BIORAD MEDISYS PVT.

LTD, PUNE

Title : Design Verification Validation Report DOC: 504-DVR-FL60-00

PROTOCOL
STATUS
SR NO DRS ID REQUIREMENT DESCRIPTION TEST AIM PROCEDURE APPLICABLE EXPECTED BEHAVIOUR ACTUALHAVIOUR REMARKS/EVIDENCE
YES NO PASS FAIL

The Quantino laser system and its accessories are
intended to be used in surgical procedures using open,
laparoscopic, and endoscopic incision, excision,
resection, ablation, vaporization, coagulation and
1 DRS-FR-01
haemostasis of soft tissue and lithotripsy of stones in its intended use.
use in medical specialties including Urology, Thoracic
and Pulmonary, ENT, Neurosurgery, Gastroenterology,
Gynecology and General Surgery.
To check whether Thulium Laser functions according to 1. Send the system to User/Surgeorn.
2.verify the received Clinical evaluation feedback form
of Thulium fiber laser system.
The Quantino laser system and its accessories should be used
in surgical procedures using open, laparoscopic, and
endoscopic incision, excision, resection, ablation,
vaporization, coagulation and haemostasis of soft tissue and
YES
lithotripsy of stones in use in medical specialties including
Urology, Thoracic and Pulmonary, ENT, Neurosurgery,
Gastroenterology, Gynecology and General Surgery as per its
intended use.
The Quantino laser system and its accessories is able to be
used in surgical procedures using open, laparoscopic, and
endoscopic incision, excision, resection, ablation, vaporization,
coagulation and haemostasis of soft tissue and lithotripsy of Pass
stones in use in medical specialties including Urology, Thoracic Refer:Clinical evaluation report
and Pulmonary, ENT, Neurosurgery, Gastroenterology,
Gynecology and General Surgery as per its intended use.

2 DRS-OC-01 Medical fiber probe should be used for optical power To test that the laser system generates output power Inspect the fenestrated cup design and geometry as NO Medical fiber probe should be used for optical power delivery The fenestrated cup design and geometry is as per drawing. Pass Refer Drawing No:
delivery from laser system to end use in surgery. of 60W at 1940nm wavelength. per drawings. from laser system to end use in surgery. Batch manufacturing Record

3 DRS-OC-02 The Thulium Fiber Laser should generate 60W of optical To inspect the output optical power at 1940nm YES The Thulium Fiber Laser should generate 75W of optical The Thulium Fiber Laser is able to generate 75W of optical Pass
power at 1940nm wavelength. Wavelength. power at 1940nm wavelength. power at 1940nm wavelength.

1.Go to Login Page

Details of Surgeons profile, Procedure details, Patients To check whether the details of surgeon profile, 2.Select login as Surgeon and enter a Surgeon Name Details of Surgeons profile, Procedure details, Patients Profile Details of Surgeons profile, Procedure details, Patients Profile
4 DRS-UR-01 Procedure details, Patients Profile etc recorded in and proceed. YES Pass Usability Validation Report : 504-UVR-FL60
Profile etc should be recorded in the system. system. 3.Enter the Patient and procedure details followed by etc should be recorded in the system. etc gets recorded in the system.
press on proceed.

Individual passcodes are generated by Admin for all

5 DRS-UR-02 The system should have restricted access for various
types of user’s surgeon, Admin, maintenance.
types of users.
1.Go to Login Page
2.Select login as Surgeon/admin/maintenance and
To inspect the restricted access feature for various enter a Name and proceed. YES The system should have restricted access for various types of The system have restricted access for various types of user’s Pass Usability Validation Report : 504-UVR-FL60
types of user’s surgeon, Admin, maintenance. user’s surgeon, Admin, maintenance. surgeon, Admin, maintenance.
3.Enter the details as per the type of user followed by
press on proceed.
4. Enter the passwords as per the type of User's and
press proceed.

After entering the surgeons password, the procedure

tab apprears.
1. Select Stone option, Dusting and Fragmentation will
The surgeon should have options for selecting the mode To test the options for selecting the mode of Lasing appear and select tissue option, Ablation and The surgeon should have options for selecting the mode of
of Lasing technique such as Dusting/Fragmentation and technique such as Dusting / Fragmentation and Coagulation will appear on user interface. Lasing technique such as Dusting/Fragmentation and The surgeon is able to select the mode of Lasing technique
6 DRS-UR-03 YES such as Dusting/Fragmentation and Ablation/Coagulation both Pass Usability Validation Report : 504-UVR-FL60
Ablation/Coagulation both on the user interface and Ablation/Coagulation both on the user interface and 2. Press Pedal "A" to activate Dusting mode and Pedal Ablation/Coagulation both on the user interface and foot on the user interface and foot controls.
foot controls. foot controls. "B" to activate Fragmentation mode in stone option. controls.
3. Similarly, Press Pedal "A" to activate Ablation mode
and Pedal "B" to activate Coagulation mode in tissue
option.

Go to Procedure tab.
The system should allow the surgeon to have flexibility To test whether the system allows the surgeon to have 1.Adjust the Power, Frequency, aming beam intensity The system should allow the surgeon to have flexibility to The system allows the surgeon to flexibily adjust the
7 DRS-UR-04 by sliding the slider to and fro. YES Pass Usability Validation Report : 504-UVR-FL60
to adjust the parameters with ease. flexibility to adjust the parameters with ease. 2.Adjust the pulse modes, standyby & ready modes, adjust the parameters with ease. parameters with ease.
presets, auto manual etc by pressing the tabs.

During lasing procedure, the data automatically gets

logged in and reports get generated containing
Procedure ID, Date/Time, Patient ID, Surgeon Name,
Duration, Procedure, Preset(if applicable), Total
User should be able to generate a report and to save the To check whether the user is able to generate a report User should be able to generate a report and to save the User is able to generate a report and save the Surgical
8 DRS-UR-05 Surgical procedure data. and save the Surgical procedure data. energy. YES Surgical procedure data. procedure data. Pass Usability Validation Report : 504-UVR-FL60
1.Go to Procedure Tab
2.Perform Lasing at different settings and Parameters.
3.Go to Reports and check the lasing data reports
automatically generated.

1.Go to Procedure Tab

System should allow the user to see his last set
9 DRS-UR-06 parameters (during manual mode) during his next use.
To inspect whether the system allows the user to see
his last set parameters (during manual mode) during
his next use.
2.Perform Lasing at different settings and Parameters.
3.Switch Off the system after the procedure is
System should allow the user to see his last set parameters System allows the user to see his last set parameters (during
completed. YES (during manual mode) during his next use. manual mode) during his next use. Pass Usability Validation Report : 504-UVR-FL60
4. Again start the system and check the settings and
parameters. (The setting and parametes should be
same as his last set parameters)

System shall have emergency controls to continue 1.Scan the QR code.

10 DRS-UR-07 surgery during malfunctioning of the touch screen To test the emergency controls to continue surgery 2.The same UI will apprear on your phone screen. YES System shall have emergency controls to continue surgery System have emergency controls to continue surgery during Pass Usability Validation Report : 504-UVR-FL60
during malfunctioning of the touch screen display. during malfunctioning of the touch screen display. malfunctioning of the touch screen display.
display. 3.Operate the controls and continue to surgery.

