio at time, t.sub.i, (AmpRat.sub.ti) to a critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, (AmpR.sub.QV.DELTA.t) or less; (b) accommodating
the neonate in the incubator; and, (c) attenuating the noise by at
least one SAM, thereby changing the sound signature, further
wherein at least one of the following is held true: (a) the noise
level in the incubator is below 45 Decibels; (b) the noise level in
the incubator is below 60 Decibels; (c) the amount of audible
related complications of neonates when utilizing the incubator is b
times lower than the average value of audible complications of
neonates; b is equal or greater than 1.05; (d) the average value of
salivary cortisol level index from noise derived stress of patient
when utilizing the incubator during MRI is n times lower than the
average value during MRI; n is equal or greater than 1.05; (e) the
incubator remains stable when tilted 10.degree. in normal use, and
when tilted 20.degree. during transportation; (f) the incubator
does not tip over when the encountered with a force of 100 N or
less; (g) the radiated electromagnetic fields in the inner volume
of the incubator, comprising electrical equipment system will be at
a level up to 3 V/m for the frequency range of the collateral
standard for EMC (electromagnetic compatibility); further the
electrical equipment is performing its intended function as
specified by the manufacturer or fail without creating a safety
harm at a level up to 10 V/m for the frequency range of the
collateral standard for EMC; and, (h) the average number of
insurable claims of a selected from a group consisting of:
manufacturer, handler, user, operator, medical care personal,
medical facility, medical facility management or any combination
thereof when utilizing the incubator is v times lower than patient
MRI associated insurable claims; v is equal or greater than
1.05.
BRIEF DESCRIPTION OF THE FIGURES
[0050] In order to understand the invention and to see how it may
be implemented in practice, a few preferred embodiments will now be
described, by way of non-limiting example only, with reference to
be accompanying drawings, in which:
[0051] FIG. 1 illustrates a neonate residing in an incubator is a
noisy environment;
[0052] FIG. 2a-e schematically illustrates in an out of scale
manner embodiments of a the location of a sound attenuating module
in connection with an incubator;
[0053] FIG. 3a-f schematically illustrates in an out of scale
manner different embodiments of a passive SAM;
[0054] FIG. 4a-d schematically illustrates in an out of scale
manner different embodiments of an active SAM;
[0055] FIG. 5 schematically illustrates an incubator/medical device
with a ventilating system with noise muffling mechanisms;
[0056] FIG. 6 schematically illustrates in an out of scale manner,
an incubator as part of a cart comprising a ventilating system at
the incubators base, and noise muffling mechanisms;
[0057] FIG. 7a is a schematic diagram describing a an incubator
comprising a ventilating system configured to stream air through at
least one sound muffler;
[0058] FIG. 7b is a schematic diagram describing a cart comprising
an incubator connected to a ventilating system through at least one
sound muffler; and,
[0059] FIG. 8a-e are schematic diagrams describing a neonate's
disturbance parameter as a function of amplitude, frequency, and
duration of sound interruption.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0060] The following description is provided so as to enable any
person skilled in the art to make use of the invention and sets
forth the best modes contemplated by the inventor of carrying out
this invention. Various modifications, however, will remain
apparent to those skilled in the art, since the generic principles
of the present invention have been defined specifically to provide
an apparatus and methods for reducing noise in medical devices.
[0061] The present invention pertains to a neonate incubator
comprising a sound attenuator for attenuating noise. The present
invention further pertains to a neonate incubator comprising an
active sound attenuator for attenuating the noise. It is in the
scope of the present invention that the active sound attenuator is
in addition to a passive sound attenuator, or that the active sound
attenuator is combined with a passive sound attenuator.
[0062] The present invention also pertains to a neonate incubator
comprising a passive sound attenuator for attenuating the noise. It
is in the scope of the present invention that the passive sound
attenuator is in addition to an active sound attenuator, or that
the passive sound attenuator is combined with an active sound
attenuator.
[0063] The essence of the present invention is to provide an
incubator, comprising an inner environment adapted to at least
temporarily accommodate a patient, and a surrounding environment
comprising at least one noise generator, the incubator is
characterized by comprising at least one sound attenuating means
configured to attenuate the noise within the inner environment,
generated by the at least one noise generator.
[0064] It is further is the scope of the invention to provide a
medical device configured to be accommodate by a neonate,
comprising at least one sound attenuator selected from a group
consisting of: an active sound attenuator, a passive sound
attenuator, a hybrid sound attenuator, and any combination thereof.
The term "medical device" interchangeably refers hereinafter to any
apparatus, device, or mechanism, configured to at least partially
accommodate a patient, during the patient's stay in a health caring
facility and/or during examination, testing, imaging, operating,
treating of the patient. This medical device can be such as any
magnetic resonance imaging device, incubator, transport incubator,
any transportable incubator, cart, CT scanner, X-ray device,
ultrasonography device, elastography, fluoroscopy device,
photoacoustic imaging device, thermography device, functional
near-infrared spectroscopy, medical photography device and nuclear
medicine functional imaging device, positron emission tomography
(PET) device, operating table, treatment table, medical transport
device, and any combination thereof.
[0065] The term `transport incubator` interchangeably refers
hereinafter to any incubator, immobilized incubator, transportable
incubator, a portable incubator and any combination thereof. It is
in the scope of the invention an immobilized permanently placed
incubator or a portable one configured for accommodating neonates
when under care.
[0066] The term `magnetic resonance imaging device` (MRD),
specifically applies hereinafter to any Magnetic Resonance Imaging
(MRI) device, any Nuclear Magnetic Resonance (NMR) spectroscope,
any Electron Spin Resonance (ESR) spectroscope, any Nuclear
Quadruple Resonance (NQR), any Laser magnetic resonance device, any
Quantum Rotational field magnetic resonance device (cyclotron), and
any combination thereof. The term, in this invention, also applies
to any other analyzing and imaging instruments comprising a volume
of interest, such as computerized tomography (CT), ultrasound (US)
etc. The MRD hereby disclosed is optionally a portable MRI device,
such as the ASPECT-MR Ltd commercially available devices, or a
commercially available non-portable device. Additionally or
alternatively, the MRD is self-fastening cage surrounding a
magnetic resonance device as depicted in U.S. Pat. No. 7,719,279
B2, filed 27/May/2008 titled: "SELF-FASTENING CAGE SURROUNDING A
MAGNETIC RESONANCE DEVICE AND METHODS THEREOF", of which is hereby
incorporated by reference in its entirety.
[0067] The term "cart" refers hereinafter to any apparatus used for
transporting the cart. This includes any transport device or any
small vehicle pushed or pulled by manually, automatically or both.
More specifically the term relates to a structure able to hold the
incubator having mobility providing elements such as one or a
plurality of a wheel, roller, sliding blade, rotating belt, etc.
For example, trolley, handcart, pushcart, electric cart, wagon,
barrow, rickshaw, ruck, wagon, barrow, buggy, dolly, carriage,
float, cab, dray, gig, gurney, handcart, palanquin, pushcart,
tumbrel, wheelbarrow, curricle, etc.
[0068] The term "incubator" interchangeably refers hereinafter to a
special unit specializing in the care of ill or premature newborn
infants. This includes a stationary incubator, a moveable
incubator, a transport incubator, a disposable incubator, a
healthcare facility incubator, portable incubator, an intensive
care incubator, an incubator intended for home use, an incubator
for imaging a neonate, a treatment incubator, a modular incubator,
an isolating incubator and any combination thereof. The neonatal
incubator is a box-like enclosure in which an infant can be kept in
a controlled environment for observation and care. The incubator
usually includes observation means to the accommodated neonate, and
openings for the passage of life support equipment, and the
handler's hands. At least partially enclosed environment formed
within the incubator is at least partially isolated from the
external environment conditions such as noise, vibration, drift,
temperature, light, gas concentrations, humidity, microorganisms,
etc., and/or regulated to reach life supporting parameters defined
by medical personal. The incubator can contain, or be connected to
life supporting equipment. The internal environment can be
controlled by environment control systems such as temperature
regulating, ventilating, humidifying, lighting, moving, noise
reduction systems, vibration reducing systems, etc.
[0069] The term "MRI-safe" interchangeably refers herein to any
material that, when used in the magnetic resonance environment,
will present no additional risk to the patient and not
significantly affect the quality of the diagnostic information. The
material is completely non-magnetic, non-electrically conductive,
and non-RF reactive, eliminating all of the primary potential
threats during an MRI procedure.
[0070] The term "human hearing" interchangeably refers herein to
any sound received by the human ear, with the typical frequency
range for normal hearing being between 20-Hz to 20,000-Hz. The
logarithmic decibel scale, dB, is used when referring to sound
power.
[0071] The term "decibels" or "dB", interchangeably refers herein
to the unit used to express the ratio between two values of such as
an amplitude. If sound power ratios are x and amplitude ratios Ix
then dB equivalents 10 log 10.times.. As depicted in Wikipedia,
when referring to measurements of field amplitude, it is usual to
consider the ratio of the squares of Ai (measured amplitude) and Ao
(reference amplitude). This is because in most applications power
is proportional to the square of amplitude, and it is desirable for
the two decibel formulations to give the same result in such
typical cases. Thus, the following definition is used:
L dB = 10 log 10 ( A 1 2 A 0 2 ) = 20 log 10 ( A 1 A 0 ) .
##EQU00001##
[0072] A change in power ratio by a factor of 10 is a change of 10
dB. The decibel is commonly used in acoustics as a unit of sound
pressure, for a reference pressure of 20 micropascals in air and 1
micropascal in water. The reference pressure in air is set at the
typical threshold of perception of an average human and there are
common comparisons used to illustrate different levels of sound
pressure. Sound pressure is a field quantity, therefore the field
version of the unit definition is used:
L p = 20 log 10 ( p rms p ref ) dB ##EQU00002##
where p.sub.ref is equal to the standard reference sound pressure
level of 20 micropascals in air or 1 micropascal in water.
[0073] On the decibel scale, the smallest audible sound (near total
silence) is 0 dB. Here are some common sounds and their decibel
ratings as known in the art: Near total silence--0 dB, A
whisper--about 15 dB, Normal conversation--about 40-60 dB, A
lawnmower--90 dB about, A car horn--about 110 dB, A rock concert or
a jet engine--about 110-150 dB, A gunshot or firecracker--140 dB.
It is known in the art that any sound above 85 dB can cause hearing
loss, and the loss is related both to the power of the sound as
well as the length of exposure. Eight hours of 90-dB sound can
cause damage to your ears; any exposure to 140-dB sound causes
immediate damage (and causes actual pain).
[0074] According to one embodiment of the invention, the passive
sound attenuator, the active sound attenuator, or both together,
are configured to maintain the sound levels at 45 dB or lower.
[0075] The present invention provides a noise-attenuating neonate
incubator (NANI) comprising sound attenuating module (SAM)
configured to decrease the sound amplitude ratio at time, t.sub.i,
(AmpRat.sub.ti) to a critical amplitude ratio value of the sound
measured over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t)
or less, wherein the sound attenuating module (SAM) comprises: (a)
at least one sound sensor in communication with the CRM, configured
for continuously sampling the sound amplitude ratio at time t.sub.i
(AmpRat.sub.ti) within the incubator; (b) at least one CRM for
storing the critical amplitude ratio value of the sound measured
over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t) and, the
sound amplitude ratio at time, t.sub.i, (AmpRat.sub.ti); and, (c)
at least one sound attenuator in communication with the CRM for
decreasing the sound amplitude ratio at time, (AmpRat.sub.ti), if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, such that
AmpRat.sub.ti<AmpRat.sub.QV.DELTA.t; wherein the critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, AmpRat.sub.QV.DELTA.t<about 178.8.sub..DELTA.t.
