[Federal Register Volume 60, Number 34 (Tuesday, February 21, 1995)]
[Proposed Rules]
[Pages 9762-9771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4212]
[[Page 9761]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 896
Performance Standard for the Infant Apnea Monitor; Proposed Rule
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 /
Proposed Rules
[[Page 9762]]
DEPARTMENT HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 896
[Docket No. 83N-0193]
RIN 0905-AD83
Performance Standard for the Infant Apnea Monitor
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing a
regulation to establish a mandatory performance standard for infant
apnea monitors, which are a subset of breathing frequency monitors also
called neonatal apnea monitors. The infant apnea monitor is a system
intended for use on infants to detect cessation of breathing. FDA
believes that a performance standard is necessary to ensure that infant
apnea monitors accurately and reliably detect the absence of effective
respiration and provide an alarm in such cases. The objective of this
proposed regulation is to establish performance requirements and test
methods that will provide reasonable assurance of the safety and
effectiveness of the infant apnea monitor.
DATES: Submit written comments by May 22, 1995. FDA is proposing that
any final rule that may issue based on this proposal become effective 1
year following its publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: James J. McCue, Center for Devices and
Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4765.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 10, 1982 (47 FR 39816), FDA
issued a final rule under section 513 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c) classifying the generic type of
device, the breathing (ventilatory) frequency monitor (21 CFR
868.2375), into class II (performance standards). In the Federal
Register of July 8, 1983 (48 FR 31392), FDA initiated a proceeding to
establish a performance standard for the breathing frequency monitor,
pursuant to section 514(b) of the act (21 U.S.C. 360d(b)) and part 861
(21 CFR part 861). The notice provided interested persons with the
opportunity to request a change in the classification of the device. In
the Federal Register of February 26, 1986 (51 FR 6886), FDA continued
the proceeding to establish a performance standard pursuant to section
514(c) of the act (21 U.S.C. 360d(c)) and part 861. The notice invited
interested persons to submit an existing standard as a proposed
performance standard under section 514 of the act for the device, or to
submit an offer to develop such a proposed standard. In that notice,
FDA limited the proceeding to those breathing frequency monitors
commonly called neonatal apnea monitors, which are intended for use on
infants to detect cessation of breathing.
In the Federal Register of July 1, 1986 (51 FR 23832), FDA
announced that, in accordance with the provisions of section 514(e)(3)
of the act and Sec. 861.32, the agency might, upon application (which
could be made before the acceptance of the offer), agree to contribute
to an accepted offeror's cost for developing a proposed standard if FDA
were to determine that its contribution would likely result in a more
satisfactory standard than would be developed without such
contribution. Subsequently, FDA allocated approximately $250,000 to
contribute to the cost for the first year of effort in developing a
proposed standard.
In the Federal Register of April 22, 1988 (53 FR 13296), FDA
advised that a notice of grant award (cooperative agreement) had been
issued to the Emergency Care Research Institute (ECRI), 5200 Butler
Pike, Plymouth Meeting, PA 19462. The cooperative agreement with ECRI
was completed on August 31, 1988. Because certain performance
requirements for the infant apnea monitor were not addressed in ECRI's
draft document, FDA proceeded to develop a proposed standard itself for
the infant apnea monitor, using the information developed during the
cooperative agreement with ECRI (21 U.S.C. 380d(f)).
In the Federal Register of January 4, 1989 (54 FR 187), FDA
announced the availability of its ``First Draft Proposed Standard for
the Infant Apnea Monitor--October 1988,'' and requested public comments
on the draft standard. In accordance with Sec. 861.30, in the same
notice, FDA also announced an open public meeting to discuss the draft
standard. The meeting was held on January 25, 1989, in conjunction with
the Seventh Annual Conference on Apnea of Infancy held in Rancho
Mirage, CA.
In the Federal Register of July 25, 1989 (54 FR 30951), FDA
announced an open public meeting that was held on September 11 and 12,
1989, at the Crowne Plaza Holiday Inn, Rockville, MD, to discuss
current sensor modalities and devices used to measure infant apnea,
combinations of sensors used to detect apnea and the pathophysiological
result of apnea, and currently used test methods.
In the Federal Register of December 6, 1989 (54 FR 50437), FDA
announced the availability of its ``Second Draft Proposed Standard for
the Infant Apnea Monitor--October 1989'' and again requested public
comments on the draft. In the same notice FDA also announced an open
public meeting to discuss the draft standard. The meeting was held on
January 24, 1990, in conjunction with the Eighth Annual Conference on
Apnea of Infancy held in Rancho Mirage, CA.
A summary of the proceedings of the public meetings and all data
and information submitted to FDA during these meetings are part of the
administrative record of this rulemaking and are available to the
public under 21 CFR 20.111 from the Dockets Management Branch (address
above).
II. The Proposed Regulation
The second draft proposed standard was based on 22 written comments
received in response to the Federal Register request for comments on
the first draft proposed standard and on the information received at
the public meetings. This proposed mandatory standard is based on 22
written comments received in response to the Federal Register request
for comments on the second draft proposed standard, on information
received at the public meeting, and on other information available to
FDA.
The proposed standard includes specific requirements for infant
apnea monitors in four areas: Patient monitoring, electrical
characteristics, mechanical and environmental characteristics, and
labeling. FDA has prepared several ancillary documents intended to
assist the manufacturer and other interested persons in understanding
both the reasons for specific requirements and the recommended means of
testing specific devices against the requirements. A document entitled:
``Recommended Test Methods--Infant Apnea Monitor Standard'' (Ref. 1)
recommends test methods and groups them in a similar manner to those in
the proposed standard. Another document entitled:
[[Page 9763]] ``Rationale for Requirements--Infant Apnea Monitor
Standard'' (Ref. 3) provides a rationale for each of the requirements
contained in the standard and an associated bibliography. In developing
the proposed standard, FDA has made extensive use of existing
international standards, particularly the International
Electrotechnical Commission standards. A section on definitions is
intended to provide precise meanings for terms used in the proposed
regulation.
The section on patient monitoring includes the requirement that
each infant apnea monitor system contain a secondary monitoring
modality. The purpose of this requirement is to increase the likelihood
that the monitor will detect apneic events. Visual and audible alarms
(status indicators) are required, as is the availability of a remote
alarm unit for monitors intended for home use. In order to alert the
care giver to any malfunction before using the device, a self test
requirement is included.
The electrical requirements for infant apnea monitors include
requirements for battery backup, operation from an ungrounded power
source, and limitation of leakage current. An extensive set of
requirements is provided to ensure electromagnetic compatibility of
infant apnea monitors, which can be a serious device problem. Given the
complexity of certain testing for these devices, FDA has prepared a
document entitled: ``Additional Guidance for Testing Immunity to
Radiated Electromagnetic Fields--Infant Apnea Monitor Standard'' (Ref.
