Volk Pictor Plus User manual

USER’S MANUAL
Volk Pictor Plus
Digital Imaging Device

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THIS SALES PACKAGE INCLUDES:
Pictor Plus camera with optics lenses and accessories:
Model:
Description:
Accessories
Retina Module (VP2RET)
Module for eye fundus imaging
eye cup, quick user guide
Anterior Module (VP2ANT)
Module for exterior ophthalmic imaging
--------------------------------
Imaging handset (VP2HAND)
Handset for general imaging
--------------------------------
Cradle (VPCRADLE)
For data transmission and battery charging
USB cord, power unit
In addition, the sales case includes:
-(2) Batteries
-Cleaning cloth
-User manual
NOTE: Refer to the Instructions for Use page on the Volk website for the most current version
of the user manual: www.volk.com/ifu
The following accessory can be purchased separately:
-Pictor Plus Slit Lamp Adapter (VP2SLM) that enables the camera to be used as stationary
imaging tool.
QUICK START GUIDE
What to do before the first use:
1. Remove the Volk Optical Pictor Plus from the sales package and
check that all parts are undamaged.
2. Install Battery as instructed in Appendix B of this manual.
3. Place the cradle on a desk next to the PC (personal computer).
4. Connect the USB cable to the PC.
5. Connect the power cable’s plug into the wall electrical
outlet
6. Place Pictor Plus on the cradle. Battery starts to charge. Charge
battery for four hours before the first use. When device is not used, it may be stored in the
cradle.
NOTE: Camera will not automatically power up in the cradle without the power cable. User needs
to press the power button.
Guideline for placing the camera to the cradle:
The camera will fit into the cradle when it is held straight while placing it. Excessive
force must be avoided in order to prevent the camera and cradle connectors from
breaking.
Guideline for battery and device storage:
If the battery is stored out of the camera for a long period of time, ensure that the
battery is fully charged before storage. During storage, the battery must be re-
charged occasionally (e.g., every 3 - 9 months).

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If the battery is stored in the camera, then the camera must be placed in the cradle
with the cradle power cable connected.
Device should not be used when battery cover is open.

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TABLE OF CONTENTS
QUICK START GUIDE ....................................................................................................................... 2
TABLE OF CONTENTS....................................................................................................................... 4
1INDICATIONS FOR USE............................................................................................................. 5
2ESSENTIAL PERFORMANCE...................................................................................................... 6
3CONTRAINDICATIONS FOR USE OF THE EYE OPTICS RETINA MODULE VP2RET AND THE EYE
OPTICS ANTERIOR MODULE VP2ANT...................................................................................... 7
4WARNINGS AND CAUTIONS .................................................................................................... 8
5IMPORTANT SYMBOLS ............................................................................................................ 9
6PARTS OF THE DEVICE ........................................................................................................... 10
7USAGE ENVIRONMENT REQUIREMENTS............................................................................... 14
8OPERATING INSTRUCTIONS................................................................................................... 15
8.1. Preparations ................................................................................................................... 15
8.2. Connection to a PC......................................................................................................... 15
8.3. Basic use –starting up, shutting down, and taking an image........................................ 16
8.4. Attaching and detaching optics module ........................................................................ 17
8.5. Device Menu .................................................................................................................. 17
8.6. Patient List editor ........................................................................................................... 21
8.7. Adjusting focus and automatic focus ............................................................................. 21
8.8. Patient Information........................................................................................................ 22
8.9. Reset button................................................................................................................... 26
9RETINAL IMAGING USING OPTICS MODULE VP2RET ............................................................ 26
9.1. Steps for Retinal Imaging: .............................................................................................. 26
10 EYE IMAGING USING ANTERIOR OPHTHALMIC MODULE VP2ANT....................................... 31
10.1. Steps for Eye Surface Imaging:....................................................................................... 31
11 ERROR MESSAGES ................................................................................................................. 37
12 CLEANING INSTRUCTIONS ..................................................................................................... 38
13 DEVICE MAINTENANCE.......................................................................................................... 39
14 TECHNICAL DESCRIPTION ...................................................................................................... 40
15 WARRANTY ............................................................................................................................ 43
APPENDIX A ELECTROMAGNETIC COMPATIBILITY INFORMATION ......................................... 44
APPENDIX B REPLACING THE BATTERY.................................................................................... 48

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1INDICATIONS FOR USE
Pictor Plus is a medical digital camera that is used with dedicated optic lenses intended to take images
of the eye fundus, and surface of the eye.
Supported optic lenses and their intended uses are:
Component:
Description:
VP2RET
Module for fundus imaging. The Pictor Plus VP2HAND digital camera
with the VP2RET optics module is intended to capture digital images
and video of the fundus of the human eye.
VP2ANT
Module for exterior ophthalmic imaging. The Pictor Plus VP2HAND
digital camera with the VP2ANT optics module is intended to capture
images and video of the surface of the human eye and surrounding
areas.
The device may only be operated by persons who have been properly trained or who have the required
knowledge and experience to do so.

