Service-User Manual
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XION Article Number EndoSTROBE PL Spectar 329 131 001
Service/User Manual
HD Camera Control Unit with Integrated Light Source
EndoSTROBE PL Spectar
This Service/User Manual is protected by copyrights. No part of it may be copied or transferred into other lan- guages without the express prior written consent of XION GmbH. The product names and names of companies used in this Service/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:
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+49 (0) 30 / 47 49 87 – 0 +49 (0) 30 / 47 49 87 – 11
[email protected] www.xion-medical.com/en
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Contents Chapter Title
Page
Important Information ... 7 Intended Purpose ... 7 Fields of Application, Indication ... 7 Contraindication ... 7 Directions for Using the Manual ... 7 Explanation of the Graphic Symbols Used ... 8 1
Safety Precautions ... 10
1.1
Safety Measures ... 10
1.2
Electromagnetic Compatibility (EMC) ... 12
2
Combination and Interaction with other Devices ... 13
2.1
Compatibilities ... 13
3
Product Description ... 14
3.1
Scope of Delivery ... 14
3.2
Properties ... 15
3.3
Example Configuration ... 16
4
Description of the System Components ... 18
4.1
Front Panel with Connector Ports, Display and Control Elements ... 18
4.2
LED Lighting Unit ... 21
4.2.1
Connector adapter for fibre-optic connections ... 21
4.3
Rear Panel of the Device ... 22
4.4
XION components ... 23
4.4.1
Clip microphone ... 23
4.4.2
EGG electrode set ... 24
4.4.3
Footswitch ... 25
5
System Variations and Cable Connections ... 26
5.1
EndoSTROBE Spectar as a Standalone Device ... 26
6
Setting up and Installation ... 27
6.1
Instructions for Setting Up ... 27
6.2
Prior to Commissioning ... 28
6.3
Mains Requirements ... 28
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4
6.4
Potential Equalizing Connector ... 28
6.5
Connecting XION Components ... 29
6.5.1
Connecting a XION application part ... 29
6.5.2
Releasing the Spectar Connector from the Control Unit ... 30
6.5.3
Connecting a Clip Microphone or an EGG Electrode Set ... 32
6.5.4
Disconnecting the Clip Microphone or EGG Electrode from the Control Unit . 32
6.5.5
Connecting a fibre-optic light conductor ... 33
6.6
Installing a Wireless Footswitch ... 34
6.6.1
Signing-on the wireless footswitch ... 34
6.6.2
Signing-off the wireless footswitch from the receiver module ... 35
6.6.3
Using several wireless footswitches ... 35
6.6.4
Signing-on another wireless footswitch ... 35
6.6.5
Signing-off an additional wireless footswitch ... 35
6.6.6
Signing-off all wireless footswitches ... 35
7
Product Application ... 36
7.1
Switching on the EndoSTROBE PL Spectar ... 36
7.2
Connecting the Application Part ... 37
7.3
3D Adjustment with EndoSTROBE PL Spectar ... 38
7.3.1
Components of the XION 3D ALIGN ... 39
7.3.2
Performing the 3D adjustment ... 40
7.3.2.1
Setting the working distance: ... 40
7.3.2.2
Inserting the instrument ... 40
7.3.2.3
Adjusting the instrument ... 41
7.3.2.4
Starting the 3D adjustment ... 43
7.3.2.5
Checking the 3D adjustment ... 44
7.4
White Balancing ... 45
7.4.1
Performing the white balance ... 45
7.4.2
White balancing failed ... 45
7.5
Functions and Interactions of the Control Unit ... 45
7.6
Function keys ... 46
7.6.1
White balancing with the WHITE key ... 46
7.6.2
Exposure adaption with the MODE key. ... 46
7.6.3
Changing overall brightness with the BRIGHTNESS key ... 46
7.6.4
Changing the edge sharpness with the CONTRAST key ... 47
7.6.5
Freeze the image with the FREEZE key ... 47
7.6.6
Switching between 2D and 3D mode with the 3D key ... 47
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7.6.7
Configuration menu with the MENU key ... 48
7.6.8
Selecting an application profile with the USER key. ... 48
7.6.9
Stroboscopy mode On/Off with button STROB
7.6.10
Selecting the synchronization source with key EGG k ... 49
7.6.11
Selecting a microphone input with key MIC l ... 49
7.7
Light Control ... 50
7.7.1
Manual brightness control ... 50
7.7.2
Automatic brightness control ... 50
7.8
Stroboscopy Mode ... 51
7.8.1
Positioning a microphone ... 51
7.8.2
Applying the EGG electrodes ... 51
7.8.3
