9762 Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules

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.

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 § 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 § 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:
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules 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:
9764 Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules

ANNUAL BURDEN FOR RECORDKEEPING

CFR section Total annual

responses

Hours per

response Total hours

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

§ 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.

§ 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 radiointerference characteristics of industrial,
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules 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.

§ 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

§ 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
9766 Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules

with §§ 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.

§ 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 §§ 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.

§ 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 § 896.54.

§ 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.

§ 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 § 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 §§ 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.

§ 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

§ 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 § 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
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 896.35 Leakage current.

Monitors shall meet the requirements

of the standard IEC 601–1 for Type BF

equipment.

§ 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
9768 Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules

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 rootmean-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-meansquare and sags to 90 volts root-meansquare, 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-linesto-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
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules 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 Efield with a peak field strength of 500,

1,000, and 2,000 volts per meter.

§ 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 § 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

§ 896.50(b)(2)(iii).

Subpart D—Mechanical and Environmental

Performance Requirements

§ 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.

§ 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 § 896.35.

§ 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.

§ 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.

§ 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.

§ 896.45 Temperature and humidity.

(a) The monitor shall be in

compliance with this standard when

operating in the environmental

temperature range of 5 °C to 40 °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

°C to 70 °C at 95 percent humidity.

§ 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 °C in an ambient of 35 °C.

The temperature of surfaces with which

the patient can come into contact shall

not exceed 40 °C in an ambient of 35 °C.

Electrochemical transcutaneous sensors

are permitted for hospital use only with

maximum temperatures up to 44 °C for

less than 4 hours (at the same site) if

adequate patient protection procedures

are clearly described in the labeling.

§ 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 § 896.50(b)(1).

§ 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

§ 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.

§ 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
9770 Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules

instructions for monitor setup, checkout, 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.

§ 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 § 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
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Proposed Rules 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.

§ 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.

§ 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.

§ 896.54 Controls, connectors, switches,

and indicators.

All controls, switches, connectors,

and indicators shall bear clear, concise

labels identifying their functions.

§ 896.55 Standard compliance.

The monitor shall bear a label which

states that it has been manufactured in

compliance with this standard.

§ 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’’.

§ 896.57 Air mattress warning.

Air mattresses shall be permanently

labeled with the warning: ‘‘Inflate only

with room air, do NOT use pure

oxygen’’.

§ 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’’.

§ 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