EndoSTROB E with EGG 328 272 600 Stroboscopy User Manual Rev Nov 2013

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 - 10 13127 Berlin Germany Fon: Fax:

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

[email protected] www.xion-medical.com

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List of Contents Chapter

Title

Page

List of Contents ... 3 Intended Purpose ... 5 Fields of Application, Indications ... 5 Combination and Interaction with Other Devices ... 5 1

Directions for Using the Manual ... 7

2 2.1 2.2

Safety Precautions ... 8 Electrostatic Discharge (ESD) ... 10 Electromagnetic Compatibility (EMC) ... 10

3 3.1 3.2 3.3 3.4 3.4.1 3.4.2

Description of the Product ... 11 Properties ... 11 Scope of Delivery ... 12 Sample Configuration (Example) ... 13 Interconnecting the Components ... 14 Safety, Commissioning ... 14 ESD protection measures / potential equalization ... 14

4 4.1 4.2 4.3 4.4 4.4.1 4.4.2 4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.6 4.6.1 4.6.2 4.6.3

Description of the Control Unit ... 15 Front Panel of Device with Connector Ports, Display Elements and Control Elements ... 15 Rear Panel with Connections and Functional Elements ... 17 Optional XION Application Parts ... 18 Connecting the Optional Application Parts ... 20 Control unit and camera application component ... 20 Control unit and EGG electrodes or cable microphone ... 21 Control Unit and Footswitch ... 21 Signing-on the wireless footswitch ... 22 Signing-off the wireless footswitch from the receiver module ... 23 Using several wireless footswitches ... 23 Signing-on another wireless footswitch ... 23 Signing-off an additional wireless footswitch ... 23 Signing-off all wireless footswitches ... 23 System Variants ... 24 EndoSTROB E as stand-alone design ... 24 EndoSTROB E with MATRIX DS data acquisition station ... 26 EndoSTROB E with more than 1 monitor ... 28

5 5.1 5.2 5.3 5.4 5.4.1

Product Application ... 30 Prior to Commissioning ... 30 Switching on EndoSTROB E ... 30 Functions and Settings ... 30 Stroboscopy Mode ... 31 Positioning a microphone ... 31

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5.4.2 5.4.3 5.4.4 5.4.5 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.5.6 5.5.7 5.6 5.7

Applying the EGG electrodes ... 31 Stroboscopic synchronization in EGG MODE ... 32 Synchronization options ... 33 Displays in stroboscopy mode ... 34 Operating the System with the Footswitch ... 35 Switching between camera mode and stroboscopy mode ... 35 Switching between Memory image and Live image ... 35 Switching between modes Slow motion and Fixed phase ... 35 Shift phase in the direction 360° ... 35 Shift phase by 0° ... 35 Shifting the slow-motion speed in the direction 2 Hz ... 36 Shifting the slow-motion speed in the direction of 0.5 Hz ... 36 Function Keys on the Control Unit ... 37 EndoSTROB E Combination with DiVAS ... 40

6 6.1 6.2 6.3 6.4

Cleaning and Disinfecting ... 41 General ... 41 Cleaning the Control Unit ... 41 Chemically Disinfecting the Control Unit ... 41 Chemically Disinfecting Optional EGG Electrodes ... 41

7 7.1 7.2 7.2.1 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6

Maintenance and Service ... 42 User Maintenance ... 42 Repair Work by the User ... 42 Replacing the fuses ... 42 Manufacturer's Service ... 43 Responsibility ... 44 Warranty ... 44 Disposal ... 44 Service address ... 44 Spare parts and accessories ... 45 Optional accessories ... 46

8

Troubleshooting ... 47

9 9.1

Technical Data ... 51 Technical Specifications of Optional EGG electrodes ... 52

10

Explanation of the graphic symbols used ... 53

11 11.1 11.2 11.3

Declarations for EMC ... 55 Electromagnetic Emissions ... 55 Electromagnetic Immunity ... 56 Recommended Safety Distances ... 58

12

Manufacturer and Distributor ... 59 List of Figures ... 60 Index ... 61

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Important information Please read before use Intended Purpose The XION EndoSTROB E camera control unit is only to be used for surgical and diagnostic interventions in the field of medical endoscopy (ENT medicine) as well as for stroboscopy of the vocal folds. The intended user is the doctor who is trained/experienced in endoscopy and/or minimally invasive surgery and who has studied the User Manual. This equipment is not intended for use by medical assistants.

