MATRIX Data Station 350 010 883 User Manual Ver 01 Nov 2018

XION Data Station

MATRIX DS

XION Article number 350 010 883

User Manual

This User Manual is protected by copyrights. No part of it may be copied or transferred into other languages without the express prior written consent of XION GmbH. The product names and names of companies used in this User Manual are in most cases registered trade marks, and as such they are subject to the relevant legal provisions. XION GmbH lays no claims whatsoever to these trademarks.

All rights reserved. Technical data are subject to change without notice. XION GmbH Pankstraße 8 13127 Berlin Germany Fon: Fax:

2

+49 (0) 30 / 47 49 87 – 0 +49 (0) 30 / 47 49 87 – 11

[email protected] www.xion-medical.com/en

Ver. 01 en 21.11.2018

Contents

Chapter

Title

Page

Contents... 3 Intended Purpose... 5 Fields of Application, Indication ... 5 Directions for Using the Manual ... 5 Combination and Interaction with other Devices... 6 1

Explanation of the Graphic Symbols Used... 7

2

Safety Precautions ... 8

2.1

Protective Measures against ESD ... 10

2.2

Electromagnetic Compatibility (EMC) ... 10

2.3

Safety during Commissioning ... 11

3

Product Description... 12

3.1

Properties ... 12

3.2

Product Variants... 12

3.3

Scope of Delivery ... 13

3.3.1 3.3.2

Scope of Delivery MATRIX DS HD... 13 Scope of Delivery MATRIX DS... 14

4

Description of the MATRIX DS ... 15

4.1

Ports and Functional Elements on the Front Panel ... 15

4.2 4.2.1

Ports and Functional Elements on the Rear Panel of the Device ... 16 Connector panel for system-related and optional components ... 18

4.3 4.3.1 4.3.2

Construction and Method of Operation / MATRIX DS HD ... 20 Frame Grabber HD... 20 Connecting additional optional components ... 23

4.4

Construction and Method of Operation / MATRIX DS ... 24

5

Product Application... 25

5.1

Prior to Commissioning ... 25

5.2 5.2.1

Operating System... 25 Installation Medium Package MS Windows 7 ... 25

5.3

Pre-installed Software ... 25

5.4

DiVAS Licensing... 25

5.5 5.5.1 5.5.2

Switching on the MATRIX DS Data Station ... 26 MATRIX DS as "standalone" device or in XION Basic equipment trolley model ... 26 MATRIX DS in the XION equipment trolley - Premium model... 28

5.6

Switching Off the MATRIX DS Data Station ... 28

5.7 5.7.1

Installing Options ... 28 Connecting optional components ... 28

350 010 883 MATRIX DS

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6

Cleaning and Disinfecting ... 29

6.1

General... 29

6.2

Cleaning the Data Station ... 29

6.3

Chemical Disinfection for the Data Station... 29

7

Maintenance and Service... 30

7.1 7.1.1

User Maintenance ... 30 Notes on transportation... 30

7.2 7.2.1

Repair Work by the User... 31 Replacing the mains fuses... 31

7.3 7.3.1 7.3.2

Service by the Manufacturer ... 32 Spare parts and accessories... 33 Recommended optional accessories ... 33

8

Troubleshooting ... 34

9

Disposal... 36

10

Technical Data ... 37

11

Declarations Regarding EMC ... 38

11.1

Electromagnetic Emissions... 38

11.2

Electromagnetic immunity ... 39

11.3

Recommended Safety Distances... 41

12

Manufacturer and Distributor... 42 List of Figures ...43

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Important Information Please read this information before use

Intended Purpose The XION MATRIX DS Data Station is a high-end medical device. It is designed for the acquisition and documentation of, for example, patient-related information within and outside of operating rooms for combined use with other XION components in a system. The XION MATRIX DS Data Station is a central control unit dedicated for XION camera systems equipped with a USB interface and using the XION DiVAS Video Archiving and Analysis software from Version 2.7 onwards. The intended user is the physician who is trained/experienced in ENT medicine, and who has completely read and understood this User Manual. This equipment is not intended for and shall not be used by medical assistants. The XION MATRIX DS Data Station is an active, mains-powered medical device.

