Performance Standard for the Infant Apnea Monitor

Federal RegisterFeb 21, 1995

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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

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

------------------------------------------------------------------------

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

(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.

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.

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.

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.

(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.

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.

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.

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.

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.

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.

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.

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.

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.

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,

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,

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,

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.

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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.