Reset Form Distribution:

1. Attachment to your Service Report

Print Form

System Check Out Protocol

CIRRUS Model 5000/500 and 4000/400

APPL. N/A
 Fill out chapter 1, 4, 5 and
  Installation
“Installation and Acceptance Report”
  Preventive Maintenance  Fill out chapter 2, 3, 4 and 5
  Corrective Maintenance  Fill out chapter 3, 4 and 5
  Safety Check  Fill out chapter 4 and 5
or or
  Safety Check with local report  Fill out local Check List
  Further documents attached

(The electrical safety test must be carried out in accordance with applicable local regulations and directives.)

System Serial Number: 5000-20359 Software Version 11.0.0.29946

Note:
For Model 5000/500 with any software version.
For Model 4000/400 with software version 6.0 and higher.

Note: Any section has to be filled in by marking "NA"(not applicable) or "OK" / "Not OK".
If you have to mark any check box "not OK", please explain in "Comments".

SM-30-5011-A05 System Check Out Protocol

Version 03, 2019-09-26 Page 1 / 10 CIRRUS Model 5000/500 and 4000/400
 Chapter 1

Follow CIR5-041 Installation Procedure

Product accessories used Type Serial number

Basic: OK Not OK
Table Maximum / Minimum Travel Verification  
Keyboard Installation  
Mouse Installation  
USB Wireless Network Adapter Installation  
External Fixation Installation  
Application Startup Checks Verification  
Instrument Alignment Test  
System Date & Time Verification  

Installation Only: N/A  OK Not OK

Installation and Acceptance Report
 
(CZM-4-50-00-01-TP-E-01)

Optional:
Network Configuration N/A  NA OK Not OK
Office Network Reconnected   
DICOM Gateway Configuration   
Connective Software (FORUM / EMR / Review Software)
  
Reconfigured

System Check Out Protocol SM-30-5011-A05

CIRRUS Model 5000/500 and 4000/400 Page 2 / 10 Version 03, 2019-09-26
 Chapter 2

Follow 2660021147634 CIRRUS Model 5000/500 Service Manual, Section 2

or 2660021146992 CIRRUS Model 4000/400 Service Manual, Section 2

Each year
Basic: OK Not OK
All external cable and cord connections secured  
Instrument powered from properly grounded AC outlet  
Instrument cooling vents unobstructed  
Chin Cup and Forehead Rest Clean  
Front Window Lens (Ocular Lens) Clean  
Instrument (Fan) Filter Clean  
Chapter 3 (Comprehensive) Completed  
PM Indicator Reset  

SM-30-5011-A05 System Check Out Protocol

Version 03, 2019-09-26 Page 3 / 10 CIRRUS Model 5000/500 and 4000/400
 Chapter 3
Follow CIR5-003 Checkout Procedure / CIRR-003 Checkout Procedure
Note: For this section, select BC checkbox (or complete BC field, if available) only if the test
passed without requiring calibration during System Checkout Protocol. Select AC checkbox (or
complete both BC and AC fields, if available) only if calibration was required during System
Checkout Protocol to pass.
* Note: For OCT SLD shutoff / maximum power, verify for either condition A or B. It is not
required to verify for both.

Basic: NA BC AC
Nominal OCT SLD Power Verification (540-660 uW) 623
Condition A *
 751
OCT SLD Shutoff Verification (675-825 uW)
Condition B *

Maximum OCT SLD Power Verification (640-775 uW)
Nominal LSLO SLD Power (900-1100 uW)  1230 1000
Maximum LSLO SLD Power (>900 uW)  2790
LSLO SLD Shutoff Verification (1200-1400 uW)

Note: For Model 4000 with LSLO SLD safety shutoff.

Basic (continued): NA OK Not OK

Watchdog Circuit Test  
Doppler Test  
Auto Coalignment Test   
SNR Test  
SNR at 250 A-Scan Depth > 28.00 (if AngioPlex is licensed)   
TestResults Collection  

Comprehensive: NA BC AC
Nominal OCT SLD Power Verification (540-660 uW) 623
Condition A *
 751
OCT SLD Shutoff Verification (675-825 uW)
Condition B *

Voltage Potentiometer (PD) Shutoff Verification
Condition B *

Voltage Potentiometer (PD) Adjustment (1.285 - 1.335 V)
Condition B *

Maximum OCT SLD Power Verification (640-775 uW)
Nominal LSLO SLD Power (900-1100 uW)  1230 1000

System Check Out Protocol SM-30-5011-A05

CIRRUS Model 5000/500 and 4000/400 Page 4 / 10 Version 03, 2019-09-26
Comprehensive: NA BC AC
Maximum LSLO SLD Power (>900 uW)  2970
LSLO SLD Shutoff Verification (1200-1400 uW)

Note: For Model 4000 with LSLO SLD safety shutoff.