Stroboscopic synchronization in EGG MODE ... 52
7.8.4
Synchronization variants ... 53
7.8.5
Displays in stroboscopy mode ... 54
7.9
Operating the System with the Footswitch ... 54
7.9.1
Switching between camera mode and stroboscopy mode ... 54
7.9.2
Switching between memory image and live image ... 54
7.9.3
Switching between modes slow motion and fixed phase ... 54
7.9.4
Shift phase by 360° ... 55
7.9.5
Shift phase by 0° ... 55
7.9.6
Shifting the slow-motion speed in the direction of 2 Hz ... 55
7.9.7
Shifting the slow-motion speed in the direction of 0.5 Hz ... 55
7.10
Procedure for Making Settings in the Menu ... 56
7.10.1
EndoSTROBE PL Spectar menu ... 56
... 49
7.10.1.1 Application profiles for 3D application parts ... 56 7.10.1.2 Application profiles for 2D application parts ... 59 7.10.1.3 3D video functions ... 61 7.10.2
2D video functions ... 62
7.10.3
Intrinsic functions ... 63
7.10.3.1 Factory settings ... 64 7.11
Keys on the Camera Head and the Footswitch ... 64
7.12
Viewing of 3D images and 3D videos ... 65
8
Cleaning and Disinfecting ... 66
8.1
General ... 66
8.2
Cleaning the Control Unit ... 66
8.3
Disinfecting the Control Unit ... 66
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8.4
Cleaning and Disinfecting the Clip Microphone ... 66
8.5
Cleaning/Disinfecting Other Optional System Components ... 66
9
Maintenance and Service ... 67
9.1
User Maintenance ... 67
9.2
Maintenance Work by the User ... 67
9.2.1
Replacing the mains fuses ... 67
9.2.2
Replacing the connector adapter ... 68
9.3
Service by the Manufacturer ... 69
9.3.1
Address for repairs and return shipments ... 69
9.3.2
Article and serial numbers ... 69
9.4
Repair Process ... 70
9.5
Responsibility ... 70
9.6
Warranty ... 71
9.7
Disposal ... 71
9.8
Service Address ... 71
9.9
Spare Parts ... 72
9.10
Accessories ... 72
10
Troubleshooting ... 73
10.1
Deviations During the 3D Adjustment ... 76
10.2
Eliminating Faults on Other Devices ... 77
11
Manufacturer and Distributor ... 78 List of Figures ... 79 List of Tables ... 81
Appendix I Technical Data ... 82 Appendix II Declarations Concerning EMC ... 84 Guidelines and Manufacturer Declaration ... 84 Electromagnetic environment ... 84 Tested lines according to IEC 60601-1-2 ... 84 Appendix III PIET ... 85 PIET lumino ... 85 PIET chromo ... 85 PIET spectro ... 85
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Important Information Please read before use Intended Purpose TheEndoSTROBEPLSpectarisacameracontrolunit,which,in combination with a suitable application part as well as in conjunction with a suitable monitor, can present high-resolution photos and image sequences for use as a diagnostic tool in medical endoscopy. The integrated LED high-performance light source provides optimum illumination of the endoscopic field of vision using continuous or stroboscopic light.
Fields of Application, Indication The device is intended for applications in 2D and 3D endoscopy. The integrated LED high-performance light source facilitates stroboscopic functions featuring the pre- cise representation of moving anatomical structures, e.g. vocal folds.
Contraindication Contraindications that relate directly to the medical device, are currently unknown. The responsible physician must decide on the basis of the general condition of the patient and professional standards, whether the intended application can be made.
Directions for Using the Manual The Service/User Manual provides information about the safe, proper and efficient use of the devices. Make sure that the Service/User Manual is always within reach. In the event that you pass the device on to a third party, make sure to also forward the Service/User Manual. TheintendeduseroftheEndoSTROBEPLSpectarCameraControlUnitisatrained/experienced physician, who has read this Service/User Manual. Excluded is the use by auxiliary medical staff and/or the patient. Lack of medical and basic technical knowledge does not and cannot be compensated by studying this Service/User Manual. 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 this medical device, which you have purchased. Acquiring special medical knowledge as well as drawing diagnos- tic and therapeutic conclusions is solely subject to the user of this medical device.
