NCJIMCARE

&
OPJICACRE
HISAR

REFERENCE No.
FMS. 4.a.b.c.d.e.f.g.h.i
MANUAL OF OPERATIONS:
BIOMEDICAL EQUIPMENT
PROGRAM

DOCUMENT No. (VERSION

No.)
DATE OF ISSUE:

(BME*) PAGE 1 of 17

1. Departmental Structure

MBTI n ei aco hnm a n e rg i gd e ei cr - a B l i o m e d i c a l

e-cd ineFa gpMn ia n S r e t m e r e n t
2. *Abbreviation used in this document
BME- Biomedical Equipment
PMS- Preventative maintenance schedule
VAC- Volts Alternating Current
FMS - Facility Management and Safety
3. Objective:
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
3.8.
3.9.
3.10.

To help the organization in planning equipments in accordance with its scope of services and
strategic plan.
To act as partner in selecting, renting, updating, and upgrading of biomedical equipments in a
collaborative process with other stakeholders & process owners.
To make the inventory and proper logs of all biomedical equipment at NCJIMCARE &
OPJICACRE.
Periodic inspection and calibration of BME.
Operational plan of BME
Preventive maintenance plan for BME
Breakdown maintenance plan for BME.
Procedure for replacement and disposal of BME
Procedure for medical equipment recalls.
Monitoring response time from reporting to inspection and implementation of corrective actions.

4. Scope:
All the areas of NCJIMCARE & OPJICACRE
5. Timings:

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5.1.
5.2.

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The Hospital Biomedical Department provides services from 9:00 AM 7:00 PM Monday to
Saturday.
Emergency coverage is provided on a 24x7 through use of on-call system.

6. Responsibility:
6.1.
6.2.
6.3.

Manager-FMS
Biomedical In charge
Biomedical Team Member

7. Procedure
7.1.

Procedure for Objective 3.1.-: To help the organization in planning of equipments in

accordance with its scope of services and strategic plan.
7.1.1. Equipment planning of BME is done as per the operational & strategic plan of the hospital or
Change in future requirement planning of end users or against condemnation of older
equipment or as per scope of service of the hospital.
7.1.2. Equipment are purchased after identifying the need & assessment of viability of business.
The technical bid, financial bid, call for quotation, selection of vendors, negotiations with
vendors etc. are done as per capital equipment Performa in material management policy of
NCJIMCARE & OPJICACRE as in annexure - 1

7.2.

Procedure for Objective 3.2.: To act as partner in selecting, renting, updating, and upgrading
of biomedical equipments in a collaborative process with other stakeholders & process owners.

7.2.1. The biomedical equipments are selected, rented, updated, and upgraded in a collaborative
manner by involving the end user, BME department before purchasing any BME equipment
for the hospital. The same is done after identifying the need & assessment of viability of
business. The technical bid, financial bid, call for quotation, selection of vendors,
negotiations with vendors etc. are done as per capital equipment Performa in material
management policy of NCJIMCARE & OPJICACRE.
7.2.2. Evidence for the objective 3.1 & 3.2 are in capital equipment purchase Performa which are
filled and records are maintained by purchase department along with comparative statement
& purchase order (the department responsible for safely storing these files is the purchase
dept. located in Room no. 554 in basement of cardiac building. The cabinet where the files
are stored has an asset log I.D. no.----------- and keys will be custody of purchase officer
(Ankush Gupta).The content of the file will be scanned & stored electronically as per
hospital IMS protocol (Sandeep Dalmia).
7.3.

Procedure for Objective 3.3. - To make the inventory and proper logs of all biomedical
equipment at NCJIMCARE & OPJICACRE in annexure-2.
7.3.1. Purchased equipment is received in the store.
7.3.2. Indent is given by the user department to the store.
7.3.3. The store in-charge issues the equipment with prefixed asset log ID done by estate office as
per policy (Fixed Asset Policy)
7.3.4. The BME department records the prefixed asset log ID given to the equipment and mentions
into Biomedical Inventory List mentioning the make, model no., Serial no., and location, date
of installation, warranty period.
7.3.5. A master log of the equipments exists at BME department.

