Aesculap Orthopaedics OrthoPilot FS101 Navigation Platform Instructions for Use Rev 1 July 2016

Instructions for Use

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Aesculap Orthopaedics OrthoPilot®

Instructions for use OrthoPilot® FS101

Aesculap Orthopaedics OrthoPilot® FS101

Legend

Slot for SD memory cards

Camera handle with integrated laser pointer 2 Polaris Spectra camera 3 19“ touch screen monitor with monitor arm 4 Main switch 5 OrthoPilot® base unit 6 Camera arm 7 Handles 8 Camera stand 9 Main power switch with power cord 10 Rolling frame (4 wheels with brakes) 1

CD/DVD RW combo drive

RS232 interface

Symbols on product Follow instructions for use Ethernet interface (100 Mbit) Equipotentialization connector

Main power switch ON

Main power switch OFF

FireWire interface Standby button

Type BF applied part

Line-in (sound)

Alternating current Unlocking the monitor Fuse

USB interface

Labeling of electric and electronic devices according to directive 2002/96/EC (WEEE), see Chapter 16. Disposal

Do not press, pull, lean against or push the stand (toppling hazard).

Type plate OrthoPilot® Basis Compact (FS101)

Laser pointer – warning notice Indicating label – cable strain relief

Aesculap Orthopaedics OrthoPilot® FS101

Contents Safe Handling …………………………………………

5.1

System set-up ………………………….………….………….1

Product description …………………………….……

5.1.1

Connecting of accessories ………….……………….……….1

2.1

System components ………………………….……...

5.1.2

Connecting the power supply ………………….……...…….1

2.2

Optional components ……………………..…...….

5.1.3

Connecting the equipotentialization cable ……………….……

2.3

Intended use ………………………………………..

5.1.4

Positioning the OrthoPilot® ………….……….…………..……

2.4

Operating principle ……………………………….

Operation ………………………………….………………...

2.4.1

Main functions and design characteristics ………..

Validated processing procedure ……………..………….………

Description of individual components and their operation...

7.1

General notes …………………………………….……….…

3.1

Base …………………………………………………..

7.2

Preparations at the place of use …………………………..…..…

3.2

Handles ……………………………………………….

7.3

Cleaning/Disinfecting ………………………………...……….

3.3

Stand …………………..………………………………..

7.4

Manual cleaning/disinfecting: OrthoPilot® Basis Compact including all modules and the OrthoPilot® monitor cart …...

3.4

Camera arm …………………………………………...

7.4.1

Wipe disinfection for electrical devices not to be sterilized …..

3.5

Laser pointer ……………………………………..…...

7.5

Manual cleaning/disinfecting: OrthoPilot® foot switch ………

3.6

OrthoPilot® foot switch FS007 ……………………….

7.5.1

Manual cleaning and wipe disinfection …………...…….……

3.7

Computer ………………………………………... 1

7.6

Inspection, maintenance and checks …………………….…...2

3.8

Touch screen monitor ………………………………1

Storage and transport ……………………..………….……...2

3.9 3.1

Patch panel ………………………………………….1 Medical power supply ……………………………...1

8.1 8.2

Storage……….………………………………………….…...2 Transport ……………………………………………….…...2

3.11

Uninterruptible power supply (UPS) ………………….1

Maintenance …………………….…………………………...2

3.12

Back plane …………………………………………...1

10.

Service life …………………………….………………….…...2

3.13 3.14

Optical navigation system …………………………..1 Polaris Spectra camera ……………………………….1

11. 11.1

Troubleshooting list ………………………………..….…...2 Changing fuses ……………………………………..…….……...2

3.15

Transmitter technology ………………………………1

12.

Technical Service ……………………………………………...

3.16

Optional: Frame grabber ……………………………..1

13.

Accessories/Spare parts ………………………………….…...

3.17

Navigated instruments ……………………………….1

13.1

Accessories ……………………………………………..……...