This Service/User Manual does not include any detailed description of endoscopy and is also not suitable for introducing beginners to this surgical technique!
The EndoSTROBE PL Spectar Camera Control Unit is an active, mains-operated medical device.
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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:
Symbol
Meaning Before using the instruments, read the Service/User Manual. Make sure that the Service/User Manual is always within reach.
Warning!
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.
CAUTION!
Indicates situations where failure to observe may jeopardize operational safety or damage equipment.
Note:
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
201x
Temperature limits for storage and use Rel. humidity Air pressure for transportation Keep dry Caution; fragile
IP 20
Degree of protection against moisture and solids entering the device Fuse specifications Class BF application part Article number
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Symbol
Meaning Serial number Potential equalizing connector Disconnect power plug Disposal considerations
Useful Information: CE marking with the number of the notified body.
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1 Safety Precautions
1
Safety Precautions
1.1
Safety Measures • The medical device shall only be used according to its intended purpose, in compliance with the regulations applicable in the country of use, the common state of the art of technology, and in compliance with the prevailing labour protection and accident prevention rules, and in the system environment delivered and installed by XION GmbH, for which XION GmbH has issued a Declaration of Conformity. Using of the EndoSTROBE Spectar Camera Control Unit outside of the XION system environment does not constitute the intended purpose of the device. • All ELECTRICAL devices located in the vicinity of patients must comply with the requirements of standards family IEC60601-1 for electrical medical devices. Only devices or accessories that have been tested to this standard shall be connected to the signal inputs/outputs of the control unit. • Exposed contacts on the control unit must not come into contact with 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 it is damaged in any way that could jeopardize the patient, the user, or third persons. • 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. • The device is not suitable for operating in MRT rooms due to the ferromagnetic interactions encountered there. • Use a firm, level and slip-resistant surface for operating the device. • 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. • When connecting the device via the power cable, make sure that the mains outlet is properly earthed Before commissioning the device, check whether the mains voltage on site matches the input voltage specified for the device. To obtain this information, please refer to Chapter 11 - Manufacturer and Distributor, on page 78, or the type plate. • Do not turn on the device until all necessary connection lines have been fully connected. • The control unit must be set up outside of the patient environment. • The device must be placed in such a way that the power plug is easily accessible but cannot be accidentally pulled out.
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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 indispensable, see also Chapter 8 - Cleaning and Disinfecting, on page 66. Before performing any cleaning or disinfection work, disconnect the device from the mains supply and from other devices connected to the mains.
• Due to the risk of electric shock, do not open the device. Repair work shall beperformed 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. • Also observe all safety instructions given in the service/user manuals of all components that are part of the system.
Warning! Heat is generated at the light exit -- tissue damage! When using the integrated LED high-intensity light source, high-energy light can exit from a fibre-optic light conductor or endoscope. Soiling in the light emission area, insufficient operating distances or direct tissue contact can result in high temperatures above 41°C and possible tissue damage due to thermal radiation. Always avoid direct contact with tissue in the light emission area! To minimise the risk of burns, always use the automatic light source control or manually adjust the light source to the minimum required illumination. Warning! Risk of fire! The high energy radiated at the distal end may give rise to high temperatures or fire if an endoscope is placed on heat-sensitive or flammable surfaces. Therefore, always place the endoscope in the suitable appliances. Clean the optics of the endoscope to prevent unwanted heat development. Always reduce the light source intensity when the endoscope is not in use between examinations. Switch off the light source during long periods between usage! Warning! Eye damage! The energy of high-capacity light sources might cause severe and lasting eye damage. Do not look directly into the light exit of the light source or of a connected fibre-optic conductor!
