Engenharia Clinica

Contents

CHAPTER 1

Introduction 1

Section I. General 1

Section II. Responsibilities 1

Section III. Maintenance Publications and Directives 3

Section IV. Maintenance Management 3

CHAPTER 2

Maintenance and Repair Procedures 5

Section I. Maintenance Procedures 5

Section II. Workload Control 6

Section III. Forms and Records Management 7

CHAPTER 3

Man-hour Accountability 11

CHAPTER 4

Repair Expenditures 15

Section I. Repair Eligibility and Evacuation 15

Section II. Maintenance Expenditure Limits 16

Section III. Waivers 18

Section IV. Life Expectancy 18

CHAPTER 5

Scheduled Services 21

Section I. General 21

Section II. Preventive Maintenance Checks and Services 21

Section III. Calibration/Verification/Certification 22

Section IV. Electrical Safety 22

CHAPTER 6

Management and Control of Diagnostic X-Ray 23

CHAPTER 7

Technical Inspection For Issue 25

Section I. General 25

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Section II. Technical Inspections 25

CHAPTER 8

Technical Inspection for Turn-In or Transfer 27

Section I. General 27

Section II. Technical Inspections 27

Section III. Serviceability Inspection Checklist 27

Section IV. Condition Coding Medical Equipment 29

CHAPTER 9

Repair Parts, Tool Control, and Test, Measurement, and Diagnostic Equipment

(TMDE) 31

Section I. Repair Parts Management 31

Section II. Tool Control 33

Section III. Test, Measurement, and Diagnostic Equipment 33

Appendixes

Appendix A

References 35

Appendix B

Medical Equipment Reporting Procedures 39

Appendix C

Maintenance Standing Operating Procedures 43

Appendix D

Desk Reference Manuals 45

Appendix E

Standard Army Management Information System 47

Appendix F

Safe Medical Devices Act 49

Appendix G

Battery Maintenance Program 51

Appendix H

Equipment Requiring Calibration/Verification/Certification 53

Appendix I

Warranty/Contract Program 55

Appendix J

Medical Equipment Maintenance Evaluation and Assessment 57

Appendix K

Preventive Maintenance Inspection Checklists 59

Appendix L

Sample Combat Support Hospital Internal Standing Operating Procedures 61

Appendix M

Sample Combat Support Hospital External Standing Operating Procedures 71

Appendix N

Medical Standby Equipment Program 81

Appendix O

Army Prepositioned Stocks 83

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Glossary

Abbreviations 85

Terms 89

List of Illustrations

Figure 2-1.

Sample DA Form 2404 to document a deficiency identified during operator PMCS 8

Figure 2-2.

Sample DA Form 2407 to request maintenance support 9

Figure 3-1.

Individual direct labor man-hours worksheet. 12

Figure 3-2.

Instructions for preparing the individual direct labor man-hours worksheet. 13

Figure 4-1.

Decision matrix for condition coding medical equipment. 17

Figure 4-2.

Sample maintenance request depicting equipment coded H 19

Figure 4-3.

Uneconomically reparable equipment disposition memo. 20

Figure 7-1.

New equipment issue flow chart. 26

Figure 8-1.

Equipment turn-in flow chart. 28

Figure B-1.

Sample of a completed DA Form 2406. 41

Figure B-2.

Sample of a completed DA Form 2406—Continued. 42

Figure J-1.

Sample Commander’s Medical Equipment Maintenance Assessment Checklist. 57

Figure L-1.

Sample CSH Medical Maintenance Internal SOP. 61

Figure M-1.

Sample CSH Medical Maintenance External SOP 71

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TB MED 750-2

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This is a new Department of the Army Technical Bulletin

1

CHAPTER 1

Introduction

Section I. General

1-1. Purpose

a. This operating guide provides policy and procedures used to manage and operate Table of

Organizational Equipment (TOE) medical maintenance operations. Use it in concert with the directives

and policies prescribed by Army regulations (ARs) and other regulatory guidance.

b. This operating guide also provides uniform guidance and direction to standardize operating

procedures. Paraphrased in this bulletin are major policies and responsibilities established in other

regulations to afford an understanding of their interaction with medical equipment maintenance

procedures.

1-2. Applicability

This operating guide applies to all Army TOE organizations authorized Medical Equipment

Repairers (MER), Military Occupational Specialty (MOS) 68A.

1-3. References

Appendix A lists related publications in addition to prescribed and referenced forms. These references

provide the regulatory basis for the guidance contained in this bulletin. Maintenance activities will

maintain a library of those publications used on a frequent basis, and be knowledgeable of the locations

of less frequently used publications.

1-4. Explanation of abbreviations and terms

Abbreviations and special terms used in this pamphlet are explained in the glossary.

1-5. Standards of medical maintenance

Equipment used by medical personnel is of critical importance since its purpose is to save lives and

prevent suffering of the sick and wounded. Therefore, the highest standards of maintenance for medical

equipment are mandatory.