The term "AmpRat.sub.ti" interchangeably refers herein to a value
of the amplitude ratio of the sound measured in a specific point in
time, t.sub.i for counts per unit of time. The unit for frequency
is hertz (Hz), 1 Hz means that an event repeats once per second.
The period, usually denoted by T, is the duration of one cycle, and
is the reciprocal of the frequency 1:
T = 1 f . ##EQU00003##
As the human hearing ranges between 20-20000 Hz, the minimal time
between two maximal amplitudes can be calculated to be 50
microsecond and the maximum as 0.05 second. Therefore, as a
non-limiting example the time lapse can be such as equal or greater
than 50 microseconds. Additionally or alternatively, it is known in
the art of signal processing that sampling of a signal usually
pertains sampling at least two time lapses of a signal. In signal
processing, sampling is the reduction of a continuous signal to a
discrete signal. A common example is the conversion of a sound wave
to a sequence of samples. A sample refers to a value or set of
values at a point in time and/or space. Sampling in order to create
a sample is called a sampling event. The signal sampled can be
monotone or comprise a plurality of tones. The value of 50
microseconds is the minimum lapse between two amplitude peaks of a
signal wave in the range of human hearing, and any tone combination
will necessarily be this value or higher.
[0076] Additionally or alternatively, the sampling frequency
(sampling rate) for audio sampling, when it is necessary to capture
audio covering the entire 20-20,000 Hz range of human hearing,
audio waveforms are typically sampled at 44.1 kHz, 48 kHz, 88.2
kHz, or 96 kHz. (as depicted in Wikipedia). It is known in the art
according to the Nyquist theorem that it is required to sample a
given signal at approximately double-rate of its highest frequency.
Sampling rates higher than about 50 kHz to 60 kHz cannot supply
more usable information for human listeners. Therefore the minimum
sampling rate for the SAM according to one embodiment of the
invention is 40 kHz. Higher Sampling rate will provide a high
resolution for determining the characteristics of the signal
sampled.
[0077] The term "AmpR.sub.QV.DELTA.t" interchangeably refers herein
to a critical amplitude ratio value of the sound measured over a
predetermined time, .DELTA.t, during this time a plurality of
sampling events can be preformed. This value is predetermined,
additionally or alternatively, this value can be configured by the
user. Additionally or alternatively, the CRM is configured to
change the AmpR.sub.QV.DELTA.t in real time by adjusting the sound
attenuation to the responses of the neonate.
[0078] The term "wave shape" is the actual shape of the wave. Some
different types of waves are: sine waves, which are pure
tones--they have no harmonics. Square waves and triangle waves both
have only odd harmonics, but the different levels of their
harmonics distinguish them from one another. Sawtooth waves have
both even and odd harmonics. It is the unique combination of the
fundamental and the harmonics that gives a sound its timbre (the
tone color, or the quality, of a sound). Timbre is also defined by
the sound envelope. The Envelope is kind of a combination of
amplitude and wavelength--it describes the individual parts of a
sound, broken down into ADSR (Attack, Decay, Sustain, Release).
Attack--How a sound is started after the sound source begins to
vibrate; Decay--the initial dying off after the attack;
Sustain--when the sound remains relatively constant after the
initial decay; Release--the time period and manner in which a sound
fades to nothing, (http://www.audioduct.com/Lessons).
[0079] The term "sound wave phase" refers herein to the time
relationship between 2 waves. In-Phase--the waves are working
together; (compression and rarefaction occur in both waves at the
same time.) This increases the amplitude. If 2 waves are totally
in-phase, then amplitude is increased by 3 dB. Out-of-Phase--the
waves are working against each other (compression is occurring in
one wave while rarefaction is occurring in in the other. If the
waves are completely out of phase) (180.degree., there will be
extreme cancellation.
[0080] It is in the scope of the invention to additionally or
alternatively sample at least one sound characteristic selected
from a group consisting of: sound levels [dB], sound frequency
[Hz], duration of cycle [sec], tone combination within the sound
signal, wavelength [feet or meters], velocity [feet per sec or
meter per sec], Wave shape, Envelope, Timbre, Phase, and any
combination thereof.
[0081] Means for sampling a signal/noise are such as: recording by
analog means such as records, tapes and etc., A Digital audio that
uses pulse-code modulation and digital signals for sound
reproduction. This includes analog-to-digital conversion (ADC),
digital-to-analog conversion (DAC), storage, and transmission.
[0082] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured for one
or more sampling events creating one or more sample values; Further
wherein the sample one or more values are analyzed to determine the
sound signature.
[0083] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured for
sampling the amplitude ratio of a signal between the time point t
and t.sub.1=l>t+50 microseconds, thereby determining
AmpRat.sub.ti.
[0084] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured for
calculating the average of at least two sampling events to
determine AmpRat.sub.ti.
[0085] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein AmpR.sub.ti is measured at
least one specific time interval. As a non-limiting example, the
amplitude ratio is measured continuously or at any time interval
such as: 50 microseconds, 50 microsecond+X [microseconds], where X
is any integer.
[0086] According to another embodiment of the invention the
sampling frequency is =l>40000 Hz.
[0087] The term "sound" interchangeably refers herein to any
audible acoustic waves, as depicted in Wikipedia, sound is a
vibration that propagates as a typically audible mechanical wave of
pressure and displacement, through a medium such as air or water,
when intercepted by any human, animal or any mechanical device or
receiver. It is in the scope of the present invention that sound
can be characterized by at least one of the following parameters:
sound levels (can be measured in as sound pressure or in decibels
[dB], overtone composition, reverberations, sound frequency [Hz],
sound wavelength [feet or meters], tone, sound wave amplitude,
sound wave velocity [meters per sec. or feet per sec], sound wave
direction, timbre, sound wave phase, sound wave shape, sound
envelope, and, sound wave energy [joules]. Any of the
aforementioned characteristics can be used to define a sound
signature.
[0088] It is further in the scope of the present invention that the
sound attenuating means generate a sound signature different than
the sound generated by any noise generator. Therefor the sound
attenuating means can completely attenuate the sound generated by
the noise generator such that it is not auditable within the limits
of the human hearing, additionally or alternatively, the sound can
be attenuated completely, or attenuated in at least one of the
sound characteristics, therefor creating a new sound signature.
[0089] The term "noise" interchangeably refers herein to any
unwanted sound defined in terms of frequency spectrum (in Hz),
intensity (in dB), and time duration. Noise can be steady-state,
intermittent, impulsive, or explosive. Transient hearing loss may
occur following exposure to loud noise, resulting in a temporary
threshold shift (i.e., a shift in the audible threshold). This term
further includes harmonious and/or non-harmonious sounds, intended
and/or unintended such as: a melody, tapping, banging, chirping,
squeaking, blast, buzz, cacophony, clamor, commotion, crash, echo,
cry, explosion, roar, babel, bang, bellow, blare, boom,
caterwauling, clang, clatter, detonation, din, discord, disquiet,
disquietude, drumming, eruption, jangle, lamentation, outcry,
pandemonium, peal, racket, knocking, shot, shouting, squawk,
stridency, thud, uproar, yell, music, or any combination thereof
including a single or plurality of each.
[0090] Noise tends to be enhanced by decreases in section
thickness, field of view, repetition time, and echo time
Furthermore, noise characteristics have a spatial dependence. For
example, noise levels can vary by as much as 10 dB as a function of
patient position within a defined space such as the bore of a
magnetic resonance system or within an incubator. The presence and
size of the patient may also affect the level of acoustic noise.
Airborne sound travels through the air and can transmit through a
material, assembly or partition. Sound can also pass under
doorways, through ventilation, over, under, around, and through
obstructions. When sound reaches a room where it is unwanted, it
becomes noise. Further noise can be prolonged and multiplied by
reverberations and reflections.
[0091] Additionally or alternatively the noise can originate from
at least one of the following: a medical device operation, a
incubator in communication with a motor, noise derived of an
attached medical device, life support equipment, a venting
mechanism, a thermo regulating system, an air filtering system, a
humidifier, rapid alterations of currents within magnetic resonance
coils, an external alarm, external speech sounds, closing or
opening of the incubator, handling of equipment in the incubator
vicinity, and etc.
[0092] The term "sound attenuation means" interchangeably refers
herein to any means configured for attenuating or muffling general
and specific sounds, including noise. These means include: passive
sound attenuators, active sound attenuators, and hybrid sound
attenuators.
[0093] The term "passive sound attenuators" or "passive acoustic
attenuators" interchangeably refer herein to such as resonators
designed for specific frequencies, sound absorptive materials and
linings, insulation padding, sound shields, bass traps, diffusers,
sound baffles, resonators, and any combination thereof. Passive
sound absorptive materials that are used can be incorporated in
connection with the incubator (from within, on top, at least partly
enveloping the incubator, along at least a portion of the incubator
inner volume and etc.), adjacent to the noise generator, connected
to at least one other sound attenuating means such as active sound
attenuating means, and any combination thereof, having at least a
portion of the sound energy dissipated within the medium itself as
sound travels through them. Absorbing materials can be such as
porous materials commonly formed of matted or spun fibers. Common
porous absorbers allow air to flow into a cellular structure where
sound energy is converted to heat. These may include a thick layer
of cloth or carpet, spray-applied cellulose, aerated plaster,
fibrous mineral wool and glass fiber, open-cell foam, and felted or
cast porous ceiling tile. Resonators can also absorb sound, this is
created by holes or slots connected to an enclosed volume of
trapped air. Further, any acoustic insulation materials can be
employed. Thickness plays an important role in sound absorption by
porous materials. Other absorbers are panel absorbers. Typically,
panel absorbers are non-rigid, non-porous materials which are
placed over an airspace that vibrates in a flexural mode in
response to sound pressure exerted by adjacent air molecules for
example thin wood paneling over framing, lightweight impervious
ceilings and floors, glazing and other large surfaces capable of
resonating in response to sound.
[0094] The term `passive attenuation means` refers also to a
passive pad-like acoustic sealing, configured to insulate the inner
environment from its surrounding environment; to a passive acoustic
diffuser; to passive absorptive acoustical surfaces (such as
acoustic foams, rags etc), configured to reduce the acoustic noise
by absorbing the sound energy, when sound waves collide with the
same (as opposed to reflecting the energy); where part of the
absorbed energy is transformed into heat and part is transmitted
and to combination thereof.
[0095] It is further well in the scope of the invention wherein the
term `passive attenuation means` also refers to means and methods
for: [0096] (a) Sound insulation: prevent the transmission of noise
by the introduction of a mass barrier such as brick, thick glass,
concrete, metal etc; [0097] (b) Sound absorption: a porous material
which acts as a `noise sponge` by converting the sound energy into
heat within the material; such as decoupled lead-based tiles, open
cell foams and fiberglass; [0098] (c) Vibration damping: applicable
for large vibrating surfaces. The damping mechanism works by
extracting the vibration energy from the thin sheet and dissipating
it as heat; such as sound deadened steel; and [0099] (d) Vibration
isolation: prevents transmission of vibration energy from a source
to a receiver by introducing a flexible element or a physical
break; such as springs, rubber mounts, cork etc.
