Operating Instructions
36 Pages
Preview
Page 1
surgiCam® HD Camera System
Operating Instructions
V. 1.1-EN (10.11)
Valid from HW Status 04
Operating Instructions surgiCam® HD Camera System
Table of Contents 1
Product Liability and Warranty ... 4
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8
General Information ... 4 Scope of Delivery... 4 Intended Use ... 4 Warranty ... 6 User’s Inspection ... 6 Claims for damages ... 6 Hotline ... 7 Disposal of the Unit ... 7
2
Notices Concerning These Operating Instructions ... 8
3
Safety Notices ... 9
4
Description ... 12
4.1 4.2
Variants ... 12 Configuration levels ... 12
4.2.1
Simplified Wiring Diagram for the surgiCam® HD Installed on Separate Arm ... 14
4.2.2
Simplified Wiring Diagram for surgiCam® HD Installed in Light Head ... 15
4.3
Interface 1 – Wall Output: Camera Signals ... 16
4.3.1
Control Unit With Connections ... 17
4.4
Installing / Deinstalling the Camera in the Light Head ... 18
4.4.1
Installing / Deinstalling the sensoGrip ... 18
4.4.2
Installing / Deinstalling the Sterile Handle ... 18
4.5
Installing / Deinstalling the Camera at the Arm System ... 19
4.5.1
Installation ... 19
4.5.2
Deinstallation ... 19
4.5.3
Electrical Connection ... 20
4.6
Installing the Monitor and Additional Equipment ... 20
4.6.1
Interface 2 – Wall Input ... 21
4.6.2
Interface 3 – Monitor Input ... 21
5
Operation ... 22
5.1 5.2 5.3
Operation via Control Unit ... 22 Switching from marLux® to marLED® ... 23 Correcting the Image Position ... 24
5.3.1
Camera on Separate Arm Version ... 24
5.3.2
Camera in Light Head Handle Version... 25
5.4 5.5
Positioning the Camera ... 25 Operation via the Light Operating Part sensoTouch ... 26
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Operating Instructions surgiCam® HD Camera System
6
Cleaning and Care ... 28
6.1 6.2 6.3
Cleaning the Camera’s Glass Window ... 28 Cleaning, Disinfecting and Sterilization of the Handle ... 28 Cleaning and Disinfecting the Camera’s Externally Accessible Parts ... 28
7
Annex ... 29
7.1
Parts List (Basic Version) for surgiCam® HD Camera System Installed in Light Head Handle ... 29 Parts List (Basic Version) for surgiCam® HD Camera System Installed on Separate Arm ... 30 Accessories and Adapters ... 31 Spare Parts ... 31 Technical Data ... 32 Assembly Units ... 33 Troubleshooting ... 34
7.2 7.3 7.4 7.5 7.6 7.7
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Operating Instructions surgiCam® HD Camera System
1
Product Liability and Warranty
1.1
General Information
We thank you for having decided to buy a KLS Martin product. This product carries the CEmark, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 [email protected] · www.klsmartin.com
1.2
Scope of Delivery
Refer to •
Chapter 7.1 “Parts List (Basic Version) for surgiCam® HD Camera System Installed in Light Head Handle”, page 29
•
Chapter 7.2, “Parts List (Basic Version) for surgiCam® HD Camera System Installed on Separate Arm”, page 30.
1.3
Intended Use
The surgiCam® HD camera system is intended for recording surgical procedures. The video images can therefore be used for patient-specific documentation as well as for training purposes, e.g. in the form of live surgery transmissions. The emission of the full-HD signal is conducted through three equivalent HD-SDI connections at the rear of the device. The surgiCam® HD camera system should not be used for surgical decision-making!
WARNING Danger of explosion! The camera system may only be used at a safe distance from openings or surfaces emitting anesthetic gases, oxygen or other flammable or oxidizing gases.
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NOTICE •
Only licensed mains adapters must be used for power supply. Refer to Chapter 7.5 “Technical Data”, page 32).
•
Accessory equipment connected to the unit’s analog or digital signal inputs or outputs or other interfaces must comply with the respective IEC standard (e.g. IEC 60950 for data processing equipment and IEC 60601 for electromedical systems). Moreover, all such configurations must comply with the system standard IEC 60601-1-1, “Safety requirements for medical electrical systems”. Any equipment that does not meet the requirements of the IEC 60601-1 standard must be removed from the immediate environment of the patient, maintaining a minimum distance of 1.5 m between such accessories and the patient or patient support as specified by the standard. Any person connecting additional equipment to the signal inputs or outputs or other interfaces is considered a system configurator with corresponding responsibility for compliance of the system with the requirements of the current version of the IEC 601-1-1 system standard. If in doubt, consult a qualified medical technician or your specialized dealer.
