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125 views28 pages

Doc-2-Bio Medical Engineering Manual

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Deepak Singh
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© © All Rights Reserved
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NATIONAL HEART INSTITUTE

CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Service Name : Bio Medical Engineering


Date Created : 15 May 2010

CEO
Approved By : Name : Dr. O.P. Yadava
Signature :

Vice CEO
Reviewed By : Name : Dr. Vinod Sharma

Signature :

Accreditation Coordinator
Coordinator
Issued By : Name : Wg. Cdr. B. Jena

Signature :

Responsibility of Updating : Manager -

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 1 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

The following are the authorized holders of the controlled copy

Controlled copy no. Name/Designation of the holder of controlled copy


1 Biomedical Engineer

Amendment Sheet

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 2 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

No. Section & Date Amendment Signature


Page
1 July 2012 Changes as per 3rd Edition

2 February 2013 Definition Changed

3 June – July 2014 No changes

4 June – July 2015 No changes

5 June – July 2016 No changes

6 June – July 2017 No changes

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 3 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Table of Contents
1. Purpose
2. Scope
3. Responsibility
4. Prime Activity
5. Equipment under Monitoring
6. Departmental Hierarchy
6.1. Hierarchy chart
7. Job Description
7.1. Biomedical Engineer
8. Departmental Policies
8.1. Statutory Requirement
8.2. Annual Maintenance Contract (AMC)
8.3. Equipment profile
8.4. Engineering department / services safety
8.5. Inspection of biomedical equipment
8.6. Condemnation
8.7. Quality and Monitoring systems
9. Departmental procedure
9.1. Complaint / Breakdown management
9.2. Preventive Maintenance
9.3. History Card
9.4. Annual Maintenance Card
9.5. Fire safety for Bio medical equipment
9.6. Equipment Calibration
10. Quality Indicator
11. Annexure
11.1. Forms / Document
11.2. Breakdown slip / Register
11.3. Mechanical maintenance Schedule and Record

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 4 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

11.4. History card


11.5. Calibration Record / History
11.6. Equipment Log & sticker

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 5 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Introduction

The appropriate and safe operation of clinical equipment is paramount to the proper
functioning of any health care facility. The Biomedical Engineering department is
responsible for testing, repairing, and maintaining in proper and safe operating condition,
the hospital’s diagnostic and therapeutic equipment

1 Purpose

The purpose of the biomedical department is to:


• Provide timely servicing, preventive maintenance to all medical equipment installed in
the hospital which help in attaining maximum utilization of machine.
• Train and guide the end user of different departments regarding the use and safety of
the equipment
• Keep track of all AMC schedules of all the equipment and ensure timely maintenance

2 Scope

The scope of the biomedical department is to provide calibration, maintenance and


servicing to the equipment in the hospital in order to ensure safety and maximum
utilisation.

3 Responsibility

Bio Medical Engineer and all the Technicians of the user departments

4 Prime activities

Major functions of Biomedical Engineering are to:


• Perform installation, preventive and corrective maintenance, and special request
service on clinical equipment owned, and/or used within the hospital in compliance
with regulatory agencies.
• Provide pre-purchase evaluations of new technology and equipment.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 6 of 28
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Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Assist clinical departments with service contract analysis, negotiations and


management.
• Provide coordination of clinical equipment installations including, planning,
scheduling, and oversight.
• Conduct device incident investigations.
• Educating by taking regular classes to Nurses, other allied, Health care
professionals, and Students on Hospital Engineering, Safety and creating awareness
on norms etc.,

5 Equipment under monitoring

Equipment Process
Medical equipment Maintenance of all the medical equipment viz.
therapeutic, diagnostic equipment
Ambulance ACLSambulance is maintained with life support
systems ventilator with oxygen backup and
other facilities such as suction, defibrillator, &
water supply
Clinical Assist in all the medical studies relating to the
Engineering engineering aspects.
Supports in all the purchase of ward equipment
work out feasibility

