RELISYS MEDICAL DEVICES LIMITED, HYDERABAD

Master Calibration List 2014-15

BALLOON DEPARTMENT
CALIBRATION DONE CALIBRATION DUE
S/N NAME OF THE INSTRUMENT MAKE LOCATION RANGE ACCURACY I.D NO
ON ON
1 Temperature Controller Omron Balloon Mfg 0 to 315°c ± 2 °C BBD/BS/TC-01 04 May 2014 03 May 2015
2 Temperature Controller Omron Balloon Mfg 0 to 315°c ± 2 °C BBD/BS/TC-02 04 May 2014 03 May 2015
3 Temperature Controller Omron Balloon Mfg 0 to 315°c ± 2 °C BBD/BBI/TC-01 04 May 2014 03 May 2015
4 Temperature Controller Omron Balloon Mfg 0 to 315°c ± 2 °C BBD/BBI/TC-02 04 May 2014 03 May 2015
5 Temperature Controller Omron Balloon Mfg 0 to 315°c ± 2 °C BBD/BBI/TC-03 04 May 2014 03 May 2015
6 Temperature Controller Cole Parmer Balloon Mfg 0 to 100°c ± 2 °C BBD/PT/TC-01 04 May 2014 03 May 2015
7 Temperature Controller Vertex Balloon Mfg 0 to 315°c ± 2 °C BBD/OV/TC-01 04 May 2014 03 May 2015
8 Pressure Gauge Ashcroft Balloon Mfg 0 to 100 Psi ± 2 psi BBD/BS/PG-01 04 May 2014 03 May 2015
2
9 Pressure Gauge Pneumatic Balloon Mfg 0 to 10 kg/cm² ±1 kg/cm BBD/PD/PG-01 04 May 2014 03 May 2015
10 Pressure Gauge Ashcroft Balloon Mfg 0 to 2000 psi ± 2 psi BBD/BBI/PG-01 04 May 2014 03 May 2015
11 Pressure Gauge Ashcroft Balloon Mfg 0 to 160 Psi ± 2 psi BBD/BBI/PG-02 04 May 2014 03 May 2015

PTCA Department
CALIBRATION DONE CALIBRATION DUE
S NO NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
ON ON
1 Pressure Gauge Ashcroft PTCA 0 to 160 Psi ± 2 psi BCA/MB/PG-01 04 May 2014 03 May 2015
2 Pressure Gauge Ashcroft PTCA 0 to 160 Psi ± 2 psi BCA/MB/PG-02 04 May 2014 03 May 2015
3 Pressure Gauge Ashcroft PTCA 0 to 160 Psi ± 2 psi BCA/DB/PG-01 04 May 2014 03 May 2015
4 Temperature Controller Omron PTCA 0 to 315°c ± 2 °C BCA/DB/TC-01 04 May 2014 03 May 2015
5 Digital Stop Watch Omron PTAC 0 to 60 min ± 2 sec BCA/DB/DSW-01 04 May 2014 03 May 2015
6 Pressure Gauge Ashcroft PTCA 0 to 160 Psi ± 2 psi BCA/HGW/PG-01 04 May 2014 03 May 2015
7 Temperature Controller Omron PTCA 0 to 315°c ± 2 °C BCA/HGW/TC-01 04 May 2014 03 May 2015
8 Digital Stop Watch Omron PTCA 0 to 60 min ± 2 sec BCA/HGW/DSW-01 04 May 2014 03 May 2015
9 Pressure Gauge Pneumatic PTCA 0 to 10 kg/cm² ±1 kg/cm2 BCA/PD/PG-01 04 May 2014 03 May 2015
2
10 Pressure Gauge Pneumatic PTCA 0 to 280 kg/cm² ±10 kg/cm BCA/GPL/01/PG-01 04 May 2014 03 May 2015
2
11 Pressure Gauge Pneumatic PTCA 0 to 280 kg/cm² ±10 kg/cm BCA/GPL/01/PG-02 04 May 2014 03 May 2015
12 Pressure Gauge Prama PTCA 0 to 25 kg/cm² ±1 kg/cm2 BCA/GPL/PG-01 04 May 2014 03 May 2015
13 SS Steel rule SS PTCA 0 to 150mm ± 0.1mm BCA/MS/01 25 July 2014 24 July 2015
14 SS Steel rule SS PTCA 0 to 300mm ± 01mm BCA/ST-01 04 May 2014 03 May 2015
15 SS Steel rule SS PTCA 0 TO 1000 MM ± 01mm BCA/ST-01 04 May 2014 03 May 2015
16 Timer Dymax PTCA 0 to 99.9 Sec ± 2 sec BCA/UV BAND/TM-01 04 May 2014 03 May 2015