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1 Safety Precautions
1.2
Electromagnetic Compatibility (EMC) • The Control Unit meets the requirements of IEC 60601-1-2/02.2014 (CISPR 11, Group 1, Class B). • The essential performance features – interruption of image display and/or interruption of the operability of the control device up to a maximum of 5 seconds – were successfully tested for their electromagnetic compatibility. EM disturbances greater than the ones prescribed for the test procedure may affect both the image representation as well as the operability. • When used in conjunction with HF-surgery devices, a direct discharge on to the endoscope (user part) may lead to a short-term failure of the image. • Mobile RF communications equipment (radios including their accessories such as antenna cables and external antennae) should NOT be used at a distance of less than 30 cm from the components identified by XION and the conductor lines of the EndoSTROBE Spectar System. Failure to observe this requirement can significantly reduce the performance of the device. • Using the control unit directly next to other devices or other devices in stacked form should be avoided, as this could result in faulty operation. However, if it is absolutely necessary to use the device as described, it is essential to keep observing the control unit and the other devices to ensure that they are working properly. • Using any accessories, transformers and conductor lines other than those specified, with the exception of transformers and conductor lines that are offered by XION in the scope of supply or as spare parts for XION components, can lead to increased electromagnetic noise emissions or cause a decrease in electromagnetic immunity of the system and thus result in faulty operation. • 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
Combination and Interaction with other Devices • It is essential to follow the service/user manuals of the medical devices being used within the arrangement. • Operating the EndoSTROBE Camera Control Unit 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 provide a system conformity declaration when the installation is made. Compliance with the safety precautions (Chapter 1 - Safety Precautions, on page 10) is mandatory. The EndoSTROBE Spectar Camera Control Unit in conjunction with the dedicated application parts meets the requirements of Class BF. It is in itself not an application part, and it is not suitable for direct contact with the patient.
Note:
The EndoSTROBE Spectar Camera Control Unit is a module of the XION GmbH HD endoscopy system. In combination with the optional component MATRIX DS Data Station and the DiVAS Video-archiving and Analysis Software installed there, the device can be used to record, edit and archive photos and video sequences.
2.1
Compatibilities The following XION devices and Products can be used together with the EndoSTROBE Spectar Camera Control Unit: • All XION devices with Spectar Connector like Video-Nasopharyngoscope, Camera Heads and Ostoscopes as well as the corresponding 3D Endoscope Attachements • Clip microphone for stroboscopy systems, LEMOSA • EGG electrodes • Receiver module, external, for wireless footswitch
For a detailed list of application parts, please see the XION product catalogues, or consult your XION service team, see Chapter 9. 3 - Service by the Manufacturer, on page 69.
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3 Product Description
3
Product Description
3.1
Scope of Delivery The table below shows the scope of delivery of the EndoSTROBE Spectar Control Unit you have purchased: Component
Article No.
EndoSTROBE PL Spectar Control Unit (incl. 3D + PIET)
329 131 001
Power cable, specific for respective country, see Table 3 - Spare parts and accessories, page 72 Micro-fuse T2.5 AL/250 V ∅ 5x20 (2 pieces)
SI-2500MAT
DVI-D cable, length 2.0 m
320 009 043
Packaging User ManualManual Service/User Table 1: Scope of delivery for EndoSTROBE Spectar Control Unit
Note:
First, please check the packaging of the goods for shipment damage. In the event of damage, make a note of the apparent scope of damage and report it to your dealer or manufacturer; see also Chapter 9. 3 - Service by the Manufacturer, on page 69. Once you have unpacked the components, make sure they are complete, undamaged and in a proper state.
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3.2
Properties • Universal support for various application parts such as endoscope, laryngoscope, nasopharyngoscope, otoscope or camera head, see Chapter 2 - Combination and Interaction with other Devices, on page 13. • Support for popular video formats in HD resolution, with 2D and 3D technology. • Very high light sensitivity, natural colour rendition. • Different individual and situational visualization options by means of Professional Image Enhancement Technology (PIET). • Digital zoom, user-selectable in steps from 1x through 2.4x. • Input for XION EGG electrode set or external monitor. • Input for XION footswitch. • Choice between a standard factory setting profile and three USER profiles, to which application-specific settings can be assigned. • Two REMOTE outputs (photo trigger, video start/stop). • Space-saving integrated LED high-performance light source. • Low-noise, flicker-free strobe effect. • High light output with automatic control of the brightness: • Manual, stepless control for light brightness, with memory function. • LED switches off automatically when the fibre-optic light conductor is removed.
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3 Product Description
3.3
Example Configuration The EndoSTROBE Spectar Control Unit is a module within a diverse system offered by XION GmbH. Due to the different system variations possible, the installation and the cable connections always depend on the respective situations and associated components of your system. The following sample configuration represents a XION system environment with different optional components.