6 Departmental hierarchy
6. 1 Hierarchy chart

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

CEO/VCEO

Director
Operations

HEAD USER
DEPARTMENT

BIOMEDICAL
ENGINEER

7 Job Description
7. 1 Bio Medical Engineer

POSITION GUIDELINES
Name: Year
Job title: Biomedical Department
Engineer
Qualification& Experience (minimum requirements preferred)

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 8 of 28
NATIONAL HEART INSTITUTE
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Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Education: BE in Electronics and Professional experience:Worked


experience:Worked with
telecommunication , MBA SIEMENS

Degree in Engineering:
Engineering:-BE 1. Worked with MAQUET
2. Worked with ARTEMIS Health Institute

Key responsibilities

• Perform a variety of routine tasks associated with the installation, maintenance, and
repair of a diverse range of clinical equipment, typically non-life support.

• Perform all the routine repair activities

• Attending break down calls, technical crisis/emergency.

• Work with departments to coordinate the availability of clinical equipment for


preventive maintenance inspections

• Maintain effective working relationships with fellow workers, clinical and medical staff,
and others they may come in contact with.

• Maintain a clean and safe work place

• Perform control tests on clinical equipment to check their functionality.

• Report all patient safety issues to Executive Quality and assist in taking corrective and
preventive actions.

• Notify user departments regarding status of repairs and works with departments to
obtain loaner or replacement equipment as and when required.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 9 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Main Job Tasks:

FINANCIAL RESPONSIBILITIES
• To ensure expense lines of equipment maintenance and calibration are within
forecast.
CUSTOMER RESPONSIBILITIES
• To take appropriate measures to prevent complaints related to functioning of
any biomedical equipment.
• To undertake a quick response time to all such complaints
• To ensure safety of the staff and the patient using the equipment
PROCESSS RESPONSIBILITIES
• Coordinate special projects and perform specialized technical tasks involved in
the installation and maintenance of clinical equipment. Interpret engineering
and vendor information, schematic diagrams, and graphic illustrations utilizing
clinical physiologic and electronic principles.
• Improve or make special test setups to conduct functional checks with
biomedical test equipment
• Execute a scheduled preventive maintenance program for clinical equipment
• Assist departments in capital equipment planning; assist in identifying and
recommending replacement of equipment that is obsolete, has extensive repair
history, or has identified safety issues.
• Work with Procurement Services and departments to ensure that all incoming
clinical equipment is inspected, installed and used as per departmental policy.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 10 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Supplementary Position Guidelines:


Position Reports to :CEO/ VCEO

Personnel reporting to the Position

Direct reports:
reports Head of the Departments

Indirect reports:Technicians
reports:

Main stakeholders
External: Patients, Vendors, Contract Agencies.
Internal: Consultants, Staff and Contract Staff.

Please Note: This is not an exhaustive list of responsibilities but provides a general guideline
of the duties assigned to the position. Position Guidelines are dynamic and will change
depending on the organizational requirement.

8 Departmental Policies
8. 1 Statutory Requirements

Scope: Biomedical Department

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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NATIONAL HEART INSTITUTE
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Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

The biomedical department will strictly adhere to:


to:
 BARC act
 AERB guidelines for construction of Nuclear Medicine Department

8. 2 Annual Maintenance Contract (AMC)


(AMC)