Fields of Application, Indications The XION EndoSTROB E camera control unit in combination with an optional XION SD camera head, a XION XION video nasopharyngoscope or a video laryngoscope produces photos and image sequences (videos). Photographic and video functions can be triggered using the optional XION footswitch or the function keys on a camera head. The integrated stroboscopic function enables the precise representation of moving anatomical structures, e.g. vocal folds. Analogue and digital interfaces on the control unit are used to send image and sound signals to medical devices or software designed for operation together with the XION EndoSTROB E camera control unit for viewing, saving and archiving. The XION EndoSTROB E camera control unit can be fully integrated into the DiVAS software environment, including DICOM and HL7 connection.

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 XION EndoSTROB E camera control unit outside of the XION system environment is not an intended use. Caution Operating the XION EndoSTROB E camera control unit in combination with "non-XION" products within one and the same system is possible, but requires basic compliance with the essential requirements for systems and requires a system-wide Declaration of Conformity during the installation. Ensure that all safety instructions, such as those described in Chapter 2 - Safety Precautions - on page 8, are followed at all times. The relevant points are indicated with a symbol

328 272 600 EndoStrob E with EGG

in this User Manual.

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Caution The EndoSTROB E camera control unit is not an application part, and it is not suitable for direct contact with the patient. Only Class BF user parts may be connected to the control unit for applications performed on the patient.

Note:

6

The EndoSTROB E camera control unit is considered as an individual component within the diverse system offered by XION GmbH. In combination with the optional MATRIX DS data station and the DiVAS video-archiving and analysis software installed there, the device can be used to control and manage photo and video functions.

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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 before use - on 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 based on the application 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.

This User Manual does not include any detailed description of endoscopy/stroboscopy and is also not suitable for beginners to perform this operational technique!

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2 Safety Precautions

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Safety Precautions This device must only be commissioned by specialists and persons instructed in the functionality of the device. 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 recognised as 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 control unit. 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. Always use a firm surface for operating the device. Make sure to comply with the permitted ambient temperature and relative humidity. The XION EndoSTROB E camera control unit is to be set up outside of the patient environment. The device is NOT suitable for operating in potentially explosive areas. When using, for example, readily combustible and explosive anaesthetic substances or flammable, slightly volatile skin cleaning and skin disinfecting substances, make sure that the system is not used in a hazard zone as defined by the manufacturer.

Caution When connecting the device via the power cable, make sure that the mains outlet is properly earthed 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 9 Technical Data - on page 51. The device must be placed in such a way that the power plug is easily accessible but cannot be accidentally pulled out! Do not turn on the device until all connection lines have been fully connected. Exposed contacts on the device must not come into contact with the patient at the same time. Connect the potential equalization connector of the device in compliance with the applicable national regulations. Do not subject the device to rain or moisture. Do not allow the device to drop. Moisture or objects dropping into the device can cause permanent damage to it or can induce the risk of 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! The camera system 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.

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The device's operational reliability and availability depend not only on your personal abilities, but also on the maintenance provided. Regular cleaning and maintenance are mandatory, see also Chapter 6 Cleaning and Disinfecting - on page 41. 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. Due to the risk of electric shock, do not open the device. All components must be maintained by authorized personnel only. Repair work may be carried out only by specialist staff authorized by the 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

Electrostatic Discharge (ESD)

This warning label marks those places on the medical device, that must not be touched or interconnected without implementing special protective ESD measures.

Caution Failure to observe can lead to electrostatic discharges, which in turn can destroy the electronics.

WARNING Always avoid directly touching any exposed plug contacts.

2.2

Electromagnetic Compatibility (EMC)

Caution Mobile HF communication facilities can influence electric medical devices! For example do not operate any mobile phones or GSM telephones in the vicinity of electric medical devices, see also Chapter 11 Declarations for EMC - on page 55. The operation of accessories, converters or lines together with electrical medical devices that are not specified for the control unit can lead to increased transmission or a reduced stability of the system. The control unit must not be positioned directly next to or stacked with other devices. If the control unit has to be operated close to or stacked with other devices, the control unit must be observed when used in this arrangement to check its proper operation.

