User Manual www.medxchange.

com
Model MDRS4 U5003-1, 2.0 2009-09-24
Contents
I. Introduction
About the MDRS4 System............................................................................... 1
MDRS4 Med X Change Version 4.7.2.7 Software Features............................ 2
Video and Still Image Formats & Quality......................................................... 3
Storage............................................................................................................. 3
Approved DVDs............................................................................................... 3
Networking....................................................................................................... 3
II. Quick Start
Starting a Recording / Taking a Still Image...................................................... 4
Selecting / Controlling Cameras....................................................................... 4
Burning to CD/DVD.......................................................................................... 5
Printing Still Images......................................................................................... 5
III. Advanced Features
Video Playback................................................................................................ 6
Viewing Still Images......................................................................................... 6
IV. System Layout and Button Descriptions
Buttons and Controls........................................................................................ 7
CD/DVD Burning.............................................................................................. 9
Start New Recording........................................................................................ 10
V. Med X Change MDRS4 Settings
Recording Storage........................................................................................... 11
System Properties............................................................................................ 12
Recording Properties....................................................................................... 12
Camera Labels................................................................................................. 12
Detail Fields..................................................................................................... 13
Watermark Tab................................................................................................. 13
VI. Disk Creation and Management
Disk Management Page................................................................................... 14
VII. MDRS4 with FL Software - Fluorescence Setup & Operation
Testing Communication.................................................................................... 15
Foot Pedal........................................................................................................ 15
Hand Control.................................................................................................... 16
Touch Screen................................................................................................... 16
VIII. Technical
MDRS4 Accessory Connections...................................................................... 17
Monitor Connection.......................................................................................... 18
Touch Screen Monitor Calibration.................................................................... 18
Room Camera Setup / Primary Camera Connections..................................... 19
MDRS4 Product Specifications........................................................................ 20
Glossary of International Symbols................................................................... 20
IX. Safety / Electrical / Maintenance / Update Record
MDRS4 Computer.............................................................................................21
Monitor..............................................................................................................21
Connecting computer and monitor to power.....................................................21
Classifications ..................................................................................................21
Notes . ..............................................................................................................22
Warranty . .........................................................................................................22
X. System Compliance Statements
System Compliance Statements & Tables....................................................... 23
XI. Med X Change Contact Information
Technical Support & Contact Information......................................................... 25

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I. Introduction
About the MDRS4 System
In the most basic terms the Med X Change MDRS4 System is a digital recording system with built in monitor,
which can record Standard Definition (SD) video from multiple sources, take digital stills without interrupting the
video, and can burn this stored information to a disk for documentation and presentation.
The system runs on the latest technology in both hardware and software. The hardware is state of the art, utilizing
Intel® Core 2 Duo Processors, high capacity hard drives, and the fastest combo DVD-R/CD-R drives available.
The software is built on MPEG-4 technology, utilizing the best compression available. Videos are stored as
Windows Media Video files (.wmv).
Because of rapid advancements in technology, it was important that the system be easy to update. This is
a dynamic system that can grow and be adapted as technologies change. The system’s software is easily
upgradeable via CD, providing you with updates that will keep your system “State of the Art”.
The MDRS4 is a Class I medical device intended to be used as an accessory to various surgical cameras to
record video and static images during surgical procedures and operations.
The MDRS4 is not intended for use with radiological imaging, ophthalmic or diagnostic systems.

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I. Introduction (continued)
MDRS4 Med X Change Version 4.7.2.7 Software Features:

RECORD PAGE
• Preview Change: The preview displays 30 frames per second.
• Still Image Capture: Still images are now de-interlaced upon capture.
• Video Compression: It is now possible to adjust the video quality (3, 4, 5, 7, 9 Megabit Stream) during
the recording.
• New Recording: Additional fields can be setup for more recording information; i.e. patient name, patient
number, doctor, hospital.
• Remote Storage: Indicator to let the user know they are recording to a remote storage drive.
• Archiving: Indicator to let the user know that archiving is enabled and working.
• Camera Buttons: System remembers which camera you had selected the last time you used the system.
• Room Camera Controls: There are camera control buttons for supported Pan Tilt Zoom controllable SD
Room Cameras.
• Video Settings: Independently adjust the brightness, contrast, hue and saturation of the video by the easy
to use slide bars.

PLAYBACK PAGE
• Thumbnails: Thumbnails of video segments and still images.