• The Equipment on AMC are identified and marked in the History card
• The record contains the following:
 Name of the Equipment
 Equipment ID number
 Service provider’s name
 Contact person
 Address
 Frequency of the service annually
 Tenure of the contract
• The history card contains the preventive maintenance frequency and calibration
requirements and break down maintenance details
• On the basis of the information gathered on the history card, Periodic Preventive
Maintenance (PPM) schedule is made
• The bio-medical engineer follows the PPM schedule in conjunction with the user
department on the availability of the machine to conduct the preventive
maintenance by the contract agency
• The bio-medical engineer collects and documents the Service report of the
maintenance conducted on the equipment by the AMC contractor :
 The break down time is recorded
 All the spares details are recorded
 The response time of the AMC contractor is recorded
• After the Service, the Machine is thoroughly tested by the bio-medial engineer and
handed over to the User department.
• The user department signs the service order/ work order request if the service was
done on a break down.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Internal calibration for equipment not covered under the annual maintenance
contract are done and recorded.
• The Contract Period is reviewed and renewed accordingly by the Purchase
committee
• The service provided during the visit by the AMC service provided is documented
and filled as Service Reports. The service reports are retained at least till completion
of the Contract tenure.
• Instruction/operating guidelines are provided to all personnel handling the
Equipment
• The frequency and visits of the AMC service provider is monitored. Reminder are
sent in case of delay and purchase committee is also informed

8. 3 Equipment profile

• An Equipment profile will be maintained in the department. The contents of the


profile are:
 Name of the Equipment
 Model No.
 Brand name
 Serial number as per the Manufacturer
 Equipment ID no as allotted by the department
 Annual Maintenance Contract status/ self maintenance by the department
 Warranty status with warranty period
 Date of installation
 Location of the Equipment in the Hospital
• Each equipment’s details will be maintained inthe Asset register.
• Equipment uptime down-time charts will be maintained for all equipment. The
cumulative downtime will be calculated at the end of every year.
Out Going Equipment
Equipment for Repair and Servicing
• Any equipment found defective will be repaired locally in the plant.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• If the Equipment is not under Annual Maintenance Contract or the nature of the
repair is out of the scope of the AMC then, the requisition for repair is raised to the
Purchase committee, quotations will be called for and analysed for issue of contract.
• In case the equipment requires any service at AMC Service provider’s premises then,
the equipment will be sent for repairs through a gate pass. No equipment will be
taken out of the Hospital premises without a gate pass. The gate pass will be signed
by the Department In charge and ultimately by the Security Officer.
Wherever possible the defective equipment will be replaced for working.

8. 4 Engineering Department/Service
Department/Service Safety

Scope: Biomedical
Procedures:
• Department head is responsible for maintaining safety standards, developing safety
rules, supervising and training personnel in departmental standards.
• Department head is responsible for notifying the Bio-medicalEngineer in case of any
safety hazard.
• All department employees shall report defective equipment, unsafe conditions, acts
or safety hazards to biomedical engineer.
• Keep electrical cords clear of passageways. Only use electrical extension cords in
compliance with policy.
• All equipment and supplies will be properly stored. Heavy items will not be stored
on top shelves.
• All personal electric appliances shall be inspected by the Engineering Department
for safe use.
• Scissors, knives, pins, razor blades and other sharp instruments will be safely stored
and used. Use of sharp spindles is prohibited.
• All electric machines with heat producing elements will be turned off when not in
use.
• Smoking is prohibited in the hospital.
• Report faulty equipment to Biomedical Engineer.
• Warning signs will be obeyed.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Use appropriate personal protective equipment.