NOTICE The device meets EMC requirements according to IEC 60601-1-2. Radio transmitters, mobile stations / cellular telephones, etc. must not be used in the immediate vicinity of the unit as they can have an adverse influence on the performance of the device. Special caution is required when using devices generating strong electromagnetic emissions (such as high-frequency surgery units). Be sure to keep HF cables away from the immediate vicinity of the device. If in doubt, consult a qualified medical technician or your specialized dealer.
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Operating Instructions surgiCam® HD Camera System
1.4
Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements diverging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. Important Notices The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the product is required to obtain from the repairer a certificate with details about the nature and scope of the repair work done. This certificate must be dated and signed and include the firm’s details. In all cases where a party other than the product manufacturer performed the work, repaired products must be additionally marked with the repairer’s ID label. Improper interventions or alterations performed by third parties during the period of limitation shall void any and all warranty claims. Unauthorized actions performed on the product shall invalidate any liability claims vis-à-vis Gebrüder Martin.
1.5
User’s Inspection
Immediately upon receipt, the goods must be checked for completeness and potential damage in transit. Notice of any such damage must be given immediately.
1.6
Claims for damages
Claims for damages can only be accepted if the carrier is notified to this effect immediately. •
Draw up a damage report with a description of the defect immediately.
•
Send this report either directly to the manufacturer or to its local representative.
•
When returning defective goods, use their original packaging wherever possible
•
Include the following information: - name and address of the owner of the goods - type and serial numbers
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Operating Instructions surgiCam® HD Camera System
1.7 •
•
Hotline
Should you have any questions on how to handle the unit / product or question on its clinical application, please do not hesitate to contact the Product Management: Tel:
+49 7461 706-243
Fax:
+49 7461 706-190
Should you have any technical questions, please do not hesitate to turn to our Martin Service Center: Tel:
+49 7461 706-343
Fax:
+49 7461 706-203
E-Mail: [email protected] Our service representatives are available Monday through Friday from 8 a.m. to 5 p.m. (CET). Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager at +49 74 61 706-332, or send an e-mail to: [email protected].
NOTICE For all technical questions, our service technicians will require the serial number of the product. The serial number can be found on the type plate. •
Camera on arm:
on camera housing
•
Camera in “light head” version:
on cardan joint / on sensoGrip
•
Control unit:
underneath the control unit
1.8
Disposal of the Unit
Special care was taken that – whenever possible – no compounds were used in the construction of the device. This concept ensures that a significant part of the unit can be recycled once it has reached the end of its useful life. We therefore offer to take back the unit so it can be appropriately disposed of and recycled. We would also like to point out that the provisions of the electronic waste regulation must be duly observed at the time of disposal.
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Operating Instructions surgiCam® HD Camera System
2
Notices Concerning These Operating Instructions
Non-observance of these Operating Instructions can lead to serious or even lethal patient injury! Understand and observe the following information! •
Every user must read and observe the usage instructions in full.
•
In particular all cautionary, warning and hazard notices must be observed.
•
The instructions for use must be accessible by the user at all times.
•
The user is responsible for ensuring that he is informed of any application, precautionary, warning and hazard information contained in these operating instructions and has understood these in order to exclude any danger to third parties (e.g. the patient).
•
The present text is in relation to both male and female persons. It is only for reasons of improved legibility that both genders are not referred to throughout.
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3
Safety Notices
The KLS Martin surgiCam® HD camera system is a quality product designed and manufactured in accordance with recognized technical rules. The system left the manufacturer’s premises in perfectly safe condition. Our quality regulations comply fully with DIN ISO 9001 provisions.
CAUTION May cause physical injury! Please note: •
Disconnect the units from the supply before connecting any cables.
•
Do not place the control unit on unstable trolleys, stands, supports or tables because it could fall off, causing serious injuries or damage the control unit.
NOTICE Risk of damage to the system Please note: •
After completing installation or servicing tasks, the service technician is required to check all functions of both the camera system and the power supply system for proper working order and operational safety.
•
No liability will be accepted for damage caused by overvoltage.
•
Low voltage (< 100 V) may cause an image dropout.