1.Go to Reports tab.

The user should be able to transfer the last procedure To test whether the USB port is able to transfer the 2.Insert a device in the USB port The user should be able to transfer the last procedure data or
The user is able to transfer the last procedure data or a history
11 DRS-UR-08 data or a history of data from a particular date to last procedure data or a history of data from a 3.Select sort by "Date" YES a history of data from a particular date to another date via of data from a particular date to another date via USB port. Pass Usability Validation Report : 504-UVR-FL60
another date via USB port. particular date to another date. 4.Select the Start Date and End Date and click on USB port.
export.

To check whether the system allows the admin to 1. Select Login as Admin.
The system should allow the admin to create an account 2. Enter the Admin Name and Proceed. The system should allow the admin to create an account of The system allows the admin to create an account of the
12 DRS-UR-09 of the surgeon by adding details such as account name, create an account of the surgeon by adding details such 3. Select New Surgeons details and enter details such YES the surgeon by adding details such as account name, hospital surgeon by adding details such as account name, hospital Pass Usability Validation Report : 504-UVR-FL60
as account name, hospital name, Registration no,
hospital name, Registration no, password etc. password etc. as account name, hospital name, Registration no, name, Registration no, password etc. name, Registration no, password etc.
password etc. and press proceed.

UI should facilitate the adjustment of critical
parameters for the surgery such asPower, Energy,
13 DRS-UR-10
Frequency, aiming beam intensity, Lasing technique,
Type, Fiber identification etc.
To test whether the UI facilitates the adjustment of
critical parameters for the surgery such asPower,
Energy, Frequency, aiming beam intensity, Lasing
technique, Fiber identification.
Go to Procedure tab.
1.Adjust the Power, Frequency, aming beam intensity
by sliding the slider to and fro. UI should facilitate the adjustment of critical parameters for UI facilitates the adjustment of critical parameters for the
YES the surgery such asPower, Energy, Frequency, aiming beam surgery such asPower, Energy, Frequency, aiming beam Pass Usability Validation Report : 504-UVR-FL60
2.Adjust the pulse modes, standyby & ready modes, intensity, Lasing technique, Type, Fiber identification etc. intensity, Lasing technique, Type, Fiber identification etc.
presets, Lasing techniques auto manual etc by
pressing the tabs.

UI should have auto selection - pre-set program options To test whether the UI have auto selection - pre-set 1.Go to procedure tab UI should have auto selection - pre-set program options with UI have auto selection - pre-set program options with fixed
2.Select the Auto mode.
14 DRS-UR-11 with fixed value of energy, pulse mode & duty cycle for program options with fixed value of energy, pulse 3.By default fixed value of energy, pulse mode & duty YES fixed value of energy, pulse mode & duty cycle for particular value of energy, pulse mode & duty cycle for particular surgical Pass Usability Validation Report : 504-UVR-FL60
particular surgical procedure. mode& duty cycle for particular surgical procedure. surgical procedure. procedure.
cycle for particular surgical procedure appreas.

1.Go to procedure tab

2.Set the lasing parameters.
15 DRS-UR-12 UI should display all the parameters of the pre-set To test whether the UI displays all the parameters of 3.Click on Save Preset. YES UI should display all the parameters of the pre-set program as UI displays all the parameters of the pre-set program as per Pass Usability Validation Report : 504-UVR-FL60
program as per user's selection. the pre-set program as per user's selection per user's selection. user's selection.
4.The lasing parameters will get saved on the
procedure screen as default presets.

The system should have controls to facilitate the To inspect whether the system have controls to 1.Go to setting Tab. The system should have controls to facilitate the adjustment The system have controls to facilitate the adjustment of Audio,
16 DRS-UR-13 facilitate the adjustment of Audio, Lasing sound, 2.Adjust the Audio, Lasing sound, Brightness etc as per YES Pass Usability Validation Report : 504-UVR-FL60
adjustment of Audio, Lasing sound, Brightness etc. Brightness etc. requirement. of Audio, Lasing sound, Brightness etc. Lasing sound, Brightness etc.

System should have an electronic version of the To inspect whether the system have an electronic 1.Go to Help Tab. System should have an electronic version of the Instructions System have an electronic version of the Instructions for Use
17 DRS-UR-14 version of the Instructions for Use (IFU) and the 2.Click on the Instructions for Use (IFU) and YES Pass Usability Validation Report : 504-UVR-FL60
Instructions for Use (IFU) and the “Installation Manual" “Installation Manual" Installation Manual. for Use (IFU) and the “Installation Manual" (IFU) and the “Installation Manual"

System information should be displayed in one of the To check whether the system information is displayed 1.Go to Help Tab. System information should be displayed in one of the screens
18 DRS-UR-15 YES System information is displayed in one of the screens in the UI. Pass Usability Validation Report : 504-UVR-FL60
screens in the UI. in one of the screens in the UI 2.Click on the Machine Status. in the UI.

To test whether the display creates strain on User's 1.Go to setting Tab.
19 DRS-UR-16 The display should not create strain on User's eyes. 2.Adjust the Brightness usling slider bar as YES The display should not create strain on User's eyes. The display does not create strain on User's eyes. Pass Usability Validation Report : 504-UVR-FL60
eyes. requirement so as to not create strain on User's eyes.

To test whether system is not getting corrupted by

20 DRS-UR-17 System should not be corrupted by Malwares or Virus YES The biopsy forceps should be able to grasp the tissue. The biopsy forceps is able to grasp the tissue. Pass Usability Validation Report : 504-UVR-FL60
Malwares or Virus.

There should be a color identification to foot switch
21 DRS-UR-18 according to dusting/fragmentation and
Ablation/Coagulation techniques.
Take the foot switch and inspect the color and coding.
To check if there is a color identification to foot switch 1.Grey colour marked as "A" is for Dusting and
according to dusting/fragmentation and Ablation.
Ablation/Coagulation techniques. 2.Black colour marked as "B" is for Fragmentation and
Coagulation.
There should be a color identification to foot switch according
YES to dusting/fragmentation and Ablation/Coagulation There is a color identification to foot switch according to Pass Usability Validation Report : 504-UVR-FL60
dusting/fragmentation and Ablation/Coagulation techniques.
techniques.

1. Switch On the system.

22 DRS-UR-19 The system should show an indication that the system is To check if the system shows an indication that the 2.Blue colour led ring around the probe socket will YES The system should show an indication that the system is The system shows an indication that the system is started Pass Usability Validation Report : 504-UVR-FL60
started when mains are switched on. system is started when mains are switched on. started when mains are switched on. when mains are switched on.
glow.

The system should have physical key switch to ON and To check if the system have physical key switch to ON 1. Switch On the system. The system should have physical key switch to ON and OFF the The system have physical key switch to ON and OFF the laser
23 DRS-UR-20 OFF the laser system and secure the laser system and OFF the laser system and secure the laser system 2.Set all the parameters for lasing. YES laser system and secure the laser system against unauthorized Pass Usability Validation Report : 504-UVR-FL60
against unauthorized use. against unauthorized use. 3.Turn On the key switch and then the lasing will start. use. system and secure the laser system against unauthorized use.