• Only non-sparking tools will be used when working around flammable or explosive
vapours or gases.
• A tool box is the safest way to carry tools and to keep them together on the job.
• Defective or broken ladder will never be used. Such defects will be reported so they
can be corrected or the ladders replaced.
• Do not use step ladders as straight ladders. Be sure that straight ladders have "safety
feet." When setting up straight ladder, its base shall stand not more or less than 1/4
the length of ladder from the wall.
• Metal ladders will not be used when working on electrical equipment, wiring or
changing light bulbs.
• Safety shoes will be worn to protect feet. Safety goggles will be worn whenever
there is a possibility of foreign bodies flying in your eyes, especially when grinding
or chipping. Sound barriers will be worn when indicated.
• Valves or switches will always be shut off when working on steam and hot water
pipelines or electrical switches and systems. Warning tags shall also be on such
switches or valves so that others will not operate them.
• TAG OUTwill
OUT be used when repairing any machinery.
• Electrical work shall be done only by qualified electricians, since poor wiring is one
of the principal causes of fire. Overloaded circuits shall not be worked on
• Adequate and proper guarding will be ensured for all machinery in maintenance
shops. Never operate equipment when guards have been removed.
• All lacquers and thinners shall be kept only in approved safety cans and stored in
accordance with the State or Local Fire Codes.
• All wheelchairs will be checked regularly from a maintenance and safety
standpoint.
• Accumulations of oily rags which could produce spontaneous combustion will be
immediately removed.
• A preventive maintenance chart and periodic check system will be maintained to
prevent many accidents.
• All tools will be handledcarefully. Tools damaged from being carelessly piled into
drawers or dropped on hard surfaces can cause mishaps.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Oil or grease from a tool will be cleaned before using it. A tool which slips out of
the user's hand is likely to cause an injury.
• Steady and secure material to be cut, sheared, chiselled or filed to prevent the tool
from slipping.
• Extreme care will be taken in the use of torches and soldering irons to prevent
explosions and burns. Always wear protective gear. The soldering iron willbe
placed so that the hot point cannot come in contact with flammable material or with
the body.
• Floors will be kept clean and free of sawdust, scraps of wood and other objects
which might cause tripping or slipping.
• Ensure that starting and stopping switches are within immediate reach of the person
operating the machine.
• Good body mechanics will be practised.
• Equipment will not be left standing in traffic lanes. Equipment will be returned to
its proper location after service.

8. 5 Inspection of Biomedical Equipment

Scope: Biomedical
Procedures:
• Basic biomedical engineering inspection of equipment shall be performed by: Bio
Medical Engineer
• Inspection
 Visual Inspection
 Performance Tests
 Calibration
 Lubrication
 Other operations specified for equipment by preventive maintenance tables

• Performance tests willbe made by bio medical engineer, or a request shall be made
for the operator to perform the check while the service engineer of the company

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Issue date: 23/06/2017
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Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

observes various meter actions, mechanical responses and operating procedures of


the operator.
• During scheduled visit, bio medical engineer will attempt correction of any minor
defects found.
• Defects which cannot be corrected during the visit, due to lack of parts or time,
willbe scheduled for repair at the earliest practical time.
• If a defect is found which is dangerous to the patient, operator or equipment, the
item willbe tagged and withdrawn from service until repaired. Upon completion of
the inspection, the respective unit will be returned to service if all aspects of the unit
are found to be satisfactory.

8. 6 Condemnation

• Any equipment, which out lives its life and requires repairs or renewals will be
condemned provided the cost of the repairs or renewals exceeds 50% of its original
value.
• Or any equipment which consumes more energy and the version is out dated and
hence can not compete with new version will condemned by the purchase
committee after through verification though it has not out lived its life prescribed by
the manufacturer.
• Condemnation Committeedecide’s upon the method of condemnation. The
Maintenance department forwards the repair status of the Machine to the Purchase
committee. This report is studied by the purchase committee and arrives at a
conclusion.
• All records pertaining to condemnation of equipment shall be maintained.

Options of condemnation:
• Scrap: If the equipment is totally Obsolete or irreparable then the equipment is sold
as scrap
• Buy back: Such equipment are replaced by new equipment and returned to the
Vendor in replacement of new equipment at discounted price. The decision for such
an option is completely on discretion of the Purchase committee.
• Sold at discounted price to any taker

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Condemned Equipment Retained by the department: Some of the equipment are


retained by the department so as to use its spare parts for future use. However the
machine will be used. Such spares would generally be not available or are expensive
otherwise and are still useful.

8. 7 Quality and Monitoring Systems

• All equipments are checked for proper functioning on a daily basis by user.
• Calibration of the equipment are done as per manufacturer’s guidelines
• Appropriate corrective and Preventive actions are taken if downtime of the
equipment is large or delay in repairs or missed calibration.
• The personnel using the equipment are educated about the safe and effective
operation and functioning of the equipment at the time of installation and as and
when required.
• The staff is trained to handle and prevent of the hazards. Supplement Guidance and
training are imparted to the concerned department. In case of any incidence
reported such accidents etc are analysed, and appropriate corrective ad preventive
actions are taken.
• Organization safety committee will also study these actions.