2), which provides manufacturers some assistance in conducting immunity
testing.
The mechanical and environmental requirements mandate tamper proof
controls, protection against misconnection of wires and tubing, and the
ability to withstand normal shock, vibration, temperature extremes, and
fluid spills.
The labeling requirements specify information to be provided by the
manufacturer to both operators and health care practitioners, and
include specific device labeling requirements.
Recommended test procedures (Ref. 1) are included for each
requirement in the standard. These procedures are referee test methods,
i.e., they are the methods FDA will use to verify that a specific apnea
monitor meets the requirements of the standard. Manufacturers are
required, after the effective date of the standard, to meet the
requirements of the standard. However, manufacturers may choose to use
alternative but equivalent or better test methods for each monitor or,
in lieu of individual testing, an analysis for a specific production
run of monitors or, in lieu of any specific testing, an analysis which
shows that each device meets the requirements of the standard.
The ``Rationale for Requirements--Infant Apnea Monitor Standard''
(Ref. 3) contains a detailed rationale for each requirement in the
proposed standard.
Accordingly, the agency is proposing to add new part 896, to the
Code of Federal Regulations, to establish a mandatory performance
standard for the infant apnea monitor.
Additional guidance for the tests used to determine the immunity of
monitors to radiated electromagnetic fields is provided in a separate
document (Ref. 2).
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impactstatement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The agency has concluded that the proposed rule will
have a minimal impact on manufacturers of infant apnea monitors. A copy
of this analysis is on file in the Dockets Management Branch (address
above).
The proposed rule will require that manufacturers comply with
performance requirements in four major areas: Patient monitoring,
electrical characteristics, mechanical and environmental
characteristics, and labeling. This is a set of minimal requirements
based on existing technologies. Additionally, the proposed rule will
not become effective for 1 year after it is issued in final form.
Current manufacturers will have ample time to meet these minimum
standards as part of a normal cycle of product improvement and
development. Therefore, the agency certifies that the proposed rule
will not have a significant economic impact on a substantial number of
small entities and, under the Regulatory Flexibility Act, no further
analysis is required.
V. Paperwork Reduction Act of 1980
This proposed rule contains information collections which have been
reviewed by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1980 and approved under control no. 0910-
0073. The title, description, and respondents of the information
collections are shown below with the annual recordkeeping burden.
Title: Standard for the Infant Apnea Monitor.
Description: The standard describes basic performance features, and
labeling information, for infant apnea monitors which are intended for
hospital and/or home use. The monitor shall be a complete system,
suitable for its intended purpose of accurately and reliably providing
alarms as needed to the caregiver.
Description of Respondents: Manufacturers of apnea monitors. The burden
of 360 hours for recordkeeping concerning the design of, and rationale
for, the tests used to meet this standard, together with analysis and
results of the tests is approved under the OMB information collection
0910-0073. The annual burden for recordkeeping is as follows:
[[Page 9764]]
Annual Burden for Recordkeeping
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Total
CFR section annual Hours per Total hours
responses response
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896.59........................... 30 12 360
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Organizations and individuals desiring to submit comments regarding
this burden or any aspects of these information collection requirements
including suggestions for reducing the burden, should direct them to
FDA's Dockets Management Branch (address above) and to the Office of
Information and Regulatory Affairs, OMB, rm. 3208, New Executive Office
Bldg., Washington, DC 20503, Attn: Desk Officer for FDA.
VI. Comments
Interested persons may, on or before May 22, 1995, submit to the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857, written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Center for Devices and Radiological Health (CDRH),
``Recommended Test Methods--Infant Apnea Monitor Standard,''
September 1993.
2. CDRH, ``Additional Guidance for Testing Immunity to Radiated
Electromagnetic Fields--Infant Apnea Monitor Standard,'' September
1993.
3. CDRH, ``Rationale for Requirements--Infant Apnea Monitor
Standard,'' September 1993.
List of Subjects in 21 CFR Part 896
Administrative practice and procedure, Incorporation by reference,
Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that new part 896 be added to read as follows:
PART 896--PERFORMANCE STANDARD FOR INFANT APNEA MONITORS
Subpart A--General Provisions
Sec.
896.10 Scope.
896.11 Applicability.
896.12 Definitions.
Subpart B--Patient Monitoring Requirements
896.20 Primary monitoring modality.
896.21 Secondary monitoring modality.
896.22 Visual status indicators (alarms).
896.23 Audible status indicators (alarms).
896.24 Remote alarm.
896.25 Self test.
Subpart C--Electrical Performance Requirements
896.30 Battery power.
896.31 Electrical power indicators.
896.32 Overcurrent protection.
896.33 Dielectric withstand.
896.34 AC (alternating current) power grounding and polarity.
896.35 Leakage current.
896.36 Electromagnetic compatibility.
896.37 Auxiliary output.
Subpart D--Mechanical and Environmental Performance Requirements
896.40 Controls protection.
896.41 Connector protective incompatibility.
896.42 Mechanical safety.
896.43 Mechanical vibration and shock resistance.
896.44 Fluid spill resistance.
896.45 Temperature and humidity.
896.46 Surface temperature.
896.47 Toxic materials.
896.48 Strangulation.
Subpart E--Labeling Requirements
869.49 General.
896.50 Operator information.
896.51 Health care practitioner information.
896.52 Servicing information.
896.53 Label specifications.
896.54 Controls, connectors, switches, and indicators.
896.55 Standard compliance.
896.56 Switched outlet warning.
896.57 Air mattress warning.
896.58 Monitors intended for hospital use only.
896.59 General test methods.
Authority: Secs. 501, 502, 513, 514, 530-542, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360c,
360d, 360gg-360ss, 371, 374); secs. 351, 361 of the Public Health
Service Act (42 U.S.C. 262, 264).
Subpart A--General Provisions
Sec. 896.10 Scope.
The standard set forth herein describes basic performance features
and labeling requirements that infant apnea monitors, intended for
hospital and/or home use, are required to meet. The monitor shall be a
complete system, suitable for its intended purpose of accurately and
reliably providing alarms as needed to the care giver.
Sec. 896.11 Applicability.
(a) General. The provisions of this standard are applicable to all
infant apnea monitors manufactured, imported, or offered for import in
any State or territory of the United States, the District of Columbia,
or the Commonwealth of Puerto Rico after (insert date 1 year after date
of publication of the final rule in the Federal Register).