1. Switch On the system.

To check if the system have an emergency stop button, 2.Set all the parameters for lasing.
The system should have an emergency stop button, to The system should have an emergency stop button, to The system have an emergency stop button, to immediately
24 DRS-UR-21 immediately interrupt the emission of laser radiation. to immediately interrupt the emission of laser 3.Turn On the key switch and start the lasing. YES immediately interrupt the emission of laser radiation. interrupt the emission of laser radiation. Pass Usability Validation Report : 504-UVR-FL60
radiation. 4.Press the emergency stop button, it will immediately
interrupt the emission of laser radiation.

The system should run auto-calibration before letting To test if the system run auto-calibration before letting
25 DRS-UR-22 YES
the system ready for surgery. the system ready for surgery.

1.Start the system

2.Connect the Foot pedal to the footswitch connector.
26 DRS-UR-23 There should be an indication symbol on the display To check if there is an indication symbol on the display 3. Indication symbol on the display which indicate the YES There should be an indication symbol on the display which There is an indication symbol on the display which indicate the Pass Usability Validation Report : 504-UVR-FL60
which indicate the status of foot pedal connection. which indicate the status of foot pedal connection. indicate the status of foot pedal connection. status of foot pedal connection.
status of foot pedal connection turns blue on
connection.

1.Start the system

2.Connect the Fiber probe to the optical fiber
27 DRS-UR-24 There should be an indication symbol on the display To check if there is an indication symbol on the display connector. YES There should be an indication symbol on the display which There is an indication symbol on the display which indicate the Pass Usability Validation Report : 504-UVR-FL60
which indicate the status of fiber probe connection. which indicate the status of fiber probe connection. 3. Indication symbol on the display which indicate the indicate the status of fiber probe connection. status of fiber probe connection.
status of fiber probe connection turns blue on
connection.
 1.Start the system and set all the parameters.
2.Do all the connections properly.
3. Turn On the key switch and keep the system in
28 DRS-UR-25 The system should have "Standby" and "Ready" state To check if the system have "Standby" and "Ready" Standby mode and try lasing, the lasing will not YES The system should have "Standby" and "Ready" state options. The system have "Standby" and "Ready" state options. Pass Usability Validation Report : 504-UVR-FL60
options. state options.
perfrom.
4.Press the Ready mode button and try lasing, lasing
will happen.

1.Start the system and set all the parameters.

29 DRS-UR-26 The system should get a beep sound each time when To test whether the system gets a beep sound each 2.Do all the connections properly. YES The system should get a beep sound each time when the foot The system gets a beep sound each time when the foot pedal Pass Usability Validation Report : 504-UVR-FL60
the foot pedal is pressed – or kept pressed. time when the foot pedal is pressed – or kept pressed. 3. Press the foot pedal, beep sound will appear each pedal is pressed – or kept pressed. is pressed – or kept pressed.
time when the foot pedal is pressed – or kept pressed.

1.Start the system and set all the parameters.

The laser system should be capable to carry out dusting To test whether the laser system is capable to carry out 2.Do all the connections properly. The laser system should be capable to carry out dusting and The laser system is able to carry out dusting and fragmentation
30 DRS-UR-27 and fragmentation of stones and ablation and dusting and fragmentation of stones and ablation and 3. Press the foot pedal and carry out dusting and YES fragmentation of stones and ablation and coagulation of tissue of stones and ablation and coagulation of tissue using dual Pass Usability Validation Report : 504-UVR-FL60
Refer Report :
coagulation of tissue using dual pedal foot switch. coagulation of tissue using dual pedal foot switch and . fragmentation of stones and ablation and coagulation using dual pedal foot switch. pedal foot switch.
of tissue using dual pedal foot switch.

During procedure, if any error occures, the data gets

System should have provision to create an "Error Log" To check if the system have provision to create an automatically logged in in the "error log".
31 DRS-UR-28 and should assist the user to solve the error or next "Error Log" and assist the user to solve the error or 1.Go to Settings YES System should have provision to create an "Error Log" and System have provision to create an "Error Log" and should Pass Usability Validation Report : 504-UVR-FL60
should assist the user to solve the error or next steps. assist the user to solve the error or next steps.
steps. next steps. 2.Go to Error Log and click on view error log.
Errors automartically saved will be listed and seen.

1.Go to the system.

The system should have a external USB communication To check if the system have a external USB 2.Connect a device in the USB port place on the front The system should have a external USB communication port The system have a external USB communication port for
32 DRS-UR-29 port for exporting the procedure data to a USB storage communication port for exporting the procedure data bezel. YES Pass Usability Validation Report : 504-UVR-FL60
drive. to a USB storage drive. 3.Detection of device will appear on the screen for for exporting the procedure data to a USB storage drive. exporting the procedure data to a USB storage drive.
transfer of data.

1.Go to the system.

2.Connect a device in the USB port place on the front
System should auto-detect the external USB storage To check if the system auto detects the external USB
33 DRS-UR-30 system storage system. bezel. YES System should auto-detect the external USB storage system System auto-detects the external USB storage system Pass Usability Validation Report : 504-UVR-FL60
3.Auto - Detection of device will appear on the screen
for transfer of data.

1.Start the system.

2.Connect the standard medical Fiber probe connector
34 DRS-UR-32 System should be compatible to standard medical fiber To check if the system is compatible to standard SMA905 to fiber port. YES System should be compatible to standard medical fiber probe System is compatible to standard medical fiber probe Pass Usability Validation Report : 504-UVR-FL60
probe connector SMA905 medical fiber probe connector SMA905. connector SMA905 connector SMA905
3. On connection, the status of fiber probe connection
turns blue.

1.Start the system and set all the parameters.

2.Do all the connections properly.
3. Press the foot pedal and carry out dusting and
35 DRS-UR-33 Enclosure shall facilitate air venting of hot air from the To check if the enclosure facilitate air venting of hot air fragmentation of stones and ablation and coagulation YES Enclosure shall facilitate air venting of hot air from the system Enclosure facilitates air venting of hot air from the system Pass Usability Validation Report : 504-UVR-FL60
system from the system.
of tissue using dual pedal foot switch.
4. Check the air vents for venting of hot air from the
system.

1.Start the system.

36 DRS-UR-34 System shall have a display unit of 10 inch with To check if the system have a display unit of 10 inch 2. Wear double rubber hand golves and try to touch YES System shall have a display unit of 10 inch with capacitive System have a display unit of 10 inch with capacitive Pass Usability Validation Report : 504-UVR-FL60
capacitive touchscreen. with capacitive touchscreen. touchscreen. touchscreen.
the display and set the parameters.
 Enclosure shall facilitate easy de-dusting and cleaning To test whether enclosure can be easily de-dusted and 1.De-Dust and Clean the system visible surface with Enclosure shall facilitate easy de-dusting and cleaning the Enclosure facilitates easy de-dusting and cleaning the visible Usability Validation Report : 504-UVR-FL60
37 DRS-UR-35 the visible surface with damp cloth. cleaned with damp cloth. damp cloth. YES visible surface with damp cloth. surface with damp cloth. Pass User Manual :
To check if the enclosure design shall facilitate easy 1. Open the back cover of the system.
38 DRS-UR-36 Enclosure design shall facilitate easy assembly and assembly and disassembly of the Components for 2.Slide the enclosure assembly backside and open the Yes Enclosure design shall facilitate easy assembly and Enclosure design facilitates easy assembly and disassembly of Pass Usability Validation Report : 504-UVR-FL60
disassembly of the Components for maintenance disassembly of the Components for maintenance. the Components for maintenance. User Manual :
maintenance enclosure.