4. 4.1 4.1.1

Preparation and setupÅÅÅÅÅÅÅÅÅÅÅÅ Preparation ………………………………………….1 First use ……………………………………...……….1

13.2 14. 14.1

Spare parts …………………………………………………………….…... Technical specifications …………………………….………….. Ambient conditions for OrthoPilot® systems and modules …3

4.1.2 5.

Voltage setting ……………………………………….1 Working with OrthoPilot® ………………………….1

15. 16.

Disposal …………………………………………………..…...3 Distributor in the US/Contact in Canada for product information and complaints …………………………..…………………….3

1. Safe handling CAUTION Federal law restricts this device to sale by or on order of a physician!

WARNING

Risk of injury due to incorrect operation of the product!  Attend appropriate product training before using the product.  Information regarding such training is available from your national Aesculap Representative.

 Clean the new product thoroughly (manually or mechanically) after removal of the transport packaging.  Prior to use, check for proper condition and functioning of the product.  Refer to “Notes on Electromagnetic Compatibility (EMC)“, see TA022130 USA.  To prevent damage caused by improper setup or operation, and to maintain warranty rights and manufacturer liability: – Use the product only according to the instructions for use. – Heed any safety information and maintenance advisories. – Combine only Aesculap products with each other. – Adhere to application instructions according to relevant norms.  Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge or experience.  OrthoPilot® is intended for operation in the non-sterile zone.  Prior to use, the user must receive appropriate instruction by a person authorized by Aesculap.  In case of OrthoPilot® failure or any other malfunction precluding the continued use of OrthoPilot®, the surgeon must be able to finish the operation by manual techniques.  The user is bound to ensure and observe all applicable national and international standards pertaining to the operation of OrthoPilot®.  The following instruction for use must be observed and kept accessible for the user: – Instructions for use OrthoPilot® FS101 – Instructions for use “OrthoPilot® operating system, operation, software“ – Instructions for use of the implants and instruments used in the respective operation – Instructions for use of the passive rigid bodies (transmitters) – Instructions for use and manuals of the respective software applications  The safety instructions and maintenance advice given in the respective instructions for use, or on the device must be adhered to.  Only combine with OrthoPilot® such devices that the manufacturer has cleared and approved for this purpose.  Do not use OrthoPilot® in an oxygen-enriched environment or in the presence of flammable substances (e.g. benzene, anesthetics).

 Operate OrthoPilot® only with the software approved for this purpose by Aesculap.  The system must undergo annual services by the manufacturer or by persons instructed by the manufacturer.  There are no known contraindications for using OrthoPilot®. If this situation should change, the manufacturer will inform the user accordingly. Risk of fatal injury by electric shock!  Do not open the product. DANGER

DANGER

 Only connect the product to power main with equipment grounding conductor. Modification of OrthoPilot®!  OrthoPilot® and its components must not be modified under any circumstances. Operating altitude of the equipment cart!  For reasons of electrical safety, the maximum operating altitude of 2 000 m above sea level must not be exceeded! Connection of third-party equipment!  For license and safety reasons, the connection of peripheral equipment (e.g. video recorders, printers, etc.) not cleared and approved by Aesculap is prohibited and would result in forfeiture of the operating license! Risk of toppling!  To avoid toppling hazard, the OrthoPilot® must be held by the appropriate handles by at least two persons when transporting the equipment along slopes or across thresholds.  If the OrthoPilot® is left on a slope, with the wheel brakes activated, any slight horizontal force acting on the OrthoPilot® can cause it to topple! Essential, actively connected applied parts!  The OrthoPilot® may only be used with the following rigid bodies: FS633, FS634, FS635.

DANGER  The user must consult the respective instructions for use!

Aesculap Orthopaedics

OrthoPilot® FS101

CAUTION

Damage to system components due to fluids entering the equipment!  Do not place fluid containers on the cart or related OrthoPilot® equipment components. Fluids penetrating into the device can damage the electrical components in the OrthoPilot®.

Art. no.