BURN PAGE (BURN MEDIA)

• Thumbnails: Thumbnails of video segments and still images.
• Review the stills and videos on the burn page.
• Memory Card: There is a tab that allows you to copy videos and stills to a USB memory stick or external
hard drive.
• Multiple Recordings: Ability to burn videos and still images from multiple cases to one or more discs or
USB drives.

PRINT PAGE
• Page Layout: You can select a different layout for each page and then select from the thumbnails to add
pictures to your page.
• Printer: This will work with any standard USB printer for Windows XP.

DISK MANAGER PAGE

• Stills and Videos: You have the ability to delete individual segments and stills from a particular recording.
• Archiving: If archiving is enabled on the settings page, the user can archive videos and still images to the
selected location from this page.
• Preview Window: There is a preview window on this page used to visually confirm what is being deleted
or archived.

SETTINGS PAGE
• Audio Device: Select the Microphone Audio Device.
• Data Fields: Customizable data fields to the system which you fill out at the beginning of the recording.
The purpose for these is for archiving and searching on a central server. These fields will also be on the
Recording Viewer that we are building for the CD/DVD’s that are created from the system.
• Audible Speech: Enables the voice notification for recording, paused and still image capture.
• Watermarking: This tab allows you to apply a watermark to your recordings. The selected item(s) will
appear in the lower right corner of each recording.
• Multiple Languages: The system interface can now be switched to multiple languages from a drop down
setting. (contact Med X Change for support).

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I. Introduction (continued)
Video and Still Image Formats and Quality
Video: The Med X Change MDRS4 System utilizes the latest in MPEG encoding and compression.Microsoft
Windows Media Video (.wmv) produces high quality video utilizing MPEG-4 compression.
Still Images: The still images will be stored as 640 x 480 (~ 1/3 of a mega pixel). Stills are captured and stored as
uncompressed bitmaps since .bmp files are best for editing and are compatible with both the Mac and PC.
Storage

* BACKUP YOUR VIDEO AND STILL IMAGES PERIDOCIALLY TO EXTERNAL STORAGE *

* THE MDRS4 IS NOT INTENDED FOR LONG TERM STORAGE/ARCHIVING *

The MDRS4 System is configured with a generous 160 GB hard drive for video storage, as well as a combination
DVD-R/CD-R recorder. This allows stored recordings to be easily copied to disk. The DVD-R/CD-R combo has
the advantage of storing up to 2.5 hours of video with stills on a DVD-R disk, or using more economical CD-R/RW
for storing smaller amounts of data. This technology is constantly evolving, and as faster burners hit the market,
the MDRS4 Systems will be ready to adapt.
Approved DVD’s:
• Taiyo Yuden 16x Premium Line DVD-R
• Sony DVD-R 16x (Version 1.3) DVD-R
Note: It should also be noted that blank DVDs labeled “For Authoring” are made for commercial, high
volume recorders and are NOT compatible with general purpose recorders, such as those used in
the Med X Change MDRS4 system.
Networking
The MDRS4 System is network ready and can be quickly deployed across a network. Because the system has
been left open, a network administrator can quickly bring the system online. TCP/IP, NetBUEI, and IIS have been
loaded to support drive mapping, network piping, and local intranet web access to the videos and still images
using NT authentication.

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II. Quick Start
Starting A Recording / Taking A Still Image
1. To start a new recording tap the ‘New’ button. The ‘Recording Information’ tab will open. (See Figure 2-1)
2. Using the on screen keyboard, type a name for the recording. Then hit the ‘Enter’ button.
3. To enter the patient’s name, tap ‘Patient Name’ and then type the patient’s name and hit the ‘Enter’ button.
4. Repeat step 3 to enter values for the remaining fields.
5. To begin recording, tap the ‘Record’ button.
6. To capture a still image while recording, simply tap the ‘Capture’ button.
7. To stop and start recording during a session, use the ‘Record’ and ‘Pause’ buttons.