(b) Applicable documents. Compliance with certain requirements of
this section shall be determined by the standards described in the
following references, to the extent specified herein, which are
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Except as otherwise indicated, copies of these publications
may be purchased from the American National Standards Institute, 11
West 42d St., New York, NY 10036, and may be examined at the Office of
Science and Technology, Center for Devices and Radiological Health
(HFZ-100), 5600 Fishers Lane, Rockville, MD; or at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC:
(1) ``IEC 601-1 (1988): Medical electrical equipment, part 1:
General requirements for safety,'' 2d edition.
(2) ``IEC 529 (1989): Classification of degrees of protection
provided by enclosures.''
(3) ``IEC 801-1 (1984): Electromagnetic compatibility for
industrial process control equipment.''
(4) ``IEC 801-2 (1991): Electrostatic discharge requirements.''
(5) ``IEC 801-3 (1984): Radiated electromagnetic field
requirements.''
(6) ``IEC 801-4 (1988): Electrical fast transient/burst
requirements.''
(7) ``CISPR 11 (1990): Limits and methods of measurement of radio-
interference characteristics of industrial, [[Page 9765]] scientific,
and medical (ISM) equipment.''
(8) ``CISPR 16 (1987): CISPR specification for radio interference
measuring apparatus and measurement methods.''
(9) ``ANSI C95.3-1991: Recommended practice for the measurement of
potentially hazardous electromagnetic fields--RF and microwave.''
(10) ``IEC 68 (1988): Environmental testing.''
(11) ``ANSI/AAMI EC13-1983: Standard for cardiac monitors, heart-
rate meters and alarms.'' Copies of this publication may be purchased
from the Association for the Advancement of Medical Instrumentation,
3300 Washington Boulevard, suite 1440, Arlington, VA 22201, and may be
examined at the Center for Devices and Radiological Health (HFZ-100),
5600 Fishers Lane, Rockville, MD; or the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(12) ``MIL-STD-461C (August 4, 1986): Electromagnetic Emissions and
Susceptibility Requirements for the Control of Electromagnetic
Interference.'' Copies of this publication may be purchased from the
Naval Publishing and Printing Service Office, 700 Robbins Ave.,
Philadelphia, PA 19111-5094, and may be examined at the Center for
Devices and Radiological Health (HFZ-100), 5600 Fishers Lane,
Rockville, MD; or the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
(13) ``MIL-STD-462 (July 31, 1967): Standard for the Measurement of
Electromagnetic Interference Characteristics.'' Copies of this
publication may be purchased from the Naval Publishing and Printing
Service Office, 700 Robbins Ave., Philadelphia, PA 19111-5094.
(c) Precedence of documents. All referenced documents shall apply
to the extent specified herein. When any requirement of this standard
conflicts with a requirement in any of the references specified in
paragraph (b) of this section, the following rules of precedence shall
apply:
(1) This standard. This standard shall have precedence over all
applicable subsidiary documents specified in paragraph (b) of this
section.
(2) Referenced documents. Any referenced document shall have
precedence over any applicable subsidiary document referenced therein.
Sec. 896.12 Definitions.
(a) Apnea means cessation of respiratory air flow. The respiratory
pause may be central or diaphragmatic (i.e., no respiratory effort),
obstructive (usually due to upper airway blockage), or mixed
(combination of central and obstructive).
(b) Artifact means a signal which may be misinterpreted by the
monitor; the three most commonly recognized types of artifacts are
cardiogenic, electromagnetic, and motion, as defined in paragraphs (d),
(g), and (n) of this section.
(c) Breath means an inhalation of a volume of at least 2
milliliters of air per kilogram of body weight.
(d) Cardiogenic artifact means an artifact produced by
theelectrical and/or mechanical activity of the heart.
(e) Component means any material, substance, piece, part, or
assembly used during device manufacture that is intended to be included
in the finished device.
(f) Damage means deformation, loosening, breakage, corrosion,
change of fit of any component or part, or any other physical condition
resulting in nonconformance of the monitor to the requirements of this
standard.
(g) Electromagnetic artifact means an artifact produced by
extraneous electromagnetic energy.
(h) Finished device means a device, or any accessory to a device,
which is intended for use, whether or not the device is packaged or
labeled for commercial distribution.
(i) Health care practitioner means a doctor, nurse, therapist, or
other health care provider who is licensed by the State or locality in
which he/she practices or is credentialed by a nationally recognized
agency.
(j) Infant apnea monitor means a complete system intended to alarm
upon the cessation of breathing and its consequences that is used on
humans less than 3 years of age. The infant apnea monitor includes:
Sensors; electrodes; leads; cables; tubing; signal processing systems;
alarm systems; power supplies; accessories supplied, recommended, or
specified by the manufacturer; complete monitoring systems when the
apnea function is supplied as a module; and labeling. The terms
``device'' and ``monitor,'' when used in this standard, also mean
infant apnea monitor.
(k) Inspection means any examination, visual or auditory, performed
without the use of special laboratory instruments or procedures and/or
verification of manufacturing and test records.
(l) Intended means the same as ``intended uses as specified by the
manufacturer.''
(m) Monitor means an infant apnea monitor.
(n) Motion artifact means an artifact produced by movement of the
patient.
(o) Operator means the individual who applies the infant apnea
monitor to the patient, or who monitors the patient and the functioning
of the device. The term ``operator'' includes individuals, such as
parents, nurses, therapists, care givers, etc., but does not include
business entities, such as hospitals, corporations, partnerships, etc.
(p) Operator maintenance means performance by the operator or
health care practitioner of those adjustments or procedures specified
in the operator or health care practitioner information provided by the
manufacturer for the purpose of assuring the continued safe and
effective performance of the monitor.
(q) Patient means the individual being monitored by the infant
apnea monitor.
(r) Primary monitoring modality means a method for detecting the
cessation of breathing (apnea).
(s) Secondary monitoring modality means a method that measures, on
a continuous basis, a physiological parameter that responds to the
pathophysiological consequences of apnea, such as bradycardia,
hypoxemia, or hypercarbia (hypercapnia).
(t) Service means performance of the procedures or adjustments
described in the manufacturer's service instructions that may affect
any aspect of the performance of the infant apnea monitor to which this
standard applies.
(u) Shall means that a provision is mandatory.
(v) Should means that a provision is recommended.
(w) Status indicator means a device subsystem that shows, in a
timely manner, either the status or condition of a physiological
parameter of the patient or a particular characteristic of the device.
Subpart B--Patient Monitoring Requirements
Sec. 896.20 Primary monitoring modality.
Each monitor shall provide:
(a) A primary monitoring modality which shall incorporate a means
for detecting the cessation of breathing or of breathing effort
(apnea). The manufacturer shall specify the types of apnea that the
primary monitoring modality will detect.