7.4.
Procedure for Objective 3.4. - Periodic inspection and calibration of BME.
7.4.1. During the inspection the calibration date and calibration due date are verified and noted for
timely calibration.

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MANUAL OF OPERATIONS:
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7.4.2. Calibration of equipment will be done yearly or as per manufacturer guidelines or whenever
required either External or Internal by certified out source agency. The list of
EXTERNAL/INTERNAL calibration is Mention in Master inventory log sheet of biomedical
equipment.
7.4.3. If internal calibration is done it will be validated by bio-medical engineer of NCJIMCARE &
OPJICACRE after satisfaction of user department. User department will sign of validation
sheet.
7.4.4. The agency doing calibration for particular equipment and their frequency are mentioned in
inspection and calibration record file.
Key parameters for testing and calibrating Bio-Medical Equipment. Only a few equipments have been listed
below for illustration
Equipment name

Defibrillators

Pulse Oximeter

Infusion pump

Patient Simulators

Ventilators

7.5.
A.
B.
C.

Parameters
Electrical Safety tests
Biphasic energy measurement ECG,
performance and arrhythmia simulation
Charge and discharge time test
Waveform simulation
Electrical safety tests
O2 Saturation
Heart rate
Pulse amplitude
Selectable pigmentation and ambient light condition
Electrical safety tests
Flow rate
Occlusion alarm tests
Pressure Patient Simulators
Electrical safety tests
ECG
Blood pressure
Cardiac Output
Respiration
Temperature
Pacemaker recognition
Tidal Volume
Inspiratory Peak flow
Inspiratory peak pressure
Peep pressure
Minute volume
I/E ratio
Oxygen level
Inspiratory hold Etc

Procedure for Objective 3.5.-Operational plan for BME

Standard operating procedure(sops)
Daily & weekly operational checklist
Equipment safety points-

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MANUAL OF OPERATIONS:
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A. Standard operating procedure(sops)

Sr. No.
1.
3.
5.
7.
9.

The table below is the list of equipments of operation plan

Operational Plan
Sr. no.
Operational Plan
Patient Monitor
2.
Ventilator
ECG machine
4.
Infusion pump
Syringe pump
6.
TMT
Nebulizer
8.
Suction Machine
Sphygmomanometer
10.
Pulse Oximeter

11.
13.
15.
17.
19.
21.
23.
25.
27.
29.
31.
33.
35.
37.
39.
41.

IABP
Heart lung machine
Auto log machine
ECHO
Fluid warmer
Sonosite(USG)
C-ARM
EMG
HD camera
Mamography
CT Scan
Work station for CT Scan
X-ray
Pulmonary Function Test
Radio-therapy equipment
Dialysis machine

12.
14.
16.
18.
20.
22.
24.
26.
28.
30.
32.
34.
36.
38.
40.
42.

43.
45.
47.
49.
51.
53.
55.
57.
59.
61.
63.
65.
67.
69.
71.
73.
75.

Weighing machine
CR system with camera
HD system
Lithotripsy machine
O.T table
Phaco machine
Laser ENT
Micro debrider for ENT
Navigation system for ortho
Drill for ortho
Sigmoidoscope
Colonoscope
Colposcope
Eye department
Dental department
Phototherapy

44.
46.
48.
50.
52.
54.
56.
58.
60.
62.
64.
66.
68.
70.
72.
74.
76.

Cath lab machine

Anesthesia Machine
ACT machine
Air warmer
Defibrillator
Cautery machine
EEG
Audiometry Machine
Blood Bank equipment
Ultrasound machine
MRI
Work Station for MRI
Endoscope
Biosafe cabinet
Lasik laser
Rebitadin machine for washing
dialyser
CRRT Machine
CSSD equipment
Harmonic system
Urolaser(hole man laser)
Microscope(Carl zeiss) for eye
Microscope for ENT
Coblator for ENT
M-seal for OG
Arthoscope machine for ortho
Microscope lieca
Endo-washer machine
DVT pump
Physiotherapy equipment
Fetal Doppler
Warmer (NICU)

NOTE : Few equipments sop mention Below for ilustration :

1.
2.
3.
4.