Figure 2-1

Selecting / Controlling Cameras

Cameras are selected and switched using the four camera buttons under the Preview Pane. (See Figure 2-2)
These buttons are labeled with the names given to them using the Med X Setup Camera Labels tab (see pg.
10). The Camera Controls work with the optional Canon VC-C50i Room Camera (SD Video) and allow the user
to control pan, tilt and zoom functions.
Note: A custom setup is required for Camera Control to function. Contact Med X Change Tech Support.
Note: If a 1394 Firewire Camera is connected, the Comp 3 button will display as Digital

Figure 2-2

Preview
Pane

Camera
Buttons

Camera
Controls

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II. Quick Start (continued)
Burning To CD/DVD
1. Insert a blank CD-R/RW or DVD-R/RW into the recorder drive tray. (See Figure 2-3)
2. From the ‘Burn Media’ mode, select the recording from which you wish to burn.
3. Select the video(s) and/or still(s) you would like to burn, by tapping the check box next to the thumbnail.
4. The progress of the burn is displayed here.
5. Use the ‘Locate Disk’ button to re-read the disk size if another disk is inserted.
6. When ready, tap ‘Burn’ to start burning.

Figure 2-3

Printing Still Images

Tap the ‘PRINT’ Tab
Printing allows the user to select individual stills from one or multiple recordings / cases.
1. Select the case and the corresponding stills you want to print. (See Figure 2-4)
2. Select the Page Layout
3. Select the individual still images by tapping each image or tapping the All button which will automatically
populate the pages to print.
4. Select the number of copies to print. This will print out multiple copies of the selected images Click Print to begin printing.
5. Select the Printer you want to print from (assuming the printer drivers are installed).
6. Tap Print

Figure 2-4

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III. Advanced Features
Video Playback
1. Tap the ‘Playback’ tab. (See Figure 3-1)
2. Select a stored recording session from the dropdown select box.
3. Select a video by tapping it’s thumbnail image.
4. Tap the play button on the media player.

Figure 3-1

Viewing Still Images

1. Tap the ‘Playback’ tab. (See Figure 3-2)
2. Select a stored recording session from the dropdown select box.
3. Select a still image by tapping it’s thumbnail image.
4. The image will load into the media player window.
Note: To delete a still capture, see pg. 14

Figure 3-2

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IV. System Layout and Button Descriptions
Buttons and Controls
1. STATUS tab displays information on current segment length, total recording time and disk usage. (See Figure
4-1) You can also change the quality of the video, select remote storage and/or enable archiving. For more
information on remote storage and archiving, see pg. 11.
2. CAMERA SWITCHING allows switching between four camera inputs during recording.
3. RECORDING CONTROLS are used for setting up and controlling recording sessions. Tap the ‘Capture’ button
to capture an image during recording. Tap the ‘New’ button to start a new recording session. Tap the ‘Record’
button to begin recording. Tap the ‘Pause’ button to temporarily pause recording. Recording will resume when
you tap the ‘Record’ button again.
4. CAMERA CONTROLS are used to control the Canon VC-C50i Room Camera. These buttons are used to pan,
tilt and zoom the camera.
A custom setup is required for Camera control to function. Contact Med X Change Tech Support.

Figure 4-1

5. VIDEO SETTINGS tab brings up slider controls to use for adjusting brightness, contrast, hue and saturation
(See Figure 4-2).

Figure 4-2

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IV. System Layout and Button Descriptions (continued)
6. RECORDING INFORMATION tab displays the name of the recording, any fields that have been assigned and
their corresponding values, and the on screen keyboard. (See Figure 4-3) Fields can be added and deleted by
switching over to the ‘Settings’ tab. For more information on how to add/delete fields, see pg. 10.

Figure 4-3

7. RECORDING drop down box allows you to select a recorded session to play back. This can be the current
session, or any previously recorded session. (See Figure 4-4)
8. VIDEO/STILL SELECT allows you to select a video or still image to play back. Just tap the video/still thumbnail
and it will load into the media player for viewing.
9. PLAYBACK CONTROLS are DVD-type buttons for controlling the current playback.

Figure 4-4

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IV. System Layout and Button Descriptions (continued)
CD/DVD Burning
Whenever the ‘Burn Media’ tab is tapped, the window in Figure 4-5 will appear. You will then have two options to
choose from: Single Recording and Multiple Recordings.
When the ‘Single Recording’ tab is selected:
(See Figure 4-5)
1. RECORDING allows you to choose a stored recording from which to burn videos and/or stills.
2. VIDEO/STILL SELECT you can select individual videos and/or stills to burn...or you can use the ‘Select All’
button to select all videos/stills. The ‘Select None’ button can be used to un-select all.
3. DISK % AVAILABLE allows you to see what percent of disk space would be used if you were to burn your
selections at that time.
4. LOCATE DISK button re-checks the CD/DVD for disk space. This is necessary if the disk has been changed
prior to the start of the burn procedure.
5. SPAN DISKS is used when the recording size exceeds the capacity of the CD/DVD. Choose ‘Break at
Recording’ or ‘One Recording Per Disk’.
6. ERASE button is used if there is previously recorded content on the disk (DVD-RW/CD-RW).
7. BURN button starts the copying.
8. Allows the user to re-burn a certain disk(s) within a multiple disk burn; this eliminates the need to burn all
disks twice.