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3

Description of the Product The EndoSTROB E camera control unit is part of the XION video system, and was developed for examinations and surgical interventions in the field of medical endoscopy. The optional 18-pin and 19-pin XION application components such as the camera heads, video nasopharyngoscope or video laryngoscope are used to record videos and images. Photographic and video functions can be triggered directly on the camera control unit, using the XION footswitch or with the application components. Also, the adapters of the camera heads and lenses make it possible to use all rigid endoscopes and flexible fibre-optic endoscopes with standard oculars. Analogue and digital interfaces in the control unit serve to transfer images to state-of-the-art peripheral devices such as computers, monitors and digital recording devices. Numerous adjustable parameters provide optimal image quality. The settings are made either directly on the camera control unit or on the camera head. The EndoSTROB E camera control unit can control an external XION light source via its CONTROL OUT control port.

3.1

Properties •

Very high light sensitivity

•

High resolution

•

Natural colour reproduction

•

Image memory

•

Brightness, contrast and image detail can be optimized

•

REMOTE output (photo triggering)

•

DVI-D / SDI / S-Video / FBAS outputs for the direct connection of monitors

•

USB port for connecting the XION MATRIX DS data station

•

CONTROL OUT for the control of external XION high intensity light sources

•

Input for footswitch

•

Input for 18-pin camera head, or 19-pin video nasopharyngoscope or video laryngoscope

•

Input for XION EGG electrode set or external monitor

•

Easy to operate

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3 Description of the Product

3.2

Scope of Delivery For a list of the items provided with your XION EndoSTROB E camera control unit, please see the following table: Component

Item No.

XION EndoSTROB E camera control unit

328 272 600

DVI-D cable, length 2.0m

320 009 043

Y/C video cable, length 1.5m

320 009 001

Mains cable, length 2m Euro standard

320 009 007

Miniature fuse T1,25 AL / 250V ∅ 5x20 (2 pieces)

SI-1250MAT

User Manual

328 272 800 bx x xxxxxx

Packaging Table 1: XION camera control unit EndoSTROB E, scope of delivery

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 - Manufacturer's Service - on page 43. Once you have unpacked the components purchased, make sure they are complete, undamaged and in a proper state.

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3.3

Sample Configuration (Example) The EndoSTROB E camera control unit is considered as an individual component within the diverse system offered by XION GmbH. The installation and cabling is always dependent on the respective situations and associated components of your system due to the different system variants possible. The following sample configuration represents a XION system environment with various optional components.

Figure 1: XION System Environment

EndoSTROB E control unit XION camera head, video nasopharyngoscope or video laryngoscope XION EGG electrode set or microphone cable XION footswitch, wireless footswitch and OR wireless footswitch Light source, e.g. MATRIX LED duo MATRIX DS data station Keyboard Monitor as live-image monitor Monitor as control monitor

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3 Description of the Product

3.4

Interconnecting the Components

3. 4.1

Safety, Commissioning

Caution While installing and operating your components, please be sure to follow the safety regulations as they are described in Chapter 2 - Safety Precautions - on page 8!

WARNING The device is generally equipped with a standby function. An all-pole power-disconnect is only accomplished by separating the mains lead from the device or the mains power supply. Do not use any accessories other than those listed in the User Manual, see also Chapter 7. 3.6 Optional accessories - on page 46.

3. 4.2

ESD protection measures / potential equalization The XION EndoSTROB E camera control unit is provided with a connecting device 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 a connection of the installed devices with a corresponding potential equalization.

Figure 2: Potential equalization connection

Please see also the additional information provided in Chapter 11 - Declarations for EMC - on page 55.

Note:

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We recommend educating all concerned persons regarding the precautions and the significance of the ESD warning label before commissioning the system.

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Description of the Control Unit

4.1

Front Panel of Device with Connector Ports, Display Elements and Control Elements

Figure 3: EndoSTROB E - front side

Mains switch with LED control display Switching between

Power ON

LED = green

STAND BY

LED = orange

The power-on behaviour of the EndoSTROB E control unit after applying the mains voltage can be configured by the POWER CONTROL switch on the rear panel of the device (see Figure 4 -EndoSTROB R rear panel, page 17) as follows: Switch setting

AUTO =

For using the control unit in a XION PREMIUM series trolley (with central control). When the mains voltage is switched on (through the trolley control), the unit immediately powers up. Mains ON --> LED = green

Switch position

MANUAL =

For using the control unit in other XION system environments (without central control). When mains power is applied, the device is initially in STANDBY MODE. STANDBY --> LED = orange In STANDBY-MODE the device can now be switched on with the power switch.