(b) A timer to measure apnea duration, and a system of visual and
audible warning status indicators designed to activate (alarm) when the
measured apnea duration is greater than the preset time, which shall
not exceed 20 seconds. The indicators shall be activated within 1
second after the preset time is exceeded in accordance
[[Page 9766]] with Secs. 896.22 and 896.23. Apnea monitors intended for
use on both infants and older patients may provide duration settings
beyond 20 seconds only if special tools or procedures are required to
effect those settings.
(c) A sensor fault alarm for determining when the signal level from
the primary sensor is outside the range of values specified for proper
operation by the monitor manufacturer. When this condition occurs,
audible and visual warning status indicators shall be activated within
5 seconds.
Sec. 896.21 Secondary monitoring modality.
Each monitor shall provide:
(a) A secondary monitoring modality, which shall incorporate a
means for detecting a pathophysiological consequence of apnea that
occurs within 60 seconds of the onset of apnea. This modality shall be
designed such that values of the critical physiological parameter that
are outside the extremes of the monitor's range are not interpreted as
being within range. A monitor that includes heart rate monitoring shall
meet the requirements of the standard ANSI/AAMI (American National
Standards Institute/Association for the Advancement of Medical
Instrumentation) EC13-1983 for pediatric monitors.
(b) A system of visual and audible warning status indicators
designed to activate (alarm) when the measured critical physiological
parameter goes above or falls below a selected preset limit. The
warning indicators shall be activated within 5 seconds after the
measured parameter is outside the range of values specified by the
preset limit in accordance with Secs. 896.22 and 896.23.
(c) A control for presetting secondary modality alarm limits.
(d) A sensor fault alarm for determining when the signal from the
sensor for the physiological parameter is outside the range of values
specified for proper operation by the monitor manufacturer. When this
condition occurs, audible and visual warning status indicators shall be
activated within 5 seconds.
Sec. 896.22 Visual status indicators (alarms).
(a) Visual status indicators shall be of two visually distinct
types:
(1) Warning indicators shall indicate the need for immediate
attention to the patient.
(2) Ready indicators shall indicate proper operation of the
monitor.
(b) Different colors shall be used to distinguish the two types of
visual status indicators as follows:
(1) Red for warning indicators; and
(2) Green for ready indicators.
(c) All visual status indicators shall be visible in both a fully
illuminated and a darkened room, and shall be located so that they are
not obscured from view in the use orientation of the monitor specified
by the manufacturer.
(d) Means for disabling any required visual status indicator during
operation shall not be provided.
(e) Reset controls for visual status indicators shall function such
that neither continuous activation nor failure of the reset control
will permanently disable the status indicators.
(f) Warning indicators shall continue being activated until
manually reset even if the condition causing indicator activation
resolves.
(g) Visual status indicators shall be subject to the labeling
requirements specified in Sec. 896.54.
Sec. 896.23 Audible status indicators (alarms).
(a) All audible status indicators shall be of two audibly distinct
types:
(1) Warning indicators shall indicate the need for immediate
attention to the patient.
(2) Ready indicators if provided shall indicate proper operation of
the monitor.
(b) Different sound characteristics, i.e., pitch, sound level, and
time duration, shall be used to distinguish between the types of
audible status indicators as follows:
(1) Warning audible indicators shall sound intermittently at 1-
second intervals. Sound level shall be at least 85 decibels at 1 meter
for home monitors and 70 decibels for hospital monitors.
(2) Ready audible indicators if provided shall have distinctly
different sound characteristics than paragraph (b)(1) of this section.
(c) Means for permanently disabling an audible status indicator
during operation shall not be provided. Activation of any manual means
(reset) for temporarily silencing an audible status indicator shall be
accompanied by an automatic realarming of the audible indicator within
2 minutes, and a clear indication of silencing (reset) shall be
provided. The audible indicator may automatically reset if the
condition causing indicator activation resolves, but any visual status
indicator that correlates with a required audible indicator shall
continue being activated until manually reset.
(d) Audible status indicator reset controls shall function such
that neither continuous activation nor failure of the reset control
will permanently disable the status indicators.
Sec. 896.24 Remote alarm.
(a) Manufacturers of monitors intended for home use shall provide a
remote alarm unit for use with the monitor. The remote alarm unit shall
include audible warning status indicators that indicate when a warning
status indicator at the site of the patient has been activated and when
the unit is unable to detect the status indicator signals from the site
of the patient as specified in Sec. 896.23.
(b) The use of a remote alarm unit shall not disable the status
indicators at the site of the patient.
(c) The remote alarm unit shall have a visual power ready status
indicator (pilot light) and an audible power interrupt warning status
indicator. If battery operated, the remote alarm unit shall have
audible and visual low battery warning status indicators (alarms) that
activate when the battery has sufficient charge remaining to supply
power to the remote alarm unit for no more than 15 minutes of operation
as specified in Secs. 896.22 and 896.23.
(d) If line power operated, battery backup shall be provided that
automatically activates within 5 seconds after the power fails for any
reason. The battery shall have sufficient capacity, when fully charged,
to supply power for normal operation for at least 8 hours.
Sec. 896.25 Self test.
Monitors shall incorporate a self test, for confirmation by the
operator, to operate or exercise all visual and audible status
indicators each time the monitor is turned on.
Subpart C--Electrical Performance Requirements
Sec. 896.30 Battery power.
(a) All line-powered monitors intended for use in the home shall
have a battery power backup which shall, unless the overcurrent
protection specified in Sec. 896.32 has activated, automatically
activate when the power fails. The monitor shall operate in compliance
with the standard within 5 seconds after the battery backup power has
activated.
(b) Monitors intended for use in the home shall have a battery of
sufficient capacity, when fully charged, to supply power for normal
operation for at least 8 hours.
(c) Monitors intended for use in the home shall have audible and
visual battery depletion warning status indicators that activate when
the battery has sufficient charge remaining to supply power for monitor
operation in accordance with the standard for at least [[Page 9767]] 60
minutes, and which remain activated until the battery is depleted. The
monitor shall have a means for silencing the audible battery status
indicator.
(d) Housings containing batteries from which gases can escape
during charging or discharging shall be ventilated to minimize the risk
of accumulation and ignition. Battery compartments shall be designed to
prevent the risk of accidentally short-circuiting the battery.
(e) If a safety hazard or monitor malfunction could result from
incorrect connection or replacement of a battery, the monitor shall be
designed to prevent incorrect polarity of connection.
Sec. 896.31 Electrical power indicators.