OrthoPilot® foot switch

FS007

Dust cover

FS101400

PC unit with integrated UPS

FS101500

Battery block for UPS

FS101501

Medical power supply

FS101502

Polaris Spectra camera system

FS101508

Touch screen monitor

FS101509

OrthoPilot® Basis Compact

FS101800

Transport!  Any transport must be carried out by persons trained and authorized by Aesculap.  Put the OrthoPilot® into proper transport position before moving it within the hospital.  Further information on transport can be found in the relevant chapter of this document.

Back plane

FS101836

Patch panel

FS101840

Instructions for use “OrthoPilot® FS101

TA012815 (USA)

Instructions for use “OrthoPilot® operating system, operation, software“

TA012816 (USA)

Water condensation!  Prior to use, warm up the OrthoPilot® for at least 1 hour at room temperature.

Getting started FS007

TA013007 (USA)

Technical documentation – EMC

TA022130 (USA)

CAUTION

2.1 System components Designation

Use of multiple sockets/extension cables!  Do not connect multiple sockets/extension cables at the ME system.

CAUTION

2. Product description

Risk of overheating!  The base unit features lateral ventilation slits to release heat generated in the unit. To avoid heat accumulation and possible consequent damage to electric components, the ventilation slits must never be covered.

CAUTION Condensed water can form after the OrthoPilot® was stored at an ambient temperature of <5 °C for longer than 3 hours.

2.2 Optional components

2.4 Operating principle

Designation

Art. no.

Country-specific power cord

FS098 (USA, Canada, Japan)

Getting Started FS007

TA013007 (USA)

2.3 Intended use

The OrthoPilot® system uses a video-optical stereo camera to register the spatial position of passive, infrared light-reflecting transmitters. From that information, Aesculap-specific application software installed on the OrthoPilot® computes the location and position of the transmitters relative to each other and, depending on where the transmitters are affixed, the location and position of surgical instruments in relation to the patient. The software allows for other data (e.g. from preoperative planning) in the calculations and thereby assists the surgeon to achieve optimum precision in their operations.

The OrthoPilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position ENDOprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total ENDOprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.

Fig. 1 Operating principle of the Polaris Spectra camera 2.4.1

Main functions and design characteristics

• The stereo-optical camera detects the location and position of passive transmitters in front of the camera, within a distance of 1.6m to 2.4 m. • The system hardware is not significantly influenced by interference factors that do not exceed IEC 60601-1-2 specifications. • The hardware used in the construction of the system was specially selected to ensure a very long service life and strong resistance to damage by shock. • The system is controlled via an OrthoPilot® foot switch and an integrated, height-adjustable touch screen. • The OrthoPilot® foot switch can be cleaned under running water. • In case of main power interruption, the PC and a monitor are powered by an integrated UPS, which ensures that data already registered will be preserved for at least 5 minutes. • Main power failure is signaled by a short acoustic warning and the power switch lighting turning off. The power failure, as well as recovery of main power, is indicated by a message displayed on the monitor. • The system offers connectivity for an external video source. • For data saving and storing, there are several USB sockets, an SD card slot and a DVD writer available. • The height of the camera stand can be adjusted semi-automatically through a gas pressure spring. 9

Aesculap Orthopaedics

OrthoPilot® FS101, • The components and gas pressure springs integrated in the camera arm system securely hold the camera in its position and allow camera rotation through 270° and camera inclination by 90°. • The arm system is fitted with a mechanical lock, which protects the delicate optoelectronics of the camera against direct knocks during transport. • All system components have been designed to maintain their essential functions and performance characteristics under normal use for at least a year (mandatory service interval).

3.2 Handles The system is fitted with handles to allow easy manipulation of the OrthoPilot® hardware. The handles serve to protect the camera in transport position and to allow a secure grip for pushing and aligning the system.