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4 Description of the Control Unit



WHITE key

For selecting "White balancing".



MODE key

For selecting the size of the exposure window, with key LED for displaying the status.



BRIGHTNESS key

For setting the brightness, with key LED for displaying the status.



CONTRAST key

For setting the contrast, with key LED for displaying the status.



FREEZE key

for "freezing" the image (freeze frame).



STROB key

For switching between stroboscopy mode (key LED = ON) and endoscopy mode (camera mode) (key LED = OFF).



Key EGG

EGG display. Only possible in stroboscopy mode, Switching between EGG-synchronization and microphone synchronization, with LED key for status display.



Key MIC

For selecting between the microphone at input EGG MIC or the microphone on the camera head/Input CAM, with key LED for status display.



Connection EGG MIC

Audio input, either for XION EGG electrodes or XION microphone



19-pin. connection CAM

for XION SD camera head or video laryngoscope/Video nasopharyngoscope.



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For descriptions of the functions and for instructions on operating the device, please refer to Chapter 5 - Product Application, from page 30.

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4.2

Rear Panel with Connections and Functional Elements

Figure 4: EndoSTROB R rear panel

AC IN

Mains connection 100 – 240V ~ 50Hz / 60Hz and fuse compartment with mains fuses

XION

Type plate with article number

P

Plug connection for potential equalization

    

REMOTE 1 output, Photo trigger (REMOTE 2 without function)

   

Signal output S-VIDEO Signal output FBAS Signal output CONTROL OUT Signal output AUDIO (audio line out), 3.5 mm stereo jack Signal output DVI-D Signal output SDI USB 2.0 port Signal input FOOTSWITCH (for footswitch / receiver module)

S

Signal input SERVICE, only for internal XION use (Must only be used by authorized personnel).

KL

KENSINGTON LOCK, housing opening for attaching a Kensington Lock anti-theft device

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4 Description of the Control Unit

4.3

Optional XION Application Parts The following application parts can be connected to and operated on your camera EndoSTROB E camera control unit: •

XION camera head with two function keys, 18-pin connector plug

= FREEZE / Photo = MODE, or the function programmed into DiVAS

Figure 5: XION camera head with 2 function keys

•

XION Video nasopharyngoscope, 19-pin connector plug

=

FREEZE / Photo

=

MODE, or the function programmed into DiVAS

Figure 6: XION video nasopharyngoscope with 2 function keys

Procedure for programming the function key DiVAS - on page 40.

Note:

•

 see Chapter 5. 7 - EndoSTROB E Combination with

XION video laryngoscope with integrated microphone, 19-pin connector plug

=

FREEZE / Photo

Figure 7: XION video laryngoscope with 1 function key

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•

XION C-mount camera head without function keys, 18-pin connector plug

Functions and settings can be performed using the function keys on the control unit or an optional footswitch.

Figure 8: XION C-mount camera head without function keys

•

XION camera head with built-in microphone, 18-pin connector plug A microphone integrated in the camera head is available, optionally • for synchronization in stroboscopy, • for additional voice recording. Functions and settings can be performed using the function keys on the control unit or an optional footswitch. Figure 9: XION Camera Head with Microphone

 •

Use only XION camera heads that are equipped with a 2 m connecting cable! The XION camera control unit EndoSTROB E is designed only for camera heads with this cable length!

XION EGG electrode set with microphone

=

EGG electrodes

=

Integrated microphone, for additional voice recording.

=

Connector plug for controller unit input EGG MIC.

Figure 10: XION EGG electrode set

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4 Description of the Control Unit

4.4

Connecting the Optional Application Parts

Note:

The designations for the ports, plug connections and control elements in the following descriptions correspond to the designations as they are given in Figure 3 -EndoSTROB E - front side, page 15 as well as Figure 4 -EndoSTROB R rear panel, page 17.

4. 4.1

Control unit and camera application component Connect the XION camera head, the video nasopharyngoscope or the video laryngoscope to the control unit by plugging the camera cable into the connector socket CAM located on the front panel of the controller.



Note:

The red markings on the plug of the camera cable and the connector socket CAM to each other as shown below.

 must be aligned

Figure 11: Markings on the camera connector

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