Figure 4-5
Single Recording

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IV. System Layout and Button Descriptions (continued)
When the ‘Multiple Recordings’ tab is selected:
(See Figure 4-6)
1. SELECT RECORDINGS TO BURN allows you to select videos/stills from different recording sessions...not just
the current session. Highlight the session(s) / video(s) / still(s) you want, and click the ‘Select’ button.

Figure 4-6
Multiple Recording

Start New Recording

(See Figure 4-7)
1. RECORDING name is recorded onto the CD/DVD. It is also important for archiving on the drive. The recording
will be stored on the D:\ drive in a folder named by this entry. If the user does not make an entry, the name
defaults to the current system date and time.
2. ON SCREEN KEYBOARD allows the user to enter information via the touch screen.
3. FIELD categories are used to store information such as patient name, case number, date, and time.
Categories can be added/deleted by switching over to the ‘Settings’ window. (see pg. 13)
4. VALUE information is entered by highlighting a field and then using the on screen keyboard to type the
desired information.

Figure 4-7

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V. Med X Change MDRS4 Settings
To access the Med X Change MDRS4 Settings window, tap the ‘Settings’ tab.
Recording Storage
(Refer to Figure 5-1)
1. Default Storage Location is used to select a drive path for storage of all videos and still images. This drive
will always be used unless a Remote Storage location is designated (see item #2 below) and an external drive
is connected.
NOTE: The default setting is “D:\” and should NEVER be changed unless instructed to do so by a Med
X Change Technician for trouble shooting purposes.
2. Remote Storage Location is used to select an alternate drive path for storage of all videos and still images
onto an external, removable hard drive. To use this feature, the external drive that will be used must first
be connected to the MDRS4 system per the drive manufacturer’s instructions. Once the MDRS4 system
recognizes the new drive, it will assign it drive letter “F:\”. Type “F:\” (no quotes!) into the Remote Storage
Location field to designate this as your preferred remote storage location. This becomes the default location
for your MDRS4 system to record to anytime the external drive is connected. To record to the MDRS4 internal
hard drive again, you must remove the external drive.
3. Archive Storage Location is used to select a drive path to store archived files. This is normally a network
drive path to a remote server which stores the files and backs them up regularly.

Figure 5-1

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V. Med X Change MDRS4 Settings (continued)
System Properties
(See Figure 5-2)
1. Enable Audible Speech when checked, will provide audible feedback when you tap certain buttons, such as
record, pause, still image.

Figure 5-2

Recording Properties
(See Figure 5-3)
1. Default Profile shows which profile is selected. To change your profile simply select another profile from the box.
2. Default Segment Time allows you to set how many minutes each segment will be.
3. Audio Device allows you to select your preferred audio device.

Figure 5-3

Camera Labels
(See Figure 5-4)
This section provides a way to change the names of the camera buttons in the Med X Recorder.
1. Camera Labels You can change the name of the camera buttons in the Med X Change Recorder by simply
changing the text in these fields.
2. SD Fireware An SD Firewire camera can be connectoed to one of the 1394 Firewire ports.

Figure 5-4

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V. Med X Change MDRS4 Settings (continued)
Detail Fields
1. To add a field to the list, type a name for the field, then tap the ‘Add’ button. (See Figure 5-5)
2. To delete a field from the list, select a field by tapping it’s name in the field list, then tap the ‘Delete’ button.
3. Tap the ‘Update’ button to update the list.
4. Tap the ‘Move Up’ or ‘Move Down’ buttons to move a field up or down the list.
5. Tap the ‘Cancel’ button to exit.

Figure 5-5

Watermark Tab
This tab allows you to apply a watermark to your recordings. The selected item(s) will appear in the lower right
corner of each recording. (See Figure 5-6)
1. Active Checking this box activates the watermark feature.
2. There are four types of watermarks available. Any one, or combination of the four, can be used:
• Include Image - The image must be loaded into the proper folder, and meet certain file restrictions, as
noted on this tabbed page.
• Text on right side - If this is selected, the text (Date, User Name) will slightly overlap the image, if an image
is used. If this is un-selected, the text will not overlap the image, it will be placed to the left of the image.
• Include Date - The date of the recording will be used.
• Include User Name - The user name logged on to the system will be used.
3. Once the watermark settings are selected, select one of the other tabs to continue the setup process.