3. Description of individual components and their operation

3.1 Base

CAUTION

Fig. 3 Handles

The OrthoPilot® is fitted with a rolling frame with four pivoted wheels. All wheels are fitted with immobilization brakes that secure the system against inadvertent movement, see Fig. 2.

3.3 Stand

CAUTION

Camera maladjustment due to knocks against the camera stand!  Be careful to avoid knocking the camera stand during operation.

The pedal board at the back of the equipment cart, see Fig. 4, is used to adjust the stand. When the pedal board is pressed, the camera stand is either pushed up, semi-automatically, by a gas pressure spring, or it can be moved down manually by the handle, see Fig. 5, at the upper end of the stand. The camera stand is fixed in its actual position when the pedal board is released. Detailed information on the navigation-related alignment of the camera can be found in the instructions for use "OrthoPilot® operating system, operation, software“.  First fully extend the camera stand, then adjust the monitor. Finally lower the stand to the required working height. This way the camera and the monitor will not collide with each other.

Fig. 2 OrthoPilot® Basis Compact

3.4 Camera arm Risk of colliding while adjusting the camera arm!

WARNING

Fig. 4 Pedal board

 When adjusting the camera arm system, make certain that no part of the body or clothing are close to hazardous areas of the camera arm.

The camera system features four camera arm LINKS, which allow optimal alignment of the camera towards the operating field: • Camera arm LINK 1: Vertical rotation +/- 60° • Camera arm LINK 2: Horizontal rotation +/-90° • Camera arm LINK 3: Horizontal rotation +/-180° • Camera arm LINK 4: Horizontal rotation +/- 130° and height adjustment by up to 30 cm. For transport, the arm can be locked in a transport position, see Chapter 9.2 Transport.

Fig. 5 Stand handle

Fig. 6 Camera arm  Release the camera lock.  Swivel forward the lower camera arm (camera arm 13) and adjust the camera height.  Pull forward the handle and perform fine-adjustment of the camera position with the camera arm, see Fig. 7.

Aesculap Orthopaedics

OrthoPilot® FS101

3.5 Laser pointer

3.6 OrthoPilot® foot switch FS007

Damage to the eye caused by laser beam!  To avoid damage or injury to the eye, do not look directly into the laser beam. WARNING

CAUTION

Risk of tripping!  When laying the main power cord and the OrthoPilot® foot switch cable, do not create tripping hazards (avoid traffic routes within the O.R.)

CAUTION

Cable damage!  To avoid damage to the cable or inadvertent disconnection of the OrthoPilot® foot switch during operation, the cable should be inserted in the strain relief, see Fig. 8.

The laser pointer is used for preoperative and intraoperative alignment of the Polaris Spectra camera with reference to the operating field. The battery-powered laser pointer is accommodated in the camera handle. It is activated by a button integrated in the handle. The diameter of the beam produced by the infrared laser pointer is less than 5mm at a distance of up to 10m.

Fig. 7 Handle and laser pointer

Fig. 8 OrthoPilot® foot switch FS007 The OrthoPilot® foot switch is the central input device for navigation within the OrthoPilot® applications. It has two pedals and a push button, through which various commands can be executed by pressing them briefly or for a longer time. For detailed information, see instructions for use “OrthoPilot® operating system, operation, software”. To use the OrthoPilot® foot switch, take it from its holder behind the front door and unwind the USB cable. Connect the USB plug at the appropriate socket and insert it in the strain relief as shown in the illustration, see Fig. 9.

Now the OrthoPilot® foot switch can be positioned in the required position in reach of the user. To allow subsequent repositioning of the OrthoPilot® foot switch and for easier handling, the steel HANDLE can be folded up by 90°. By using the HANDLE OrthoPilot® t h e foot switch can be lifted and moved by foot from its initial position.

The main switch for powering up the computer is fitted at the front of the base unit, see Fig. 10. The system is started by briefly pressing the push button, which will light up in blue. The computer can be switched off properly only via the IntroScreen. Detailed information can be found in the instructions for use “OrthoPilot® operating system, operation, software”.

