endoSTORE vertical Qualification Report Ver 02 Rev 02 Sept 2017

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Qualification plan IQ-OQ-PQ Client Contact person Equipment location Manufacturer Equipment / Model Serial number Date Inspector Cycle of performance qualification

Name

Checklist / Protocol

Referred

1. IQ

1.1 Installation preparation

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Installation qualification (page 3 -7)

1.2 Briefing protocol

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2.1 Operation / Acceptance protocol

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Performance qualification (page 9)

3.1 Performance protocol

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4. Reference to routine tests

Routine tests Optional routine tests

2. OQ Operation qualification (page 8)

3. PQ

(page 10)

(according to DIN EN 16442:2015)

5. Attachment

Product documentation

(page 11)

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Notes:

Customer: ………….……………………………………………

Technician: ………….………………………………………………..

(Date, Signature)

(Date, Signature)

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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1. IQ – Installation qualification 1.1 Checklist installation preparation Technical specifications

OK

1. General

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1.1 Dimensions: 100x225x69 cm

1.7 Input power: 145 W / heat emission

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2. Air supply

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2.1 Compressed air quality: ISO 8573-1:2010 class 1.4.1 2.2 Consumption: max. 200 l/min (ANR), 33 l/min @ 5 bar

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2.4 Nominal size (DN): ¼” or 6 mm inner diameter (max. 2 m, min. 10 bar) or DIN 13260-2 profile 2

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3. Electrical power supply

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3.1 100-240 VAC +/- 10 %, 50/60 Hz, 16 A (FI Fuse)

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3.2 Outlet should be located within the operator’s reach or emergency stop

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4. Endoscope and user information

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4.1 Endoscope data

4.3 Contact data of contact person

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5. Interface

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5.1 LAN connection (1xRJ45)

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5.2 Network settings ▪ IP address ▪ TCP-Ports: 80, 20, 21, 445, 1433, 1034, 37223 ▪ UDP-Ports: 80, 1900 ▪ LM-authentication for network logons

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1.2 Minimum ceiling height: 285 cm 1.3 Minimum door width: 95 cm (incl. packaging) 1.4 Weight: 315 kg (incl. packaging 550 kg) 1.5 Operating temperature: 10 °C to 40 °C 1.6 Relative humidity: 10 % to 75 %

2.2 Air pressure: 5-10 bar (73-145 psi)

4.2 User data

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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optional

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1.2 Briefing protocol Briefing

Instructed

1. Health and safety briefing

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1.1 The device may only be operated by authorized and instructed personnel

1.4 The device may only be used in a proper condition

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2. Device function

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2.1 Circulation of filtered air in all channels of flexible endoscopes (e.g. biopsy, water, jet channel) of every manufacturer after reprocessing

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2.2 Circulation of filtered air in the interior space of the cabinet – Module supports external drying (adjustable in the process settings)

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2.3 Safe depository for the endoscopes in lying/horizontal position

2.6 Three different air pressures (adjustable in the process settings)

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2.7 Reduction of the air pressure reaching a minimum time of circulation (adjustable in the process settings)

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2.8 Documentation of endoscope and slot via bar code reader, time measurement for drying

2.15 Recording of all process data in log file

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3. Connections

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3.1 Power cable 230 V

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1.2 Please read the respective user manual before operation carefully 1.3 Only use endoscopes which have been previously reprocessed or cleaned and disinfected

2.4 Adaption in the drawer via transport cassette 2.5 Interface between reprocessing and operating room (two-sided version)

2.9 Warning in case of failure or exceeded storage time (> 72 h or adjustable in the process settings) 2.10 Door lock (user authorization via bar code reader) (two-sided version optional) 2.11 Touch display / bar code reader (two-sided version optional) 2.12 Equipping detection 2.13 Time recording per adapted slot 2.14 Visualization of drying time for reprocessing and operating room (optional)

3.2 Pneumatic connection 3.3 LAN connection

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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Briefing

Referred

4. Accessories

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4.1 Bar code reader / -holder / -helix cable

4.3 Brief instruction

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5. Device operation

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5.1 Preparation

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5.1.1 Import endoscope data

5.1.7 Activate and set add-ons

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5.2 Insert endoscope

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5.2.1 Log in via barcode scanner

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4.2 Operating manual

5.1.2 Import user data 5.1.3 Set date and time 5.1.4 Set language 5.1.5 Set process parameter 5.1.6 Set maximum storage time (definition by operator / hospital hygiene)

5.2.2 Open the door 5.2.3 Scan the endoscope 5.2.4 Hang in the endoscope 5.2.5 Connect the connector 5.2.6 Scan the slot 5.2.7 Close the door 5.2.8 Check the display

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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Briefing

Referred

5.3 Unload endoscope

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5.3.1 Log in via barcode scanner

5.3.7 Check the display

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6. Cleaning

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6.1 Cleaning cabinet 6.2 Cleaning slots

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7. Notifications

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7.1 Pressure malfunction

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5.3.2 Open the door 5.3.3 Scan the endoscope 5.3.4 Enter or scan patient’s data (optional) 5.3.5 Disconnect the connector and unload the endoscope 5.3.6 Close the door

7.2 Power failure 7.3 Door is not closed 7.4 Troubleshooting

Briefed by

Name:…………….…………………………………………. (Date, Signature)

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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Briefing: Date: Endoscope storage cabinet with drying function Authorised and instructed user name

Departement

Siganture

With his signature the instructed person confirms, that the content of the briefing has been understood.