Figure 5-6

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VI. Disk Creation and Management - Disk Management Page
Warning: Files deleted using the Disk Management Page are permanently deleted from the hard
drive. To guard against total loss of valuable recordings, it is recommended that all recordings be
archived before deletion. For instructions on how to record to a CD or DVD, see the instructions in
this manual for burning to a CD/DVD or External drive.

Figure 6-1 Preview

Pane

Stored
Recordings File
Information

Disk Management Page

Allows users to easily delete old recordings from the MDRS4 system’s hard drive.It features a built-in viewer to
preview the recordings before deleting them, as well as a table indicating the available recording time at various
stream rates. The Disk Management Page will automatically pop up whenever hard drive capacity drops below
10% and a new recording session is started. The user may choose to delete old files to ensure there is plenty of
disk space, or they may click the “Done” button to close the Disk Management Page.
To delete recordings:
1. Select the recordings you want to delete in the ‘Select Recordings to Delete or Modify’ window by tapping to
highlight them and then tapping the ‘Select’ button.
2. To preview the recording before deleting it (highly recommended!), tap the image in the preview pane.
3. Once all the videos slated for deletion have been previewed and selected, simply click the ‘Delete’ button to
permanently delete the recordings.

Caution: This will permanently delete the selected images from the hard drive – they cannot be recovered!

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VII. MDRS4 with FL Software - Fluorescence Setup and Operation
Testing Communication
Connect the MDRS4(FL) to the microscope while both systems are powered off. After the MDRS4(FL) is
connected, power on both systems.
On the FL-800 page, of the MDRS4(FL) software; check to see if the “FL Set Zoom” button appears. If not, the
MDRS4(FL) and microscope are not communicating. Also check connectivity by pressing the record button while
on the FL-800 page, look for the light being adjusted and the camera switching.
If you are unable to get the communication working on the scope please call technical support at 888-982-4469.

Figure 7-1
MDRS4(FL), FL800
LOOP MODE
CONTROLS

FOOT PEDAL
The foot pedal is dedicated to recording regular video and will not control the loop recordings. The foot pedal
record button is disabled during a loop recording. If the foot pedal record button is pressed while you are in
loop mode but not recording, the system will automatically switch back to the regular recording page and start
recording video segments.
If the surgeon presses the record loop from the hand switch, no matter what mode the MDRS4(FL) is in, the
MDRS4(FL) will stop what it is doing and switch over to loop mode and start recording. This is to ensure that the
surgeon can at anytime switch to the loop mode and record the injection. NOTE: If the surgeon is burning a CD or
DVD this will not work.

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VII. MDRS4 with FL Software - Fluorescence Setup and Operation (continued)
HAND CONTROL
1. To set optimum zoom, push the joystick to the 12 o’clock position and the microscope will automatically adjust
to the preset optimum zoom for IR.
2. To record, push the joystick to the 9 o’clock position once. This will put the MDRS4(FL) in FL-800 mode; raise
the light, turn on the IR filter, turn on the DIC-500, and switch cameras.
3. To stop, push the joystick to the 9 o’clock position again. This will stop the recording of a loop, lower the light,
remove the IR Filter, change cameras back to the normal light camera, and turn off the DIC-500.
4. To playback video, push the joystick to the 3 o’clock position once and the MDRS4(FL) will begin playing back
the last video loop that was recorded. You can switch video loops by pushing the joystick to the 6 o’clock
position. This mode will turn on the DIC-500 and playback the video on both the monitor and in the eyepiece
and will loop it continuously until stopped. The loop number will appear in the microscope eyepiece overlaid on
the video.
5. To stop playback video, push the joystick to the 3 o’clock position.

Figure 7-2
MDRS4(FL), FL800
12
LOOP MODE
CONTROLS

9 3

F Z

TOUCH SCREEN
The user cannot Record IR Loop Video Segments. This is only done by using the Microscope Hand Switches.

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VIII. Technical
MDRS4 Accessory Connections
Figure 8-1 shows the correct locations for connecting MDRS4 accessories. Accessories should only be
connected as shown and/or described below.
• If a microphone is to be used, it should be attached to the MICROPHONE jack.
• Any video device that is to be used for capturing video, should be attached to one of the 4 video capture
connections (1 S-Video, 3 Composite).
• An SD firewire camera can be connected to one of the 1394 firewire ports.