Figure 1: XION System environment
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Legend:
EndoSTROBE PL Spectar
EGG electrode set
Clip microphone for stroboscopy systems
MATRIX DS Data Station incl. DiVAS software 2D monitor/Live-image monitor 3)
XN HD Video Nasopharyngoscope
Spectar Video-Otoscope
Spectar HD Camera Head
2D sterile adapter Endoscope 3D monitor/Live-image monitor 3) 3D glasses
3D Spectar camera head
Sterile adapter
3D Endoscope Attachment
Wireless OR Footswitch
2D monitor/Work-image monitor 4)
the keyboard
3) Live-image monitor:
Monitor for directly displaying the camera image of the camera control unit.
4) Work-image monitor:
Monitor for displaying the Windows desktop, DiVAS and the necessary control commands, Office programs for creating medical reports or protocols, as well as the camera image of the camera control unit. With the option to temporarily switch over to a live-image display in conjunction with DiVAS applications, as described in the corresponding DiVAS documentations.
Warning! Use the live image monitor only for viewing the camera image during a surgical intervention or an examination! In the event of a system crash, only the image transmitted to the live-image monitor ensured.
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4 Description of the System Components
4
Description of the System Components
4.1
Front Panel with Connector Ports, Display and Control Elements
Figure 2: EndoSTROBE PL Spectar Front side
Power key with LED control light Switching between Mains ON LED = green STANDBY LED = orange The switch-on behaviour of the EndoSTROBE Spectar Control Unit when mains power is switched on can be configured as follows with the POWER CONTROL switch located at the back of the device (see Figure 4 - EndoSTROBE Spectar Rear panel, page 22): Switch setting AUTO =
Switch setting MANUAL =
The control unit can be used in a XION PREMIUM series trolley (with central control). When the mains voltage is applied (through the trolley control unit) the device is switched on immediately. Mains ON --> LED = green
The control unit can be used in all other XION system environments (without central control). When mains power is switched on, the device is initially in STANDBY MODE. STANDBY --> LED = orange
In STANDBY MODE the device can now be turned on with power button (not via the trolley control). Note:
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The Mains ON status also switches on the connected application part (camera, microphone or EGG electrodes). The application parts do not have their own power-on function.
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Note:
WHITE key
Selecting “White balancing”.
MODE key
Selecting the size of the assessment window with LED for displaying status, as well as Cursor to the left in the Settings menu, with LED
BRIGHTNESS key
Setting the brightness with LED for displaying status, as well as Cursor upwards in the Settings menu, with LED
CONTRAST key
Setting image sharpness with LED for displaying status, as well as Cursor to the right in the Settings menu, with LED
FREEZE key
"Freezing" the image (freeze frame) as well as Return in the Settings menu, with LED
3D key
Switching 2D/3D display
MENU key
Selecting the menu for the following settings: PIET, monitor safety connection, USER setup, camera-key settings, etc.
USER key
Selecting application profile 0, 1, 2 or 3, with LED for displaying the selected application profile, as well as Cursor downwards in the Settings menu, with LED
STROB
key for switching between Stroboscopy mode (LED key = ON) and Endoscopy mode (LED key = OFF)
To be able to switch to stroboscopy mode, the LED-lighting unit must be active (fibre-optic cable connected) or an application part with integrated LED-lighting must be connected to the device. EGG key
Selecting between the following synchronization sources: EGG electrodes or microphone, only when stroboscopy mode is active.
MIC key
for selecting either: Clip microphone on MIC input, or Built-in microphone of the camera head.
LED key
Manually switching ON and OFF the LED light source, with LED key for displaying ON/OFF status.
Brightness control
for manual stepless control of brightness.
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4 Description of the System Components
AUTO key
LED fibre-optic light guide connector
CAM Spectar Connector
EGG / MIC connector
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For switching between: Manual brightness control (via the brightness control ) or Automatic brightness control (using the exposure control provided by the camera’s electronics).
Connector for a light conductor connector stud, type STORZ
Connector socket for an intended XION application part, see Chap. 2. 1 - Compatibilities, p. 13. Connector for either: XION EGG-electrodes, or XION Clip-microphone for stroboscopy
For descriptions of the functions and for instructions on operating the device, please refer to Chapter 7 - Product Application, on page 36.
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