Section II. Responsibilities

1-6. Commanders

Maintenance of equipment is a command responsibility. Adequacy and completeness of a unit’s

maintenance program are a reflection of command interest. Maintenance operations, regardless of the

unit size or mission, are analyzed on nine factors that can affect maintenance: command, personnel,

time, tools, repair parts, records, publications, facilities, and communications. Command is the most

critical factor since it is the only factor that has direct influence on each of the others. Commanders will:

a. Publish and make compulsory a directive emphasizing the responsibilities of equipment operators to

perform effective operator maintenance, and the accountability of supervisors and leaders to ensure

operators are properly trained and competent in the use and care of medical equipment.

b. Allocate adequate time for equipment operators (EO) to perform operator preventive maintenance

services on a scheduled basis. Operator level maintenance should be included in the unit’s training

schedule.

c. Ensure current operator manuals for all medical equipment are on hand and readily available to the

operators.

d. Evaluate the performance of operator and unit maintenance programs through inspections. Correct

deficiencies found during inspections.

e. Establish periodic in-service and/or formal training in operator maintenance programs for operators.

f. Prevent the abuse of materiel under user control. Investigate the evidence of abuse and take

corrective action.

g. Program periodic in-service training, formal Army training, and/or manufacturer training for

equipment maintainers, particularly for new equipment introduced into the activity.

h. Use assigned MERs for medical maintenance duties. The MER should not be assigned additional

duties that may adversely affect the maintenance posture and readiness of medical equipment.

i. Make available the resources (i.e. tools, parts, and test equipment) necessary to maintain the

organization’s medical equipment.

j. Provide maintenance services to associate and subordinate activities on a scheduled basis.

k. Provide the best maintenance facilities possible. Arrange maintenance facilities to efficiently use the

allotted space. The shop should be as centrally located as possible, be accessible, and have ample,

secure, storage space for repair parts, supplies, tools, test equipment, and equipment awaiting repair

and/or parts.

l. Maintain the appropriate medical equipment maintenance records IAW TB 38-750-2, Maintenance

Management Procedures for Medical Equipment, or approved automated equipment management system.

m. Maintain organization’s medical equipment in a fully mission capable status IAW AR 220-1, Unit

Status Reporting and AR 700-138, Equipment Readiness Reporting.

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n. Medical equipment repairers should be included in the Medical Proficiency Training (MPT) program.

Participation should not detract from the unit’s medical maintenance posture.

o. Provide communication capability to ensure DA approved automated medical equipment

maintenance and performance reporting procedures are achieved. To the maximum extent possible,

medical maintenance automation systems should be provided broadband access to ensure effective

communication is attained.

1-7. Maintenance managers

The senior medical equipment repairer will accomplish organizational maintenance for medical equipment

in a timely, economical, and professional manner. Due to ever-changing operational requirements and

conditions, effective maintenance management requires leadership, planning, organization, assignment of

responsibilities, functions and resources, direction, and flexibility. Management of resources (tools, test

equipment, standby equipment, repair parts, time, and personnel) should be a daily concern. All

resources must be present in sufficient quantity when needed to accomplish the maintenance mission.

The establishment of priorities is a primary task. Managers will:

a. Attain the basic concepts, objectives, and policies of The Surgeon General for the maintenance of

medical equipment.

b. Effectively achieve the maintenance of Army-owned or supported medical materiel throughout the

equipment’s life cycle.

c. Execute maintenance programs for the repair, preventive maintenance checks and services (PMCS),

electrical safety testing and calibration/verification/certification (CVC) of medical materiel.

d. Establish Standing Operating Procedures (SOPs) for the operation of the maintenance activity IAW

command guidance. See appendix C which addresses SOP requirements and the applicable appendix for a

sample SOP depending on the type of unit assigned.

e. Review internal and external SOPs minimally every 18 months and update to reflect changes in DA

maintenance policies.

f. Provide planning, guidance, and assistance to other organizational elements that impact on the

maintenance mission. This includes providing guidance and assistance to:

(1) Commanders and staff in the development of medical maintenance related educational and

training programs for equipment operators and assigned MERs;

(2) Personnel Division (S-1) in the timely reporting of projected personnel losses.

g. Establish a system for identifying defective equipment to alert potential users. Use of equipment

serviceability tags DD Form 1577 and DD Form 1577-2.

h. Keep Commanders and staff informed on the status of medical equipment maintenance and

associated programs.

i. Establish a master file of both operator and maintenance manuals in the maintenance activity for all

medical equipment. Maintenance literature can be in either paper or electronic format.

j. Establish a functional file system to ensure maintenance records are maintained.

k. Establish and maintain a library of current administrative publications needed in the management of

the maintenance activity.

l. Facilitate medical equipment repairer participation in a Medical Proficiency Training (MPT) program.

m. Identify activities requiring medical maintenance support from your activity.

n. Identify the activity responsible for providing your next level of medical maintenance support.