Figure 8-1
MDRS4 Computer
Back Panel Firewire 1394 S-Video Composite NA

1 2 3
Foot
Pedal

Power

Line In
Mouse
Line Out

Keyboard Mic

Scope
LAN USB (4) LAN NA

DVI Out
VGA

Figure 8-2
MDRS4 Computer
Front Panel

DVD Drive

Audio Out

Mic In

Leica MDRS4
Power USB (2)

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VIII. Technical (continued)
Monitor Connection
1. USB Downstream Ports (Figure 8-3)
These two USB ports are available for connecting USB type peripheral devices such as keyboard, mouse,
printer and so on.
2. USB Upstream Port
This Port is for connecting the USB Upstream cable to computer’s or other hub’s USB port.

Figure 8-3

Touch Screen Monitor Calibration

The touch screen monitor is aligned to its computer before shipping. If re-alignment becomes necessary, follow
this procedure to realign the touch screen:
1. Ensure the keyboard/trackball is connected
2. Open the “Start” menu. (Use the “Windows” key on the keyboard. This key is on the lower left row, between
the “Ctrl” and “Alt” keys.)
3. Click on “Programs”.
4. Click on “Calibration Tool”.
5. Follow the on-screen directions to align the touch screen.
(Note: When tapping on the alignment targets, be sure to view the monitor from the angle it will be
used. Ensure that each target is tapped as close to center as possible, and hold each target for at
least 3 seconds.)
6. When the alignment process is finished, tap “OK” on the dialog box.
7. The touch screen is ready for use.

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VIII. Technical (continued)
Room Camera Setup / Primary Camera Connections

Contact Med X Change for proper setup of this Room Camera. A custom setup is required.

• For proper operation, the camera must be connected to the MDRS4 computer prior to starting the computer.
• The camera VIDEO OUT jack must be connected to the VIDEO IN 2 jack on the MDRS4 system for the
camera controls (pan, tilt, zoom) to operate properly.
• The Canon VC-C50i camera will mount securely on any standard tripod camera mount.

Figure 8-4
CANON VC-C50I
PTZ CAMERA

B1 B10

DC IN 13V VIDEO OUT A1 A10

Not Used
Connect to
Video In #2

S-Video

Camera
Control
Cable

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VIII. Technical (continued)
MDRS4 Product Specifications
Still Capture:
640 x 480 pixels- BMP, JPEG file format
Motion Video Capture:
640 x 480 pixels, 30 fps
MPEG-4 compression
WMV File Format
Hard Drive Capacity:
160GB for video and still images
CD/DVD Writer:
8X Speed (DVD)
Inputs:
SD Video: S-Video, Composite x 3 (RCA)
Audio: Mic and Line level
2x RS-232
Outputs:
Audio output: Line level
Data I/O:
USB 2.0 x4
Ethernet: RJ45 x2
Fire wire: IEE1394 x2
Keyboard/Mouse I/O: USB or PS2
Operating System: Windows XP Professional
Power Input:
100 - 240 VAC, 47-63Hz Max 4.0 A
Overall Dimensions:
CPU: 11.11cm H x 26.67cm W x 21.50cm D
Weights:
CPU: 2.72 kgs

Glossary of International Symbols

Symbol Reference Title Symbol Reference Title
IEC 60417- Alternating current IEC 60417- Equipotentiality
5032 5021

IEC 60417- Direct current IEC 7000- Caution risk of danger

5031 0434 or Attention, consult

IEC 60417- Standby NA Power Input

5009

EN980 5.2 Manufacture

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IX. Safety / Electrical / Maintenance / Update Record
The MDRS4 computer has no internal serviceable parts. If for any reason the MDRS4 computer fails please
contact customer service at 888-982-4469 or email [email protected]
MDRS4 Computer

WARNING: Disconnect power supply before servicing.