DX DEPARTMENT
CALIBRATION CALIBRATION
S NO NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
DONE ON DUE ON
1 Ammeter Indotec Dx Room 0 to 10 A ± 1A DXC/IM/AM-01 04 May 2014 03 May 2015
2 Ammeter Meco-G Dx Room 0 to 10 A ± 1A DXC/IM/AM-02 04 May 2014 03 May 2015
3 Ammeter Meco-G Dx Room 0 to 10 A ± 1A DXC/IM/AM-03 04 May 2014 03 May 2015

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 RELISYS MEDICAL DEVICES LIMITED, HYDERABAD

4 Ammeter Meco-G Dx Room 0 to 10 A ± 1A DXC/IM/AM-04 04 May 2014 03 May 2015

5 Volt meter Meco-G Dx Room 0 to 500 V ± 5V DXC/IM/VM-01 04 May 2014 03 May 2015
2
6 Pressure Gauge Wika Dx Room 0 to 210 kg/cm² ±10 kg/cm DXC/IM/PG-01 04 May 2014 03 May 2015
7 Temperature Sensor Dx Room 0 to 300°c ± 5 °C DXC/IM/TS-01 04 May 2014 03 May 2015
8 Temperature Sensor Dx Room 0 to 300°c ± 5 °C DXC/IM/TS-02 04 May 2014 03 May 2015
9 Temperature Sensor Dx Room 0 to 300°c ± 5 °C DXC/IM/TS-03 04 May 2014 03 May 2015
10 Pressure Gauge Ashcroft Dx Room 0 to 30 Psi ± 2 psi DXC/SW/PG-01 04 May 2014 03 May 2015
11 Pressure Gauge Ashcroft Dx Room 0 to 30 Psi ± 2 psi DXC/SW/PG-02 04 May 2014 03 May 2015
12 Pressure Gauge Ashcroft Dx Room 0 to 15 psi ± 2 psi DXC/CG/PG-01 04 May 2014 03 May 2015
13 Pressure Gauge Ashcroft Dx Room 0 TO 160 Psi ± 2 psi DXC/CG/PG-02 04 May 2014 03 May 2015
14 Dial Gauge CDI Dx Room 0 to 50 mm ± 01mm DXC/CG/DG-01 04 May 2014 03 May 2015
2
15 Pressure Gauge Vac Pneumatic Dx Room 0 to 10 kg/cm² 1 kg/cm DXC/PD/PG-01 04 May 2014 03 May 2015
16 Temperature Controller Osworld Dx Room 0 to 60° C ± 2 °C DXC/OVE/TC-01 04 May 2014 03 May 2015
17 Pressure Gauge Ashcroft Dx Room 0 to 30 Psi ± 2 psi DXC/RFW/PG-01 04 May 2014 03 May 2015
18 Pressure Gauge Ashcroft Dx Room 0 to 30 psi ± 2 psi DXC/RFW/PG-02 04 May 2014 03 May 2015