•
Ensure that all connecting cables are properly connected to the system as specified in the attached connection diagram (refer to Chapter 5 “Operation”, page 22) and that all cables and connectors make safe and solid contact.
•
Avoid kinks in the cables. Do not lay cables in too narrow a radius.
•
The cable shields must be reliably and securely connected to the correct, specially marked metal grounding terminals and connector housings.
•
Operate the camera system only within the temperature range specified herein (refer to Chapter 7.5 “Technical Data”, page 32 ).
•
Do not open the device! Only authorized service technicians may perform such work!
•
All system components must be protected from dropping, shocks and strong vibrations! Improper handling or storage can damage the camera and the control unit.
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Operating Instructions surgiCam® HD Camera System
NOTICE Risk of damage to the system Please note: •
Cleaning: All devices and connectors must be protected from moisture. Ensure that all devices are switched off before cleaning.
•
Ventilation: Do not operate the control unit in an enclosed space where no proper ventilation is guaranteed (such as built-in cupboards or closed racks). Never stack devices directly on top of each other!
•
Ingress of liquids or entry of objects: Never insert tools or other objects because you might touch dangerous voltage points (live components), thus causing fire or an electric shock! Do not let any liquid infiltrate the device!
•
Maintenance: Do not attempt to service the camera beyond the recommended care and cleaning measures. Any necessary repairs must be performed by qualified specialists. Check the device for damages - if liquids or objects have penetrated into the camera - if the camera no longer functions in accordance with the Operating Instructions - if the device has fallen - if the image quality deteriorates markedly
•
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Spare parts: If replacement parts are needed, ensure that the service technician uses only genuine spare parts as prescribed and supplied by the manufacturer. Note that the use of nonauthorized parts voids the warranty given.
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Operating Instructions surgiCam® HD Camera System
NOTICE Risk of damage to the system Please note: •
Safety check: Following completion of any service or repair work, make sure that the service technician performs a safety check to ensure that the product is in safe working condition.
•
Transportation and storage: For transportation and storage periods up to 15 weeks, the following conditions apply: Temperature: -50 °C to +50 °C Relative humidity: 10 % to 75 % Atmospheric pressure: 500 hPa to 1060 hPa
•
Operating conditions: Temperature: Relative humidity: Atmospheric pressure: Storage:
•
0 °C to +45 °C 30 % to 75 % 700 hPa to 1060 hPa shock-free in closed / roofed rooms
Regular safety checks: the following checks must be carried out on this device at least every 24 months by fully qualified and sufficiently trained and experienced persons capable of performing such work competently and independently: - Visually inspect the device and its accessories for mechanical damage. - Check safety-relevant markings and inscriptions for legibility. - Enter the results of these checks, together with the date, in a medical equipment log. - If the device is not functionally and / or operationally safe, it must either be repaired or the operator must be informed of the hazards associated with its use.
•
Use in conjunction with other units: External equipment can cause image interference (e.g. HF surgical units). Video devices ideally work with decoupled video signals.
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Operating Instructions surgiCam® HD Camera System
4
Description
4.1
Variants
Fig. 4-1: Camera installed in light head (1)
Fig. 4-2: Camera installed on separate arm (2)
There are two different variants available for use in combination with the marLux® and marLED® lighting systems. Both have 120-x zoom (10 x optical / 12 x digital) and a Full HD video output. •
The “light head” camera version (1) The camera is integrated in the center of the light-head’s sterile handle and thus always identically aligned like the surgical light.
•
The “camera installed on separate arm” version (2) In this case the camera, in the form of a separate, height-adjustable tracking arm, can be combined with a light system, enabling independent positioning of both the light and the camera. The camera on a separate arm can also be used as a “stand-alone” solution.
4.2
Configuration levels
•
The “Economy” configuration level (“camera in light head” versions only) “Economy” has zoom and image rotation functions and is controlled via the surgical lamp’s control panel.
•
The “Basic” configuration level For comfortable operation of all camera functions, “Basis” has a separate control device with the following functions - Video signal and control signal interface via universal wall outlet - 3 x BNC (digital HD-SDI video signal) / Multi-DIN (control signals) - Zoom and image rotation - Manual / Auto-focus
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Operating Instructions surgiCam® HD Camera System - Manual / Automatic shutter - Servo-motor driven and remote-controllable camera rotation function - White balance In its Basic version, the camera is controlled via a separate control unit in the operating room. The control unit can also be approached and remote-controlled from a separate computer via RS232. The approach firmware is already integrated in the control unit. On how to operate the control unit, please refer to Chapter 5.1 “Operation via Control Unit”, page 22.