Standard Operating procedure for Monitor

Connect to main power supply (220 Vac+/-10 Vac)
Press to turn ON, a green LED light appears beside the switch and the screen illuminates.
Enter the patient Name and patient ID
Attaching the Patient to the Monitor as required:

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MANUAL OF OPERATIONS:
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5. Attach the ECG cable to the connector, perform skin preparation and attach the leads to the patient;
6. Attach the SpO2 cable to the connector, and the sensor to the patient;
7. Attach the NBP tubing to the connector, select the correct cuff size, and apply to the patient starting
NBP Measurements
8. Select the NBP numeric on the screen to enter the set-up menu.
9. Select Start/Stop to start NBP measurements. Select Repeat Time to change the frequency of
automatic NBP measurements.
Standard Operating procedure for Ventilator
1. Connect with main power supply 100Vac to 240Vac, 50/60HZ,Battery 10Vdc to 30Vdc
2. Press to turn ON On-Screen Controls Wait until the 10-second test phase is complete
3. The start-up values for the tidal volume (VT) and frequency (frq.) required for the patient are
determined by ventilator
4. Either as a function of the ideal body weight Or as a function of the patient mode (paediatrics or
adults).
5. Adjustment ranges
Adult ventilation:
Tidal volume VT 0.1 litre to 2 litres
Inspiration flow 6 L/min to 120 L/min
6. Paediatric ventilation:
Tidal volume VT 20 mL to 300 Ml
Inspiration flow 6 L/min to 30 L/min
7. Please set the above value as per Dr. recommendation.
8. Start-up values VT, frq. dependent on ideal weight.
9. The hospital-specific start-up values can be entered in the table.
Factory Setting
Tidal volume VT mL

Ventilation
Weight Kg
frequency fbpm
3
20
30
15
110
26
65
450
13
100
700
10
10. Press the rotary knob start ventilation

Hospital-specific setting
Tidal volume VT mL Ventilation
frequency fbpm

Standard Operating procedure for ECG

1. Connect to main Input Supply (220Vac+/- 10Vac)
2. Press to turn ON, a green LED light appears beside the switch.
3. Turn on the machine and enter the patient name, date of birth, patient ID number or other protocol
specific information. Verify information against the chart
4. Attaching the Patient to the ECG as required

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5. Attach the ECG cable to the connector perform skin preparation where the electrodes will be placed,
by rubbing the lower legs, lower forearms, and chest area with alcohol swabs. Dry the areas with gauze
pads and attach the leads to the patient;
6. When a satisfactory ECG is acquired, save, and print. Follow manufacturers Operational instructions
if additional copies for the ECG tracing are needed.

1.
2.
3.
4.
5.
6.

Standard Operating procedure for Infusion pump

Connect to main Input Supply (220Vac+/- 10Vac)
Attached a infusion pump containing IV fluid infusion set.
Eliminate air bubbles from IV set.
Set the flow rate with up and down key.
Cannulate the vein set to the patient access.
Press start key to start the infusion

1.
2.
3.
4.
5.
6.
7.
8.

Standard Operating procedure for Syringe pump

Connect to main Input Supply (220Vac+/- 10Vac)
Power on.
Attached a syringe containing IV fluid.
Check the syringe.
Set the flow rate with up and down key.
Eliminate air bubbles from IV set.
Cannulate the vein set to the patient access.
Press start key to start the infusion

Standard Operating procedure for TMT

1. Connect to main Input Supply (220Vac+/- 10Vac)
2. PC On

3.
4.
5.
6.

Connect ECG cable with patient as per picture.

Exercise will be start by patient
When a satisfactory ECG is acquired, save, and print. Follow manufacturers
Operational instructions if additional copies for the ECG tracing are needed.