EXTRUSION DEPARTMENT
CALIBRATION CALIBRATION
S NO NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
DONE ON DUE ON
1 Measuring Pin Gauge set FAE Extrusion 0.30 to 1 mm ± 0.002 mm EXT/PIN-01 03 May 2014 02 May 2015
2 Measuring Pin Gauge set FAE Extrusion 1.01 to 2.5 mm ± 0.002 mm EXT/PIN-02 03 May 2014 02 May 2015
3 Measuring Pin Gauge set FAE Extrusion 2.5 to 5 mm ± 0.002 mm EXT/PIN-03 03 May 2014 02 May 2015
4 RPM Indicators Collin Extrusion 0 to 100 Rpm ± 1 rpm EXT/E30/MTR/EM-01 04 May 2014 03 May 2015
5 RPM Indicators Collin Extrusion 0 to 100 Rpm ± 1 rpm EXT/EM/E16/TU-02 04 May 2014 03 May 2015
6 RPM Indicators Collin Extrusion 0 to 100 Rpm ± 1 rpm EXT/EM/TU-03 04 May 2014 03 May 2015
7 Temperature Sensor Collin Extrusion 0 to 50°c ± 2 °C EXT/E16/EZ1/TC-01 04 May 2014 03 May 2015
8 Temperature Sensor Collin Extrusion 0 to 50°c ± 2 °C EXT/E16/EZ2/TC-02 04 May 2014 03 May 2015
9 Temperature Sensor Collin Extrusion 0 to 100°c ± 2 °C EXT/E16/EZ3/TC-03 04 May 2014 03 May 2015
10 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E16/EZ4/TC-04 04 May 2014 03 May 2015
11 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E16/EZ5/TC-05 04 May 2014 03 May 2015
12 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E16/EZ6/TC-06 04 May 2014 03 May 2015
13 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E16/EZ7/TC-07 04 May 2014 03 May 2015
14 Temperature Sensor Collin Extrusion 0 to 50°c ± 2 °C EXT/E30/EZ1/TC-01 04 May 2014 03 May 2015
15 Temperature Sensor Collin Extrusion 0 to 50°c ± 2 °C EXT/E30/EZ2/TC-02 04 May 2014 03 May 2015
16 Temperature Sensor Collin Extrusion 0 to 100°c ± 2 °C EXT/E30/EZ3/TC-03 04 May 2014 03 May 2015
17 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ4/TC-04 04 May 2014 03 May 2015
18 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ5/TC-05 04 May 2014 03 May 2015
19 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ6/TC-06 04 May 2014 03 May 2015
20 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ7/TC-07 04 May 2014 03 May 2015
21 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ8/TC-08 04 May 2014 03 May 2015
22 Temperature Sensor Collin Extrusion 0 to 400°c ± 2 °C EXT/E30/EZ9/TC-09 04 May 2014 03 May 2015
23 Pressure Gauge Collin Extrusion 0 to 2.5 Bar ± 0.05 bar EXT/PG-01 04 May 2014 03 May 2015
24 Pressure Gauge Collin Extrusion 0 to 4 Bar ± 0.1 bar EXT/PG-02 04 May 2014 03 May 2015

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 RELISYS MEDICAL DEVICES LIMITED, HYDERABAD

25 Pressure Gauge Collin Extrusion 0 to 10 Bar ± 0.3 bar EXT/PG-03 04 May 2014 03 May 2015
26 Pressure Gauge Collin Extrusion 0 to 10 Bar ± 0.3 bar EXT/PG/04 04 May 2014 03 May 2015
27 Pressure Gauge Collin Extrusion 0 to 10 Bar ± 0.3 bar EXT/PG-05 04 May 2014 03 May 2015
28 Vacuum Gauge Collin Extrusion 0 to 10 Kpa ± 0.1 Kpa EXT/V.G/-01 04 May 2014 03 May 2015
29 Die Temperature Controller Collin Extrusion 0 to 400°c ± 2 °C EXT/DIA-TC-01 04 May 2014 03 May 2015
30 Die Temperature Controller Collin Extrusion 0 to 400°c ± 2 °C EXT/DIA-TC-02 04 May 2014 03 May 2015
31 Die Temperature Controller Collin Extrusion 0 to 400°c ± 2 °C EXT/DIA-TC-03 04 May 2014 03 May 2015
32 Furnace Temperature Controller Collin Extrusion 0 to 500°c ± 2 °C EXT/FTC-01 04 May 2014 03 May 2015
33 Water Temperature Controller Collin Extrusion 0 to 60°c ± 2 °C EXT/WTC-01 04 May 2014 03 May 2015
34 Process Temperature Controller Bry-Air Extrusion 0 to 200°c ± 3 °C EXT/DHD/PTC-01 04 May 2014 03 May 2015
35Deactivation Temperature Controller Bry-Air Extrusion 0 to 200°c ± 3 °C EXT/DHD/D.IN-TC-01 04 May 2014 03 May 2015
36Deactivation Temperature Controller Bry-Air Extrusion 0 to 200°c ± 3 °C EXT/DHD/D-OUT-TC-01 04 May 2014 03 May 2015