[0100] The term "Acoustic insulation material" or "sound insulation
padding" interchangeably refers herein to any material with the
ability to absorb sound, act as a barrier of sound, or both. This
can refer in a non-limiting manner to materials such as: cork,
wool, cotton, Eel grass, fiber glass, glass wool, wood, paper,
Cobalt Quilt, sugarcane, hydrated Calcium sulphate, POP, Coir,
plastic, PVC, perforated metal, Mineral fiber board, or Micore,
Thermocole, Polyurethane, Jute, Mylar film, melamine, rubber, rock
wool, cellulose, polystyrene, polyethylene, polyester, metal any of
these materials when recycled, and etc. Further the acoustic
material can be in one or more forms such as a sheet, fabric, tile,
blanket, foam, rug, carpet, drape, curtain, panel, board, any
casted shape, rod, block, beads, straw like, gravel like particles,
Fabric can be wrapped around substrates to create what is referred
to as a "pre-fabricated panel", and any combination thereof.
Additionally or alternatively, the insulation material can be at
least partially constructed from Composite foams, these are
acoustical foams that are made by layering different facings or
foams together to create enhanced performance for specific
application types. Composite foams can meet more than one
acoustical requirements at the same time such as providing both
sound blocking and sound absorbing capabilities. These can be open
or closed cell foams. Additionally or alternatively all the
aforementioned materials can be at least partly porous.
Additionally or alternatively, all the aforementioned materials can
be combined with fire resistant materials.
[0101] The term "resonators" interchangeably refers herein to a
structure configured to typically act to absorb sound in a narrow
frequency range. Resonators include some perforated materials and
materials that have openings (holes and slots). Such as a Helmholtz
resonator, which has the shape of a bottle. The resonant frequency
is governed by the size of the opening, the length of the neck and
the volume of air trapped in the chamber. Typically, perforated
materials only absorb the mid-frequency range unless special care
is taken in designing the facing to be as acoustically transparent
as possible.
[0102] The term "Bass Traps" interchangeably refers herein to
acoustic energy absorbers which are designed to damp low frequency
sound energy with the goal of attaining a flatter low frequency
(LF) room response by reducing LF resonances in rooms. Similar to
other acoustically absorptive devices, they function by turning
sound energy into heat through friction. There are generally two
types of bass traps: resonating absorbers and porous absorbers. By
their nature resonating absorbers tend toward narrow band action
[absorb only a narrow range of sound frequencies] and porous
absorbers tend toward broadband action [absorbing sound all the way
across the audible band--low, mid, and high frequencies], though
both types can be altered to be either more narrow, or more broad
in their absorptive action. Examples of resonating type bass traps
include Helmholtz resonators, and devices based on diaphragmic
elements or membranes which are free to vibrate in sympathy with
the room's air when sound occurs. Resonating type bass traps
achieve absorption of sound by sympathetic vibration of some free
element of the device with the air volume of the room. Such free
elements in a resonating device can come in many forms such as the
air volume captured inside a Helmholtz resonator--or a thin wooden
panel held only by its edges [a style of diaphragmic absorber].
Resonating absorbers can be made from just about any material that
can either form a stiff walled vessel [a glass bottle for example]
or any membrane stiff enough to be susceptible to being induced to
vibrations by impinging sound.
[0103] It is in the scope of the invention wherein the term
"diffusion" refers to the efficacy by which sound energy is spread
evenly in a given environment. A perfectly diffusive sound space
is, as defined in Wikipedia, one that has certain key acoustic
properties which are the same anywhere in the space. A non-diffuse
sound space would have considerably different reverberation time as
the listener moved around the room. Virtually all spaces are
non-diffuse. Spaces which are highly non-diffuse are ones where the
acoustic absorption is unevenly distributed around the space, or
where two different acoustic volumes are coupled. The diffusiveness
of a sound field can be measured by taking reverberation time
measurements at a large number of points in the room, then taking
the standard deviation on these decay times. Alternately, the
spatial distribution of the sound can be examined. Small sound
spaces generally have very poor diffusion characteristics at low
frequencies due to room modes.
[0104] Still in the scope of the invention, "diffusors", and
"diffusers" are interchangeably used herein to define means to
treat sound aberrations within a medical device, such as echoes. As
depicted in Wikidepia, diffusers are an excellent alternative or
complement to sound absorption because they do not remove sound
energy, but can be used to effectively reduce distinct echoes and
reflections while still leaving a live sounding space. Compared to
a reflective surface, which will cause most of the energy to be
reflected off at an angle equal to the angle of incidence, a
diffusor will cause the sound energy to be radiated in many
directions, hence leading to a more diffusive acoustic space. It is
also important that a diffusor spreads reflections in time as well
as spatially. Diffusors can aid sound diffusion, but this is not
why they are used in many cases; they are more often used to remove
coloration and echoes. The term `diffusers` also relates to MLS
Diffusors, 1000 Hz Quadratic-Residue Diffusor, Primitive-Root
Diffusors, Optimized Diffusors, Two Dimensional ("Hemispherical")
Diffusors etc.
[0105] The term "sound baffle" interchangeably refers herein to a
construction or device which reduces the strength (level) of
airborne sound, as measured in dB (decibels). Sound baffles are a
fundamental tool of noise mitigation, for the practice of
minimizing noise or reverberation. An important type of sound
baffle is a noise barrier/sound shield. Sound baffles are also
applied to walls and ceilings in building interiors to absorb sound
energy and thus lessen reverberation. These include, as
non-limiting examples, wave baffles, fabric coated baffles, curtain
baffles, panel baffles and etc.
[0106] The term "active sound attenuator" or "active sound
controlling devices" interchangeably refer herein to any device or
mechanism that involves the investment of energy in order to
attenuate sound. As a non-limiting example, Active noise control
(ANC), also known as noise cancellation, or active noise reduction
(ANR), is a method for reducing unwanted sound by the addition of a
second sound specifically designed to cancel the first. For example
a device that creates destructive interferences using a secondary
source of noise such as using actuator loudspeakers. As depicted in
Wikipedia, since sound is a pressure wave, which consists of a
compression phase and a rarefaction phase, it can be effected by
another wave. A noise-cancellation speaker emits a sound wave with
the same amplitude but with inverted phase (also known as
antiphase) to the original sound. The waves combine to form a new
wave, in a process called interference, and effectively cancel each
other out--an effect which is called phase cancellation. Some
active sound controlling devices use active feedback mechanisms
utilizing information received from sound sensors in various
locations, and respond to the specific frequency and sound level
received. An active sound control mechanism can be efficiently
employed in a system whose generated sound characteristics such as
amplitude, frequency, speed, sound levels, and etc., can be
calculated. Another mean of active sound attenuation can be a sound
masking system. Other means for active noise control involve the
use of analog circuits or digital signal processing. Adaptive
algorithms are designed to analyze the waveform of the background
aural or nonaural noise, then based on the specific algorithm
generate a signal that will either phase shift or invert the
polarity of the original signal. This inverted signal (in
antiphase) is then amplified and a transducer creates a sound wave
directly proportional to the amplitude of the original waveform,
creating destructive interference. This effectively reduces the
volume of the perceivable noise.
[0107] According to another embodiment of the invention the sound
attenuation module comprises at least one noise-cancellation
speaker. Additionally or alternatively, the speaker comprises at
least one of the following features: (a) the noise cancelling
speaker or the sound masking speaker is co-located with the sound
source to be attenuated; (b) the noise cancelling speaker or the
sound masking speaker is configured to emit about the same audio
power level as the source of noise.
[0108] According to another embodiment of the invention the sound
attenuating module comprises at least one transducer configured to
emit a cancellation signal. Additionally or alternatively, at least
one transducer is located adjacent to the noise source, at the
inner environment of the incubator, near the neonates head, or in
any combination thereof. Alternatively, at least one transducer is
located where sound attenuation is wanted.
[0109] According to another embodiment of the invention the sound
attenuating module comprises a plurality of signal generating
speakers configured to effectively cancel or reduce sound, and a
plurality of sound sensors providing feedback at of the sound
characteristics of a plurality of locations in a defined space;
further wherein the plurality of speaker and sensors is in
communication with a CPU, a CRM or both configured to reactively
control the sound reduction or cancellation according to predefined
parameters and feedback received by the sensors. This is especially
beneficial as the three-dimensional wave fronts of the unwanted
sound and the cancellation signal could match and create
alternating zones of constructive and destructive interference,
reducing noise in some spots while doubling noise in others.
Further unexpected sound reflections and reverberations can alter
sound cancellation or reduction, emphasizing the need for a
feedback mechanism. Additionally or alternatively, the sound
attenuation module further comprises passive sound attenuation
means configured to operate together with active sound attenuators
to achieve the sound attenuation desired.
[0110] The term "sound masking" interchangeably refers herein to
the addition of natural or artificial sound (such as white noise or
pink noise) into an environment to cover up unwanted sound by using
auditory masking. As depicted in Wikipedia, this is in contrast to
the technique of active noise control. Sound masking reduces or
eliminates awareness of pre-existing sounds in a given area and can
make a work environment more comfortable, while creating speech
privacy so workers can better concentrate and be more productive.
Sound masking can also be used in the outdoors to restore a more
natural ambient environment. Sound masking is a similar process of
covering a distracting sound with a more soothing or less intrusive
sound. The masking must reduce the difference between the steady
background level and the transient levels associated with both
speech and other sounds. Motivation and productivity are improved
when this is accomplished. The masking sound itself must not change
rapidly and should be as meaningless as possible. As a non-limiting
example, masking can be obtained by the generation of an acoustic
noise signal such as: white noise, pink noise, blue noise, gray
noise, brownian noise, violet noise, a repetitive noise derived in
nature (such as the sound of waves), music, speech, and any
combination thereof. Additionally or alternatively, the noise
signal can be repeated over a predefined amount of time or be
administered intermittently, continuously, or in any pattern or
combination of the different kinds.
[0111] The term "hybrid sound attenuation means" interchangeably
refer herein to means or systems that employ both active and
passive elements to achieve sound reduction, and adaptive-passive
systems that use passive devices whose parameters can be varied in
order to achieve optimal noise attenuation over a band of operating
frequencies, such as a tunable Helmholtz resonator. As a
non-limiting example, disclosed in the art is "Air transparent
soundproof window", arXiv: 1307.0301
[cond-mat.mtrl-sci]arxiv.org/abs/1307.0301,
http://phys.org/news/2013-07-materials-scientists-window-mutes-air.html#j-
Cp describing a screen that although passable to air, lowers the
sound transmitted by up to 35 dB, by designing specific chambers
and holes configured to capture and attenuate sound, consisting of
a three-dimensional array of diffraction-type resonators with many
holes centered at each individual resonator. Further, the
researchers note that changing the size of the hole allows for
muting different frequencies.
[0112] It is further within the scope of the invention an
incubator, comprising an envelope fitting for housing a neonate,
comprising at least one air flow opening, the opening comprising at
least one resonator configured to attenuate sound. Additionally or
alternatively, the envelope comprises volume having height
represented by h, and is measured preferably in millimeters. The
value of h can be constant or variable throughout the medical
device. In at least a portion of this volume resonators and
attenuators can be implemented. Further this volume can be filled
with sound absorptive material situated around the
perforations.
[0113] The term "sound shield" refers herein after to any sound
barriers or sound reflection panel, sound absorbing panel, screens,
baffle, or any combination thereof, single or a plurality of,
configured to lowering the sound reaching the patient.