1. Open the dust protector when the fiber optic

Enclosure design must facilitate a dust protector for the To check if the enclosure design facilitate a dust SMA905 is to be connected to the fiber connector. Enclosure design must facilitate a dust protector for the Fiber Enclosure design facilitates a dust protector for the Fiber Optic
39 DRS-UR-37 2.Close the dust protector when the fiber optic Yes Pass Usability Validation Report : 504-UVR-FL60
Fiber Optic SMA905 connector. protector for the Fiber Optic SMA905 connector. SAM905 connector is not connected to prevent dust Optic SMA905 connector. SMA905 connector.
from entering the system.

40 DRS-UR-38 The system should have label indications of safety, To check if the system have label indications of safety, 1.Check the system for safety, warning, cautions Yes The system should have label indications of safety, caution, The system have label indications of safety, caution, warning Pass Usability Validation Report : 504-UVR-FL60
caution, warning on the system for easy identification caution, warning on the system for easy identification labels. warning on the system for easy identification on the system for easy identification User Manual:

To inspect whether the system enclosure is light

41 DRS-MR-01 The system enclosure should be a light weight and weight and portable design & can be placed inside a 1.The system weight should be less than 50kg and NO The system enclosure should be a light weight and portable The system enclosure is light weight and portable design & can Pass Refer drawing :
portable design & to be placed inside a trolley bag. compact design to fit inside a trolley bag. design & to be placed inside a trolley bag. be placed inside a trolley bag. Refer weight report:
trolley bag.

42 DRS-MR-02 The enclosure shall be durable and rugged construction. To inspect whether the enclosure is durable and rugged 1.Conduct Packaging and Transportation Validation Yes The enclosure shall be durable and rugged construction. The enclosure is durable and rugged construction. Pass Packaging validation Report:
construction. test and Verify the test report as per the standard Transportation Validation report:

1.Check the position and dimensions of the

43 DRS-MR-03 The enclosure shall have an arrangement to facilitate To inspect if the enclosure have an arrangement to emergency switch provision on the front bezel as per NO The enclosure shall have an arrangement to facilitate The enclosure have an arrangement to facilitate placement of Pass Refer drawing :
placement of emergency switch. facilitate placement of emergency switch. placement of emergency switch. emergency switch. Refer BMR
drawing.

44 DRS-MR-04 The enclosure shall have an arrangement to facilitate To inspect if the enclosure have an arrangement to 1.Check the position and dimensions of the USB port NO The enclosure shall have an arrangement to facilitate The enclosure have an arrangement to facilitate placement of Pass Refer drawing :
placement of USB port. facilitate placement of USB port. provision on the front bezel as per drawing. placement of USB port. USB port. Refer BMR

The system shall have an arrangement to facilitate a To inspect if the system have an arrangement to 1.Check the position and dimensions of the foot pedal The system shall have an arrangement to facilitate a provision The system have an arrangement to facilitate a provision for Refer drawing :
45 DRS-MR-05 connection provision on the front bezel as per NO Pass
provision for foot pedal connection. facilitate a provision for foot pedal connection. drawing. for foot pedal connection. foot pedal connection. Refer BMR

The system shall have an arrangement to facilitate an To inspect if the system have an arrangement to 1.Check the position and dimensions of the foot pedal The system shall have an arrangement to facilitate an The system have an arrangement to facilitate an arrangement Refer drawing :
46 DRS-MR-06 connection provision on the front bezel as per NO Pass
arrangement for fiber probe connection. facilitate an arrangement for fiber probe connection. drawing. arrangement for fiber probe connection. for fiber probe connection. Refer BMR

The system shall have a provision to facilitate an To inspect if the system have a provision to facilitate an 1.Check the position and dimensions of the air vents The system shall have a provision to facilitate an arrangement The system have a provision to facilitate an arrangement for Refer drawing :
47 DRS-MR-07 provision on the enclosure assembly and back cover as NO Pass
arrangement for air vents. arrangement for air vents. per drawing. for air vents. air vents. Refer BMR

The system shall have an arrangement to facilitate To inspect if the system have an arrangement to 1.Check the position and dimensions of the 10 inch The system shall have an arrangement to facilitate placement The system have an arrangement to facilitate placement of 10 Refer drawing :
48 DRS-MR-08 placement of 10 inch with capacitive touchscreen facilitate placement of 10 inch with capacitive capacitive touchscreen display provision on the front NO Pass
display. touchscreen display. bezel as per drawing. of 10 inch with capacitive touchscreen display. inch with capacitive touchscreen display. Refer BMR

The Enclosure design must have an arrangement to To inspect if the Enclosure design have an arrangement 1.Check the position and dimensions of the dust The Enclosure design must have an arrangement to facilitate a The Enclosure design have an arrangement to facilitate a dust Refer drawing :
49 DRS-MR-09 facilitate a dust protector for the Fiber Optic SMA905 to facilitate a dust protector for the Fiber Optic protector for the Fiber Optic SMA905 connector NO Pass
connector. SMA905 connector. provision on the front bezel as per drawing. dust protector for the Fiber Optic SMA905 connector. protector for the Fiber Optic SMA905 connector. Refer BMR

The enclosure shall have an arrangement to facilitate To inspect if the enclosure have an arrangement to 1.Check the position and dimensions of the key switch The enclosure shall have an arrangement to facilitate The enclosure have an arrangement to facilitate placement of Refer drawing :
50 DRS-MR-10 provision on the enclosure assembly and back cover as NO Pass
placement of key switch. facilitate placement of key switch. per drawing. placement of key switch. key switch. Refer BMR

The enclosure shall have an arrangement to facilitate To inspect if the enclosure have an arrangement to 1.Check the position and dimensions of the EMI/EMC The enclosure shall have an arrangement to facilitate The enclosure have an arrangement to facilitate placement of Refer drawing :
51 DRS-MR-11 placement of EMI/EMC switch to connect the power facilitate placement of EMI/EMC switch to connect the NO placement of EMI/EMC switch to connect the power cable and EMI/EMC switch to connect the power cable and turn on the Pass
cable and turn on the switch. power cable and turn on the switch. switch provision on the back cover as per drawing. turn on the switch. switch. Refer BMR

1.Check the position and dimensions of the defined

The system shall have a defined space to place a QR To inspect if the system have a defined space to place a The system shall have a defined space to place a QR code
52 DRS-MR-12 code which acts as a smart mobile interface in case of QR code which acts as a smart mobile interface in case space to place QR code which acts as a smart mobile NO which acts as a smart mobile interface in case of display The system have a defined space to place a QR code which acts Pass Refer drawing :
interface in case of display malfunctions as per as a smart mobile interface in case of display malfunctions Refer BMR
display malfunctions of display malfunctions drawing. malfunctions