CHILLER PLANT
CALIBRATION CALIBRATION
S.NO NAME OF THE INSTRUMENT MAKE LOCATION RANGE ACCURACY ID.NO
DONE ON DUE ON
2
1 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-01 05 May 2014 04 May 2015
2
2 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-02 05 May 2014 04 May 2015
2
3 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-03 05 May 2014 04 May 2015
2
4 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-04 05 May 2014 04 May 2015
2
5 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-05 05 May 2014 04 May 2015
2
6 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-06 05 May 2014 04 May 2015
2
7 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-07 05 May 2014 04 May 2015
2
8 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-08 05 May 2014 04 May 2015
2
9 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-09 05 May 2014 04 May 2015
2
10 Presser gauge Forbes Marshal AHU-01 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-01/PG-01 05 May 2014 04 May 2015
2
11 Presser gauge Forbes Marshal AHU-01 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-01/PG-02 05 May 2014 04 May 2015
2
12 Presser gauge Forbes Marshal AHU-02 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-02/PG-01 05 May 2014 04 May 2015
2
13 Presser gauge Forbes Marshal AHU-03 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-03/PG-01 05 May 2014 04 May 2015
2
14 Presser gauge Forbes Marshal AHU-04 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-04/PG/01 05 May 2014 04 May 2015
2
15 Presser gauge Forbes Marshal AHU-05 0 to 10 kg/cm² ± 0.2 kg/cm ENG/AHU-04/PG-01 05 May 2014 04 May 2015
2
16 Presser gauge Forbes Marshal Chiller plant 0 to 10 kg/cm² ± 0.2 kg/cm ENG/CHIL/PG-10 05 May 2014 04 May 2015

STENT Department
CALIBRATION CALIBRATION
S NO NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
DONE ON DUE ON
0
1 Temperature Controller Omron Quarantine AMB to 99°c ±5C STENT/PRO/01/TC-01 06 May 2014 05 May 2015
0
2 Temperature Controller Omron Quarantine AMB to 99°c ±5C STENT/PRO/02/TC-01 06 May 2014 05 May 2015
3 Timer Esma Quarantine 0 to 99 min ±0.1sec STENT/PRO/02/TM-01 06 May 2014 05 May 2015
4 D.C Volt Meter Shurite Quarantine 0 to 25 V DC ±1V STENT/PRO/02/VM-01 06 May 2014 05 May 2015
5 D.C Ammeter Shurite Quarantine 0 to 10 A ±0.5Amp STENT/PRO/02/AM-01 06 May 2014 05 May 2015