Fig. 9 Strain relief of the OrthoPilot® foot switch cable

3.7 Computer

CAUTION

Switch-off of the computer!  Pressing the main switch for a longer period (4 seconds) forces the computer to switch off without shutting down the operating system. This involves the loss of all registered data!  It is impossible to switch off the system via the main power switch, since in this case the uninterruptible power supply is activated and will keep the computer powered for at least 5 minutes. Installation and maintenance of the operating system/application software!  The operating system and application software may be installed and maintained, and the computer and monitor maintained and serviced only by Aesculap Technical Service or by persons authorized by Aesculap. Data loss and system malfunction due to improper software installation or incorrect powering down of the system!  Software may only be installed by the manufacturer or by a person authorized by Aesculap.  For further information, see the instructions for use ”OrthoPilot® operating system, operation, software”.

Fig. 10 Main switch

3.8 Touch screen monitor

CAUTION

Damage to the touch screen membrane!  Do not use sharp or pointed objects for operating the touch screen.  Clean the touch screen monitor only with the appropriate cleaning agents. For further advice see Chapter 7. Validated processing procedure.

In addition to the OrthoPilot® foot switch, a touch screen monitor is used for operating the navigation system and the application software.  Prior to use, fold up the monitor from its transport position. Make certain the monitor is held upright by the lock spring and is positioned in such a way that an unobstructed view of the application will be maintained throughout the operation, see Fig. 11.  Press the locking button on the left side of the monitor arm to fold the monitor up or down.

A medical computer accommodated in the base of the system serves as the central control element of OrthoPilot®.

Aesculap Orthopaedics

OrthoPilot® FS101

3.10 Medical power supply The OrthoPilot® is equipped with a multi-range power supply, which automatically detects and adapts to the local main line voltage (100– 240 V). The power supply unit can be separated from main power supply through main power switch at the rear of the base system.

For instructions on replacing the fuse sets, see Chapter 12. Troubleshooting list.

3.11 Uninterruptible power supply (UPS)

WARNING

Fig. 11 Folding up the monitor/Releasing the monitor lock

3.9 Patch panel

DANGER

Risk of electric shock!  Never touch any interface and the patient at the same time.

The patch panel holds various interfaces for connecting external devices and data storage media: • DVD-RW drive • SD card reader • Serial interface (RS232) • 4 x USB 2.0 sockets • FireWire socket • Ethernet interface (100Mbit/s) • S-Video (only available with optional frame grabber)  Before connecting any accessories, see Chapter 5.1.1 Connecting of accessories.

Fig. 12 Patch panel

CAUTION

Damage to sockets due to devices (e.g. USB stick) plugged in at the patch panel when closing the unit door!  Remove all devices plugged in at the patch panel before closing the unit door.

No camera function while the system is powered by the UPS!  Halt the operation of the OrthPilot System until normal power supply is resumed and the camera signals ‘ready for operation’.

In cases of voltage drop or power failure, the computer and monitor are kept supplied by the integrated UPS for another 5 minutes. Although the UPS can bridge periods of main power interruption, the application workflow can not be continued through such periods! The power interruption and, consequently, operation through the UPS is signaled by an acoustic warning (3 second beep, 1 second pause, 3 times) and a warning message on the monitor screen. Detailed information can be found in the instructions for use “OrthoPilot® operating system, operation, software”.  If the cause of the voltage drop can not be found and remedied within 5 minutes, the computer must be shut down properly to obtain safe system status.

3.12 Back plane

CAUTION

Contamination and destruction of electrical components!  The plug connection covers, which serve to protect the back plane against penetration by solid objects and ingress of fluids, must be kept closed.  The covers may only be opened by a person authorized by Aesculap.