The system shall have an arrangement to facilitate To inspect if the system have an arrangement to
The system shall have an arrangement to facilitate placement The system have an arrangement to facilitate placement of a
placement of a blast shield to check any detection of facilitate placement of a blast shield to check any 1.Check the position and dimensions of the blast Refer drawing :
53 DRS-MR-13 efficiency decrease in laser emission or failures of the detection of efficiency decrease in laser emission or sheild placement provision as per drawing. NO of a blast shield to check any detection of efficiency decrease blast shield to check any detection of efficiency decrease in Pass Refer BMR
in laser emission or failures of the connected optical fibers. laser emission or failures of the connected optical fibers.
connected optical fibers. failures of the connected optical fibers.
To inspect if the enclosure have space to affix temper Refer drawing :
54 DRS-MR-14 Enclosure shall have space to affix temper proof labels. proof labels. 1.Check the labels positions as per drawings. NO Enclosure shall have space to affix temper proof labels. Enclosure have space to affix temper proof labels. Pass Refer BMR
The system shall have an arrangement to facilitate easy To inspect if the system have an arrangement to 1.Assemble the system as per drawings. The system shall have an arrangement to facilitate easy The system have an arrangement to facilitate easy assembly Refer drawing :
55 DRS-MR-15 assembly and disassembly .of the components for facilitate easy assembly and disassembly of the 2.Reverse the assembly procedure to disassemble the NO assembly and disassembly of the components for Pass
maintenance components for maintenance system. maintenance and disassembly .of the components for maintenance Refer BMR

Enclosure must meet Ingress protection standard of To test if the enclosure must meet Ingress protection of 1.Conduct the Ingress Protection test and Verify the
56 DRS-MR-16 IP20 IP20 as per IEC 60529 standard test report as per the standard IEC 60529. Yes Enclosure must meet Ingress protection standard of IP20 Enclosure meets Ingress protection standard of IP20 Pass Refer ingress Protection Report :

1.Check the position and dimensions of anti -skid Refer drawing :

The base of the enclosure shall have Anti-skid mounting To check if the base of the enclosure have Anti-skid mounting pads placement provision as per drawing.
57 DRS-MR-17 pads. mounting pads. 2.Place the system on a flat surface and push/ drag NO The base of the enclosure shall have Anti-skid mounting pads. The base of the enclosure have Anti-skid mounting pads. Pass Refer BMR
Refer report:
the system.

To inspect that the overall system weight does not

58 DRS-MR-18 Overall system weight shall not exceed 50kgs 1.Check the overall system weight NO Overall system weight shall not exceed 50kgs Overall system weight does not exceed 50kgs Pass Refer the system weight report:
exceed 50kgs.
Enclosure design shall facilitate safe mounting of all To inspect whether enclosure design facilitate safe Enclosure design shall facilitate safe mounting of all Enclosure design facilitate safe mounting of all components Refer drawing :
59 DRS-MR-19 components within the system. mounting of all components within the system. 1. Assemble the complete system as per drawings. NO components within the system. within the system. Pass Refer BMR
1.Check the position and dimensions of handles Refer drawing :
The enclosure shall have handle arrangement to To check whether the enclosure have handle provision as per drawing. The enclosure shall have handle arrangement to facilitate the The enclosure have handle arrangement to facilitate the
60 DRS-MR-20 facilitate the picking up of system. arrangement to facilitate the picking up of system. 2.Place the system on a flat surface and with the help NO picking up of system. picking up of system. Pass Refer BMR
Refer report:
of handles pick the system up.
The system shall have an arrangement to facilitate To check if the system have an arrangement to 1.Check the position and dimensions of the remote The system shall have an arrangement to facilitate connection The system have an arrangement to facilitate connection for Refer drawing :
61 DRS-MR-21 connection for remote interlock facilitate connection for remote interlock. interlock provision as per drawing. NO for remote interlock remote interlock Pass Refer BMR
To test if the optical engine have a compact and robust 1.Conduct transportation Validation test and Verify
62 DRS-OR-01 Optical engine shall have a compact and robust design. Yes Optical engine shall have a compact and robust design. Optical engine have a compact and robust design. Pass Refer Transportation Validation Report:
design. the test report as per the standard.

To inspect if the system have a medical grade SMPS to

System should have a medical grade SMPS to run laser 1.Check the MSDS for medical grade SMPS to run laser System should have a medical grade SMPS to run laser diode System have a medical grade SMPS to run laser diode (CCM)
63 DRS-OR-02 diode (CCM) and other supporting control systems. run laser diode (CCM) and other supporting control diode (CCM) and other supporting control systems. NO (CCM) and other supporting control systems. and other supporting control systems. Pass Refer MSDS
systems.

64 DRS-OR-03 Optical engine should have four numbers of fan To inspect if the optical engine have four numbers of 1.Check the Material data sheet. NO Optical engine should have four numbers of fan attached to Optical engine have four numbers of fan attached to heat sink Pass Refer drawing:
attached to heat sink with 56.5 CFM fan attached to heat sink with 56.5 CFM heat sink with 56.5 CFM with 56.5 CFM Refer MSDS
Optical engine should be kept safe in controlled To check if the optical engine is kept safe and not 1.Check the temperature and humidity of the
65 DRS-OR-04 NO Optical engine should be kept safe in controlled environment. Optical engine is kept safe in controlled environment. Pass Refer Temperature and humidity report
environment. exposed to heat or dust. controlled environment.
The Laser system shall use a Thulium Doped Fiber Laser To test the Laser system uses a Thulium Doped Fiber The Laser system shall use a Thulium Doped Fiber Laser The Laser system uses a Thulium Doped Fiber Laser working at
66 DRS-OR-05 working at 1.94-micron wavelength Laser working at 1.94-micron wavelength 1.Check the Wavelength Characteritisation report. YES working at 1.94-micron wavelength 1.94-micron wavelength Pass Refer Wavelength Characteritisation report

Laser shall be configured for both Dusting/ To test if the laser is configured for both Dusting/ Laser shall be configured for both Dusting/ Fragmentation and Laser is configured for both Dusting/ Fragmentation and
67 DRS-OR-06 Fragmentation and ablation/coagulation mode i.e., Fragmentation and ablation/coagulation mode i.e., 1.Check the temporal profile of output optical pulse. YES ablation/coagulation mode i.e., pulsed(QCW) and CW modes ablation/coagulation mode i.e., pulsed(QCW) and CW modes Pass Refer Temporal Profile Report
pulsed(QCW) and CW modes respectively. pulsed(QCW) and CW modes respectively. respectively. respectively.

68 DRS-OR-07 Laser system shall accommodate different sizes of To inspect if laser system accommodate different sizes 1. Check the compatibility of various Delivery fibers YES Laser system shall accommodate different sizes of Delivery Laser system accommodate different sizes of Delivery fibers Pass Refer Compatibility report
Delivery fibers e.g., 200, 365 & 550microns. of Delivery fibers e.g., 200, 365 & 550microns. with different core diameters. fibers e.g., 200, 365 & 550microns. e.g., 200, 365 & 550microns.