9 Departmental procedures
9. 1 Complaint/ Breakdown management

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Receives Complaints

Technician goes to the site & checks the work order


which is raised to get the details of complaint

Checks the History card on site & identifies if


the equipment is on AMC or not

AMC Not on AMC

Log complaint with the Biomedical engineer


contract agency, & Record todiagnose the fault
time in the work order

Contract representative, Spares not Spares available


reports to biomedical team, available
Signs his arrival in the work
order and proceeds to the
location of faulty equipment Purchase through Fix the problem
stores

Agency fixes the problem Final status entered


updates history card & gets in to Complaint
the Biomedical engineer to Register
Validate

User verification
Biomedical engineer validates done and sign’s the
the equipment for use work order

Agency signs the history card


for completion & user records
time & signs the work order
for completion

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

9. 2 Preventive Maintenance

Routine
machinemaintena
nce

Biomedical engineer checks the Periodic Preventive Maintenance


Schedule (PPM) everyday

Equipment not on AMC Equipment on AMC

Biomedical Engineer performs the PPM Check the availability of


based on the maintenance check list for equipment for shut down
equipment

Coordinate with the contract


Spares not Spares available agency, to carry out the PPM
available during the time when equipment
is available for shut down

Purchase Carry out PPM Agency carries out PPM on the


through stores Equipment, & generates the
service report

Final status Biomedical engineer validates


entered in the the PPM, & updates the history
History card card

User verification User department takes the


done and sign’s equipment & signs the History
the work order card

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

S. No. Procedural steps Responsibility

1. Receive call memo from any department which is Bio-medical


possessing biomedical equipment for its breakdown Engineering Dept.
and maintenance

2. If the movement of equipment is possible should be Bio-medical


brought down to workshop shall be provided necessary Engineering Dept.
preventive, maintenance, or rectification of breakdown
can be done.

3. If movement is not possible biomedical engineer shall Bio-medical


visit and provide service there itself Engineering Dept.

4. In problem solving equipment manual shall be use as a Bio-medical


referral tool Engineering Dept.

5. If any component is damaged check for availability of Bio-medical


the component in the store Engineering Dept.

6. Depending upon the availability of the component Bio-medical


rectification/information to the purchase department Engineering Dept.
shall be done

7. The date and time of complain solved shall be Bio-medical


documented Engineering Dept.

8. If correlated medical equipment problem arises inform Bio-medical


to the related service centre and supervise the Engineering Dept.
troubleshooting done by the service engineer

9. Obtain the signature of the service provider and Bio-medical


warrantee if any given to maintain the record Engineering Dept.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


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Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

9. 3 History card

• All the Equipment in the hospital will have an individual History card
• All the history cards will be maintained by the engineering services department and
a copy maintained at the user department
• These history cards would be updated by the Engineering service team as per the set
parameter requirements

9. 4 Annual Maintenance Contract (AMC)

• The Equipment on AMC are identified and marked in the History card
• The history card contains the preventive maintenance frequency and calibration
requirements and break down maintenance details
• On the basis of the information gathered on the history card, Periodic Preventive
Maintenance (PPM) schedule is made
• The bio-medical engineer follows the PPM schedule in conjunction with the user
department on the availability of the machine to conduct the preventive
maintenance by the contract agency
• The bio-medical engineer collects and documents the Service report of the
maintenance conducted on the equipment by the AMC contractor
• The break down time is recorded
• All the spares details are recorded
• The response time of the AMC contractor is recorded
• After the Service, the Machine is thoroughly tested by the bio-medial engineer and
handed over to the User department.
• The user department signs the service order/ work order request if the service was
done on a break down.