[0114] The term "reverberation" interchangeably refers herein to a
prolongation of the sound in the room caused by continued multiple
reflections is called reverberation. This can happen in an at least
partially enclosed space during the time it takes a sound to become
inaudible and stop emitting energy. When room surfaces are highly
reflective, sound continues to reflect or reverberate. The effect
of this condition is described as a live space with a long
reverberation time. A high reverberation time will cause a build-up
of the noise level in a space.
[0115] The term "reflection" interchangeably refers herein to a
phenomenon that sound reflects back from at least one surface or
object before reaching the receiver. These reflections can have
unwanted or even disastrous consequences. Reflective corners or
peaked ceilings can create a "megaphone" effect potentially causing
annoying reflections and loud spaces. Reflective parallel surfaces
lend themselves to a unique acoustical problem called standing
waves, creating a "fluttering" of sound between the two surfaces.
The standing waves can produce natural resonances that can be heard
as a pleasant sensation or an annoying one. Reflections can be
attributed to the shape of the space as well as the material on the
surfaces. Domes and concave surfaces cause reflections to be
focused rather than dispersed which can cause annoying sound
reflections. Absorptive surface treatments can help to eliminate
both reverberation and reflection problems.
[0116] The term "NRC" or "Noise Reduction Coefficient"
interchangeably refers herein to a characteristic of a
material/product presenting the average absorption across four
octave band center frequencies. (250 Hz, 500 Hz, 1000 Hz, 2000
Hz.). It can be roughly estimate that a product with an NRC 0.75
will absorb about 75% of the sound energy that hits it. The highest
level is NRC 1.0. Substantially this is the average of the mid
frequency absorption rate, rounded to the near 5%, and does not
include the high and low frequencies.
[0117] The term "STC" or "Sound Transmission Class" interchangeably
refers herein to a number rating of the transmission loss
properties of a material and/or product. It is a single-number
rating of a material's or an assembly's ability to resist airborne
sound transfer at the frequencies 125-4000 Hz. Substantially, this
refers to a material's barrier ability qualities. In general, a
material/product with higher STC rating blocks more noise from
transmitting through a partition. STC is highly dependent on the
construction of the partition. A partition's STC can be increased
by: adding mass, increasing or adding air space, adding absorptive
material within the partition, and likewise. A partition is given
an STC rating by measuring its Transmission Loss over a range of 16
different frequencies between 125-4000 Hz. The STC rating does not
assess the low frequency sound transfer. Doors, windows, walls,
floors, etc. are tested to determine how much noise passes
through.
[0118] The term "about" interchangeably refers herein to a
divergence of up to plus or minus 20% around a given value.
[0119] The term "patient placement" interchangeably refers herein
to any location within the inner volume of the medical device
configured to accept a patient, e.g. neonate. Additionally or
alternatively, this location can comprise a bed, a restraint, a
mattress, concave shape, pillow, ergonomic shape, belts, straps,
flat surface, at least partially flexible surface, a disposable
portion, a sterilizable portion, confinement means, and any
combination thereof.
[0120] The term "fluid communication" refers hereinafter to a
communication between two objects that allow flow of matter (gas,
fluid or solid) at least one direction between them.
[0121] The term "venting module" refers hereinafter to a module
that circulates air and distributes it either evenly or in a
defined direction. More specifically the term relates to a fan, a
jet, a blower, a compressor, a pump, air streamer, propeller,
ventilator, thermantidote, axial-flow fans, centrifugal fan,
cross-flow fan, airflow generated using the Coand{hacek over (a)}
effect, etc.
[0122] The term "neonate" interchangeably refers herein after to:
patient, newborn, baby, infant, toddler, child, adolescent, adult,
elderly, patient, individual, subject, inmate, sufferer,
outpatient, case, client, etc.; further this term refers to person,
animal, or sample, as a whole, or a portion thereof.
[0123] The term "neonate disturbance parameter" interchangeably
refers herein to any parameter known in the art as signifying a
neonate unfavorable reaction. As a -limiting example, this can be
an acceleration or deceleration of the neonate heart rate (as
depicted in Willlams et. al, 2009, and in Schulman et al. 1969) a
rise in blood pressure (as depicted in Jurkovicova and Aghova et
al, 1989), a change in the breathing pattern, (as depicted in
Wharrad and Davis et al, 1997, and Long et al, 1980), or different
oxygen saturation (as depicted in Zahr and Balian et al, 1995);
excess movement or a reduction in the movement of the neonate in
reference to a normal average, a change in brain patterns, crying
more than a normal average, an interruption or change in sleeping
patterns or eating patterns, and etc. Additionally or
alternatively, the Anderson Behavioral Scale can be used to assess
behavioral and sleep states as depicted in Anderson et al, 1990,
further techniques like magnetic imaging, EEG, as depicted in
Huotilainnen et al 2003, Cheour et al, 1998, 2002), have been shown
to be reliable measurements for the reaction of neonates.
[0124] The term "transparent material" interchangeably refers
hereinafter to materials such as, poly-methyl methacrylate,
thermoplastic polyurethane, polyethylene, polyethylene
terephthalate, isophthalic acid modified polyethylene
terephthalate, glycol modified polyethylene terephthalate,
polypropylene, polystyrene, acrylic, polyacetate, cellulose
acetate, polycarbonate, nylon, glass, polyvinyl chloride, etc.
Further in some embodiments at least a portion of this material is
imbedded with non-transparent materials for means of strength
and/or conductivity such as metallic wires.
[0125] The term "sensor" interchangeably refers hereinafter to any
device that receives a signal or stimulus (heat, pressure, light,
motion, sound, humidity etc.) and responds to it in a distinctive
manner. This manner can be such as inducing the action/inaction of
other devices, inducing the action/inaction of indicators (visual,
auditable or sensible), inducing the display of the input received
by the sensor, inducing the data storage/analysis of input in a
central processing unit, etc.
[0126] The term "life supporting equipment" interchangeably refers
hereinafter to any element that provides an environmental
condition, a medical condition or monitoring of an environmental or
medical condition thereof that assists in sustaining the life of a
neonate and/or bettering their physical and physiological
wellbeing. This element can be: (a) any medical equipment: all
devices, tubes, connectors, wires, liquid carriers, needles,
sensors, monitors, etc., that are used by medical personal in
association with the patient. This equipment is such as bilirubin
light, an IV (intravenous) pump, oxygen supplementation systems by
head hood or nasal cannula, continuous positive airway pressure
system, a feeding tube, an umbilical artery catheter, a fluid
transport device, hemofiltration system, hemodialysis system, MRI
contras solution injection, imaging the neonate etc.; (b) medical
measurement and observation systems (including sensors and/or
monitors) of temperature, respiration, cardiac function,
oxygenation, brain activity such as ECG (electrocardiography)
monitor, blood pressure monitor, cardio-respiratory monitor, pulse
oximeter; and (c) environmental control systems such as ventilator,
air conditioner, humidifier, temperature regulator, climate control
systems, noise muffling device, vibration muffling device, etc. and
any combination thereof.
[0127] The term "medical equipment tubing" interchangeably refers
hereinafter to all tubes, cables, connectors, wires, liquid
carriers, gas carriers, electrical wires, monitoring cables,
viewing cables, data cables, etc., that is used in connection to
life support equipment, medical equipment or physical environment
maintenance or monitoring.
[0128] The term "life parameters" interchangeably refers herein to
any measurable value or parameter of the neonate that can be used
as an indicator of life or/and well-being. This parameter can be
detected from afar by a viewing system, monitoring system,
ultrasound technology, medical equipment, camera from afar, or by
physically touching the neonate by a connected sensor. This
parameter is such as temperature, cardiovascular activity (heart
rate, blood pressure, breathing rate, and etc.), blood oxygenation,
movement, brain activity, and etc.
[0129] The term "CPU", central processing unit, interchangeably
refers hereinafter to the hardware within a computer that carries
out the instructions of a computer program by performing the basic
arithmetical, logical, and input/output operations of the system.
In the embodiments of the invention the CPU can be connected to: at
least one CRM, a user interface, at least one sensor, at least one
indicator, at least one venting module, at least one temperature
regulating vent, at least one air filter, at least one sound
filter, at least one humidifier, at least one air circulating
mechanism, life supporting equipment, a control panel, a monitoring
device, a viewing or filming device, and etc., at last one engine
configured to convert electrical power into movement of such as a
vent, a baffle, a recline-able neonate restraint means, sealing of
at least one opening in the incubator, or and etc., thus providing
the user monitoring and/or control over various aspects of the
invention.
[0130] The term "Computer readable media", (CRM), interchangeably
refers hereinafter to, a medium capable of storing data in a format
readable by a mechanical device (automated data medium rather than
human readable). Examples of machine-readable media include
magnetic media such as magnetic disks, cards, tapes, and drums,
punched cards and paper tapes, optical disks, barcodes and magnetic
ink characters. Common machine-readable technologies include
magnetic recording, processing waveforms, and barcodes. Any
information retrievable by any form of energy can be
machine-readable.
[0131] The term "plurality" interchangeably refers herein to one
and/or more than one.
[0132] According to one embodiment of the invention a
noise-attenuating neonate incubator (NANI) comprising sound
attenuating module (SAM) configured to decrease AmpR.sub.ti to
AmpR.sub.QV.DELTA.t or less. The NANI can comprise one or more SAM.
Each SAM can hold one or more sound attenuators, the sound
attenuators can attenuate sound or at least change the sound
signature by passive sound attenuating means such as: insulation
padding, sound shield, sound baffle, sound diffuser, sound
absorber, bass trap, resonator and etc. The passive sound
attenuation means can also appear at least partially in the form of
a layered construction. Another option for the SAM is to comprise
active and passive sound attenuators utilizing active or passive
attenuating means. Another option is only active attenuating
means.
[0133] According to another embodiment of the invention, a
noise-attenuating neonate incubator (NANI) comprising sound
attenuating module (SAM) configured to decrease the sound amplitude
ratio at time, (AmpRat.sub.ti) to a critical amplitude ratio value
of the sound measured over a predetermined time, .DELTA.t,
(AmpR.sub.QV.DELTA.t) or less, wherein the sound attenuating module
(SAM) comprises: (a) at least one sound sensor in communication
with the CRM, configured for continuously sampling the sound
amplitude ratio at time t.sub.i (AmpRat.sub.ti) within the
incubator; (b) at least one CRM for storing the critical amplitude
ratio value of the sound measured over a predetermined time,
.DELTA.t, (AmpR.sub.QV.DELTA.t) and, the sound amplitude ratio at
time, t.sub.i, (AmpRat.sub.ti); and, (c) at least one sound
attenuator in communication with the CRM for decreasing the sound
amplitude ratio at time, t.sub.i, (AmpRat.sub.ti), if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, such that
AmpRat.sub.ti<AmpRat.sub.QV.DELTA.t; wherein the critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, AmpRat.sub.QV.DELTA.t<about
178.8.sub..DELTA.t.
[0134] It is known in the art that amplitude ratio of 178.8 is
equivalent to about 45 dB.
[0135] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM is configured to
decrease AmpR.sub.ti to AmpR.sub.QV.DELTA.t or less.
[0136] Additionally or alternatively, any sound characteristic is
measured and/or stored by the CRM such as: sound levels, tone,
overtone composition, reverberations, sound frequency, sound
wavelength, sound wave amplitude, sound wave speed, sound wave
direction, sound wave energy, sound wave phase, sound wave shape,
sound wave envelope, sound timbre, and etc. Additionally or
alternatively, the CRM is configured to differentiate background
noise from a specific predefined noise, and attenuate only the
desired noise.