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2ESSENTIAL PERFORMANCE
The essential performance of Volk Pictor Plus camera is to take images and video for consultation and
documentation purposes with safe illumination levels according to the standard ISO 15004-2:2007.

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3CONTRAINDICATIONS FOR USE OF THE EYE OPTICS RETINA MODULE VP2RET AND THE EYE
OPTICS ANTERIOR MODULE VP2ANT
Because prolonged intense light exposure can damage the retina, the use of the device for ocular
examination should not be unnecessarily prolonged, and the brightness setting should not exceed what
is needed to provide clear visualization of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure
time. If the value of radiance were reduced in half, twice the time would be needed to reach the
maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it
is recommended that the intensity of light directed into the patient's eye be limited to the minimum
level which is necessary for diagnosis. Infants, adults, and persons with diseased eyes will be at greater
risk. The risk may also be increased if the person being examined has had any exposure with the same
instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours.
This will apply particularly if the eye has been exposed to retinal photography.
Pictor Plus VP2RET and VP2ANT are classified as Group 2 based on standard ISO 15004-2:2007. The
daily usage time and maximum allowed number of pulses is calculated based on optical classification
results according to standard ISO 15004-2:2007.
CAUTION:
The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure and the greater the number of pulses, the greater the risk of
ocular damage. Exposure to light from this instrument when operated at maximum
output will exceed the safety guideline after:
Maximum number of pulses (still images) allowed daily:
-VP2RET: 6300 pulses (still images) / eye
-VP2ANT: 250 pulses (still images) / eye
Total daily usage time for continuous light (video usage time and aiming light duration)
shall be limited to:
-VP2RET: 1 hour 30 minute video usage / eye
-VP2ANT: 8 minute video usage / eye

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4WARNINGS AND CAUTIONS
Use only the accessories and battery provided by Volk Optical with this product.
Place PC and cradle outside of the patient environment (at least 4 feet distance from
the patient).
Connection between the camera and the workstation is USB and/or Wi-Fi. Any
authorization procedures should be carried out in the workstation.
Images and videos can be copied from camera to workstation via USB and/or Wi-Fi,
and then viewed in the workstation.
USB write protection is on by default. When protection is on this feature will prevent
writing to camera memory card from PC when connected to the cradle.
USB connection works without power cable. There is no USB charging in Pictor Plus
camera.
No modification of this equipment is allowed.

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5IMPORTANT SYMBOLS
Symbol
Description
The CE mark on this product indicates it has been tested and
conforms to the provisions noted within the 93/42/EEC Medical
Device Directive.
2797
CE mark with notified body identification number indicates a
Class IIa product.
Read accompanying user documentation indicates that important
operating instructions are included in this User’s and Maintenance
Manual. Failure to follow these instructions could place the patient or
operator at risk.
WARNING
Indicates a hazardous situation which could result in patient injury,
harm or death if the appropriate safety precautions are not followed.
CAUTION: Indicates the need for the user to consult the instructions
for use for important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be presented on the
device itself.
Type BF applied parts. Applied part is a part of Pictor Plus that in
normal use necessarily comes into physical contact with the patient.
9V / 1.1A
Charger polarity symbol, voltage, and power.
The symbol indicating separate collection for Waste Electric and
Electrical Equipment per Directive 2002/96/EC.
The symbol indicating that the device is capable of wireless data
communication based on the 802.11 IEEE network standard. When
using Wi-Fi functionality, interference may occur in the vicinity of
equipment.
Sticker at the front of the device indicating Volk Optical’s address,
integrated general imaging optics focal length, and F-number.

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6PARTS OF THE DEVICE
1. Bayonet
connector
2. Bayonet hole
3. Optics release
button
4. Dual action
shutter
5. Snap for
opening
battery cover
6. System
connector
1
2
4
3
5
6