System shall have a provision for an aiming beam at To check if the system have a provision for an aiming System shall have a provision for an aiming beam at 520nm System have a provision for an aiming beam at 520nm (guide
69 DRS-OR-08 520nm (guide laser) to allow surgeon to position the beam at 520nm (guide laser) to allow surgeon to 1.Check the green guide laser beam through medical YES (guide laser) to allow surgeon to position the laser probe laser) to allow surgeon to position the laser probe before Pass Refer report
probe on white surface.
laser probe before active lasing. position the laser probe before active lasing. before active lasing. active lasing.

Optical characteristics and optical power shall be To verify the optical characteristics and optical power Optical characteristics and optical power shall be verified for Optical characteristics and optical power is verified for
70 DRS-OR-09 verified for optimum Dusting and Fragmentation and for optimumDusting and Fragmentation and ablation 1.Check reports of In-vitro trials. YES optimum Dusting and Fragmentation and ablation and optimum Dusting and Fragmentation and ablation and Pass Refer In-Vitro reports
ablation and coagulation in a Saline Solution and coagulation in a Saline Solution. coagulation in a Saline Solution coagulation in a Saline Solution

Laser shall not produce unwanted heat that can damage To test if the laser produce unwanted heat that can Laser shall not produce unwanted heat that can damage the Laser does not produce unwanted heat that can damage the
71 DRS-OR-10 the tissue during lithotripsy procedure. damage the tissue during lithotripsy procedure or not. 1.Check reports of In-vitro trials. YES tissue during lithotripsy procedure. tissue during lithotripsy procedure. Pass Refer In-Vitro reports

72 DRS-OR-11 Optical engine should give desired output power with To test optical engine gives desired output power with 1.Check output power Vs Current report. YES Optical engine should give desired output power with Optical engine gives desired output power with controlled Pass Refer output power Vs Current report
controlled input current. controlled input current. controlled input current. input current.
Optical engine should deliver output power after To test optical engine delivers output power after Optical engine should deliver output power after medical
73 DRS-OR-12 medical probe with minimum loss in coupler box to medical probe with minimum loss in coupler box to 1.Check output power Vs Current report. YES probe with minimum loss in coupler box to have a efficient Optical engine delivers output power after medical probe with Pass Refer output power Vs Current report
minimum loss in coupler box to have a efficient laser system.
have a efficient laser system. have a efficient laser system. laser system.

74 DRS-OR-13 There should be no overshoot and under shoot of the To test there is no overshoot and under shoot of the 1.Check the temporal profile of output optical pulse. NO There should be no overshoot and under shoot of the optical There is no overshoot and under shoot of the optical output in Pass Refer Temporal Profile Report
optical output in temporal profile of optical engine. optical output in temporal profile of optical engine. output in temporal profile of optical engine. temporal profile of optical engine.

To test if pump laser drivers are capable of driving the

Pump laser drivers should be capable of driving the laser Pump laser drivers should be capable of driving the laser Pump laser drivers is capable of driving the laser sources on a
88 DRS-ER-01 sources on a modulated manner having pulse width of laser sources on a modulated manner having pulse 1.Check the temporal profile of output optical pulse. NO sources on a modulated manner having pulse width of 0.25 to modulated manner having pulse width of 0.25 to 50ms and Pass Refer Temporal Profile Report
width of 0.25 to 50ms and frequency varying from 5 Hz
0.25 to 50ms and frequency varying from 5 Hz to 1 KHz to 1 KHz 50ms and frequency varying from 5 Hz to 1 KHz frequency varying from 5 Hz to 1 KHz

Adequate driver and controller of TEC required to To check if adequate driver and controller of TEC are
89 DRS-ER-02 maintain the temperature stability of the pump laser used to maintain the temperature stability of the pump
assembly. laser assembly.

Connect all the power cables and accessories with the

Controlled current source for guiding laser is required To check if controlled current source for guiding laser motherboard and make the power ON. Controlled current source for guiding laser is required which Controlled current source for guiding laser is capable of
90 DRS-ER-03 which will be capable of controlling the intensity of the required is capable of controlling the intensity of the 1. Go to Procedure tab on UI and change the intensilty NO Pass Refer report
same same. of aming beam. will be capable of controlling the intensity of the same controlling the intensity of the same
2.Observe the intensity of guide laser visually

91 DRS-ER-04 Ethernet connectivity should be there in the system. To check if ethernet connectivity is there in the system. 1.Connect the system with ethernet port to laptop
2.Check the IP address.
 1.Check the MSDS for components of
92 DRS-ER-05 Medical grade controlling system should be there. To check if medical grade controlling system is there. NO Medical grade controlling system should be there. Medical grade controlling system is there. Pass Refer MSDS
motherboard/SOM

Dual Foot Pedal Selectable switching circuit is required To check if dual Foot Pedal Selectable switching circuit 1.Test the footpedal connector with the system to Dual Foot Pedal Selectable switching circuit is required to Dual Foot Pedal Selectable switching circuit switches between
93 DRS-ER-06 to switch between CW and QCW modes. is required to switch between CW and QCW modes. change between CW and QCW modes. YES switch between CW and QCW modes. CW and QCW modes. Pass Usability Validation Report : 504-UVR-FL60

10.1", 1280*800 pixels, 16:9 colour TFT Display driving To inspect if 10.1", 1280*800 pixels, 16:9 colour TFT Connect all the power cables and display with the 10.1", 1280*800 pixels, 16:9 colour TFT Display driving circuit 10.1", 1280*800 pixels, 16:9 colour TFT Display driving circuit
94 DRS-ER-07 circuit is required along with driving circuit with Display driving circuit is used along with driving circuit motherboard and make the power ON. YES is required along with driving circuit with attached capacitive is required along with driving circuit with attached capacitive Pass Usability Validation Report : 504-UVR-FL60
attached capacitive touch panel with attached capacitive touch panel. 1. Go to UI and check the touch. touch panel touch panel

Connect all the power cables and emergency switch

95 DRS-ER-08 Driving electronic circuit is required for the functioning To inspect if driving electronic circuit is used for the with the motherboard and make the power ON. YES Driving electronic circuit is required for the functioning of Functioning of emergency switch is possible with driving Pass Usability Validation Report : 504-UVR-FL60
of emergency switch functioning of emergency switch. emergency switch electronic circuit.
1.Trigger emergency switch and check.

96 DRS-ER-09 EEPROM circuit arrangement is required to verify To inspect if EEPROM circuit arrangement is used to 1.Connect the probe to the system and check the YES EEPROM circuit arrangement is required to verify authorized EEPROM circuit arrangement verifies authorized Laser probes Pass Usability Validation Report : 504-UVR-FL60
authorized Laser probes verify authorized Laser probes probe indication on procedure tab. Laser probes
USB connectivity and supporting circuit is required for To inspect if USB connectivity and supporting circuit is 1.Connect the device to the USB port and check the USB connectivity and supporting circuit is required for USB connectivity and supporting circuit is able to diagnostic
97 DRS-ER-10 YES Pass Usability Validation Report : 504-UVR-FL60
diagnostic data transfer. used for diagnostic data transfer. auto detection of the device. diagnostic data transfer. data transfer.