The computer system and its internal components meet the requirements for applicable ETL, FCC, CE, CB, CIB
and other required certifications.
The plastic material used for the front of the MDRS4 pc enclosure has a UL94 flammability classification of 94H-2.
A warm damp cloth can be used to wipe the outside of the unit.
CMOS battery: Lithium: CR2032
Ground Leakage: Closed-Normal-Chassis: 34 µA Open-Normal-Chassis: 31 µA
Closed-Normal-Earth: 34 µA Open-Normal-Earth: 69 µA
Closed-Reversed-Chassis: 31 µA Open-Reversed-Chassis: 32 µA
Closed-Reversed-Earth: 36 µA Open-Reversed-Earth: 69 µA
Monitor
The touch screen monitor meets the requirements for applicable ETL, CE, CSA, FCC-B, TUV/GS, EPA and other
required certifications. The power supply for the monitor does not meet the requirements of 60601-1. This is
allowed under the guidelines of 60601-1-1, Safety Requirements for Systems, but the monitor or any other device
that is connected will contribute to a higher enclosure leakage current. This will need to be checked for each
system installation. Under normal conditions the limit is 0.1mA and 0.5mA under a single fault. If the monitor is
approved to a standard other than 60601-1, the system shall be evaluated to 60601-1-1.
The MDRS4 Monitor has no internal serviceable parts. If for any reason the MDRS4 Monitor fails please contact
customer service at 888-982-4469 or email [email protected]
Ground Leakage: Closed-Normal-Chassis: 38 µA Open-Normal-Chassis: 66 µA
Closed-Normal-Earth: 38 µA Open-Normal-Earth: 66 µA
Closed-Reversed-Chassis: 38 µA Open-Reversed-Chassis: 66 µA
Closed-Reversed-Earth: 38 µA Open-Reversed-Earth: 66 µA
Connecting computer and monitor to power
The MDRS4 system comes with 1 HOSPITAL GRADE power cord which is indicated by the Green dot on the
male end of the cord for connecting the computer and monitor to the electrical outlet. In order to achieve proper
grounding of the MDRS4 system, use the provided HOSPITAL GRADE power cord or equivalent.

WARNING: Do not connect any items which are not specified as part of the system.
WARNING: A multiple port power strip or extension cord should not be used to connect the system
because it can increase the over all leakage for the system.

Classifications
The MDRS4 is classified as a Class I Device:
• The product uses a grounded plug.
• There are no patient applied parts.
• Does not protect against ingress of liquids.
• It is not for use in APG situations.
• Not to be installed near an MRI or within any other magnetic field.
• This system can be continuously used.

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IX. Safety / Electrical / Maintenance / Update Record (continued)
Notes
WARNING:
There are no known potential electromagnetic or other interference between the MDRS4 system and other
devices. If the system does cause harmful interference, the user is encouraged to correct the interference by one
of the following methods:
• Relocate the MDRS4 or the device that is receiving the interference.
• Increase the separation between the MDRS4 and the device that is receiving the interference.
• Connect the MDRS4 into an outlet on a circuit different from that to which the device is connected.
There are preventative measures that can be taken to ensure proper functionality of the MDRS4 system. The
system should be shutdown and restarted periodically (at least every other day). A proper shutdown sequence
would be to go to “Start&.Shut Down...then choose Shut Down...click OK”. Do not just hit the power button on the
box to turn off the system.
The fuses used in the MDRS4 system are non-replaceable by the user. If there is a problem with a fuse, please
contact customer service at 888-982-4469 or email [email protected]
There are no repairable component parts in the MDRS4 system. Any system that needs repair should be returned
to the manufacturer for such repair.
The MDRS4 system should be transported and stored at or close to room temperature (room temperature
is roughly 70-73 degrees Fahrenheit, 21-23 degrees Celsius, or 294-296 kelvins). The system should not be
exposed to extremely hot or cold conditions. The range percent of relative humidity is 20-60 Rh. The atmospheric
pressure should be in the range of 850-1050 hPa.
This equipment is not suitable for use in the presence of flammable anesthetic mixture or with nitrous oxide.
Med X Change Inc can not be held responsible for any data loss in accordance to the MDRS4 (Digital
Recording System)
Med X Change Inc strongly recommends the client burn all videos immediately to a DVD or CD or use our auto
archiving in accordance to the MDRS4 (Digital Recording System)
Med X Change Inc strongly recommends you purchase and hook up a battery back up system as well as a surge
protector (ex. 1100 VA surge protector), in accordance to the MDRS4 (Digital recording System)
Med X Change Inc will not be held responsible for any personal / internet use. The MDRS4 is to be used for
Digital Recording only. The warranty will be null and void, in response to any repairs that may be needed, if
personal / internet use is apparent.
Warranty
Med X Change, Inc. will provide a warranty against manufacturer’s defect of all MDRS4 hardware, which will
extend for a period of 12 months from manufacturer date; covering parts and labor only. During the respective
warranty periods Med X Change, Inc. will repair or replace defective parts and maintain software applications
to original specifications. Claims under warranty are null and void if the defect has been caused by improper
handling/use, or if the MDRS4 at issue has been serviced by unauthorized persons or product/service providers.
Med X Change, Inc. warrants that the MDRS4 is free of defects in material and manufacture at the time of delivery
and that the MDRS4 meets the specifications.

