Medical Device Inspection Form

Excimer Laser

Date: February 21, 2012

Inspector Name: John Doe

Manufacturer: Wavelight

Model: ALLEGRETTO

Serial number: xxxxx-xxxxx/xxxx

Year of manufacturing: 2005

Warranty period: None

Provided by: manufacturer / refurbisher / re-manufacturer / dealer / broker / other: N/A

Product status: operational / stored (from date: 05/2008) / packed / refurbish stage /
other: ________

System Components

Component Serial number Description Manufacturer

Laser system xxxx/xxxxx Wavelight 200 hertz Wavelight
excimer laser
Laptop N/A System laptop Sony
Patient bed N/A
Monitor N/A Eye tracker monitor
screen
Plume extractor N/A Fume extractor for
laser system
* Please specify name of component manufacturer, if defers from the manufacturer of the system

Device Documentation

Operation manual (please mark if available) Manual available

Technical manual (please mark if available) No
Log book (please mark if available) Any available sent electronically with report
Other documentation (if available) N/A
External Inspection

Excellent Very Good Good Fair Poor Comments

Cleanliness v
Condition of v Some minor blemishes
paint
Absence of rust v No corrosion
and corrosion
Integrity and v
condition of the
plastic parts
The operation v
panel condition
(including
indicators,
displays, meters,
switches and
controls)
Labeling of v
various functions
and parts (please
indicate condition
and whether
labels are
present or
missing)
Condition of N/A
transducers
Condition of v
accessories
Condition of v
cables
Proper motion of v
moving parts and
components (if
applicable)
Condition of N/A
casters and
brakes
If battery N/A
operated, please
check the battery
compartment for
signs of corrosion
Is there any None
evidence of
misuse or neglect
of the inspected
device?
Please note that most inspection tasks are device specific. Appropriate tasks are called out in the individual
procedures, or should be derived from device specification and an understanding of the devices clinical application and
design.
Please pay special attention for functional inspection and operational of the audible and visible alarms.
Functional Inspection

# Description of Pass Fail Comments

the function
1 Operation v Laser has not
been used much
since installation
but has had
regular laser gas
changes. Laser
energy is okay.
2
3
4
5
6
7
8
9
10

Electrical Safety Inspection

Tasks Results Comments

Ground leakage current machine partially dismantled
(microamp) for storage
Ground lead resistance
(ohm)
External breakers and fuses

EMC Performance Evaluation (if applicable)

Task Acceptable effect Unacceptable effect Comments

Interference N/A
susceptibility (please
use an electromagnetic
noise source, e.g. hand
held electric drill, etc.)
Emitted interference N/A
(please use a sensitive
RF detector, e.g. a
portable AM radio)

Notes (for additional findings and comments):

N/A

Summary / Conclusion / Recommendation:

System operates okay. Physical condition is good for age. Laser energy okay. System requires full
alignment prior to use owing to removal of laser head for relocation.
Please include photographs taken on the date of the inspection. Photos should cover all angles, depicting the system,
all its parts and accessories. This is necessary to document the system’s condition and functionality on the date of
inspection. In case a faulty or damaged system is received, the photograph may help determine if it was damaged
during shipping.

Number of photos taken:

* Please attach all relevant documents.

Total inspection time: 4 hours, including report preparation.

Inspector’s signature: John Doe

* MedWOW is not responsible for aspects of equipment, functionality, not specifically delimited as part of the inspection, as
stipulated in the inspection form.