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 RELISYS MEDICAL DEVICES LIMITED, HYDERABAD

0
6 Temperature Controller Autonics Quarantine AMB to 99°c ±5C STENT PRO/03/TC-01 06 May 2014 05 May 2015
7 Timer Esma Quarantine 0 to 60 min 0.1sec STENT/PRO/03/TM-01 06 May 2014 05 May 2015
8 D.C Volt Meter Shurite Quarantine 0 to 25 V DC ±1V STENT/PRO/03/VM-01 06 May 2014 05 May 2015
9 D.C Ammeter Shurite Quarantine 0 to 10A ±0.5Amp STENT/PRO/03/AM-01 06 May 2014 05 May 2015
0
10 Temperature Controller Autonics quarantine AMB to 99°c ±5C STENT/PRO/04/TC-01 06 May 2014 05 May 2015
11 D.C Volt Meter Shurite Quarantine 0 to 25 V DC ±1V STENT/PRO/04/VM-01 06 May 2014 05 May 2015
12 D.C Ammeter Shurite Quarantine 0 to 10 A ±0.5Amp STENT/PRO/04/AM-01 06 May 2014 05 May 2015
0
13 Temperature Controller N480D Quarantine 0 to 1200°c ±5C STENT/PRO/04/TC-01 06 May 2014 05 May 2015
2
14 Pressure Gauge Wika Oxy Cylinder 0 to 280 kg/cm² ±10 kg/cm STENT/PRO/06/PG-01 06 May 2014 05 May 2015
2
15 Pressure Gauge Wika Oxy Cylinder 0 to 280 kg/cm² ±10 kg/cm STENT/PRO/06/PG-02 06 May 2014 05 May 2015
2
16 Pressure Gauge Wika Ni Cylinder 0 to 280 kg/cm² ±10 kg/cm STENT/PRO/06/PG-03 06 May 2014 05 May 2015
2
17 Pressure Gauge Wika Ni Cylinder 0 to 280 kg/cm² ±10 kg/cm STENT/PRO/06/PG-04 06 May 2014 05 May 2015
0
18 Temperature Controller Carel Laser Cutting Room 10 to 200°c ±1C STENT/PRO/06/TC-01 06 May 2014 05 May 2015
2
19 Pressure Gauge Prama Laser Cutting Room 0 to 16 kg/cm² ±0.5 kg/cm STENT/PRO/07/PG-01 06 May 2014 05 May 2015
2
20 Pressure Gauge Prama Laser Cutting Room 0 to 16 kg/cm² ±0.5 kg/cm STENT/PRO/07/PG-02 06 May 2014 05 May 2015
2
21 Pressure Gauge Prama Laser Cutting Room 0 to 16 kg/cm² ±0.5 kg/cm STENT/PRO/07/PG-03 06 May 2014 05 May 2015
22 Temperature Controller Omron Crimping Room AMB to 99°c ±0.1°C STENT/CRI/01/TC-01 06 May 2014 05 May 2015
2
23 Digital Pressure Gauge Smc Crimping Room 0 to 10 kg/cm² ±0.1 kg/cm STENT/CRI/01/PG-01 06 May 2014 05 May 2015
2
24 Digital Pressure Gauge Smc Crimping Room 0 to 10 kg/cm² ±0.1 kg/cm STENT/CRI/01/PG-02 06 May 2014 05 May 2015
2 2
25 Pressure Gauge Prama Crimping Room 0 to 16 kg/cm ±0.5 kg/cm STENT /CRI/01/PG-01 06 May 2014 05 May 2015
26 Magnelic Gauge Magnahelic Crimping Room 0 to 25 mm WC ±1 mm WC STENT/CRI/01/MG-01 06 May 2014 05 May 2015
27 Laminar Air Flow Gauge Magnahelic Clean room 0 to 25mm WC ±1 mm WC STENT/PRO/CT/LAF/PG-01 06 May 2014 05 May 2015
28 Laminar Air Flow Gauge Magnahelic Clean room 1 to 25mm WC ±1 mm WC STENT/PRO/CT/LAF/PG-02 06 May 2014 05 May 2015
29 Pressure Gauge Ashcroft Clean room 0 to 10 Psi ±1 Psi STENT/PRO/CT/PG-01 06 May 2014 05 May 2015
30 Pressure Gauge Ashcroft Clean room 0 to 10 Psi ±1 Psi STENT/PRO/CT/PG-02 06 May 2014 05 May 2015
31 Pressure Gauge Prama Clean room 0 to 10 Psi ±1 Psi STENT/PRO/CT/PG-03 06 May 2014 05 May 2015
32 Pressure Gauge Vac Clean room 0 to 10 Psi ±1 Psi STENT/PRO/CT/PG-04 06 May 2014 05 May 2015
33 Pressure Gauge Ashcroft Clean room 0 to 10 Psi ±1 Psi STENT/PRO/CT/PG-02 06 May 2014 05 May 2015
34 Electronic Tensile testing Machine Instron Quarantine 2 KN ±10N STENT/PRO/TST/01 14 July 2014 13 July 2015
SUB STATION ROOM
CALIBRATION CALIBRATION
NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
DONE ON DUE ON
Substation
1 Ammeter Nippen 0 to 500 Amps ±2 A ENG/AM-01 06 May 2014 05 May 2015
(Stabilizer Panel)
Substation
2 Voltmeter Nippen 0 to 750 V ±2V ENG/VM-01 06 May 2014 05 May 2015
(Stabilizer Panel)
Substation
3 Ammeter Conzerv 0 to 500 Amps ±2 A ENG/A-/02 06 May 2014 05 May 2015
(Main Panel)
Substation
4 Voltmeter Conzerv 0 to 750 V ±2V ENG/VM-02 06 May 2014 05 May 2015
(Main Panel)
Substation
5 Ammeter Conzerv 0 to 500 Amps ±2 A ENG/AM-03 06 May 2014 05 May 2015
(Capacitor Panel)