[0137] According to another embodiment of the invention the SAM is
configured to attenuate any sound level over a selected from a
group consisting of 45 dB, 50 dB, 60 dB, and any combination
thereof.
[0138] According to another embodiment of the invention, the SAM is
configured to attenuate any sound level over a selected from a
group consisting of: 100.sub..DELTA.t AmpR, 178.8
AmpR.sub..DELTA.t, 316.2 AmpR.sub..DELTA.t, 1000 AmpR.sub..DELTA.t,
or any combination thereof.
[0139] According to another embodiment of the invention, the SAM is
configured to modify the sound within the incubator such that it is
of at least one different sound characteristic selected from a
group consisting of: sound levels, tone, overtone composition,
reverberations, sound frequency, sound wavelength, sound wave
amplitude, sound wave speed, sound wave direction, sound wave
energy, sound wave phase, sound wave shape, sound wave envelope,
sound timbre, and any combination thereof.
[0140] According to another embodiment of the invention the SAM is
configured to attenuate any sound level over a predefined level,
that lasts for over 50 microseconds, over 1 millisecond, over 0.1
second, over 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds,
10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60
seconds, 2 minutes, 3 minutes, 4 minutes, 5 minutes, above 5
minutes, and any combination thereof.
[0141] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the sensor is further in
communication with a selected from a group consisting of: at least
one indicator, at least one user interface, at least one alarm
system, at least one CPU, and any combination thereof. Additionally
or alternatively the CPU in connection with the CRM can be
configured to generate a status report to describing the sound
within the incubator, or the physical state of the system. Further
the CPU can be configured to trigger an alarm system according to
preset parameters of sound sensed by at least one sensor. In an
embodiment the CRM can be remotely controlled by a cellular phone,
a remote computer, a remote control, and etc.
[0142] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured to
control the sound attenuator according to a selected from a group
consisting of: parameters received by means of at least one sensor,
parameters inputted through a user interface, parameters received
from neonate medical equipment, and any combination thereof.
Additionally or alternatively, the CRM is able to control the
output of the sound attenuator according to specific sound levels
and sound frequencies.
[0143] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured to
differentiate the sound attenuation of predefined hours. As an
example, the sound attenuation can be of different sound signature
during the night and day, during feeding hours, during physical
examination and etc.
[0144] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the CRM is configured to record
and store a history of sound and the reaction of the neonate.
Additionally or alternatively, the CRM is configured to attenuate
at least one sound characteristic correlated with the most neonate
disturbances.
[0145] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the sound attenuator comprises
an active sound masking system, configured to emit at least one
acoustical sound signal, by means of at least one acoustical
sound-speaker. According to another embodiment of the invention, a
NANI as defined above is disclosed, wherein at least one acoustical
sound signal is selected from a group consisting of: white noise,
pink noise, grey noise, brownian noise, blue noise, violet noise,
and any combination thereof. According to another embodiment of the
invention, a NANI as defined above is disclosed, wherein the sound
attenuator comprises a reactive acoustical device, configured to
cancel the noise by means of a destructive interference
generator.
[0146] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM is configured to
attenuate the noise by a selected from a group consisting of:
reduce the sound levels, reduce sound reflections, reduce sound
reverberation, create sound diffusion, mask sound, cancel sound,
change the sound signature, and any combination thereof. According
to another embodiment of the invention, a NANI as defined above is
disclosed, wherein the SAM is configured to change at least one
sound characteristic selected from a group consisting of: sound
levels, tone, overtone composition, reverberations, sound
frequency, sound wavelength, sound wave amplitude, sound wave
speed, sound wave direction, sound wave energy, sound wave phase,
sound wave shape, sound wave envelope, sound timbre, thereby
generating a different sound signature.
[0147] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the sound signature is selected
from a group consisting of: configurable by the user, predefined,
automatically adjustable in reference to the neonate's life
parameters, and any combination thereof.
[0148] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM comprising at least one
means selected from group consisting of: active sound attenuating
means, passive sound attenuating means, hybrid sound attenuating
means, and any combination thereof.
[0149] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least one passive sound
attenuating means is selected from a group consisting of: at least
one sound absorptive material, at least one resonator, at least one
sound shield, at least one bass trap, at least one sound baffle, at
least one diffuser, at least one insulation padding, at least one
sound reflector, at least one sound muffler (SM), and any
combination thereof. According to another embodiment of the
invention, a NANI as defined above is disclosed, wherein the SAM
comprises at least one sound shield comprising at least a portion
of a material selected from a group consisting of: at least one
insulating material, at least one sealing material, at least one
sound absorbent material, at least one vibration absorbing
material, and any combination thereof.
[0150] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM comprises at least one
insulation padding configured to insulate the neonate placement
within the NANI; further wherein the insulation comprises at least
one opening configured to permit access to within the NANI.
[0151] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least a portion of the
insulation comprises a material selected from a group consisting
of: thermo insulating material, sealing material, foam material,
fire retardant materials, at least partially transparent material
and any combination thereof.
[0152] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least a portion of the
insulation comprises means for shielding at least a portion of the
incubator from a selected from a group consisting of: magnetism,
electromagnetic interference, physical damage and any combination
thereof.
[0153] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least a portion of the
insulation comprises at least one conduit having at least one first
aperture into the incubator and at least one aperture to the
external environment, fitted for the passage of tubing within;
further wherein the conduit is configured to attenuate the passage
of frequencies selected from a group consisting of: 0 to about 1000
MHz, 0 to about 500 MHz, 0 to about 200 MHz and any combination
thereof.
[0154] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM is a modular component
reversibly attachable to the incubator.
[0155] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM comprises at least one
sound reflector configured to direct the noise to a selected from a
group consisting of: at least one absorptive surface, at least one
sound diffuser, at least one sound baffle, at least one reflective
surface, at least one resonator, at least one sound shield, a
location directed away from the neonate, and any combination
thereof.
[0156] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the incubator further comprises
at least one conduit having at least one SAM configured to muffle
the sound passing through the conduit.
[0157] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM, the incubator, or both
are made of MRI safe materials.
[0158] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the incubator further comprises
at least one sensor selected from a group consisting of: sound
level sensor, sound frequency sensor, sound direction sensor, sound
amplitude sensor, sound tone sensor, sound speed sensor, sensor
configured to sense life parameters of the neonate, and any
combination thereof.
[0159] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM is configured to reduce
reverberation of sound, reflections of sound, or both within the
inner volume, by means of at least one selected from a group
consisting of; absorptive material, a sound baffle, a sound
diffuser, an active sound cancellation device and any combination
thereof.
[0160] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the incubator further comprises
at least one air inlet, air outlet, or both, configured for the
entry and/or exit of air; further wherein at least one air inlet,
outlet, or both further comprises at least one SAM.
[0161] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the incubator is at least
temporarily accommodated in a cart comprising at least one SAM.
[0162] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM comprises hybrid sound
attenuating means comprising active and passive sound attenuating
means combined in at least one sound attenuator.
[0163] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the sound attenuating means is
configured to reduce reverberation of sound, reflections of sound,
or both within the inner volume, by means of at least one selected
from a group consisting of; absorptive material, a sound baffle, a
sound diffuser, an active sound cancellation device and any
combination thereof.
[0164] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the sound attenuating means are
placed within the incubator, outside the incubator, on top the
incubator, remotely from the patient, adjacent to the patient,
aside the incubator, remote from the incubator, and in any
combination thereof.
[0165] According to one embodiment of the invention, MLS Diffusors
are used. Maximum length sequence based diffusors are made of
strips of material with two different depths. The placement of
these strips follows an MLS. The width of the strips is smaller
than or equal to half the wavelength of the frequency where the
maximum scattering effect is desired. In ideal situations small
vertical walls should be placed between lower stripes, improving
the scattering effect in the case of tangential sound incidence.
The bandwidth of these devices is rather limited, one octave above
the design frequency they behave like a flat surface.
[0166] According to another embodiment of the invention,
Quadratic-Residue Diffusors are used. According to another
embodiment of the invention, 1000 Hz Quadratic-Residue Diffusors
are used. MLS based diffusors are superior to geometrical diffusors
in many respects; they have limited bandwidth. The new goal was to
find a new surface geometry that would combine the excellent
diffusion characteristics of MLS designs with wider bandwidth.
Quadratic-Residue Diffusors can be designed to diffuse sound in
either one or two directions.
[0167] According to another embodiment of the invention,
Primitive-Root Diffusors are used. They are based on a number
theoretic sequence. Although they produce a notch in the scattering
response, in reality the notch is over too narrow a bandwidth to be
useful. In terms of performance, they are very similar to
Quadratic-Residue Diffusors.
[0168] According to another embodiment of the invention, Optimized
Diffusors are used. By using numerical optimization, it is possible
to increase the number of theoretical designs, especially for
diffusors with a small number of wells per period. But the big
advantage of optimization is that arbitrary shapes can be used
which can blend better with architectural forms.
[0169] According to another embodiment of the invention, Two
Dimensional ("Hemispherical") Diffusors are used. Those are
designed, like most diffusors, to create "a big sound in a small
room," unlike other diffusors, two dimensional diffusors scatter
sound in a hemispherical pattern. This is done by the creation of a
grid, whose cavities have wells of varying depth, according to the
matrix addition of two quadratic sequences equal or proportionate
to those of a regular diffusor. These diffusors are very helpful
for controlling the direction of the diffusion, particularly in
studios and control rooms.
[0170] Reference is now made to FIG. 1, illustrating in a
non-limiting, out of scale schematic manner a neonate (1) residing
within an incubator (100). The neonate is subject to sounds/noise
originating from the outside (10) or from within (11). The neonate
is also subject to reverberations and reflective of sound (12)
within the incubator. These sounds can cause distress or even harm
the neonate (1).
[0171] Reference is now made to FIG. 2a-e, illustrating in a
non-limiting, out of scale schematic manner an incubator (100)
configured to be accommodated by a neonate (1), the incubator
comprising at least one SAM, sound attenuating module, (150). The
sound attenuating module can be passive, active or a combination
thereof. In FIG. 2a the SAM (150) is connected to the ceiling of
the incubator (100) from within, and can be a passive sound
attenuating means such as a baffle, a diffuser, a resonator; or
active as a reactive, predefined or both. FIG. 2b shows more than
one SAM (150a, 150b) in connection with the incubator (100) housing
at least temporarily the neonate (1). 150a is a suspended along the
inner wall of the incubator, and can cover at least apportion of
the incubator inner wall. 150b is an embodiment of the sound
attenuating module placed ontop the incubator (100). FIG. 2c shows
a SAM (150a) in a configuration having at least a portion thereof
outside the incubator (100), and at least a portion thereof within
the incubator (100). Another embodiment is a SAM embedded within
the incubator wall and at least partially accessible from outside
the incubator (100). FIG. 2d shows another embodiment where the SAM
(150) is embedded at least in part within the incubator wall and
accessible at least partially through the incubator front face.
FIG. 2e describes yet another embodiment where the noise
muffling/sound attenuating device/SAM is located in a remote
location without physical connection with the incubator. This
embodiment is possible utilizing active sound attenuation means,
comprising at least one transducer configured to generate a
disruptive signal to the sound, a masking system configured to
provide sound parallel to the noise such as white, pink, grey,
brownian, blue violet noise. The attenuating mask in an embodiment
be a melody, music, or any sound generated for this purpose.