(a) Visual ready status indicators shall be provided to indicate
that the monitor is energized. Such indicators shall be located
conspicuously on the device and shall distinguish between battery power
and line power sources when both sources are provided.
(b) In monitors incorporating a means for battery charging, the
charging mode shall be visible to the operator.
Sec. 896.32 Overcurrent protection.
(a) Overcurrent protection shall be provided for all line powered
monitors.
(b) An audible warning status indicator shall be activated if the
overcurrent protection device is activated and the monitor cannot be
operated; this status indicator (alarm) shall be capable of sounding
for at least 15 minutes.
(c) Monitors shall not be fitted with protective devices which may
cause disconnection of the monitor from the power line (supply mains)
by producing a short circuit which results in operation of an
overcurrent protection device.
Sec. 896.33 Dielectric withstand.
Power source lines, patient contact circuits, and transducer
circuits shall be adequately insulated to assure protection of the
patient and monitor from overvoltages. The monitor shall meet the
requirements of the standard IEC 601-1, Clause 20.
Sec. 896.34 AC (alternating current) power grounding and polarity.
All monitors intended for home use that operate or recharge
batteries from the AC power line shall comply with this standard when
operating from an ungrounded power source. If monitor power line
connectors are not polarized, the monitor shall operate in compliance
with this standard in both polarities of power line connector
insertion.
Sec. 896.35 Leakage current.
Monitors shall meet the requirements of the standard IEC 601-1 for
Type BF equipment.
Sec. 896.36 Electromagnetic compatibility.
All monitors shall meet the electromagnetic compatibility
requirements contained herein. Monitors intended for home use shall
also meet these requirements when recharging batteries, or operating,
from a grounded or an ungrounded AC power source. If monitor power line
plugs are not polarized, the monitor shall meet these requirements in
both polarities of power line plug insertion.
(a) Emissions. The monitor shall operate in compliance with this
standard without emitting electromagnetic energy in excess of the
levels specified in paragraphs (a)(1) and (a)(2) of this section. The
required emission limit shall be that specified by the referenced
document, adjusted downward by the root-mean-square sum of all errors
in the measurement of that quantity.
(1) Radiated and conducted electromagnetic energy. The monitor
shall comply with the relevant requirements of CISPR 11 when tested
according to the test methods contained therein. These tests shall be
conducted using passive patient simulators, which need not simulate
normal patient signals. A 1-kilohm resistor shall be used for impedance
and electrocardiograph sensors, room air shall be used for CO2
sensors, a rigid cylinder shall be used for circumference and cross-
sectional-area sensors, and an optical filter having optical density
between 2 and 4 at both red and infrared wavelengths shall be used for
oxygen saturation sensors.
(2) Magnetic fields. The monitor shall comply with the relevant
requirements of RE01 of the standard MIL-STD-461C, when tested
according to RE01 of the standard MIL-STD-462.
(b) Immunity. The monitor shall operate in compliance with this
standard during and after exposure to electromagnetic interference at
the levels specified in paragraphs (b)(1), (b)(2), and (b)(3) of this
section. The required immunity level shall be the level stated,
adjusted upward by the root-mean-square sum of all errors in the
measurement of that quantity, with the exception of the lower steady-
state AC voltage limit and the line-voltage sag level, which shall be
adjusted downward by the root-mean-square sum of the measurement
errors. Unless expressly permitted in paragraphs (b)(1), (b)(2), and
(b)(3) of this section, the monitor shall not, as a result of the
specified test condition: Detect a false primary or secondary
monitoring modality event, indicate a false primary or secondary
monitoring modality alarm, indicate an equipment alarm, exhibit
temporary degradation or loss of function or performance requiring
operator intervention or system reset, or exhibit loss or corruption of
stored data. Except as specified in paragraphs (b)(1), (b)(2), and
(b)(3) of this section, patient simulators shall be used to provide
simulated normal stimulus to primary and secondary sensors during
electromagnetic immunity testing.
(1) Electrostatic discharge. The monitor shall operate in
compliance with this standard within 5 seconds of air discharges of 2,
4, 6, and 8 kilovolt and contact discharges of 2, 4, and 6 kilovolt,
both positive and negative, to any point on the monitor accessible to
the operator or patient, when tested according to the standard IEC 801-
2, with the conditions and modifications specified in paragraphs
(b)(1)(i) through (b)(1)(iv) of this section. The monitor shall operate
in compliance with this standard within 5 seconds of when contact
discharges are applied to horizontal and vertical conducting planes in
the vicinity of the monitor, as specified in paragraph (b)(1) of this
section, with the exception that detection of a single false primary or
secondary monitoring modality event is permitted as a result of each
discharge.
(i) The monitor shall be tested according to the test method
described in standard IEC 801-2 for tabletop equipment.
(ii) The relative humidity shall not exceed 50 percent during air
discharges.
(iii) Air discharges shall be conducted at 2, 4, 6, and 8 kilovolt.
Contact discharges shall be conducted at 2, 4, and 6 kilovolt.
Discharges of both positive and negative polarity shall be conducted at
each voltage.
(iv) In addition to air and contact discharges directly to the
monitor, contact discharges shall be made to the horizontal coupling
plane under the monitor and to the vertical coupling plane positioned
parallel to the faces of the monitor. At least 10 single discharges at
each voltage (2, 4, and 6 kilovolt) and polarity shall be applied to
each test point.
(2) Radiated electromagnetic fields. The monitor shall operate in
compliance with this standard during and after exposure to
electromagnetic fields at frequencies between 10 megahertz and 1
gigahertz at field strengths of 0.3, 1, and 3 volts per meter, when
unmodulated, amplitude modulated 80 percent with a 0.5-hertz
[[Page 9768]] sine wave. Test conditions shall be as follows:
(i) The radiated electric-field (E-field) shall be uniform and
linearly polarized in a horizontal plane.
(ii) The test shall be performed with each of the six faces of the
monitor facing the antenna. All cables shall be aligned with the
horizontal E-field vector over the majority of their length throughout
the test. For exposure methods in which the monitor cables cannot be
extended fully, if the length of any conducting cable is greater than
1.5 meters, the first 0.75 meters of cable (closest to the monitor)
shall be aligned with the horizontal E-field vector and the remaining
length shall be bundled in a noninductive, serpentine configuration.
(iii) The test shall be performed with all monitor components and
cables positioned at an appropriate distance from any radio frequency
(RF)-reflecting object and at a distance from any conducting ground
plane that is appropriate for tabletop equipment.