9. 5 Fire safety for Bio Medical Equipment

• In the event of Fire the area is electrically isolated by cutting of the Main circuit
Breaker

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 22 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Elevators are brought to ground level and power shut off


• Bio-medical engineer monitors and shuts off the section affected by fire of medical
gases or the entire Manifold room if required
• All electrical equipment will be effectively grounded.
• All the power controls will be identified by appropriate labels.
• Gasoline powered equipment will be operated in well ventilated areas.
• Fuel and flammable gas cylinders will be stored separately from oxidizing gas
cylinders.
• Staff shall be adequately trained on fire fighting. Department shall be equipped with
adequate no. of fire extinguishers
• Once the Patients are shifted from the area on fire, Equipment are salvaged.

9. 6 Equipment Calibration

• All the equipment when purchased the manufacturer defined frequency of


calibration is taken as frequency of calibration.
• The frequency of calibration is entered in the Inventory log.
• As the per the frequency stipulated the equipment are calibrated internally or
through the AMC provider All the necessary certification will be maintained
• The history card is upgraded with calibration codes.
• The next calibration due will be mentioned in the History Card.

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 23 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

10 Quality Indicator

Quality Indicator is based on average downtime for rectification, repair or purchase of the
required product.
• Internal Repair : ______hrs
______hrs
• External Repair : _____hrs
_____hrs (in case of delay beyond 72 hours the
reasons have to be vetted by the Department head
head and the CEO/ VCEO)
VCEO)
• Out station assistance : within
within a week
Sl. Objectives Performance Parameters Measurement Criteria
# Method Period
1 Reduce cost of Reduce break down Break down Records Quarterl
maintenance y
Stand arise the spares Number Quarterl
y
2 Response Time Time of repair Days / hours Quarterl
y

11 Annexure
11.1 Forms/ Documents
11.

• Master List
• Preventive Maintenance Plan (PMP) schedule
• Preventive maintenance Monthly Check list
• History card
• Complaints Register: Retention period: 1 yr
• Equipment Log book: Retention Period: Till the life of the equipment
• AMC Contract Records
• Service Reports: Retention period: Till the tenure of the contract
• Equipment Manual: Retention period: Till the life of the Equipment
• Spare Catalogue: Retention period: Till the life of the Equipment

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 24 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

• Uptime-downtime charts: Retention period: Till the life of the equipment

11.
11.2 Breakdown Slip/ Register

Breakdown Slip No. Department: Date:


Time:
Equipment/ Instrument Name

Equipment/ Instrument Code


No.

Equipment/ Instrument
Location

Nature of Breakdown

Time Required / Due Date

Actual Time Consumed

Signature of concerned Head

Date :
Received Signature of Maintenance concerned
Remarks: Section Head

Time Signature of concerned Section Head /In-charge

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 25 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

11.
11.3 Mechanical Maintenance Schedule and Records

Check Points

Sl.# Daily Check points Sl.# Monthly Check points


1 1
2 2
3 3
4 4

11.
11.4 History Card

Unit Name:
Model :

Date Equipment Maintenance / Maintenance Spares Remarks &


Code Breakdown Details Done Change Sig. Of I / C
s

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 26 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

11.
11.5 Calibration Record & History

Sl. Location / Instrume Mark / Rang Contr Dat Du Frequen Remark


No Departme nt Identificati e Or ol # . e e cy &
. nt on G/L Of Dat Of Cal. Status.
Cal. e (Histor
Of y)
Cal.

11.
11.6 Equipment Log Sticker

Calibration Record / Status


Name of the equipment
Item no.
Date of purchase
Last preventive maintenance
Next preventive maintenance

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 27 of 28
NATIONAL HEART INSTITUTE
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual

Reference NABH standard Next Rev : 25/ 05/ 2018


(4th Edition)

Last breakdown maintenance


Name and contact no. of the service engineer

Wg. Cdr. B. Jena Dr. O.P. Yadava

Prepared & Issued By Approved By


Page 28 of 28

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