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MANUAL OF OPERATIONS:
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*Note- The operational plan for given category of equipment is generic. Variations in the equipment
category due to difference in manufacture are accounted for that particular equipment in the department
itself. This will also take into account the manufacturers recommendations.
Standard Operating procedure for NEBULIZER

1. Two Types of NEBULIZER Electrical and Manual

2. Bring the equipment next to the patient.

3. Prepare the drug according to the Doctors prescription (salbutamol in normal saline)
4. The patient should be in sitting up position, well supported in a chair or on a bed.
5. Place the face mask over the patients mouth and nose and place the strap over her/his head.
6. Ensure that Nebulizer chamber is in upright position
7. Plug in the socket
8. Switch on from the main, stabilizer then on the Nebulizer.
9. Instruct the patient to breath in and out as normal.
10. When the Nebulizer starts to splutter the treatment is complete, this will take between 10-20 minutes. A
small amount of solution may be left in Nebulizer at this stage, but this is normal.

Standard Operating procedure for SUCTION MACHINE

1. Two Types of SUCTION MACHINE Electrical and Manual

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2.
3.
4.
5.

Plug into the socket and switch on the mains, stabilizer and machine.
Ensure the pilot lamp lights.
Connect the suction tube to the patient connector.
Fill the collecting bottles not more than 2 /3 as the secretions will over flow to the motor causing
damage.
6. When one bottle is 2 /3 filled, shift to the other bottle.

Standard Operating procedure for SPHYGMOMANOMETER (BLOOD PRESSURE MACHINES)

Types

1. Explain
the
procedure to
the
patient/client
using simple
terms.
2. Put the patient/client in comfortable position preferably lying on the back or sitting up in the chair. and
avoid crossing the legs.
3. Open the mercury column lever (mercury type only)
4. Fit the cuff around the patients upper arm above the elbow.
5. Close the pressure relief valve.

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6. Feel for the pulse at the brachial artery.

7. Pump the bulb until it reaches 200 mm Hg reading (mercury & aneroid only).
8. With the stethoscope in position slowly open the pressure relief valve, deflating the cuff at 2-3 mm Hg
reading per second. (Mercury & aneroid only).
9. Take the reading when you hear the first soft thumping of the patient/client pulse. This is the systolic
pressure. (Mercury & aneroid).
10. Take the second reading when the sound of the pulse begins to fade. This is the diastolic pressure.
(Mercury & aneroid).
11. Open the pressure relief valve to release the air completely.(mercury and aneroid)
12. Remove the cuff from the patients/clients arm
13. Record the results i.e. BP = Systolic pressure (mmHg)/Diastolic pressure

Standard Operating procedure for Pulse oximeter

2-1: Desk top - Electrical
2-2: Sports pulse Oximeter (non-electrical)

1. Plug the electric cable in the socket.

2. Switch on the mains, stabilizer and machine.
3. Put the finger probe on the patients finger (index)
4. Read the pulse and the amount of oxygen in the blood.
5. Record the readings. (Normal pulse 60 to 100 bpm, Normal oxygen concentration 90 to 100%)

B. Daily operational checklist

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S.N
O

Equipme
nt/Make

Asset
ID/Location

Function
Test

battery
status

Cleaning
Status

Physical
check

All the cable

connection

All the cable and Acc.

are well kept when not
in use

Remarks

Check Point

1
2
3
4
5

C. Equipment safety points The following precautions will be used while operating equipment:
1. Operator will be alert to situations which may damage equipment or Injure personnel.
2. Sufficient space is required around and above all medical equipment and electrical services to
permit safe operation and to encourage good maintenance.
3. Operator shall be familiar with the normal equipment sounds to be Able to detect the abnormal.
4. Operator shall investigate and report to Clinical Engineering
5. Department abnormalities indicated by erratic meter responses, electrical flashing or arcing,
burning smell, unusual grinding sounds of gears or other evidence of improper operation.
The following list of general safety factors will be continuously monitored:
1.
2.
3.
4.
5.
6.
7.
8.
7.6.

Proper grounding of equipment.

Current Biomedical Engineering Green Tag
Accuracy of critical timing devices.
Adequate physical mounting for support of installed items.
Proper operation of safety valves.
Serviceable good condition of electrical cords.
Calibration of systems whose accuracy is absolutely
Essential in treatment or diagnosis.
Procedure for Objective 3.6. - Preventive maintenance plan of BME.