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Substation
6 Voltmeter Conzerv 0 to 750 V ±2V ENG/VM-03 06 May 2014 05 May 2015
(Capacitor Panel)
Microbiology 2 2
7 Pressure Gauge Shreeji 0 to 2kg/cm ±0.05 Kg/cm QC/MIC/AUT/PG-01 06 May 2014 05 May 2015
(Autoclave)
Microbiology
8 Temperature Controller Ion 0 to 100° C ±2°C QC/MIC/INB/TC-01 06 May 2014 05 May 2015
(Cooling Incubator)
Microbiology(Lamin
9 Magnelic Gauge Minihelic 0 to 25 MM wc ±1 mm WC QC/MIC/LAF/MG-01 06 May 2014 05 May 2015
ar Flow
10 Pressure Gauge Ashcroft Engg Dept 0 to 160 Psi ± 1 Psi ENG/PG-01 06 May 2014 05 May 2015
11 Pressure Gauge Ashcroft Engg Dept 0 to 160 Psi ± 1 Psi ENG/PG-02 06 May 2014 05 May 2015
12 Digital Thermo Meter Schwille Engg Dept 50°C to 200° C ±2°C ENG/CR/TH-01 06 May 2014 05 May 2015
13 Magnelic Gauge Dwayer Stent Coating room 0 to 10 mm WC ±1 mm WC ENG/CT/MG-01 06 May 2014 05 May 2015
14 Magnelic Gauge Dwayer Balloon Mfg 0 to 10 mm WC ±1 mm WC ENG/BD/MG-01 06 May 2014 05 May 2015
15 Magnelic Gauge Dwayer Stent Crimping Dept 0 to 10 mm WC ±1 mm WC ENG/CR/MG-01 06 May 2014 05 May 2015
16 Magnelic Gauge Dwayer Microbiology 0 to 25 MM wc ±1 mm WC QC/MIC/LAF/MG-01 06 May 2014 05 May 2015
17 Weighing balance Sartorius Q.C. 1 mg to 200 g ±1 mg QC/MIC/WB-01 18 June 2014 17 June 2015
18 Temperature Controller Watlow R&D 0 to 40° c 0.1°C QC/LMS/TC-01 06 May 2014 05 May 2015
19 Pressure Gauge Ashcroft R&D 0 to 160 Psi ±5 psi QC/LMS/PG-01 06 May 2014 05 May 2015
20 Temperature Controller Tempo R&D 0 to 100 c ±2°C QC/PSC/TC-01 06 May 2014 05 May 2015
21 Humidity Controller Tempo R&D 20 to 70 %Rh ±5 %Rh QC/PSC/H.T.C-01 06 May 2014 05 May 2015
22 Ultra-Micro Balance Sartorius Stent Coating room 0 to 2 g ± 0.001 mg QC/MIC/WB-02 18 June 2014 17 June 2015
23 Weighing balance Tulaman Stores 0 to 50 Kg ± 1 gm STR/WB/01 24 January 2014 23 January 2015
ETO DEPARTMENT
CALIBRATION CALIBRATION
S NO NAME OF THE INSTRUMENT MAKE LOCATOIN RANGE ACCURACY I.D NO
DONE ON DUE ON
2
1 Compound Gauge Forbes Marshall ETO -1 to 6kg/cm² ± 0.05 Kg/cm ETO/CG-01 05 May 2014 04 May 2015
2
2 Compound Gauge Forbes Marshall ETO -1 to 6kg/cm² ± 0.05 Kg/cm ETO/CG-02 05 May 2014 04 May 2015
2
3 Compound Gauge Forbes Marshall ETO -1 to 6kg/cm² ± 0.05 Kg/cm ETO/CG-03 05 May 2014 04 May 2015
2
4 Compound Gauge Forbes Marshall ETO -1 to 6kg/cm² ± 0.05 Kg/cm ETO/CG-04 05 May 2014 04 May 2015
2
5 Pressure Gauge Forbes Marshall ETO 0 to 6 kg/cm² ± 0.05 Kg/cm ETO/PG-01 05 May 2014 04 May 2015
2
6 Pressure Gauge PALL ETO 0 to 16kg/cm² ± 0.05 Kg/cm ETO/PG-02 05 May 2014 04 May 2015
2
7 Pressure Gauge Vac Pneumatic OLD ETO 0 to 10kg/cm² ± 0.05 Kg/cm OETO/PG-01 05 May 2014 04 May 2015
2
8 Pressure Gauge Forbes Marshall ETO 0 to 6 kg/cm² ± 0.05 Kg/cm ETO/VC/PG-01 05 May 2014 04 May 2015
2
9 Pressure Gauge Vac Pneumatic ETO 0 to 10kg/cm² ± 0.05 Kg/cm ETO/VC/PG-02 05 May 2014 04 May 2015
10 Temperature Controller Radic ETO 0 to 200°c ±1°C ETO/TC-01 05 May 2014 04 May 2015
11 Temperature Controller Radic ETO 0 to 200°c ±1°C ETO/TC-02 05 May 2014 04 May 2015
12 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-01 05 May 2014 04 May 2015
13 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-02 05 May 2014 04 May 2015
14 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-03 05 May 2014 04 May 2015
15 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-04 05 May 2014 04 May 2015
16 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-05 05 May 2014 04 May 2015
17 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-06 05 May 2014 04 May 2015
18 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-07 05 May 2014 04 May 2015