[0172] Reference is now made to FIG. 3a-d, illustrating in a
non-limiting, out of scale schematic manner different embodiments
of the invention, shown in a section viewed from the incubator face
(FIG. 2 e 44), along the `A` dashed line (FIG. 2e). FIG. 3a shows
an incubator (100) with passive sound attenuating means (110)
comprising at least a portion of insulation padding, and an active
sound attenuation module (150). The incubator further harbors at
least one diffuser (170) allowing the diffusion of sound within the
incubator. FIG. 3b shows an incubator (100) having at least one SAM
(150) and at least one sound generating speaker (155) generating a
sound mask. FIG. 3c shows the face of the incubator (100), having
insulation padding completely covering and sealing the inner
environment of the incubator. Further, the incubator is openable
and/or closable by a door (220) attach on such as a hinge (200),
pivot point, axis turning point, joint and etc. The door further
comprises at least one conduit (300) attenuating the passage of RF
frequencies that can disrupt the reading or an imager such as an
MRI, or disrupt any electrical mechanisms and circuits while
allowing the passage of life support tubing (310) from the external
environment to within the incubator (100). FIG. 3d shows an open
incubator (100) from the face side (44 FIG. 2e), further comprising
an insulating layer covering at least a portion of the inner
envelope, configured to passively attenuate sound, and fitted to
accommodate a neonate. The incubator further comprises at least one
resonator (185), and at least one sound shield (180), configured to
attenuate sound. The resonator can be a passive or hybrid sound
attenuator. In an embodiment the incubator comprises a bass trap or
any active or passive means configured to attenuate the low
frequency sounds, such as the sounds emitted by an incubator motor
(as disclosed in Seleny and Streczyn 1969, that found that the
noise emitted by the incubator motor is of maximal energy at 125
Hz).
[0173] Reference is made to FIG. 3e schematically illustrating in a
non-limiting, out of scale manner an embodiment of the invention.
In this embodiment the incubator (100) comprises a plurality of
layers (110, 111, 112). Additionally or alternatively, each layer
can be of different size, materials and over all sound attenuating
quality. According to another embodiment of the invention, a NANI
as defined above is disclosed, wherein at least a portion of the
SAM comprises n layers; further wherein each of the n layers
comprising an inner side towards the neonate, and an opposite outer
side facing away from the neonate.
[0174] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein each of the n layers comprising
a predefined Noise Reduction Coefficient (NRC) value, Sound
Transmission Class (STC) value, or both; further wherein the NRC
value, STC value, or both, can be equal or different for the each
of one of n layers.
[0175] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least 2 of the n layers
comprising a Noise Reduction Coefficient (NRC) value for each of
the n layers; where each of the layers comprising at least one
sound level S [dB] measured on the layer outer side, and at least
one first sound level S.sub.1 [dB], measured on the layer inner
side, having a dS.sub.1- . . . dSn, wherein dS of the SAM equals
S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0176] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least 2 of the n layers
comprising a Sound transmission class (STC) value for each of the n
layers; where each of the layers comprising at least one sound
level S [dB] measured on the layer outer side, and at least one
first sound level S.sub.1 [dB], measured the layer inner side,
having a dS.sub.1- . . . dSn, wherein dS of the SAM equals
S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0177] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM further comprising: (a)
a space, S.sub.1, between at least one of n layers to the
incubator, a space S.sub.n between each of the n layers, or both;
(b) STC.sub.1 (sound transmission class) value, measured for the
layers.sub.1-n; and, (c) mobilization means, connected to at least
one of the n layers, configured to mobilize at least one of the n
layers, having a space S.sub.1a, between at least one of n layers
to the incubator, a space S.sub.na between each of the n layers, or
both, and STC.sub.2 value measured for the layers.sub.1-n, where
S.sub.1<S.sub.1a, S.sub.n<S.sub.na, or both, and where
STC.sub.1<STC.sub.2.
[0178] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least one of the n layers is
reversibly connectable to the incubator, the one of n layers, or
both.
[0179] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least one of n layers
comprises at least one passive sound attenuating means configured
to a selected from a group consisting of: reduce reverberation,
reduce reflection, reduce sound levels, or any combination thereof,
of the sound within the inner environment generated by the sound
generator.
[0180] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least one layer comprises at
least a portion of a selected from a group consisting of: an
electrical isolating material, electrically conductive material
configured to closes conductive circle, disposable material, at
least partially transparent material, fire resisting material, MRI
safe material, sterilizable material, and any combination
thereof.
[0181] Reference is made to FIG. 3f schematically illustrating in a
non-limiting, out of scale manner an embodiment of the invention.
In this embodiment, various layer types are shown (115, 116). These
layers can be of porous material, solid material, flexible
vibration absorbing material, fire resistive material, and etc. The
layers each cover at least a portion of the incubator inner
walls.
[0182] Reference is now made to FIG. 4a-d, schematically
illustrating in a non-limiting, out of scale manner, different
embodiments of an active SAM. FIG. 4a shows a neonate (l),
accommodated within an incubator (100). The incubator (100)
comprises at least one sound attenuating module (150) comprising at
least one sound sensor (160), and at least one transducer (168)
configured to emit a destructive signal configured to cancel or at
least reduce the sound reaching the neonate's (l) ears. The SAM
further comprises at least one CRM in communication with at least
one sensor and at least one transducer. Additionally or
alternatively, the SAM (150) is in wired or wireless communication
with an acoustic sound speaker (152) in a different location than
the 168, (e.g. on the ceiling, the wall, the floor, of the inner
environment of the incubator) configured to generate sound for
masking the noise within the incubator. Additionally or
alternatively, the SAM is further connected to at least one another
transducer (151) that together with the first one (168) is
configured to destruct a sound effects from the three dimensional
qualities of the noise colliding with the destructive signal.
Additionally or alternatively, the SAM is connected to at least one
power source such as electrical line, a battery, a generator, and
etc. FIG. 4b shows a SAM (150) comprising a CRM (162), at least one
speaker, and at least one sensor (160) on a reversibly connectable
panel. Further the incubator (100) comprises at least one passive
sound attenuating means such as insulation or sealing material.
FIG. 4c illustrates an embodiment of a CRM (162) comprising a
processor (164). The CRM (162) is in communication with a plurality
of sensors (160) dispersed in various location within the incubator
(100), and at least one sound attenuator (152) configured to
attenuate the sound sensed by the sound sensors (160) and
predefined by the user as disruptive. This embodiment represents a
reactive sound attenuation means that refers directly to the
specific noise reaching the inner enclosure of the incubator (100).
In an embodiment, the CRM is configured to differentiate the
background sound from specific sound disturbing for neonates and
attenuate only the disturbing sound by generating a specific
destructive signal. FIG. 4d illustrates at least one SAM (150)
comprising at least one sound attenuating means (152). Additionally
or alternatively, the incubator further comprises at least one
sensor such as a sound sensor, a sensor sensing the neonate life
parameters, and/or a viewing device. Additionally or alternatively,
the SAM further comprises a user interface (comprising a screen,
keys, buttons, scroll, mouse, and such) configured to allow
programming of the SAM via the CRM.
[0183] Reference is now made to FIG. 5, illustrating in a
non-limiting, out of scale schematic manner an medical device that
can be embodied as an incubator (100), an imaging device, a
treatment device and as such, having an inner portion (2) where
patient is imagined. In this medical device with a noise muffling
mechanism, passive and active means are provided to reduce as a non
limiting example the MRI-noise (gradient noise), and outside noise
(hospital noise). A passive pad-like acoustic sealing (10) is
affixed to MRI's opening, configured to insulate the inner
environment from its surrounding environment. A further a passive
absorptive acoustical surface (11) is located in the inner
environment. Moreover, an active acoustical sound-speaker, located
adjacent to the patient (12a) and adjacent to MRI's
gradient-oriented noise generator (12b). The sound speakers emit
white acoustical noise such the noise is filtered and masked.
Additionally or alternatively, one or more a reactive acoustical
device (can be presented by 12a and/or 12b), are configured to
cancel MRI's surrounding acoustical noise by destructive
interference. Additionally or alternatively, an air ventilating
mechanism (14) is configured to facilitated the effective air flow
(2) through (3) the MRI away from the patients ears such that
acoustical noise is deflected away form the patients ears of the
device.
[0184] Reference is now made to FIG. 6, similarly illustrating in a
non-limiting, out of scale schematic manner an infant's incubator
(200) comprising a passive absorptive acoustical surface (11) is
located in the inner environment. Additionally or alternatively, an
active acoustical sound-speaker/a reactive acoustical device
located adjacent to the patient (101). Additionally or
alternatively, an air ventilating mechanism (14) comprising a fan
(heater and humidifier as an option) is configured to facilitated
the effective air flow (2) through in incubator away from the
patient such that acoustical noise is deflected away from the
patient of the device. The sound generated by the air flow and/or
the ventilation system can be attenuated by at least one sound
attenuating module (12) comprising active sound attenuating means.
Additionally or alternatively, the ventilating system is located at
the column (201) supporting the upper tray of the cart comprising
the incubator, in this embodiment additional sound attenuating
mechanisms are added adjacent to the vent, and air inlets and
outlets.
[0185] Reference is now made to FIG. 7a, schematically illustrating
in a non-limiting, out of scale manner an embodiment of the
invention. A neonate incubator (102) configured by means of size
shape and material to accommodate a neonate (1). The incubator
includes a ventilating system comprising at least one
thermo-regulating vent (14) in fluid communication with the
incubator base through at least one sound attenuating module, SAM,
configured to change at least one parameter of the sound signature
reaching the neonate. The SAM is configured such that it allows air
to enter the incubator through ports (190a, 190b) from a
compartment (160c) below the incubator floor through air inlets
(175).
[0186] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the medical device further
comprises an air ventilating mechanism, configured to facilitated
effective air flow through the medical device away from the
patients ears such that the acoustical noise is deflected away from
the patients ears.
[0187] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the ventilating mechanism
further comprises at least one air inlet, air outlet, or both,
configured for the entry and/or exit of air; further wherein the at
least one air inlet, outlet, or both further comprises at least one
SAM.
[0188] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the ventilating mechanism
further comprises at least one vent configured to stream air
through the at least one air inlet towards the inner environment;
further wherein the ventilating mechanism further comprises at
least one SAM configured to attenuate noise generated by the
vent.
[0189] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SAM comprising at least one
sound muffler (SM) comprising at least one cylindered conduit,
having at least one length (l) and at least one width (w); the
cylinder comprising at least one air inlet, and at least one air
outlet; further wherein the SM is configured such as that sound
exiting at least one air outlet is of a different sound signature
than sound entering at least one air inlet.
[0190] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SM comprises at least a
first cylinder, and at least a second cylinder, connected
therebetween, the connection comprises at least one opening
configured to permit a fluid communication therebetween.
[0191] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein at least one cylinder width (w)
is selected from a group consisting of: width (w) is equal along
the length (l), is differential along the length (l) or any
combination thereof.
[0192] According to another embodiment of the invention, a NANI as
defined above is disclosed, wherein the SM comprises a plurality of
n cylinders, where the length (l).sub.1- . . . n and the width
(w).sub.1- . . . n of the each cylinder, are selected from a group
consisting of: (l).sub.1=(l).sub.n, (l).sub.1>(l).sub.n,
(l).sub.1<(l).sub.n, (l).sub.1.noteq.(l).sub.n,
(w).sub.1=(w).sub.n, (w).sub.1>(w).sub.n,
(w).sub.1<(w).sub.n, (w).sub.1.noteq.(w).sub.n, and any
combination thereof.