Electronic circuit arrangement is required to ring a To inspect electronic circuit arrangement used to ring a 1.Connect the footpedal to the system and check the Electronic circuit arrangement is required to ring a buzzer Electronic circuit arrangement is able to ring a buzzer during
98 DRS-ER-11 buzzer during the time of foot pedal operation. buzzer during the time of foot pedal operation. beep sound on pressing the foot pedal. YES during the time of foot pedal operation. the time of foot pedal operation. Pass Usability Validation Report : 504-UVR-FL60

Wi-Fi connectivity should be enable for mirroring screen To verifiy if Wi-Fi connectivity is able to help for Wi-Fi connectivity should be enable for mirroring screen and Wi-Fi connectivity gets enable for mirroring screen and
1.Scan QR code on mobile device to get the UI control
99 DRS-ER-12 and controls on any authenticated mobile system(by mirroring screen and controls on any authenticated YES controls on any authenticated mobile system(by scanning controls on any authenticated mobile system(by scanning Pass Usability Validation Report : 504-UVR-FL60
scanning respective QR code) mobile system(by scanning respective QR code on mobile screen. respective QR code) respective QR code)

Key switch should be implemented to control the access To check if key switch is able to control the access of 1.Turn the key switch ON and OFF and check the Key switch should be implemented to control the access of
100 DRS-ER-13 YES Key switch is implemented to control the access of system Pass Usability Validation Report : 504-UVR-FL60
of system system. lasing. system

101 DRS-ER-14 EMI/EMC switch should be implemented for main To test if EMI/EMC switch is implemented for main 1.Connect the power cable to EMI/EMC switch and YES EMI/EMC switch should be implemented for main power EMI/EMC switch is implemented for main power control Pass Usability Validation Report : 504-UVR-FL60
power control power control. turn on the switch to power up the system. control

Thermally regulated exhaust fan should be To verify if thermally regulated exhaust fan is Thermally regulated exhaust fan should be implemented with Thermally regulated exhaust fan is implemented with low
102 DRS-ER-15 implemented with low noise temperature implemented with low noise temperature. 1.Check the noise with dB meter. NO low noise temperature noise temperature Pass Refer dB meter report

105 DRS-SR-01 System optics and photonics shall be in accordance with To test if system optics and photonics is in accordance 1.Conduct the test and Verify the test report as per Yes System optics and photonics shall be in accordance with Laser System optics and photonics is in accordance with Laser Pass Refer Report:
Laser standard iso 11145. with Laser standard iso 11145. the standard. standard iso 11145. standard iso 11145.

System shall be tested in accordance with IEC 60601-2-
22, Medical Electrical Equipment–Part 2-22: Particular
106 DRS-SR-02 Requirements for Basic Safety and Essential
Performance of Surgical, Cosmetic, Therapeutic and
Diagnostic Laser Equipment standards.
To test if the system is in accordance with IEC 60601-2-
22, Medical Electrical Equipment–Part 2-22: Particular
Requirements for Basic Safety and Essential
Performance of Surgical, Cosmetic, Therapeutic and
Diagnostic Laser Equipment standards.
1.Conduct the test and Verify the test report as per
the standard.
System shall be tested in accordance with IEC 60601-2-22,
Medical Electrical Equipment–Part 2-22: Particular
Yes Requirements for Basic Safety and Essential Performance of
Surgical, Cosmetic, Therapeutic and Diagnostic Laser
Equipment standards.
System is in accordance with IEC 60601-2-22, Medical
Electrical Equipment–Part 2-22: Particular Requirements for
Basic Safety and Essential Performance of Surgical, Cosmetic, Pass Refer Report:
Therapeutic and Diagnostic Laser Equipment standards.

System shall be tested in accordance with IEC 60601-1-
2, Medical Electrical Equipment – Part 1-2: General
107 DRS-SR-03 Requirements for Basic Safety and Essential
Performance – Collateral Standard: Electromagnetic
Disturbances – Requirements and Tests
To test if the system is in accordance with IEC 60601-1-
2, Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential
Performance – Collateral Standard: Electromagnetic
Disturbances – Requirements and Tests.
1.Conduct the test and Verify the test report as per
the standard.
System shall be tested in accordance with IEC 60601-1-2,
Medical Electrical Equipment – Part 1-2: General
Yes Requirements for Basic Safety and Essential Performance –
Collateral Standard: Electromagnetic Disturbances –
Requirements and Tests
System is in accordance with IEC 60601-1-2, Medical Electrical
Equipment – Part 1-2: General Requirements for Basic Safety
and Essential Performance – Collateral Standard: Pass Refer Report:
Electromagnetic Disturbances – Requirements and Tests

System shall be tested in accordance with IEC 60601-1-
6, Medical Electrical Equipment – Part 1-6: General
108 DRS-SR-04 Requirements for Basic Safety and Essential
Performance – Collateral Standard: Usability
To test is the system is in accordance with IEC 60601-1-
6, Medical Electrical Equipment – Part 1-6: General
Requirements for Basic Safety and Essential
Performance – Collateral Standard: Usability
1.Conduct the test and Verify the test report as per
the standard.
System shall be tested in accordance with IEC 60601-1-6,
Medical Electrical Equipment – Part 1-6: General
Yes Requirements for Basic Safety and Essential Performance –
Collateral Standard: Usability
System is in accordance with IEC 60601-1-6, Medical Electrical
Equipment – Part 1-6: General Requirements for Basic Safety Pass Refer Report:
and Essential Performance – Collateral Standard: Usability

System software shall be validated in accordance with To test if the system software is in accordance with IEC 1.Conduct the test and Verify the test report as per System software shall be validated in accordance with IEC System software is validated in accordance with IEC 62304,
109 DRS-SR-05 IEC 62304, Medical Device Software – Software Life 62304, Medical Device Software – Software Life Cycle Yes 62304, Medical Device Software – Software Life Cycle Pass Refer Report:
Cycle Processes. Processes. the standard. Processes. Medical Device Software – Software Life Cycle Processes.

System shall be tested in accordance with IEC 60825- To test if the system is in accordance with IEC 60825- 1.Conduct the test and Verify the test report as per System shall be tested in accordance with IEC 60825-1:2014, System is in accordance with IEC 60825-1:2014, Edition 3.0,
110 DRS-SR-06 1:2014, Edition 3.0, Safety of Laser Products – Part 1: 1:2014, Edition 3.0, Safety of Laser Products – Part 1: Yes Edition 3.0, Safety of Laser Products – Part 1: Equipment Safety of Laser Products – Part 1: Equipment Classification and Pass Refer Report:
Equipment Classification and Requirements. Equipment Classification and Requirements. the standard. Classification and Requirements. Requirements.

111 DRS-SR-07 System shall be tested in accordance with IEC 60529 To test if the system is in accordance with IEC 60529 1.Conduct the test and Verify the test report as per Yes System shall be tested in accordance with IEC 60529 Degrees System is in accordance with IEC 60529 Degrees of protection Pass Refer Report:
Degrees of protection provided by enclosures (IP code). Degrees of protection provided by enclosures (IP code). the standard. of protection provided by enclosures (IP code). provided by enclosures (IP code).