Fields of Application, Indication The XION MATRIX DS Data Station manages image, video, audio and measurement data acquired from endoscopic and surgical interventions. When the MATRIX DS is incorporated into a computer network such as the HIS (Hospital Information System) via a network interface, any processed image and video data can be transferred to a PACS system. CAUTION The XION Matrix DS Data Station is not an application part, and it is not suitable for direct contact with the patient. It just serves as database, data archive and data evaluation system.

Directions for Using the Manual The User Manual provides information about the safe, proper and efficient use of the medical device. We recommend that you take the time to read the User Manual carefully prior to commissioning the medical device; start with Chapter - Important Information - Please read this information before use, from page 5. Make sure that the User Manual is always within reach. The contents of this User Manual does not, however, replace any medical or technical knowledge. Such expertise is subject to the user’s special education or further education. XION GmbH is not liable for diagnoses and interpretations of findings that are based on the use of this medical device. Acquiring special medical knowledge as well as drawing diagnostic and therapeutic conclusions is solely subject to the user of this medical device.

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Combination and Interaction with other Devices Use the medical device only as intended in compliance with the relevant “Betreibervorschriften für Medizintechnikprodukte” (German Medical Devices Operator Ordinance - Ordinance on the Installation, Operation and Use of Medical Devices – MPBetreibV) in the system environment delivered and installed by XION GmbH, for which XION GmbH has issued a Declaration of Conformity. Using the MATRIX DS Data Station outside of the XION system environment does not constitute the intended purpose of the device.

CAUTION Operating the MATRIX DS Data Station in combination with optional components within one and the same system requires compliance with the basic requirements for systems, and requires that the user must in his own responsibility prepare a system conformity declaration whenever any modification, installation or addition etc. is made. Compliance with the safety precautions (Chapter CAUTION - When using the MATRIX DS Data Station on patients, connect only application parts classified as "BF"!, from page 6) is mandatory. The relevant points are highlighted by the symbol

in this User Manual.

CAUTION When using the MATRIX DS Data Station on patients, connect only application parts classified as "BF"!

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Explanation of the Graphic Symbols Used To provide a better overview, the following drawings or graphic symbols are used in the text, on the product or on the packaging: Before using the equipment, read the User Manual. Make sure that the User Manual is always within reach.

Caution! WARNING Note:

The safety of the patient, user or a third person is at risk! To avoid injuries to the patient, user or any third person, make sure to observe this warning. Indicates situations where failure to observe may jeopardize operational safety or damage equipment.

Recommends actions for improving situations and enhancing operational safety, however failure to observe these recommendations does not lead to failures or damage. Manufacturer information Year of manufacture

Article number

SN

Serial number

Potential equalization

ESD protection

Disconnect device from the power supply.

Power switch

Note on compliance with IEC 60601

Temperature limits for operation

Temperature limits for storage and transport

Do not dispose of in domestic waste.

DVD/CD multi-function drive

CE marking

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2 Safety Precautions

2

Safety Precautions The medical device should only be used according to its intended purpose as to the regulations of the MPG, the common state of the art, and as to the prevailing labour protection and accident prevention rules. In combination with other medical devices, the arrangement can only be considered technically safe if the intended purpose and the interface specifications of the medical devices allow such combination. It is essential to follow the user manuals of the medical devices being used within the arrangement.

CAUTION All devices located in the vicinity of patients must comply with the requirements of standard IEC 60601 for medical devices. Devices or accessories that have not been tested to this standard must not be connected to the signal inputs/outputs of the data station Do not touch exposed contacts on the data station while touching the patient at the same time. Before using the medical device, visually check and make sure that it is functionally safe and in a proper working condition. Do not use the device if you have detected any damage that could jeopardize the patient, the user, or third persons. The device may only be used by persons who, through their training or knowledge and practical experience, can reliably handle the device in a proper manner. When connecting the device via the power cable, make sure that the mains outlet is properly earthed The device must be placed in such a way that the power plug is easily accessible but cannot be accidentally pulled out! Prior to commissioning the device, check whether its operating voltage is the same as the local mains voltage. See the type plate or the technical data for the correct operating voltage, see Chapter 10 Technical Data, from page 37. Do not turn on the device until all connection lines have been fully connected. Connect the potential equalization connector of the device in compliance with the applicable national regulations. Observe the approved operating temperatures. CAUTION The device is NOT suitable for operating in potentially explosive areas. When using the system in an environment with e.g. readily combustible and explosive anaesthetic substances or flammable, slightly volatile skin cleaning and skin disinfecting substances, make sure that it is not used in a hazard zone as defined by the manufacturer. The device must be set up outside of the patient environment. Always use a firm surface for operating the device. Avoid soft underlays that may cover ventilation slots in the bottom of the device. Make sure to provide adequate air circulation so that the device does not overheat. Make sure that the ventilation slots at the bottom of the device and in the rear panel of the device are not covered. Maintain a distance of at least 10 cm from the back of the device.