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19 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-08 05 May 2014 04 May 2015
20 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-09 05 May 2014 04 May 2015
21 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-10 05 May 2014 04 May 2015
22 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-11 05 May 2014 04 May 2015
23 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-12 05 May 2014 04 May 2015
24 Temp Sensor HI-TECK ETO 0 to 200°c ±1°C ETO/FL/TS-13 05 May 2014 04 May 2015
25 Temperature Controller Prima OLD ETO 0 to 100°c ±1°C OETO/TC-01 05 May 2014 04 May 2015
26 Temperature Controller U-CON-96D OLD ETO 0 to 100°c ±1°C OETO/TC-02 05 May 2014 04 May 2015
2
27 Pressure Gauge Vac Pneumatic OLD ETO 0 to 16kg/cm² ± 0.05 Kg/cm OETO/PG-01 05 May 2014 04 May 2015
2
28 Compound Gauge Vac OLD ETO -1 to 2kg/cm² ± 0.05 Kg/cm OETO/CG-01 05 May 2014 04 May 2015
29 Weighing balance kissan OLD ETO 0 to 300 kgs 5 gm OETO/WB-01 05 May 2014 04 May 2015

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 RELISYS MEDICAL DEVICES LIMITED
DEPARTMENT: QA
PRODUCT FEEDBACK ANALYSIS

PRODUCT FEEDBACK REPORT SEQUENTIAL No.: FY2014-15/65

Device Name Release-R Description 2.50X10 Mfg. Date 2014-07
Serial Number 25010110714005 Lot Number 411011026 Exp. Date 2016-06
Distributor: Nirmayi Biomed
Name of Complainant: Sri Sai Baba Hospital Date Received: 02-11-2014
Complainant Address: Shiridi, Maharastra

A. Event Description:
In the event of coronary stenting (radial catheterization), the Interventional cardiologist
complained of proximal shaft breakage during the procedure. No other details are available either
from the Operator or Hospital on the event. Later the same lesion in the patient was predilated
with a semi- compliant balloon and another stent - delivered and deployed successfully.

B. Manufacturer Evaluation
Unimplanted Stent and SDS was received / inside a plastic bag with the outer pack from the affiliate.

Image: 1 Complained pack as received from the affiliate showing the serial and lot no.

Page 1 of 3
 RELISYS MEDICAL DEVICES LIMITED
DEPARTMENT: QA
PRODUCT FEEDBACK ANALYSIS

a. Physical verification – Stent, Hub, distal shafts were intact and the proximal shaft was broken
near to hub. 0.36mm Guide wire was compatible.

Image: 2 Microscopic Image ( 40X) of the broken proximal shaft as a result of excessive
Stress - Push- Force - fatigue

b. Review of Manufacturing and Inspection Records Review of feedback sample Lot (No
411011026) revealed no anomalies during the manufacturing and inspection processes that
can be associated with the reported feedback. No other issues were noted that were
considered potentially related to the reported feedback.

c. No non - conformance records were issued for these lots for Proximal shaft brekage, Stent
dislodgement, Crossing profile, guide wire incompatibility, Inflation/deflation and balloon
burst test results were reviewed and no anomalies were encountered during manufacturing
process of this lot.

d. No non - conformance records were issued for these lots for stent material selection, stent
manufacturing process and stent QC tests like Stent recoil - meet the specifications.

e. Functional test, leak test and 100% inspection results were reviewed and no anomalies were
found.

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