[0193] Reference is now made to FIG. 7b, similarly illustrating in
a non-limiting, out of scale schematic manner an infant's incubator
(103) situated in a cart having at least one mobile base (500)
connected by at least one pillar (400). The cart comprises at least
one ventilating system situated within the pillar (400) and/or
within the cart base (500). The ventilating system comprises at
least one vent (14) in fluid communication with at least one sound
muffler, SM, (151a, 151b), configured to have at least one air
inlet to receive a stream of air from the vent, and at least one
air outlet to distribute air to the incubator. The SM is configured
to change at least one sound characteristic of the sound generated
by the vent and entering the incubator, through a compartment on
the bottom of the incubator (160b). Additionally or alternatively,
the air leaving the incubator can also pass through at least one SM
configured to change the sound signature thereby creating a less
noisy environment. Additionally or alternatively, the SM and
ventilating system are at least partially made of MRI safe
materials.
[0194] According to another embodiment of the invention, the
incubator is connected to a cart comprising at least one mobile
base, interconnected by at least one support pillar; further
wherein the cart is configured by means of size and shape to be at
least partly inserted into an MRD having an open bore; further
wherein the incubator and cart are configured such that the cart
effectively shuts the MRD bore when inserted; further wherein at
least a portion of the cart and at least a portion of the incubator
are made of MRI--safe materials. Additionally or alternatively, all
components of the incubator, cart, SAM and/or ventilation system
that are inserted into the MRD bore are made of MRI safe
materials.
[0195] Reference is now made to FIG. 8a, schematically illustrating
in a non-limiting, out of scale manner a diagram representing the
neonate disturbance parameter as a function of the sound levels
over time. The dashed line `A` represents the disturbance of a
neonate, according to the Anderson Behavioral Scale, exposed to
noise in relatively high levels over time, without a sound
attenuation module. It is shown that the disturbance grows over
time. When using a reactive sound attenuation module, the neonate
disturbance parameter decreases as the system detects the
disturbance and generates masking sound and/or a destructive signal
effectively lowering the sound levels reaching the neonate to under
45 dB.
[0196] Reference is now made to FIG. 8b, schematically illustrating
in a non-limiting, out of scale manner a diagram representing the
neonate disturbance parameter, according to the Anderson Behavioral
Scale (as a non-limiting example), as a function of the sound
amplitude ratio over time. The dashed line (A) shows the
disturbance of the neonate rising over time in reference to the
rise in the sound amplitude ratio. The line (B) shows only a
minimal rise in the disturbance of the neonate when utilizing at
least one SAM having at least one passive sound attenuation
means.
[0197] Reference is now made to FIG. 8c, schematically illustrating
in a non-limiting, out of scale manner a diagram representing the
neonate disturbance parameter, according to the Anderson Behavioral
Scale (as a non-limiting example), as a function of the sound
frequency over time. The dashed line `A` represents the disturbance
of a neonate exposed to noise in relatively high frequencies over
time, without a sound attenuation module. It is shown that the
disturbance grows over time. When using a reactive sound
attenuation module, the neonate disturbance parameter decreases as
the system detects the disturbance and generates masking sound
and/or a destructive signal effectively lowering the sound
frequencies reaching the neonate to a predefined parameter (as a
non-limiting example--under 1600 Hz, under 1000 Hz, under 600 Hz,
800-1200 Hz, 600-1500 Hz, 1000-2000 Hz, 200-2000 Hz, 100-800 Hz,
1-100 Hz, 1200-1500 Hz, 2000-300 Hz, 2000-3000 Hz, 3000-4000 Hz,
4000-20000 Hz, 20 Hz-20000 Hz, 20-15000 Hz; and any combination
thereof; additionally or alternatively, the system can change the
sound signature reaching the neonate to filter out low frequency
sounds, and leave the high frequency sounds, or filter out all
frequencies out of a predefined range, as a non-limiting example,
leave only frequencies between 800-1200 Hz, 600-1500 Hz, 1000-2000
Hz, 200-2000 Hz, 100-800 Hz, 1-100 Hz, 1200-1500 Hz, 2000-300 Hz,
2000-3000 Hz, 3000-4000 Hz, 4000-20000 Hz, 20 Hz-20000 Hz, 20-15000
Hz and any combination thereof, Additionally or alternatively or
eliminate at least one frequency, and allow at least one
frequency.
[0198] Reference is now made to FIG. 8d, schematically illustrating
in a non-limiting, out of scale manner a diagram representing the
neonate disturbance parameter, according to the Anderson Behavioral
Scale (as a non-limiting example), as a function of the sound level
in dB over time. The dashed line (A) shows the disturbance of the
neonate rising over time in reference to the rise in the sound
levels. The line (B) shows only a minimal rise in the disturbance
of the neonate when utilizing at least one SAM having at least one
passive sound attenuation means.
[0199] Reference is now made to FIG. 8e, schematically illustrating
in a non-limiting, out of scale manner a diagram representing the
neonate disturbance parameter, according to the Anderson Behavioral
Scale (as a non-limiting example), as a function of generation of a
disturbing sound over time. The dashed line (A) shows the
disturbance of the neonate rising over time in reference to
accumulation of exposure time to the disturbance. The line (B)
shows only a minimal rise in the disturbance of the neonate when
utilizing at least one SAM having at least one sound attenuation
means configured to change the sound signature reaching the
neonate.
[0200] According to one embodiment of the invention, a method for
sound attenuating a neonate incubator, characterized by: (a)
obtaining a noise-attenuating neonate incubator (NANI) comprising
at least one sound attenuating module (SAM) configured to decrease
the sound's amplitude ratio at time, t.sub.i, (AmpRah.sub.ti) to a
critical amplitude ratio value of the sound measured over a
predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t) or less; (b)
accommodating the neonate in the NANI; and, (c) attenuating the
noise by at least one SAM, thereby changing the sound
signature.
[0201] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the
following steps: (a) obtaining the SAM further comprising: at least
one CRM, at least one sound sensor in communication with the CRM,
at least one sound attenuator in communication with the CRM; (b)
storing the critical amplitude ratio value of the sound measured
over a predetermined time, .DELTA.t, (AmpR.sub.QV.DELTA.t) and, the
sound amplitude ratio at time, t.sub.i, (AmpRat.sub.ti); and, by
means of the CRM; (c) continuously sampling the sound amplitude
ratio at time, t.sub.i, AmpRat.sub.ti within the NANI, by means of
at least one sound sensor; and, (d) decreasing the sound amplitude
ratio at time, t.sub.i, (AmpRat.sub.ti), if
AmpRat.sub.ti>AmpR.sub.QV.DELTA.t, such that
AmpRat.sub.ti<AmpRat.sub.QV.DELTA.t; wherein the critical
amplitude ratio value of the sound measured over a predetermined
time, .DELTA.t, AmpRat.sub.QV.DELTA.t<about 178.8.sub..DELTA.t,
by means of the sound attenuator.
[0202] As known in the art, amplitude ration of 178.8 is equivalent
to about 45 dB.
[0203] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
further relaying information from the sensor to a selected from a
group consisting of: at least one indicator, at least one user
interface, at least one alarm system, at least one CPU, and any
combination thereof.
[0204] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
controlling the sound attenuator by means of the CRM according to a
selected from a group consisting of: parameters received by means
of at least one sensor, parameters inputted through a user
interface, parameters received from neonate medical equipment, and
any combination thereof.
[0205] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) configuring the CRM for one or more sampling events
creating one or more sample values; (b) sampling at least one
signal thereby creating at least one sample value; and, (c)
analyzing at least one sample comprising one or more values, to
determine the sound signature.
[0206] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
configuring the CRM for sampling the amplitude ratio of a signal
between the time point t and t.sub.1= or > from t+50
microseconds, thereby determining AmpRat.sub.ti.
[0207] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
calculating the average of at least two sampling events to
determine AmpRat.sub.ti by means of the CRM.
[0208] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the sound attenuator comprising an active sound masking
system having at least one acoustical sound speaker, and emitting
at least one acoustical sound signal, by means of the speaker.
[0209] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
emitting at least one acoustical sound signal selected from a group
consisting of: white noise, pink noise, grey noise, brownian noise,
blue noise, violet noise, and any combination thereof.
[0210] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the sound attenuator comprising a reactive acoustical
device, configured for cancelling the noise by means of a
destructive interference generator, and generating a destructive
interference, thereby at least partly destructing the noise.
[0211] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
configuring the SAM to attenuate the noise by a selected from a
group consisting of: reducing the sound levels, reducing sound
reflections, reducing sound reverberation, creating sound
diffusion, masking sound, cancelling sound, changing the sound
signature, and any combination thereof.
[0212] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
changing at least one sound characteristic selected from a group
consisting of: sound levels, tone, overtone composition,
reverberations, sound frequency, sound wavelength, sound wave
amplitude, sound wave speed, sound wave direction, sound wave
energy, sound wave phase, sound wave shape, sound wave envelope,
sound timbre, and any combination thereof, by the SAM, thereby
generating a different sound signature.
[0213] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising at least one
of the following steps: (a) configuring the sound signature by the
user in real time; (b) predefining the sound signature by the user;
and, (c) automatically adjusting the sound signature in reference
to the neonate's life parameters.
[0214] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the SAM comprising at least one means selected from group
consisting of: active sound attenuating means, passive sound
attenuating means, hybrid sound attenuating means, and any
combination thereof.
[0215] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising at least one
of the following steps: (a) actively attenuating the noise by the
active sound attenuating means; and, (b) passively attenuating the
noise by the passive sound attenuating means.
[0216] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
selecting at least one passive sound attenuating means from a group
consisting of: at least one sound absorptive material, at least one
resonator, at least one sound shield, at least one bass trap, at
least one sound baffle, at least one diffuser, at least one
insulation padding, at least one sound reflector, at least one
sound muffler (SM), and any combination thereof.
[0217] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
selecting the SAM comprises at least one sound shield comprising at
least a portion of a material selected from a group consisting of:
at least one insulating material, at least one sealing material, at
least one sound absorbent material, at least one vibration
absorbing material, and any combination thereof.
[0218] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the SAM comprising at least one sound muffler
(SM) comprising at least one cylindered conduit, having at least
one length (l) and at least one width (w); the cylinder comprising
at least one air inlet, and at least one air outlet; (b)
configuring the SM such that sound exiting at least one air outlet
is of a different sound signature than sound entering at least one
air inlet, (c) Thereby changing the sound signature.
[0219] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the SM additionally comprising at least a first cylinder,
and at least a second cylinder, connected therebetween, the
connection comprises at least one opening configured to permit a
fluid communication therebetween.
[0220] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining at least one cylinder width (w) is selected from a group
consisting of: width (w) is equal along the length (l), is
differential along the length (l) or any combination thereof.
[0221] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the SM comprising a plurality of n cylinders, having the
length (l).sub.1- . . . n and the width (w).sub.1- . . . n of the
each cylinder, are selected from a group consisting of:
(l).sub.1=(l).sub.n, (l).sub.1>(l).sub.n,
(l).sub.1<(l).sub.n, (l).sub.1.noteq.(l).sub.n,
(w).sub.1=(w).sub.n, (w).sub.1>(w).sub.n,
(w).sub.1<(w).sub.n, (w).sub.1.noteq.(w).sub.n, and any
combination thereof.
[0222] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the SAM comprising at least one insulation
padding, and at least one opening in the insulation; (b) insulating
the NANI by means of the insulation; (c) accessing the NANI and the
neonate residing within by means of the opening.