Figure 1: Air supply

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The data station and the respective components are high-end electronic, precision-engineered devices. Make sure to treat them with care. Avoid sudden severe temperature variations or warming above 40°C and mechanical loads such as hard knocks. CAUTION Do not subject the device to rain or moisture. Avoid moisture or objects penetrating the device as this can cause permanent damage to the device or the risk of an electric shock. In such a case immediately switch off the device, disconnect it from the mains and commission qualified service personnel to perform the required repair work! Due to the risk of electric shock, do not open the device. All components must be maintained by authorized personnel only. The operational reliability and availability of the device depend not only on your ability, but also on the maintenance provided. Regular cleaning and maintenance are mandatory, see also Chapter 6 - Cleaning and Disinfecting, from page 29. CAUTION Prior to performing any cleaning or disinfection work, turn off the device and disconnect it from the mains supply and from other devices connected to the mains. Repair work must be carried out only by specialist staff authorized by XION GmbH. Qualified service and the use of original spare parts ensure that the device's operational reliability, its availability and its value are preserved. Cautious and careful work is the best protection against accidents!

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2 Safety Precautions

2.1

Protective Measures against ESD Electrical, electronic and optoelectronic components are at risk when subjected to electrostatic charges, which can cause them to malfunction or even to be destroyed. The MATRIX DS Data Station has been tested for its ESD resistance within the scope of DIN EN 60601-1-2. However, the user is required to ensure that ESD protection measures are maintained to protect the medical device from destruction. These include: •

Avoiding direct contact with exposed connectors.

•

Avoiding synthetic clothing or footwear that has a highly electrically insulated sole.

•

Before handling the MATRIX DS Data Station (e.g. connecting or disconnecting accessories or optional components), you should discharge any possible electrostatic charges on your body (e.g. by touching earth potential or ground potential).

•

Before installing the system or connecting/attaching the medical device to accessories or optional components, all persons responsible for handling the equipment (including MT-staff) must be informed about the above named ESD protection measures and trained to ensure their effective implementation. The training syllabus should include at least:

  2.2

The physical principles underlying the formation and effects of electrostatic discharge: Electrostatic charging is caused by frictional electricity (e.g. walking on carpet, wearing synthetic clothing) and, due to the high potential difference that arises, this in turn leads to sparking or to a disruptive discharge of voltage pulses up to 30,000 V. These voltage pulses discharge within a very short space of time (fractions of picoseconds to nanoseconds) with sometimes devastating effects on the electronic components of devices. Explanation of preventive methods and the effectiveness of protective measures: Effective measures of protection are aimed at avoiding the original cause of electrostatic charging, i.e. preventing or minimizing such charging, for example by dissipation or by grounding the human body, wearing clothes and shoes made of nonsynthetic materials.

Electromagnetic Compatibility (EMC) Mobile RF communication facilities can influence electric medical devices! For example, do not operate any mobile phones in the vicinity of electric medical devices, see also Chapter 11 - Declarations Regarding EMC, on page 38. Using any accessories, transformers and lines other than those specified, with the exception of transformers and lines that are offered by XION in the scope of supply or as spare parts for XION components, can lead to increased emissions or cause a decrease in immunity of the system. Using XION accessories, converters or lines in combination with equipment other than the specified XION devices and systems can lead to increased emissions or a reduction in the immunity of the system.

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2.3

Safety during Commissioning

CAUTION While installing and operating your components, please be sure to follow the safety regulations as they are described in Chapter - Important Information - Please read this information before use, from page 5!

CAUTION The device is generally equipped with a standby function. An all-pole power-disconnect is only accomplished by separating the mains leads from the device or the mains power supply.

CAUTION When connecting to a LAN use a network isolator!

The MATRIX DS Data Station is equipped with a connector for potential equalization. This connection must be connected with the corresponding connection on site during installation if one of the following conditions exists: •

In combination with other devices, the sum of the leakage currents for all installed devices exceeds the maximum permissible value defined in the provisions of the current IEC 60601.