7.6.1. Quarterly preventive maintenance check list

7.6.2. Six monthly preventive maintenance check list
7.6.3. Yearly preventive maintenance check list
7.7.
Procedure for Objective 3.7. - Breakdown maintenance plan of BME.
7.7.1. At the time of breakdown the concerned area in-charge has to register their complain on a
facility management services no. 9896498965.
7.7.2. Al BME complains will be notified to incharge BME 08053910222 in emergency hours

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7.7.3. BME will attendant the complaint after registration of complains in normal/routine working
hours (09:00AM to 07:00 PM). After routine working hours only emergency complain will be
attended on call basis by BME department.
7.7.4. The Breakdown will be recorded in BME breakdown and response record time Performa.
7.7.5. Breakdown record will be maintained in daily breakdown logbook.
BME Maintenance Department should:
1. Ensure that information regarding breakdown is passed to all concerned staff, including all shift
in-charges and head of the institution.
2. Install spare machine in area of breakdown.
3. Attach label not working to the faulty equipment(s). Record and check details of the defect(s)
and repairs.
4. repair the equipment if possible.
5. if required contact Service engineer of manufacturer/supplier/hired agency by telephone
number/fax/email and keep a record of the same.
6. Ensure that information regarding reworking/repair of machine is passed to all concerned staff, incharges and head of the institution in all shifts.
All the breakdowns occurring in the department should be documented and record of the same will
be kept as follows Annexure-9
Note: - The replacement of the defective part(s) should be done at the earliest feasible after taking
the necessary concurrence from the purchase department and sanction from the AdministratorFMS. The reason(s) for the delay if any should be recorded. Breakdown Maintenance can be kept
on a single sheet. The desired information are recorded and analyzed as given below.
7.8.

List of equipments whose breakdown will be termed/mean as incident at NCJIMCARE &

OPJICACRE, and will be reported in incident reporting system (CQI.8, ROM.6.c,)
1. IABP
11. Cath lab machine
2. Heart lung machine
12. CSSD machine
3. MRI
13. Auto-log machine
4. CT-scan
14. Bio-safe cabinate
5. Radio-therapy machine
15. IT failure
6. Laundry machine
16. Transformer
7. Generator
17. Water supply failure
8. Fire system & fire incident
18. HVAC system
9. Sexual harassment incident
19. Wrong transfusion incident
10.
20.

7.9.

Procedure for objective 3.8 - Procedure for replacement and disposal of BME
Replacement & disposable of BME equipment is done twice a year as per hospital
condemnation policy (available with purchase department)

7.10. Procedure for objective 3.9- Procedure for medical equipment recalls.
7.10.1. Objective for recalling of equipment
After calibration or preventive maintenance of medical equipment.

If equipment is not properly functioning or giving an in-correct reading or parameters.

If the equipment is found to be defective or unsafe for patient use

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7.10.2. Equipment recall process- For recalling of equipment follow the Breakdown maintenance plan
present in section 7.5.3.(page no.7) of this document.
7.10.3. An equipment recall register/logbook is maintained at the BME department.
7.11.

Procedure for objective 3.10. - Monitoring response time from reporting to inspection and
implementation of corrective actions.
7.11.1. Hospital has a dedicated facility management service no. 9896498965 to lodge any complain
of BME breakdown.
7.11.2. BME department will attend the complain as soon as possible & record the complain in BME
breakdown and response record time Performa. (annexure-)

7.12.

The following are the PPE (Personal protective equipments) for operation and maintenance of
Medical Equipment.
List of Personal protective equipments

1.Helmet
2.Safety shoes
3. Fire insulated cloths.
4. Safety Glove
7.13.
7.14.