The back plane accommodates the bus system that supplies all connected modules and devices with the appropriate supply voltages and signal lines. The two plug connectors, see Fig. 13, allow the connection of additional modules  Optional modules may be installed only by persons authorized by Aesculap. 14

3.14 Polaris Spectra camera

CAUTION

Fig. 13 Back plane

Malfunction of the OrthoPilot® system!  Align the camera in such a way that the optical axis does not point towards incoming or stray light (e.g. from windows or O.R. lighting).  For further information, see instructions for use ”OrthoPilot® operating system, operation, software”. Camera warm-up effects!  The electrical and optical components of OrthoPilot® are subject to temperature-related fluctuations. Insufficient stability of measurements can have significant detrimental effects on the system precision. Therefore, to ensure adequate stability, Aesculap recommends powering up the OrthoPilot® system 10 minutes prior to any operation.

3.13 Optical navigation system The navigation system consists of the “Polaris Spectra” infrared camera and a range of passive transmitters (rigid bodies). These are installed, via adapters on the instruments their spatial location and position relative to the patient IS registered. The OrthoPilot® CAN ONLY be USED with Aesculap-specific transmitters. “Passive Tracking Technology“ is licensed according to patents USA 6,351,659 and D 196 39 615. 8. The following rigid bodies are used for navigation with the OrthoPilot® system: • FS633, FS634, AND FS635: passive transmitters (reflectors without cables) irradiated by the camera

Further detailed information on the handling and operation of the rigid bodies can be found in the respective instructions for use.

CAUTION

Adverse effects on system functions due to camera maladjustment and scratched or damaged lenses!  The Polaris Spectra camera is fitted with an integrated shock indicator, which is triggered if the forces acting on the camera by shaking or knocking were found to be beyond the tolerances, with the effect of possible maladjustment of the Polaris Spectra camera. Once the shock indicator was triggered, the Polaris Spectra camera must be inspected by an Aesculap service technician and replaced, if necessary, prior to continued application. This is necessary to ensure the continued accuracy of the measurements.  The Polaris Spectra camera is equipped with a lens system through which infrared light is emitted and received. Damaged or scratched lenses can affect the proper functioning of the camera. Therefore, if lenses are found to be scratched or damaged, the Polaris Spectra camera must be replaced before further application of the system.

Aesculap Orthopaedics

OrthoPilot® FS101,

Power supply of the camera under UPS conditions!

CAUTION

 The operation of the OrthoPilot System must be halted when the UPS warning sounds and the UPS status message is displayed on the monitor screen.  Once the main power supply is re-established, the camera initializes itself after a few seconds and the system is operational again as soon as the UPS message disappears from the screen.  For further information, see the instructions for use ”OrthoPilot® operating system, operation, software”.

CAUTION

Detrimental effect on system precision!  Make certain the camera is protected against knocks (especially during transport).  For detailed information on how to secure the camera, see Chapter 9.2 Transport.

The camera needs to be aligned, using the laser pointer integrated in the handle, so that the transmitters are "visible" for the camera. The distance between the camera and the operating field should be between 1.7 m and 2.1 m. The actual distance is shown in the application software, see instructions for use “OrthoPilot® operating system, operation, software”.

Fig. 14 Legend A Power LED, B Status LED, C Error LED

Power LED (A)

Status LED (B)

Error LED (C)

Meaning

flashing

(any status)

Warming-up phase

permanent on

Camera ready for operation

permanent on

flashing

Fault, e.g. shock indicator triggered. The accuracy of measurements can not be guaranteed anymore. Inform Aesculap Technical Service!

permanent on permanent on or off

permanent on

Critical fault; system not operational. Inform Aesculap Technical Service!

permanent on

Critical fault; system not operational. Inform Aesculap Technical Service!

3.15 Transmitter technology The OrthoPilot® is used with passive transmitters (‘rigid bodies’):

Fig. 15 Legend Rigid bodies, passive (patents USA 6,351,659 and D 196 39 615.8.)