Comprehensive (continued): NA OK Not OK

Watchdog Circuit Test  
Iris Viewer Alignment & Clocking Test  
Fixation Focus Test  
Fixation Alignment Test  
OCT-Fixation Alignment Test  
LSLO Line Focus Test   
Iris-LSLO Alignment Test   
Doppler Test  
Iris-OCT Alignment Test   
X&Y Galvo Scaling Test   
LSLO Scaling Test   
Auto Coalignment Test   
SNR Test  
SNR at 250 A-Scan Depth > 28.00 (if AngioPlex is licensed)   
External Anterior Segment Lenses Test   
TestResults Collection  
External Fixation Device Verification  
Instrument (Fan) Filter Verification  
Front Window Lens (Ocular Lens) Verification  
Application Startup Checks Verification  
OD and OS Chin Sensors Verification  
Scan Acquisition and Saving Verification  
Polarization Test  
Z-position Calibration Verification  

SM-30-5011-A05 System Check Out Protocol

Version 03, 2019-09-26 Page 5 / 10 CIRRUS Model 5000/500 and 4000/400
Optional:
Network Configuration N/A  NA OK Not OK
Office Network Reconnected   
DICOM Gateway Configuration   
Connective Software (FORUM / EMR / Review Software)
  
Reconfigured

Product accessories used Type Serial number

System Check Out Protocol SM-30-5011-A05

CIRRUS Model 5000/500 and 4000/400 Page 6 / 10 Version 03, 2019-09-26
 Chapter 4
 Reference “Installation and Acceptance Report”

 In addition follow your national regulations and if applicable all national standards!
CZ Service Customer*
The Safety test according to EN/IEC 62353 is performed by:  

* In case the customer is responsible, no further action is required from FSE, but it is mandatory to
add this information to your service report.

Visual inspection
N/A OK Not OK
(EN/IEC 62353)

 All marking, labels and labeling are present, complete and

legible
 All protective earth connections and power cords are
undamaged
 All externally accessible fuses comply with the manufacturer’s
specification
 The mechanical parts are undamaged --  
 No damage or contamination that may impair safety is present
 The associated accessories are tested together with the ME
equipment /ME system
 All accompanying system documentation is present, complete
and up to date

Protective earth impedance Max.

N/A OK Not OK
(EN/IEC 62353) (Class I) reading

ME equipment / system with power

connector (e.g. cold condition connector) ≤ 0.3 Ω   
and detachable power cord

ME equipment / system with non-detachable

≤ 0.3 Ω   
power cord

Permanently installed ME equipment/system

≤ 0.3 Ω   
(e.g. ceiling mount)

ME system with multiple connector (e.g.

≤ 0.5 Ω   
table & equipment)

Detachable power cords only ≤ 0.1 Ω   

SM-30-5011-A05 System Check Out Protocol

Version 03, 2019-09-26 Page 7 / 10 CIRRUS Model 5000/500 and 4000/400
Insulation resistance (optional)
Reading N/A OK Not OK
(EN/IEC 62353)

Measurement at 500 VDC ≥ 2 MΩ   

Leakage current Max.

N/A OK Not OK
(EN/IEC 62353) reading

Equipment leakage current

Differential measurement: Class I max. 500 µA   
Class II max. 100 µA

Direct measurement: Class I max. 500 µA

  
Class II max. 100 µA

Equivalent leakage current: Class I max. 1000 µA

  
Class II max. 500 µA

Leakage current of applied parts (BF type only)

  
Direct measurement: max. 5000 µA

Function test
N/A OK Not OK
(EN/IEC 62353)

Function test according to SM-30-8005-116 section 9.5

--  
incl. safety and warning functions

Further tested
functions/parameters:
  
________________________________________________________

System Check Out Protocol SM-30-5011-A05

CIRRUS Model 5000/500 and 4000/400 Page 8 / 10 Version 03, 2019-09-26
Chapter 5
Calibration
Test equipment used Type Serial number
valid until
Safety tester as per EN 62353
or VDE 0751 or EN 60601
Calibration
Accessories used Type Serial number
valid until

Calibration
Test equipment used Type Serial number
valid until
 Newport
Power Meter 0267L19R 2022-07-02
 Field Master
 LabMax
Power Meter Head  OP-2 VIS 0207L19R 2022-07-02

6617 2022-07-06
Tool Kit CIRRUS
Calibration
Accessories used Type Serial number valid until

Calibration
Test equipment used Type Serial number
valid until

Calibration
Accessories used Type Serial number
valid until

SM-30-5011-A05 System Check Out Protocol

Version 03, 2019-09-26 Page 9 / 10 CIRRUS Model 5000/500 and 4000/400
 Further annexes / reports relating to the test? Yes  No 

Which:

Additional tested
Type Serial number Result
equipment

Accessories:

Rating:

 No safety or functional deficiencies were detected; functional tests successfully completed

 No direct risk; the detected deficiencies can be quickly corrected (see service report)
 Substantial safety deficiencies. ME equipment/system must not be operated!

6 12 24 36 19.07.2022
Next repeat check is due in months or not later than ____________________
(mark as applicable)

Comments

Tested by Alexandru Stanescu

Stanescu Alexandru Alexandru
2021-07-19
Digitally signed by Stanescu

Date Signature ROSTAN

ROSTAN
Date: 2021.07.19 15:28:18 +03'00'

System Check Out Protocol SM-30-5011-A05

CIRRUS Model 5000/500 and 4000/400 Page 10 / 10 Version 03, 2019-09-26