Fig. 4-3:
V. 1.1
Separate control unit for the “Basic” configuration level
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Operating Instructions surgiCam® HD Camera System 4.2.1
14
Simplified Wiring Diagram for the surgiCam® HD Installed on Separate Arm
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Operating Instructions surgiCam® HD Camera System Simplified Wiring Diagram for surgiCam® HD Installed in Light Head
Power supply adapter for wall control panel
84-419-10-04 Adapter for wall control panel
4.2.2
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Operating Instructions surgiCam® HD Camera System
4.3
Interface 1 – Wall Output: Camera Signals
The wall box is connected to the rear panel of the control unit via two cables (item numbers 84-419-72-04 and 84-419-74-04). Each of the wall box connections Y, PB, PR and surgiCam have an identically labeled counterpart on the control unit.
CAUTION Wrong connections can damage the unit! •
Only use the connections specified. Avoid changes to original wiring, such as extensions. Using connections other than those provided threatens the safety of the unit and also poses a hazard to people.
•
The connecting cables should be laid so that no one steps on them and they are not squashed by objects placed on or against them. Pay particular attention to critical points, e.g. at the plugs, at the equipment sockets and in places where cables exit from the wall box.
•
Only cables recommended and approved by the manufacturer guarantee the correct operation of the surgiCam® HD system!
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Operating Instructions surgiCam® HD Camera System 4.3.1
Control Unit With Connections
Fig. 4-4:
Rear of control unit
Fig. 4-5:
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1
Ground connection
2
surgiCam® HD control connection
3
surgiCam® HD signal input (color coding for cable connections: Pb=blue, Y=green, Pr=red, refer to image on left)
4
HD-SDI out (3 connections) for Full-HD devices (e.g. monitor, video recorder, line to auditorium). Cover unused connections with cap!
5
RS232 connection for external control
6
Connection for voltage supply
7
Terminal resistance at F-plug
Signal input with terminal resistance (7) and F-plug on Y-signal
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Operating Instructions surgiCam® HD Camera System
4.4
Installing / Deinstalling the Camera in the Light Head
4.4.1
Installing / Deinstalling the sensoGrip 1
Rectangular connector
2
Screw (x3)
3
sensoGrip with camera
•
Insert the sensoGrip handle (3) flush into the light head, making sure that the rectangular plug engages correctly with connector (1) on the light head.
•
Tighten the three screws (2) on the sensoGrip handle (3).
•
To deinstall, loosen the three screws (2) and carefully remove the sensoGrip (3) with the camera downwards, whereby the rectangular plug must be disconnected from connector (1).
4.4.2
Installing / Deinstalling the Sterile Handle 1
Unlocking button
2
Sterile handle
•
Installation: Push the sterile handle (2) up onto the sensoGrip and rotate until it audibly clicks into place.
•
Deinstallation: Detach the sterile handle (2) by pressing the unlocking button (1) and removing downward.
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Operating Instructions surgiCam® HD Camera System
4.5
Installing / Deinstalling the Camera at the Arm System
4.5.1
Installation 1
Elbow plug
2
Ball-joint clamping mechanism
3
Arresting lever with adapter sleeve
4
Camera pin with guide pin
The camera is installed in the arm system by locking the camera pin (4) in the designated adapter sleeve (3). To install, insert the camera pin with guide pin (4) correctly into the matching adapter sleeve (3) and slide it forward (see arrow) until it audibly clicks into place.
NOTICE •
Before letting go of the camera, ensure that the connection is safely engaged.
•
Never move the adapter sleeve (3) unless you have taken firm hold of the camera.
4.5.2
Deinstallation 1
Elbow plug
3
Adapter sleeve
•
Hold camera firmly and push adapter sleeve (3) upwards.
•
Remove the camera in opposite direction.
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Operating Instructions surgiCam® HD Camera System 4.5.3
4.6
Electrical Connection 1
Knurled nut
2
Elbow plug
3
ON / OFF switch (only “separate arm” version)
Installing the Monitor and Additional Equipment
•
The surgiCam® HD system may only be connected with devices which are approved in accordance with IEC 60601-1.
•
Anybody who installs additional equipment at the signal input or output configures a medical system and is therefore also responsible for the system’s compliance with the IEC 60601-1-1 system standard requirements. If in doubt, please consult the Technical Service of your local representative.
•
All user manuals and instructions relating to all units belonging to the camera system must be observed!
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