The passive transmitter technology, by which the infrared light emitted by the Polaris Spectra camera is reflected by the marker spheres on the transmitters, is the standard technology for OrthoPilot®. The passive transmitters, which are not part of the OrthoPilot® system, are documented in the respective instructions for use (TA011029 USA, FS633, FS634, FS635). The passive transmitters FS633, FS634 , and FS635 are marked with a color code. FS633 – Yellow FS634 – Blue FS635 - Red

CAUTION

Fixation of the marker spheres on the passive transmitters!  Make certain the passive, single-use marker spheres are firmly connected to the appropriate adapters of the passive transmitters.  Ensure that the passive, single-use marker spheres engage audibly in the appropriate adapters.

Aesculap Orthopaedics

OrthoPilot® FS101 4. Preparation and setup 3.16 Optional: Frame grabber The frame grabber option adds the possibility to connect imaging devices to the base unit via an S-Video cable. The frame grabber device itself is accommodated in the base module and can not be accessed from outside. The frame grabber allows to access within the application software current image information relevant for the operation. (e.g. an endoscope can be connected.) The connection is always via the S-Video interface on the patch panel, see Fig. 12.  Before connecting any accessories, see Chapter 5.1.1 Connecting of accessories.  The connection must be made with an S-Video cable with triple shielding to exclude interference from external devices and electromagnetic fields.

3.17 Navigated instruments Detailed information on the handling and operation of the navigated instruments can be found in the respective instructions for use of the OrthoPilot® software applications.

4.1 Preparation Non-compliance with the following rules will result in complete exclusion of liability on the part of Aesculap:  When setting up and operating the product, always observe: – the national regulations for installation and operation, and – national regulations on fire and explosion protection  The OrthoPilot® must be set up by a trained person authorized by Aesculap.  Lay non-system cables and cords in separation from the OrthoPilot® components and the OrthoPilot® main unit. HF cables, in particular, can cause strong interference.  If interference from external devices is suspected, immediately deactivate those devices, if possible, until the source of interference is found. In some cases it can be necessary to consult a specialist in medical electrical devices to remedy the interference.

4.1.1 First use Risk of injury and/or product malfunction due to incorrect operation of the ME system!  Adhere to instructions for use of all medical WARNING devices.  The OrthoPilot® must be set up by a trained person authorized by Aesculap. This also applies, particularly, to the installation of the main power cord and its strain relief.

4.1.2 Voltage setting  The main voltage range must be in agreement with the range specified on the type plate of the device.  The power supply is a multi-range supply that automatically detects and adapts to the local main line voltage (110–240 V).

5. Working with OrthoPilot®

5.1.1

Connecting of accessories

5.1 System set-up DANGER

DANGER

WARNING

CAUTION

Risk of explosion due to the use of flammable substances (e.g. anesthetics and skin cleaning and disinfecting agents) in explosion hazard areas!  Do not use the equipment cart in explosion hazard zones within rooms used for medical purposes.  Do not use the equipment cart in oxygen-enriched environments or in the presence of flammable substances (e.g. benzene, anesthetics). Risk of injury caused by toppling of the equipment cart or shifting objects!  Prior to use, check the stability against toppling of the fully mounted equipment cart.  Be careful when rolling the cart over obstacles. Equipment malfunction due to magnetic and electric fields!  Keep adequate distance to x-ray devices, tomography equipment etc.  Carry out function checks before using the equipment.  Check all power cords and connecting cables for damage prior to each system startup.  Immediately replace damaged cables and leads.  Observe all specifications regarding ambient conditions, see Chapter 15. Technical specifications

DANGER

CAUTION

Risk of injury due to unapproved configuration using additional components!  For all applied components, ensure that their classification (e.g. Type BF or Type CF) matches the classification of the applied device. Connection of third-party equipment!  For license and safety reasons, connecting of peripheral equipment (e.g. video recorders, printers, etc.) that have not been cleared and approved by Aesculap is not permitted and would result in forfeiture of the operating license! System failure caused by connecting of an external USB hard drive!  Do not connect an external USB hard drive to the system.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Also, all equipment connected at the interfaces must demonstrably meet the respective IEC standards (e. g. IEC 60950 for data processing equipment, EN 60601 for electromedical devices). All configurations must meet the system standard IEC 60601-1-1. The person connecting the units is responsible for the configuration and must ensure compliance with system standard IEC 60601-1-1 or equivalent national standards. Please contact your Aesculap Representative or Aesculap Technical Service (address: see Chapter 13. Technical Service) with any inquiries in this respect. 5.1.2 Connecting the power supply