[0223] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step
obtaining at least a portion of the insulation comprising a
material selected from a group consisting of: thermo insulating
material, sealing material, foam material, fire retardant
materials, at least partially transparent material and any
combination thereof.
[0224] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining at least a portion of the insulation comprising
at least a portion of shielding means; and, (b) shielding at least
a portion of the incubator from a selected from a group consisting
of: magnetism, electromagnetic interference, physical damage and
any combination thereof, by the shielding means.
[0225] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining at least a portion of the insulation comprising
at least one conduit having at least one first aperture into the
incubator and at least one aperture to the external environment,
fitted for the passage of tubing within; and, (b) attenuating the
passage of frequencies selected from a group consisting of: 0 to
about 1000 MHz, 0 to about 500 MHz, 0 to about 200 MHz and any
combination thereof, by means of the conduit.
[0226] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the SAM configured to reversibly attach and
detach to the incubator; and, (b) reversibly attach and detach the
SAM to the NANI.
[0227] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the SAM comprises at least one sound reflector;
(b) reflecting at least partially the noise to a selected from a
group consisting of: at least one absorptive surface, at least one
sound diffuser, at least one sound baffle, at least one reflective
surface, at least one resonator, at least one sound shield, a
location directed away from the neonate, and any combination
thereof.
[0228] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining at least a portion of the SAM comprising n layers; each
of the n layers comprising an inner side towards the neonate, and
an opposite outer side facing away from the neonate.
[0229] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) selecting each of the n layers comprising a predefined
Noise Reduction Coefficient (NRC) value, Sound Transmission Class
(STC) value, or both; and, (b) selecting the NRC value, STC value,
or both, to be equal or different for the each of one of n
layers.
[0230] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
selecting at least 2 of the n layers comprising a Noise Reduction
Coefficient (NRC) value for each of the n layers; where each of the
layers comprising at least one sound level S [dB] measured on the
layer outer side, and at least one first sound level S.sub.1 [dB],
measured on the layer inner side, having a dS.sub.1- . . . dSn, and
dS of the SAM equals S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0231] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
selecting at least 2 of the n layers comprising a Sound
transmission class (STC) value for each of the n layers; where each
of the layers comprising at least one sound level S [dB] measured
on the layer outer side, and at least one first sound level S.sub.1
[dB], measured the layer inner side, having a dS.sub.1- . . . dSn,
and dS of the SAM equals S.sub.1-Sn, and S.sub.1-Sn<S.sub.1.
[0232] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the SAM further comprising: (i) a space, S.sub.1,
between at least one of n layers to the incubator, a space S.sub.n
between each of the n layers, or both; (ii) STC.sub.1 (sound
transmission class) value, measured for the layers.sub.1-n; and,
(iii) mobilization means, connected to at least one of the n
layers, configured to mobilize at least one of the n layers, having
a space S.sub.1a, between at least one of n layers to the
incubator, a space S.sub.na between each of the n layers, or both,
and STC.sub.2 value measured for the layers.sub.1-n; and, (b)
mobilizing at least one layer such that S.sub.1<S.sub.1a,
S.sub.n<S.sub.na, or both, and STC.sub.1<STC.sub.2.
[0233] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
reversibly connecting at least one of the n layers to the
incubator, the one of n layers, or both.
[0234] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining at least one of n layers comprises at least one passive
sound attenuating means configured to a selected from a group
consisting of: reducing reverberation, reducing reflection,
reducing levels, and any combination thereof, of the noise within
the NANI.
[0235] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
selecting at least one layer comprising at least a portion of a
selected from a group consisting of: an electrical isolating
material, electrically conductive material configured to closes
conductive circle, disposable material, at least partially
transparent material, fire resisting material, MRI safe material,
sterilizable material, and any combination thereof.
[0236] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the NANI further comprising at least one conduit having
at least one SAM, and muffling the noise passing through the
conduit into the NANI.
[0237] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the SAM made of MRI safe materials.
[0238] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the steps
of: (a) obtaining the incubator further comprises at least one
sensor selected from a group consisting of: sound level sensor,
sound frequency sensor, sound direction sensor, sound amplitude
sensor, sound tone sensor, sound speed sensor, sensor configured to
sense life parameters of the neonate, and any combination thereof;
(b) sensing by means of the sensor;
[0239] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
configuring the SAM to reducing reverberation of sound, reflections
of sound, or both within the NANI, by means of at least one
selected from a group consisting of; absorptive material, a sound
baffle, a sound diffuser, an active sound cancellation device and
any combination thereof.
[0240] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
obtaining the NANI further comprising at least one air inlet, air
outlet, or both, configured for the entry and/or exit of air; and
connecting to at least one air inlet, outlet, or both further at
least one SAM.
[0241] According to another embodiment of the invention, a method
as defined above is disclosed, additionally comprising the step of
at least temporarily accommodating the NANI in a cart comprising at
least one SAM.
[0242] According to one embodiment of the invention a standard of
care for sound attenuating an incubator, comprising steps of: (a)
obtaining a noise-attenuating neonate incubator comprising sound
attenuating module (SAM) configured to decrease AmpR.sub.ti to
AmpR.sub.QV.DELTA.t or less; (b) accommodating the neonate in the
incubator; and, (c) attenuating the noise by at least one SAM,
thereby changing the sound signature, further wherein at least one
of the following is held true: (a) the noise level in the incubator
is below 45 Decibels; (b) the noise level in the incubator is below
60 Decibels; (c) the amount of audible related complications of
neonates when utilizing the incubator is b times lower than the
average value of audible complications of neonates; b is equal or
greater than 1.05; (d) the average value of salivary cortisol level
index from noise derived stress of patient when utilizing the
incubator during MRI is n times lower than the average value during
MRI; n is equal or greater than 1.05; (e) the incubator will remain
stable when tilted 10.degree. in normal use and when tilted
20.degree. during transportation; (f) the incubator will not tip
over when the force is 100 N or less; (g) the radiated
electromagnetic fields in the inner volume of the incubator,
comprising electrical equipment system will be at a level up to 3
V/m for the frequency range of the collateral standard for EMC
(electromagnetic compatibility); further the electrical equipment
is performing its intended function as specified by the
manufacturer or fail without creating a safety harm at a level up
to 10 V/m for the frequency range of the collateral standard for
EMC; and, (h) the average number of insurable claims of a selected
from a group consisting of: manufacturer, handler, user, operator,
medical care personal, medical facility, medical facility
management or any combination thereof when utilizing the incubator
is v times lower than patient MRI associated insurable claims; v is
equal or greater than 1.05.
[0243] According to one embodiment of the invention, sound
parameters are assessed to meet the noise criterion curves of
NC-noise criteria (L. Beranek (ed.), "Noise reduction",
McGraw-Hill, New York, 1960), NR-noise rating (C. Kosten, G. van
Os, "Community reaction criteria for external noise in the control
of noise", NPL symposium no. 12, HMO, London 373, 1962), RC-room
criteria'(M. Crocker (ed.), "Encyclopedia of Acoustics, J. Wiley
& Sons, New York, 3, 1166-1170, 1997 and NCB-balanced noise
criteria (D. Egan, "Architectural Acoustics", McGrow-Hill, New
York, 1988).
[0244] According to one embodiment of the invention an ANTI, (100)
having all means for standing all applied regulations, especially
the following standards and sections thereof: ANSI/AAMI/IEC
60601-2-19:2009 Medical Electrical Equipment--Part 2-19: Particular
requirements for the basic safety and essential performance of
infant incubators. This standard applies to the basic safety and
essential performance of baby incubators. This standard can also be
applied to baby incubators used for compensation or alleviation of
disease, injury or disability. More specifically this especially
applies to sections 201.2 Normative references; 201.4 General
requirements; 201.8 Protection against electrical HAZARDS from ME
EQUIPMENT; 201.9 Protection against MECHANICAL HAZARDS of ME
EQUIPMENT and ME SYSTEMS; 201.10 Protection against unwanted and
excessive radiation HAZARDS; 201.11 Protection against excessive
temperatures and other HAZARDS; 201.12 Accuracy of controls and
instruments and protection against hazardous outputs; 201.13
HAZARDOUS SITUATIONS and fault conditions; 201.14 PROGRAMMABLE
ELECTRICAL MEDICAL SYSTEMS (PEMS); 201.15 Construction of ME
EQUIPMENT; 201.16 ME SYSTEMS; 201.17 Electromagnetic compatibility
of ME EQUIPMENT and ME SYSTEMS; 202 Electromagnetic
compatibility--Requirements and tests; 210 Requirements for the
development of physiologic closed-loop controllers 201.3.201; FIG.
201.101--INFANT SKIN TEMPERATURE measurement; FIG.
201.102--Variation of INCUBATOR TEMPERATURE; all incorporated
herein in its entirely as a reference.
[0245] Additionally or alternatively the medical device enclosed
inner volume, configured to at least temporarily accommodate at
least a portion of the patient is configured to meet the noise
criteria and/or comprises all means for standing at least one of
the applied regulations and in any combination thereof, especially
the following standards and sections thereof: ANSI/AAMI/IEC
60601-2-20:2009 Medical Electrical Equipment--Part 2-20: Particular
requirements for the basic safety and essential performance of
infant transport incubators; and more specifically to section
201.3.201; AIR CONTROLLED TRANSPORT INCUBATOR in which the air
temperature is automatically controlled by an air temperature
sensor close to a value set by the OPERATOR; 201.3.202 AVERAGE
TEMPERATURE average of temperature readings taken at regular
intervals at any specified point in the COMPARTMENT achieved during
STEADY TEMPERATURE CONDITION; 201.3.203 AVERAGE TRANSPORT INCUBATOR
TEMPERATURE average of the INFANT TRANSPORT INCUBATOR TEMPERATURE
readings taken at regular intervals achieved during STEADY
TEMPERATURE CONDITION; 201.3.204 BABY CONTROLLED TRANSPORT
INCUBATOR AIR CONTROLLED TRANSPORT INCUBATOR which has the
additional capability of automatically controlling the INCUBATOR
air temperature in order to maintain the temperature as measured by
a SKIN TEMPERATURE SENSOR according to the CONTROL TEMPERATURE set
by the OPERATOR NOTE An INFANT TRANSPORT INCUBATOR operating as a
BABY CONTROLLED INCUBATOR is a PHYSIOLOGIC CLOSED-LOOP CONTROLLER
as defined in IEC 60601-1-10; 201.3.205 COMPARTMENT
environmentally-controlled enclosure intended to contain an INFANT
and with transparent section(s) which allows for viewing of the
INFANT; 201.3.206 CONTROL TEMPERATURE, temperature selected at the
temperature control; 201.3.207 INFANT PATIENT up to the age of
three months and a weight less than 10 kg; 201.3.208 INFANT
TRANSPORT INCUBATOR, TRANSPORTABLE ME EQUIPMENT that is equipped
with a COMPARTMENT and a TRANSPORTABLE electrical power source with
the means to control the environment of the INFANT primarily by
heated air within the COMPARTMENT; 201.3.209 SKIN TEMPERATURE,
temperature of the skin of the INFANT at a point on which the SKIN
TEMPERATURE SENSOR is placed; 201.3.210 SKIN TEMPERATURE SENSOR
sensing device intended to measure the INFANT'S SKIN TEMPERATURE,
noise levels accepted for a neonate were taken from "Acceptable
noise levels for neonates in the neonatal intensive care unit"
Knutson, A. J. et al., Washington University School of Medicine",
2013, all incorporated herein in its entirely as a reference.
* * * * *
References