(iv) Patient simulators used during the test shall be either simple
passive devices, isolated from earth ground using fiber optic links, or
battery operated and shielded. For impedance and electrocardiograph
sensors, testing for erroneous breath and heartbeat detection shall be
performed using a 1-kilohm resistor as a patient simulator, or a more
suitable value defined by the manufacturer for a particular model of
apnea monitor. Testing for erroneous breath detection shall also be
performed using a battery operated simulator set to produce
electrocardiograph signals, but not respiration signals (i.e., set to
the apnea mode). Testing for all other fault conditions shall be
performed using a battery operated simulator set to produce both
respiration signals and electrocardiograph signals.
(v) Connections not normally used during monitor operation that are
made to the monitor to assess performance during the test shall be
isolated using fiber optic links.
(3) AC voltage fluctuations, transients, and conducted
interference. The following requirements apply to all monitors that
recharge batteries or operate from the AC power line:
(i) Steady-state voltage. The monitor shall remain in compliance
with this standard, without changing a voltage selection switch, when
powered from line voltages between 95 and 132 volts root-mean-square.
For monitors intended for home use, the battery power backup shall
activate automatically when the line voltage falls below the minimum
level necessary for line powered monitor operation, which shall be no
greater than 95 volts root-mean-square, and line powered operation
shall automatically resume when the line voltage returns to the 95-to
132-volt range.
(ii) Dropout. The monitor shall operate in compliance with this
standard during and after line voltage dropouts for durations of 10
milliseconds and less.
(iii) Slow sags and surges. The monitor shall operate in compliance
with this standard during and after line voltage surges to 150 volts
root-mean-square and sags to 90 volts root-mean-square, for durations
of 500 milliseconds and less.
(iv) Fast transient bursts. The monitor shall operate in compliance
with this standard during and after bursts of transients of 0.5, 1, and
2 kilovolts applied to AC power leads, and transients of 0.25, 0.5, and
1 kilovolts coupled by way of a capacitive clamp to signal leads, when
tested according to IEC 801-4, with the exception that the burst
repetition frequency shall not exceed 30 per minute.
(v) Fast surges. The monitor shall operate in compliance with this
standard during and after exposure to common-mode and differential-mode
combination voltage/current transients, both positive and negative,
applied to AC power leads.
(A) The test generator used shall have the following
specifications:
Open-circuit voltage, differential mode: 0.5 and 1 kilovolts.
Open-circuit voltage, common mode: 0.5, 1, and 2 kilovolts.
Open-circuit voltage risetime: 1.2 microseconds.
Open-circuit voltage falltime: 50 microseconds.
Generator source impedance: 2 kilohm.
Short-circuit current risetime: 8 microseconds.
Short-circuit current falltime: 20 microseconds.
Peak short-circuit current: 1 kilo ampere.
(B) Capacitive coupling shall be used to apply the combination wave
to the AC power leads of the monitor under test. Surges shall be
applied at the point where the monitor normally would be connected to
AC line power.
(C) A decoupling network shall be used to isolate the monitor under
test from the AC power network.
(D) A line-to-line test (differential mode) shall be performed
using 0.5 and 1-kilovolt surges of both positive and negative polarity
applied using a generator source impedance of 2 kilohm and coupling
capacitance of 18 micro farads.
(E) A line-to-ground and a both-lines-to-ground test (common mode)
shall be performed using 0.5, 1, and 2-kilovolt surges of both positive
and negative polarity applied using a generator source impedance of 12
kilohm (10-kilohm resistor in series with test generator) and coupling
capacitance of 9 micro farads.
(F) Surges at each amplitude and polarity shall be applied at phase
angles of 0, 45, 90, 135, 180, 225, and 270 degrees with respect to the
AC line.
(G) Each test shall be repeated 10 times at a rate between 1 and 30
surges per minute.
(vi) Conducted electromagnetic energy. The monitor shall operate in
compliance with this standard during and after exposure to both
differential and common mode conducted electromagnetic energy on the AC
power leads at frequencies between 150 kilo Hertz and 80 megahertz at
voltages of 0.3, 1, and 3 volts root-mean-square (when unmodulated),
amplitude modulated 80 percent with a 0.5 hertz sine wave, added to the
power line voltage, when tested according to CS02 of the standard MIL-
STD-462, with the modifications and additions specified in paragraphs
(b)(3)(vi)(A) through (b)(3)(vi)(E) of this section. If continuous
sweep of the test frequency is used, the sweep rate shall not exceed 1
x 10-3 decades per second. If discrete frequency steps are used,
the maximum step size is 1 percent of the test frequency, and the
minimum dwell time is 10 seconds per step.
(A) The impedance of AC inputs shall be stabilized using line
impedance stabilization networks appropriate for the test frequency
range.
(B) The power leads under test shall be elevated 5 centimeters
above the ground plane.
(C) The interference signal shall be injected at a distance of 5
centimeters from the point at which AC line power enters the monitor.
For battery chargers which plug directly into AC outlets, a 10
centimeter length of wire shall be added between the line impedance
stabilization networks (LISN's) and the charger. The low-voltage output
cable of the charger shall be elevated 5 centimeters above the ground
plane.
(D) The differential-mode test shall be conducted as specified in
CS02 of the standard MIL-STD-462. The lead between the capacitor and
the AC line shall be as short as possible.
(E) The common-mode test shall be conducted as specified in
paragraph (b)(3)(vi) of this section, except that two identical
capacitors shall be used, one connected from the signal source to the
[[Page 9769]] AC phase lead and one connected from the signal source to
AC neutral.
(4) Magnetic fields. The monitor shall operate in compliance with
this standard during and after exposure to magnetic fields as specified
in RS01 and RS02 of the standard MIL-STD-461C. The standard MIL-STD-462
also shall apply with the exception that the pulse repetition frequency
for RS02 shall not exceed 30 per minute.
(5) Quasi-static electric fields. The monitor shall operate in
compliance with this standard during and after exposure to a 0.5 hertz
sinusoidal E-field with a peak field strength of 500, 1,000, and 2,000
volts per meter.
Sec. 896.37 Auxiliary output.
Where an auxiliary output is provided:
(a) The monitor shall meet all the requirements of this standard
during and after application of a short circuit applied to the
auxiliary output for 1 minute.
(b) The leakage current requirements of Sec. 896.35 shall not be
exceeded upon proper connection of an auxiliary device to the auxiliary
output. This proper connection shall be described in the operator's
manual as specified in Sec. 896.50(b)(2)(iii).
Subpart D--Mechanical and Environmental Performance Requirements
Sec. 896.40 Controls protection.
The controls of monitors intended for home use shall be protected
from inadvertent or unauthorized changes or adjustment. The means of
protection shall be such as to preclude their defeat by patients,
siblings, or other unauthorized persons.
Sec. 896.41 Connector protective incompatibility.