1-8. Supervisory/leader personnel

Although supervisory duties and responsibilities are inherent in the management of all sub-functions of a

medical equipment maintenance activity, those listed herein pertain primarily to maintenance and repair

operations. Supervisors will:

a. Ensure the assignment of scheduled and unscheduled workloads to qualified repairers

commensurate with their training and skill level.

b. Maintain timely and informative communications with medical equipment operators/hand-receipt

holders concerning maintenance services.

c. Ensure the interpretation and application of maintenance service procedures are according to

manufacturer’s specifications and instructions.

d. Ensure individuals are knowledgeable of regulatory requirements such as Center for Devices and

Radiological Health (CDRH), Codes of Federal Regulation (CFR) and National Fire Protection

Association (NFPA) codes.

e. Ensure MERs are knowledgeable of hazard communications (HAZCOM), lockout/tagout and other

applicable Occupational Safety and Health Act (OSHA), Department of the Army (DA), and local safety

program requirements.

1-9. Medical Equipment Repairers

Maintenance services must be accomplished within established guidelines in a timely, professional

manner. Repairers will:

a. Adhere to safety procedures during maintenance operations.

b. Bring unsafe equipment operations to the attention of user/operator personnel and their

supervisors, by identifying defective equipment and alerting potential users.

c. Maintain accountability of entrusted resources. Of significant importance is the availability and

accountability of time and effective man-power utilization. See chapter 3 for instructions on accountability

of time and use of timesheets.

d. Perform PMCS and CVC services according to the manufacturer’s instructions or Army technical

manuals (TMs). Perform electrical safety inspections and testing IAW NFPA 99 and this bulletin.

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e. Ensure documentation and associated maintenance forms are legible and in compliance with local

SOPs and other applicable directives.

f. Assume personal responsibility for identifying and pursuing professional or technical training and

career development.

1-10. Equipment Operators

The range and complexity of medical equipment used to provide healthcare requires that operators and

their supervisors be responsible for their portion of the activity maintenance program. The operators

and/or supervisors will:

a. Perform before, during, and after operation maintenance tasks according to TMs and manufacturers’

instructions utilizing DA Form 2404. Operator tasks usually consist of the care and cleaning of exterior

surfaces, components, and accessories. Operator tasks also include the replacement of bulbs, tubing,

etc., that are easily accessible and do not require tools or test equipment.

b. Promptly report malfunctioning equipment to immediate supervisor and the supporting medical

maintenance activity.

c. Initiate a maintenance request for any maintenance services beyond those authorized as part of the

operator’s daily operations.

d. Maintain operator manuals for all medical equipment.

e. Maintain accountability of medical equipment and sets.

Section III. Maintenance Publications and Directives

1-11. Commander’s implementing directives

Commanders will publish a maintenance support directive for use by their customers and supported

activities.

1-12. Standing operating procedures

a. Each activity having an organic medical maintenance capability will publish an internal SOP The

internal SOP will designate individual responsibilities and, as a minimum, will provide instructions for the

performance of maintenance tasks related to the areas identified in appendix C.

b. Each maintenance activity will develop and publish an external SOP. This SOP will establish the

procedures a customer must follow when acquiring maintenance support.

1-13. Desk reference manuals

a. In addition to the internal SOP, the maintenance activity should develop a desk reference for each

MER’s use. Consider the development of a desk reference manual for repair parts, tool room operations,

and automated record keeping procedures.

b. Desk reference manuals give a person performing routine day-to-day tasks the detailed instructions

necessary to complete the tasks with the least amount of supervisory assistance. The manual should

contain step-by-step procedures in sufficient detail to enable a newly assigned repairer to perform

assigned duties.

c. Providing adequate instructions and sample formats in a desk reference manual results in less time

being required by the supervisor to train new personnel. Appendix D lists suggested items for inclusion in

each desk reference manual.

d. The repair parts and automated record keeping procedures desk references provide details to the

extent that other personnel could assume these duties in the event assigned personnel are replaced.

Section IV. Maintenance Management

1-14. Management

a. Maintenance management is the process of establishing objectives to carry out maintenance

responsibilities. Maintenance management consists of those continuing actions of planning, organizing,

directing, coordinating, controlling, and evaluating the use of personnel, funds, and facilities to

accomplish missions and tasks.

b. A prime management objective is to ensure optimal managerial control of critical maintenance

resources. Accomplish this objective by establishing standards of performance for operational elements

and a management data collection and reporting system for measuring and evaluating each medical

maintenance activity’s performance.

1-15. Management sub-functions

Shop management is composed of three basic sub-functions: supervision and administration, workload

control, and maintenance and repair operations.

a. Supervision and administration.

(1) Supervision is the element of management that makes the organizational maintenance facility

productive by effectively managing the resources available to accomplish the maintenance mission. It

consists of forecasting requirements and planning for the acquirement of resources used in the

performance of the maintenance mission (i.e., funds, personnel, supplies, repair parts, tools, TMDE,

publications, and facilities).

(2) Administration includes the tasks related to obtaining resources, maintaining equipment historical

records, providing performance evaluation and reporting, man-hour accounting, and maintaining

reference files. Also included are those tasks that are indirect to the physical performance of maintenance

services and/or repair actions.