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X. System Compliance Statements
System Compliance Statements & Tables
FCC Compliance
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this
device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Electrostatic Discharge Precaution
When using USB devices do not touch the USB ports. Contacting the ports may create electrostatic discharge
(ESD) which may cause the system to freeze and prevent the USB peripherals from functioning properly. Before
restarting the computer, attempt to restore functionality by unplugging the USB device and re-plugging it back
into the port. Wait approximately 10 seconds to determine if functionality has been restored. If not, restart the
computer.
Precautions
• This equipment/system is intended for use by healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as reorienting or relocating the equipment or shielding the location.
• The system must be installed per the requirements of this manual. Failure to properly install the system
may result in degraded performance or loss of functionality.
• Mobile and portable RF communications equipment may affect the system.
• If the system is installed near or on other electronic devices, please observe to verify normal operation.
Other devices may emit harmful radiation or interference that could affect system performance.
• Use of accessories and cables other than those provided with the system could result in increased
emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the
requirements of IEC 60601-1-2:2004.
IEC 60601-1-2:2004 Table 201 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should
assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The equipment uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class A The equipment is suitable for use in all establishments other than domestic,
CISPR 11 and may be used in domestic establishments and those directly connected to
the public low-voltage power supply network that supplies buildings used for
domestic purposes, provided the following warning is heeded: Warning: This
Harmonic emissions Class A
equipment/system is intended for use by healthcare professionals only. This
IEC 61000-3-2
equipment/ system may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures, such
Voltage fluctuations/ Complies as re-orienting or relocating the equipment or shielding the location.
flicker emissions
IEC 61000-3-3

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X. System Compliance Statements (continued)
IEC 60601-1-2:2004 Table 202 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Equipment should
assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air with Floors should be wood, concrete or ceramic tile.
(ESD) IEC 61000-4-2 documented necessary If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast transient/ ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical
burst IEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV ±1 kV line(s) to line(s) ±2 kV Mains power quality should be that of a typical
line(s) to earth line(s) to earth commercial or hospital environment.
Voltage dips, short <5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT) Mains power quality should be that of a typical
interruptions and voltage for 0,5 cycle 40 % UT (60 % for 0,5 cycle 40 % UT (60 % commercial or hospital environment. If the
variations on power supply dip in UT) for 5 cycles 70 % dip in UT) for 5 cycles 70 % user of the equipment requires continued
input lines IEC 61000-4-11 UT (30 % dip in UT) for 25 UT (30 % dip in UT) for 25 operation during power mains interruptions, it is
UT = 230 Vac cycles <5 % UT (>95 % dip cycles No anomalies 95% recommended that the equipment be powered
in UT) for 5 sec dip meets requirements. from an uninterruptible power supply or a
battery.
Power frequency (50 Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at
magnetic field IEC 61000- levels characteristic of a typical location in a
4-8 typical commercial or hospital environment.
Conducted RF IEC 61000- 3 Vrms 150 kHz to 80 MHz 3 V 3 V/m Portable and mobile RF communications
4-6 Radiated RF IEC 3 V/m 80 MHz to 2,5 GHz equipment should be used no closer to any
61000-4-3 part of the equipment including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter. Recommended separation
distance
3,5
V1
3,5
80 MHz to 800 MHz
E1
7
800 MHz to 2,5 GHz
E1
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya should be less than the compliance
level in each frequency rangeb Interference may
occur in the vicinity of known RF transmitting
devices and equipment marked with the
following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location
in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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XI. Med X Change Contact Information
Contact Information U.S.

Med X Change, Inc. Local Phone: (941) 794-9977

525 8th Street West Toll Free: (888) 982-4469
Bradenton, FL 34205 Fax: (941) 794-8432

www.medxchange.com Business Hours: 9-5pm EST

[email protected]

Authorized Representative EU

RMS - UK, Limited

28 Trinity Road
Nailsea, Somerset
BS48 4NU England
* Prior to sending the MDRS4 in for service; please backup video and still images to external storage. *
* Med X Change, Inc. is not liable for data loss on the MDRS4 *

NOTES:

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