5. Face Mask
6. Goggles
7. Ear Puff

Firefighting equipment is installed across the hospital to deal with any minor or major fire
occurred during working in the hospital.
List of hazardous identification & risk analysis are enlisted and MSDS (Material Safety Data
Sheet)

List of hazardous identification & risk analysis

1. Unearthing of electric wires & cables
4. Overheat of electric Cable
2. Water leakage
5. Fire Catching material & Chemical
3. Over heat of Machine
6. Storage of Flammable Materials Near
equipment

7.15. Training of staff

7.15.1. Staff will be provided with a departmental training like departmental function, HIRA (Hazard
Identification and Risk Assessment), MSDS, within first 15 days of their joining.
7.15.2. Other training related to department like PPE, code red, emergency codes etc. will be given
to staff at the time of induction or as per hospital training calendar every year.
7.15.3. Staff will be provided with the training whenever any new BME equipment is added to the
hospital by the company engineer.
7.15.4. All staff will be trained to upgrade their skills for smooth operation, maintenance and
breakdown activities on a periodic basis.
Annexure-1
Biomedical engineering Breakdown & Response Time Record

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Complaint
Complaint Details

Example

Actual Complaint

Name of product

Syringe pump

Company name

Top

Model/Log No.

Top 20

Problem

Power supply

Caller

Mr. Danker

Department

ICU

Complaint Resolving Flow Chart

Complaint
Resolving Date/Time
Parameters

Remarks

Complain logged by SMS/ Phone

Complaint
Receiving
Person/Time
Updates/ Trailing call to the user
after inspection of the equipment
Departmental engineer called
Solved/ escalate the call.
Trailing call to user till problem
solved
Remarks by user department
on solving the complaint

Annexure-2

Calibration of Bio-Medical Equipment

S.NO
1
2

Equipmen
t

Make

Serial
no.

Locatio
n

Calibration
Done
Due date
date

Certificate
No.

Remark
s

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Comparative Statement
3
4
5 JIMS
6 Model Town, Hisar 125005
Phone01662-221169,220169,329868
7

Enquiry No -

Enquiry Due Date & Time -

Date -

Contact Person

Annexure-3
Biomedical Preventive Maintenance Schedule
Sr.
No.

Nameof the
Equipment

Dateof
Installation

Asset
I.D

Location

AMC/CMC/Ser
vices

Operational
Plan(SOP)

Preventive
Maintenance Plan
DONE
DATE

DUE
DATE

Annexure-5
Sr. No.

Description

Packaging
&Forwardin
g:
Sales Tax:

Excise Duty :

Recommendation:
Authorised By:

Supplier

Supplier

Payment
Terms :

Packaging &
Forwarding :

Freight :

Sales Tax:

Supplier

Excise
Duty :

Supplier
RATE

Paymen
t Terms:

Packaging &
Forwarding :

Freight
:

Sales Tax:

Checked by:

Break
down Plan

NCJIMCARE
&
OPJICACRE
HISAR
Prepared By:

REFERENCE No.
FMS. 4.a.b.c.d.e.f.g.h.i
MANUAL OF OPERATIONS:
BIOMEDICAL EQUIPMENT
PROGRAM

DOCUMENT No. (VERSION

No.)
DATE OF ISSUE:

(BME*) PAGE 15 of 17

NCJIMCARE

REFERENCE No.

DOCUMENT No. (VERSION

Annexure-6

12. L.iCstoonfditeemmnsattoiobnse acorendpeemrfonemdeadretwpicreepaaryeedabry departments with

34..ItCemonsdteombneecdointedmems naered arceepivheydsiicnatlhyecshtoercekeadndweithntleisrtdanind certifed by the condemnation of icer ap ointed
5. 6. Of ers ar(eJucnael andfrvoDamelucpeamortfbieesar)cfohristemli.ng the
78..PIfanrtey odfeer,insgechuigrihtyesitsthrdetsptsorsaitredgbisyteepr ebdyahnodsfpintalizAedmbiny sthreatHionspital
9.1F0i.nAalLyisgtoofdItsemacorsentdoabmnedneprdoocitvuermersdto.agh inpsatrtcyoannddemthneabtioanl insce payment is rec ived by
Fol w Purchtahseeparty Admin stra ion
tprepared(3hVeeancdoorusn)ts department
F lo w C h a r t

1.
2.
3.
4.

Check the following

Value of condemned items
Value of condemned items to be sold / buy-back from
Vendors