•

The in-house regulations or directives on site generally require that the installed devices are connected to appropriate potential equalization.

Figure 2: Connector for potential equalization



Use no other accessories than those listed in the User Manual, Chapter 7. 3.1 - Spare parts and accessories, from page 33. The data station unit must not be positioned directly next to or stacked with other devices. If the data station must be operated close to or stacked with other devices, the data station must be observed when used in this arrangement to check its proper operation.

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3 Product Description

3

Product Description

3.1

Properties The XION Matrix DS Data Station is designed as the basic component of a XION system environment. It is used to acquire and manage image, video, audio and measurement data together with other optional XION components. Equipped with an Intel® Q170 Express chipset that is configured with a CPU, graphic card and memory components with appropriate capacity and speed, the station meets the current requirements for the Microsoft Windows operating system. The standard scope of delivery includes the DiVAS Video-Archiving and Analysis software with the Base / Patient Administration module for connecting various optional XION camera control units. A series of clearly structured menus provides easy control, for example to freely assign functions to the buttons on the camera head, and to transfer your data to the Hospital Information System. For additional product features, see Chapter 10 - Technical Data, from page 37.

3.2

Product Variants The equipment of your MATRIX DS Data Station can be compiled and configured according to your specific tasks and field of application, and can also be extended with helpful hardware or software options.

CAUTION However, compliance with the relevant “Betreibervorschriften für Medizintechnikprodukte” (German Medical Devices Operator Ordinance - Ordinance on the Installation, Operation and Use of Medical Devices – MPBetreibV) must always be ensured, because only one conformity declaration has been issued by XION GmbH for one of the system environments supplied and installed by XION GmbH (see also Chapter - Combination and Interaction with other Devices, from page 6). The MATRIX DS Data Station is offered in the following basic extension levels: •

MATRIX DS HD Data Station For use in conjunction with XION HD camera systems.

•

MATRIX DS Data Station For use in conjunction with XION USB camera or XION USB otoscope.

For consultation, individual configuration or an optional enhancement for your MATRIX DS Data Station, please contact your XION Service Team, see Chapter 7. 3 - Service by the Manufacturer, from page 32.

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3.3

Scope of Delivery For a complete overview of the scope of supply, please consult the delivery note of your Matrix DS Data Station.

3. 3.1

Scope of Delivery MATRIX DS HD Component

Article No.

MATRIX DS Data Station

350 010 883

HDD removable disk, capacity dependent on device (used in device) OS MS Windows Option: Frame Grabber HD (installed)

350 010 030

incl.:

350 009 064 350 009 061 ---

Connection cabel 4x Matrox DVI Monitor emulator adapter DVI BNC/SMB adapter

DiVAS Base / Patient Administration module (installed) USB stick with camera drivers, DiVAS and activation number

350 020 000

MATRIX DS Data Station User Manual

350 010 882 bx x xxxxxx

DiVAS Basic / Patient Management Module User Manual

350 020 000 bx x xxxxxx

Mains cable, country-specific, according to Table 3 - Spare parts and accessories - on page 33 DVI cable, single link, length 2 m

320 009 043

Audio cable jack 3.5 mm, length 1.2m

320 009 045

USB 2.0 cable, A->B (plug/plug), length 1.0m

320 009 056

Miniature fuse T2.5 AL 250V ∅ 5x20 (2 pieces)

SI-2500MAT

Packaging Table 1: XION MATRIX DS HD, Scope of Supply

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3 Product Description 3. 3.2

Scope of Delivery MATRIX DS Component

Article No.

MATRIX DS Data Station

350 010 882

HDD removable disk, capacity dependent on device (used in device) MS Windows 7 ULTIMATE 32BIT

CA903405

DiVAS Base / Patient Administration module (installed) USB stick with camera drivers, DiVAS and activation number

350 020 000

MATRIX DS Data Station User Manual

350 010 882 bx x xxxxxx

DiVAS Basic / Patient Management Module User Manual

350 020 000 bx x xxxxxx

Mains cable, country-specific, according to Table 3 - Spare parts and accessories - on page 33 DVI cable, single link, length 2 m

320 009 043

Audio cable jack 3.5 mm, length 1.2m

320 009 045

USB 2.0 cable, A->B (plug/plug), length 1.0m

320 009 056

Miniature fuse T2.5 AL 250V ∅ 5x20 (2 pieces)

SI-2500MAT

Packaging Table 2: XION MATRIX DS, Scope of Supply

Note:

First, please check the packaging of the goods for shipment damage. In the event of damage, make a note of the quantifiable scope of damage and report it to your dealer or manufacturer; see also Chapter 7. 3 - Service by the Manufacturer, from page 32. Once you have unpacked the components, make sure they are complete, undamaged and in a proper state.