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2. OQ – Operation qualification 2.1 Operation / Acceptance protocol / Maintenance protocol Tests (see “Service Manual”)

OK

Note

1. General visual inspection

Value:

3. Air changes: > 160 l/min (ANR), 0,5 bar, full load

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4. Air quality: Visual inspection of filter. Free of particles and oil after 1 hour of operation (> 100 l/min (ANR))

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5. Humidity < 10 % after 1 hour of operation (> 100 l/min (ANR)) 6. Channel aeration test (EN 16442 chapter 6.7) Check for air bubbles from a glass of water

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7. Drying phase 1 (0,5 bar)

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2. Value pressure controller: 5-10 bar

8. Drying phase 2 (0,3 bar) 9. Storage phase (0,1 bar) 10. Pressure controller setting: min. 4,9 bar 11. Pressure controller setting: max. 10 bar 12. Filter pneumatic module (1 pc.) / Filter fan (4 pc.) 13. Warning check #003 (Failure input pressure) 14. Check the function of the inlet air pin 15. Check the flow rate of each nozzle 17. Function of the rotating module 18. Check of tubes and connections 19. Check door hinges, adjust if necessary 20. Check latching mechanism 21. Visual check of the sealing lips 22. Check bar code reader cable and plug 23. Functionality of bar code reader and touch display 24. If necessary, update software (check version) 25. Check inlets / outlets (via Diagnostic Menu)

with option sensors

with option sensors

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This confirms that the installation and the commissioning were completed to our satisfaction.

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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3. PQ – Performance qualification 3.1 Performance protocol Tests: Flow rate test

OK

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(according to Service Manual)

Air quality of the inlet air, moisture content (according to ISO 8573-3) Check for ISO 8573-1:2010 at least class 4 Air quality of the inlet air, oil content (according to ISO 8573-2) Check for ISO 8573-1:2010 class 1

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Air quality of the inlet air, particle contamination (according to ISO 8573-4) Check for ISO 8573-1:2010 class 1 Contamination levels on inside surfaces (EN 16442 chapter 6.5 or ATP-smear) ATP testing surface threshold 0-5 good, 6-25 attention, >25 failure [RLU] endoscope threshold 0-25 good, 26-50 attention, >50 failure [RLU] Air quality of the air in the cabinet, particle contamination ISO 14644: check for class 8

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Optional tests:

Referred

Drying function (EN 16442 chapter 6.4.3 and 6.4.4) After drying phase check inside and outside. After 1 h blow the internal channels of the endoscope on blotting paper, after 3 h wipe off exterior on blotting paper. Airborne microbial contamination (EN 16442 Attachment C) Maintaining the quality of the endoscopes (EN 16442 Attachment E.2)

Qualification report IQ-OQ-PQ – endoSTORE® vertical

Note

Note

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4. Reference to routine tests Routine tests according to DIN EN 16442:2015 Air quality of supply air, moisture content (according to ISO 8573-3) Air quality of supply air, oil content (according to ISO 8573-2) Air quality of supply air, particle contamination (according to ISO 8573-4) Air quality of the air in the cabinet, particle contamination ISO 14644: check for class 8 Microbiological quality of the endoscope (EN 16442 conditioning E.2) Smear for maximum storage time

Referred

Optional routine tests according to DIN EN 16442:2015 Drying function (according to EN 16442 chapter 6.4.3 and 6.4.4) Channels of endoscope after 1 h Exterior surface of endoscope after 3 h Channel aeration (EN 16442 section 6.7) Check for air bubbles from a glass of water Microbiological contamination of the inner surfaces (EN 16442 chapter 6.5 or ATP-smear) ATP testing Surface threshold 0-5 good, 6-25 attention, >25 failure [RLU] Endoscope threshold 0-25 good, 26-50 attention, >50 failure [RLU] Airborne microbial contamination (EN 16442 Attachment C)

Referred

Qualification report IQ-OQ-PQ – endoSTORE® vertical

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5. Attachment 5.1 Declaration of conformity 5.2 Certificate EN 16442 5.3 Certificate EMC 5.4 Operating manual 5.5 Service manual

ESCAD Medical GmbH Zur Öhmdwiesen 5 D-88633 Heiligenberg Germany phone +49 7554 9999 500 fax +49 7554 9999 558 www.escad-medical.com [email protected] Qualification report IQ-OQ-PQ – endoSTORE® vertical

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