(a) Monitor connectors, including those on wires and tubing, shall
be designed such that insertion into a receptacle other than the one
into which they are intended to be inserted or into a receptacle using
an improper orientation is not possible.
(b) Electrical connectors of a monitor (e.g., electrical lead
wires) shall include a mechanism to prevent connection of the patient
to a power source that may cause a current flow in excess of that
specified in Sec. 896.35.
Sec. 896.42 Mechanical safety.
Each monitor shall:
(a) Not have any exposed sharp edges.
(b) Be mechanically stable in the intended position(s) of use.
(c) Provide protection to the operator and patient from moving
parts.
Sec. 896.43 Mechanical vibration and shock resistance.
The monitor shall remain in compliance with this standard following
mechanical shock and vibration as follows:
(a) Shock test specifications shall be as follows:
(1) Peak acceleration: 100 g (1,000 meters per second2) (g
means acceleration of gravity),
(2) Duration: 6 milliseconds, and
(3) Pulse shape: half sine.
(b) Sinusoidal vibration test specifications shall be as follows:
(1) Frequency range: 10 to 500 hertz,
(2) Acceleration amplitude: 1 g (9.8 meters per second2), and
(3) Duration: 10 sweep cycles in each axis.
(c) Wide band random vibration test specifications shall be as
follows:
(1) Frequency range: 20 hertz to 500 hertz, and
(2) Acceleration spectral density: 0.022 per hertz, Duration:
9 minutes.
Sec. 896.44 Fluid spill resistance.
The monitor shall be so constructed that it will continue to
operate in compliance with this standard even in the event that fluids
are dripped on it. The monitor shall meet the requirements for drip
proof equipment as specified in Clause 44.6 of the standards IEC 601-1
and IEC 529.
Sec. 896.45 Temperature and humidity.
(a) The monitor shall be in compliance with this standard when
operating in the environmental temperature range of 5 deg.C to 40
deg.C, and in the environmental humidity range of 15 percent to 95
percent, noncondensing.
(b) The monitor shall not be damaged, and shall remain in
compliance with this standard, after storage in the environmental
temperature range of -40 deg.C to 70 deg.C at 95 percent humidity.
Sec. 896.46 Surface temperature.
The temperature of all surfaces of the monitor with which an
operator might come into contact during operation shall not exceed 50
deg.C in an ambient of 35 deg.C. The temperature of surfaces with
which the patient can come into contact shall not exceed 40 deg.C in
an ambient of 35 deg.C. Electrochemical transcutaneous sensors are
permitted for hospital use only with maximum temperatures up to 44
deg.C for less than 4 hours (at the same site) if adequate patient
protection procedures are clearly described in the labeling.
Sec. 896.47 Toxic materials.
No toxic material from a monitor shall come in contact with the
patient or operator during normal use as specified in
Sec. 896.50(b)(1).
Sec. 896.48 Strangulation.
Provision shall be made in routing, retention devices, or other
means to minimize the risk of strangulation of the patient by wires or
tubing.
Subpart E--Labeling Requirements
Sec. 896.49 General.
In addition to the labeling requirements for prescription devices
in part 801 of this chapter, each infant apnea monitor shall comply
with the labeling requirements of this section. The labeling for each
monitor shall prominently state the intended uses and limitations of
the device, provide clear instructions, describe potential device
malfunctions, and contain adequate operation, maintenance, and service
information.
Sec. 896.50 Operator information.
Manufacturers of infant apnea monitors intended for home use shall
provide, with each monitor, an operator instruction manual for
laypersons that has been prepared at the fifth-grade reading
comprehension level and that includes numerous supporting
illustrations. A means of determining the effectiveness of instruction
shall also be provided. The manual shall contain:
(a) A statement of the purpose (indications for use) of the monitor
and an explanation of how the monitor accomplishes that purpose,
including:
(1) A discussion of the types of apnea that the device monitors as
well as the parameters monitored by the secondary monitoring modality.
(2) An explanation of how the monitor accomplishes its purpose,
including the type of sensors used.
(b) Information pertaining to operating conditions that may affect
the efficacy or safety of the monitor, including the following:
(1) Monitor information, including:
(i) An explanation of the function and meaning of each alarm and
indicator provided with the monitor,
(ii) A statement that the monitor may not be able to detect all
episodes of inadequate breathing,
(iii) Recommended precautions to minimize the risk of
strangulation,
(iv) A list of the toxic materials used in the manufacture of the
monitor and protective means employed to prevent contact during normal
use,
(v) A discussion of the hazards and risks associated with the
monitor.
(2) Operator information, including: General operating information,
adequate [[Page 9770]] instructions for monitor setup, check-out,
operation, operator maintenance, and service, including:
(i) General operating information, including:
(A) A list of additional reference materials available to the
layperson about apnea monitoring and the location where such materials
can be obtained,
(B) Reprints of applicable FDA safety alerts,
(C) A statement of when it is advisable to contact the prescribing
physician or health care professional,
(D) A recommendation that the operator be trained in
cardiopulmonary resuscitation (e.g., Red Cross/American Heart
Association Certification),
(ii) Setup shall include unpacking instructions, an accessory
checklist, and a visual safety inspection of the monitor, including
accessories,
(iii) A check-out of the monitor, including:
(A) A step-by-step procedure for checking proper functioning of all
controls, indicators, and alarms,
(B) A troubleshooting guide for use when there are indications of a
monitor malfunction during checkout and/or operation,
(iv) Simplified diagrams and illustrations of the fully assembled
and ready to operate monitor. Information on device operation shall
include:
(A) Each step that must be taken by the operator to achieve the
clinical purpose of both the primary and secondary modality, as well as
the steps required to prepare the monitor for operation,
(B) Proper connection of auxiliary devices,
(C) Any pre-use cleaning or disinfecting procedures for the
monitor, including any accessories,
(D) A description of appropriate warm-up procedures and intervals,
(E) A discussion of the positioning of sensors or electrodes,
alternate electrode placement, proper preparation of electrodes and
patient for electrode attachment, and identification of loose sensors
or electrodes,
(F) Diagrams and illustrations showing proper connection of the
patient to the monitor and other equipment, if applicable, including
alternate recommended electrode or sensor placement,
(G) Legible reproductions of all required labels and hazard
warnings, and graphic representation of all controls, alarms, and
indicators provided with the monitor. An explanation of the use of the
controls, alarms, and indicators,
(H) A list of error messages from the monitor, if applicable, their
meaning, and the corrective steps that can be taken by the operator,
(I) Clear warnings concerning the precautions necessary to avoid
possible misoperation or unsafe use of the monitor,
(J) Recommended procedures to be followed in the event of a monitor
alarm condition,
(K) A discussion of the proper use of remote alarm units, including
recommended placement and the importance of the operator being able to
access the patient within 1 minute of alarm activation.
