[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]]

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Part V





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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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              
------------------------------------------------------------------------
896.59...........................           30           12          360
------------------------------------------------------------------------

  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