The system should meet the biocompatibility The system should meet the biocompatibility requirements as The system meets the biocompatibility requirements as per
112 DRS-SR-08 requirements as per ISO 10993-1 ,ISO 10993-5 , ISO To test the system as per ISO 10993-1 ,ISO 10993-5 , 1.Conduct the Biocomptability test and Verify the test Yes per ISO 10993-1 ,ISO 10993-5 , ISO 10993-7 , ISO 10993-10 , ISO 10993-1 ,ISO 10993-5 , ISO 10993-7 , ISO 10993-10 , ISO Pass Refer Biocompstibility Report:
ISO 10993-7 , ISO 10993-10 , ISO 10993-11. report as per the standard
10993-7 , ISO 10993-10 , ISO 10993-11. ISO 10993-11. 10993-11.

The system should be packed in box with foam backed To test whether the system packed in box with foam The system should be packed in box with foam backed heavy The system is packed in box with foam backed heavy duty
1.Conduct Packaging Validation test and Verify the test
113 DRS-PL-01 heavy duty plastic shipper box to protect it from backed heavy duty plastic shipper box protect it from Yes duty plastic shipper box to protect it from damage during Pass Refer Packaging Validation report:
damage during shipping. damage during shipping.
report as per the standard
shipping. plastic shipper box to protect it from damage during shipping.

Label Should be attached to the system containing all To inspect if the Labels are attached on the system Label Should be attached to the system containing all Label are attached to the system containing all important data Refer Drawing:
114 DRS-PL-02 important data for the identification of laser system and containing all inportant data for the identification of 1.Check the system for all labels as per drawings. Yes important data for the identification of laser system and for the identification of laser system and specifications of the Pass
specifications of the mains supply. lasre system and specifications of the mains supply. specifications of the mains supply. mains supply. Refer BMR:

To inspect if system Label have symbols such as

System Label should have symbols such as
Manufacturer, Date of Manufacture, Serial Number,
Model number, Laser Output, Operating Temperature,
115 DRS-PL-03 Mass of system, Protection, dispose conditions, CE mark
(if applicable), explanatory label such as Laser radiation,
Laser Class, Electrical Rating, Optical Rating, as warning
signs for laser beam output, Labelling of Laser stop etc.
Manufacturer, Date of Manufacture, Serial Number,
Model number, Laser Output, Operating Temperature,
Mass of system, Protection, dispose conditions, CE
mark (if applicable), explanatory label such as Laser
radiation, Laser Class, Electrical Rating, Optical Rating,
as warning signs for laser beam output, Labelling of
Laser stop etc.
System Label should have symbols such as Manufacturer, Date System Label have symbols such as Manufacturer, Date of
of Manufacture, Serial Number, Model number, Laser Output, Manufacture, Serial Number, Model number, Laser Output,
1.Check the symbols as per drawing and as per Operating Temperature, Mass of system, Protection, dispose Operating Temperature, Mass of system, Protection, dispose Refer Drawing:
Yes conditions, CE mark (if applicable), explanatory label such as conditions, CE mark (if applicable), explanatory label such as Pass
standards ISO 15223 Laser radiation, Laser Class, Electrical Rating, Optical Rating, as Laser radiation, Laser Class, Electrical Rating, Optical Rating, as Refer BMR:
warning signs for laser beam output, Labelling of Laser stop warning signs for laser beam output, Labelling of Laser stop
etc. etc.

Take the foot switch and inspect the color and coding.
1.Grey colour marked as "A" is for Dusting and
116 DRS-PL-04 Foot switch shall be marked for Dusting/ Fragmentation To inspect whether the foot switch is marked for Ablation. Yes Foot switch shall be marked for Dusting/ Fragmentation and Foot switch is marked for Dusting/ Fragmentation and Pass Refer Drawing:
and Ablation/coagulation or should be colour coded. Dusting and Fragmentation or colour coded. Ablation/coagulation or should be colour coded. Ablation/coagulation and also colour coded. Refer BMR:
2.Black colour marked as "B" is for Fragmentation and
Coagulation.

Label should be affixed on the foot switch containing To inspect if the label is affixed on the foot switch
necessary information such as Part Name/Code, Brand, containing necessary information such as Part Label should be affixed on the foot switch containing Label are affixed on the foot switch containing necessary Refer Drawing:
117 DRS-PL-05 1.Check the footswitch for all labels as per drawings. Yes necessary information such as Part Name/Code, Brand, information such as Part Name/Code, Brand, Connection Pass
Connection details, rating, and symbols for Name/Code, Brand, Connection details, rating, and Connection details, rating, and symbols for identification. details, rating, and symbols for identification. Refer BMR:
identification. symbols for identification.

1.Check the position and dimensions of the defined

118 DRS-PL-06 Screen mirroring QR code label should be on system To inspect the screen mirroring QR code label on the space to place QR code which acts as a smart mobile Yes Screen mirroring QR code label should be on system Screen mirroring QR code label is on system Pass Refer Drawing:
system. interface in case of display malfunctions as per Refer BMR:
drawing.

119 DRS-PL-07 The packaging should meet the packaging requirements To inspect that the system packaging meets ISO 11607- 1.Conduct the packaging validation test and Verify the Yes The packaging should meet the packaging requirements as per The packaging meets the packaging requirements as per ISO Pass Refer Packaging Validation report:
as per ISO 11607-1 and ISO 11607-2. 1 and ISO 11607-2 requirements. test report as per the standard ISO 11607-1 and ISO 11607-2. 11607-1 and ISO 11607-2.

120 DRS-PL-08 The labelling should comply the regulatory To inspect labels as pet the requirements. 1.Check the system for all labels as per standards Yes The labelling should comply the regulatory requirements (Ref The labelling complies the regulatory requirements (Ref Pass Refer Drawing:
requirements (Ref standard BS EN ISO 15223-1:2020) standard BS EN ISO 15223-1:2020) standard BS EN ISO 15223-1:2020) Refer BMR:

When transporting and storing the laser system, the To test if whether while transporting and storing the When transporting and storing the laser system, the When transporting and storing the laser system, the
1.Conduct transportation Validation test and Verify the
121 DRS-ST-01 temperature should be between -15 °C to +50 °C, the laser system, the temperature is between -15 °C to +50 test report as per the standard. Yes temperature should be between -15 °C to +70 °C, the relative temperature is between -15 °C to +70 °C, the relative humidity Pass Refer Transportation Validation report:
relative humidity 35% to 60% (non-condensing) °C, the relative humidity 35% to 60% (non-condensing) humidity 35% to 60% (non-condensing) 35% to 60% (non-condensing)

122 DRS-ST-02 The system should meet the transportation To inspect that the system meets transportation 1.Conduct transportation Validation test and Verify the
Yes The system should meet the transportation requirements as The system meets the transportation requirements as per Pass Refer Transportation Validation report:
requirements as per ASTM D4169. requirements as per ASTM D4169. test report as per the standard. per ASTM D4169. ASTM D4169.

123 DRS-RR-01 Shelf life of the product should be minimum -- year.

To inspect that the device is stored in controlled storage

124 DRS-ER-01 The system should meet the controlled storage To inspect that the system meet specified storage conditions as per requiements.
Yes
conditions. condition. 1.Take the laser system IFU and Label
2. Inspect for Symbol and statment for 'storage conditions'.