(v) Operational maintenance information, including:
(A) Recommendations for methods and materials for cleaning and
disinfecting the monitor,
(B) A schedule of operator initiated maintenance necessary to keep
the monitor in compliance with this standard,
(C) Battery care and maintenance procedures, including instructions
for recharging or replacement,
(D) A description of periodic visual safety inspections that should
be performed by the operator,
(vi) Service information, including:
(A) The frequency of any calibration, repair, or periodic
inspections of the monitor necessary to keep it in compliance with this
standard,
(B) A list of facilities, and their locations, that may provide
these services,
(3) Patient information, including:
(i) A description of any clinical circumstances which might require
sensor adjustment or checking for proper operation.
(ii) A description of any circumstances in which there is a
possibility of allergenic or chemical reactions and instructions for
preventing such reactions, e.g., periodically repositioning electrodes.
(4) Facility information, including a description of what should be
expected if electricity to the monitor is lost.
(5) Environmental information, discussing known or recognizable
conditions of the infant's environment that may affect the safe and
effective use or operation of the monitor, such as lint, dust, sun,
light, heat, or humidity, including:
(i) A discussion of the effects and possible sources of
electromagnetic interference, e.g., conducted and radiated,
(ii) A discussion of the effects and causes of electrostatic
discharge,
(iii) A list of other devices that pose potential electrical
problems,
(iv) A description of conditions of the sensors or electrodes, such
as loosened electrodes, that can cause environmental effects to be more
pronounced,
(v) A description of steps which can be taken by the operator to
identify and resolve environmental interference with the safe and
effective use of the monitor.
Sec. 896.51 Health care practitioner information.
Manufacturers of monitors shall provide a health care practitioner
instruction manual with each monitor. The manual shall contain all of
the information specified in Sec. 896.50 in such detail as is
sufficient for the needs of the practitioner, but the information need
not be restricted to the fifth-grade reading comprehension level. In
addition, the manual shall contain:
(a) A description of equipment required for monitor use and
mechanical and/or electrical specifications for electrodes, sensors,
leads, cables, tubing, batteries, and accessories with which the
monitor will operate in compliance with this standard.
(b) Step-by-step procedures necessary to prepare the monitor for
initial and subsequent use. If a manual sensitivity control is
provided, instructions as to when to use manual sensitivity and how to
adjust the control for optimal breath detection.
(c) Step-by-step procedures recommended for determining whether the
monitor is susceptible to the levels of electromagnetic interference
occurring at the intended-use site, a recommendation to repeat the
testing periodically, and recommended action to be taken if the monitor
fails the test. The preferred testing procedure for impedance monitors
is as follows:
(1) Set the monitor apnea duration to 20 seconds.
(2) Connect the monitor to a patient simulator with all cables in
extended rather than coiled configuration.
(3) Determine that the monitor detects normal respiration and heart
beats.
(4) Place the simulator in the apnea mode for 2 minutes.
(5) Determine that the monitor continues to alarm for apnea at full
volume beginning at 20 seconds. Alarming at reduced volume, false heart
rate alarms, or self-silencing of the apnea alarm prior to the end of
the simulated apnea constitute failure of this test.
(d) Precautions and a schedule of maintenance and calibrations
necessary to keep the monitor in compliance with this standard.
(e) Complete equipment specifications, including signal processing
functions, algorithms, and [[Page 9771]] averaging times for any
monitor function applicable to the operation and use of the device;
statements as to whether or not pacemaker pulse rejection and
defibrillator protection are included.
(f) For monitors using heart rate as a secondary monitoring
modality, a caution statement that low heart rate may not occur during
apnea if the patient is receiving drugs or substances which could
affect heart rate, e.g., such as theophylline.
(g) A discussion of the importance of evaluating for each patient
the response to apnea of candidate secondary monitoring parameters; how
this information should be used in the selection of an appropriate
secondary monitoring modality and in setting the secondary parameter
alarm limits; and the importance of reevaluating the appropriateness of
the secondary monitoring parameter and its alarm limit settings as
conditions change.
(h) For monitors intended for home use, a discussion of home apnea
monitoring that includes:
(1) Instruction and education of the parent and other care givers
in the normal operation and hazards of the device and its limitations.
(2) An explanation of the equipment used in home monitoring.
(i) A list of additional reference materials for the health care
practitioner about apnea monitoring.
(j) The date of issuance and the date of any revision of the health
care practitioner instruction manual provided.
(k) The results of clinical testing for the specific model of apnea
monitor and the methods by which these results were obtained.
Sec. 896.52 Servicing information.
Manufacturers of monitors shall provide to servicing dealers and
distributors adequate instructions for service adjustment and service
procedures necessary to keep the device in compliance with this
standard, including: Theory of operation, block diagrams, software flow
charts, schematics, parts lists, and any necessary test procedures.
Sec. 896.53 Label specifications.
Labels or other equivalent markings required by this section shall
be legible, clearly visible during operation, permanently affixed or
inscribed on the exterior of the finished device, and shall resist
removal or blurring from disinfectants or other normal use of the
device.
Sec. 896.54 Controls, connectors, switches, and indicators.
All controls, switches, connectors, and indicators shall bear
clear, concise labels identifying their functions.
Sec. 896.55 Standard compliance.
The monitor shall bear a label which states that it has been
manufactured in compliance with this standard.
Sec. 896.56 Switched outlet warning.
Each monitor intended for use in the home that can recharge
batteries or operate from the AC power line shall bear a label stating:
``DO NOT connect to an electrical outlet controlled by a wall switch''.
Sec. 896.57 Air mattress warning.
Air mattresses shall be permanently labeled with the warning:
``Inflate only with room air, do NOT use pure oxygen''.
Sec. 896.58 Monitors intended for hospital use only.
Monitors intended for hospital use only shall be permanently
labeled on the front of any module intended to comprise an infant apnea
monitor as follows: ``NOT FOR HOME USE''.
Sec. 896.59 General test methods.
Information concerning the design of, and rationale for, the tests
used to meet this standard, together with analyses and results of these
tests, shall be available to any person from the manufacturer upon
request. In addition, this information shall be maintained in the
manufacturer's device master file for a period of 5 years after
production of the device has ceased.
(Information collection requirements in this section were approved
by the Office of Management and Budget (OMB) and assigned OMB
control number 0910-0073)
Dated: February 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-4212 Filed 2-17-95; 8:45 am]
BILLING CODE 4160-01-F