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Description of the MATRIX DS

4.1

Ports and Functional Elements on the Front Panel

Figure 3: XION MATRIX DS Data Station, front panel

1

Mains switch (mains / standby) with LED control display LED = green, mains ON LED = orange, standby

2

USB 2.0/1.1 interfaces 2 ports in compliance with USB 2.0 specification, for connecting optional USB components.



further to

*)

*):

Switch-on behaviour The switch-on behaviour of the MATRIX DS Data Station after applying the mains voltage can be configured as required, see also Chapter 5. 5 - Switching on the MATRIX DS Data Station, on page 26. Please consult your XION Service Team, see Chapter 7. 3 - Service by the Manufacturer, from page 32

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4 Description of the MATRIX DS

4.2 Device

Ports and Functional Elements on the Rear Panel of the

Figure 4: MATRIX DS Data Station rear panel

a

Mains connection and replaceable mains fuses

b

Potential equalizing pin

c

Chassis connector, 12VDC, Connector for optional XION components

d

Fuses for 12VDC connector For fuse rating, see rear panel of the device

e

Frame grabber HD.

f

1 x SSD Memory card slot The SSD memory card slot is reserved for your operating system as well as for WINDOWS and Office. Avoid installing other software or saving data on your SSD memory card! Refer to your delivery note for the capacity specifications.

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g

2 x HDD Removable disk compartment, loading and capacity depends on the device Height 9.5 mm. Upper compartment: Removable work disk for • XION DiVAS software • DiVAS databases • Operating system backup • Additional optional programs (video, audio, graphics, etc.) Lower compartment: Can be optionally equipped for DiVAS enhancements Refer to your delivery note for the assemblies and capacity specifications We recommend setting up the optional removable disk in the lower removable disk compartment for enhancing your DiVAS application environment, but not for using it for data backups or a DiVAS backup. You should generally always carry this out over the data network! For configuring an optional second removable disk, consult your XION service team, see Chapter 7. 3 - Service by the Manufacturer, on page 32.

Note:

h

Connector panel for system-related and optional components; a description of the functions and connectors follows, see Chapter 4. 2.1 - Connector panel for system-related and optional components, on page 18.

KL

Housing opening for attaching a Kensington Lock anti-theft device.

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4 Description of the MATRIX DS 4. 2.1

Connector panel for system-related and optional components

Figure 5: Connector panel for components

a

PS/2 port for connecting a PS/2 keyboard.

b

PS/2 port for connecting a PS/2 mouse.

c

4 x USB 2.0/1.1 port 4 connectors in compliance with the USB 2.0 specification.

d

Display port V1.2 / LVDS not used

e

Serial (RS232, FIFO, 16550 compatible) port not used

f

RJ-45 LAN port This Ethernet LAN interface supports Internet connections up to a data rate of 1Gbps.

LED for transmission speed

LED for transmission activity display

Control LEDs provide information about the current status of the data connection. LAN1 is activ LAN2 optional, not used

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Figure 6: RJ-45 LAN port

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

Status of the LAN port LEDs:

LED for transmission speed Status

Description

Orange

1 Gbps transmission speed

Green

100 Mbps transmission speed

Off

10 Mbps transmission speed

LED for transmission activity display Status

Description

Flashing

Data transmission, send or receive

Off

No data traffic

Audio inputs and outputs.

g

LINE IN Audio input (blue), 3.5 mm stereo jack, Connection to audio output of the XION camera control unit in your DiVAS system.

h

LINE OUT Audio output (green), 3.5 mm stereo jack, Connection to XION loudspeaker system in your DiVAS system

i

Microphone input (pink), 3.5 mm jack, Connection to an optional microphone.

j

4 x USB 3.0/2.0 port 2 ports in compliance with USB 3.0 specification, compatible with USB 2.0/1.1.

k

DVI-D port for connecting a XION flat-panel monitor via the DVI-port. Supports a resolution up to max. 1920 x 1200 pixels, depending on the monitor connected.

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