Risk of fatal injury by electric shock!  Only ever connect the product to power main with equipment grounding conductor. DANGER  Fully unwind power cord 9 of the base unit from the cable holder and plug it in at the wall socket of the power main. The correct country- specific plug for non-heating equipment must be used.  Completely unwind the power cord before switching on the OrthoPilot® system.  The OrthoPilot® must be set up in such a way that it can easily be disconnected from main power.

Aesculap Orthopaedics

OrthoPilot® FS101

5.1.3 Connecting the equipotentialization cable the  Connect the potential equalization cable between equipotentialization connector, see Fig. 24, at the rear panel of the OrthoPilot® base unit and the corresponding connector at the main power supply. The optional OrthoPilot® Flex monitor cart is connected with its potential equalization cable at the connector provided at the rear of the base module. The equipotentialization wiring serves to ensure that all components of the OrthoPilot® system share the same ground potential with the other components in the O.R.

Fig. 25

Fig. 24 Equipotentialization connector 5.1.4 Positioning the OrthoPilot® To take the OrthoPilot® from the transport mode to the operating mode, unlock the system by turning the locking pin, see Fig. 25. The OrthoPilot® system has to be positioned to ensure that the transmitters remain visible during the entire length of the operation. Once the OrthoPilot® Basis Compact system has been positioned, the wheel brakes must be engaged. Fully extend the monitor stand, move the touch screen monitor from its transport position to the operating position, and adjust the monitor to the appropriate operating height. If necessary, loosen the brakes at this point to adjust the horizontal viewing angle relative to the monitor screen by swiveling the entire system. Finally lower the stand to the required working height. In this way the camera and the monitor will not collide with each other. The handle, see Fig. 7, can be used for adjusting the Fig. 26 camera position according to individual requirements. The laser pointer To ensure failure-free navigation, it is important that the line of view should be directed to the center of the operating field. between the rigid bodies and the camera will not be obstructed at any time during the operation. Detailed instructions for the installation of the transmitters can be found in the instructions for use “OrthoPilot® operating system, operation, software” and in the respective application manuals. The next step is to remove the OrthoPilot® foot switch from its holder, see Fig. 9, and position it under the operating table, in reach of the user. The cable must be laid in such a way that the traffic routes in the O.R. are not impeded. As the equipment cart can not be sterilized, it must be set up and used at a distance to the sterile zone of at least 1.5 m.

6. Operation Risk of injury and/or malfunction!  Carry out function checks application of the product.

prior

each

WARNING Risk of injury due to application of the product outside the surgeon’s field of view!  Apply the product only under visual control. WARNING  To activate the system, first press main power switch 9 at the rear panel of the base unit and at the rear panel of any additional modules connected to the system.  Switch on the computer at main switch 4 which will light up in blue. The system loads the OrthoPilot® IntroScreen, see Fig. 27, which allows selecting among various software applications and tools.

Fig. 28 Quitting the application software With the workflow of the respective software completed, the software application can be closed via the X symbol in the top left corner of the monitor screen, see Fig. 28. OrthoPilot® will return to its top-level graphic user interface (OrthoPilot® IntroScreen). The OrthoPilot® Basis Compact system is switched off by pressing the “Shutdown” field on the IntroScreen. After that, the OrthoPilot® hardware can be fully power down via main power switch 9 the base module.

at the back panel of

Fig. 27 OrthoPilot® IntroScreen Select the appropriate OrthoPilot® software on the touch screen monitor and follow the instructions. Further information can be found in the instructions for use ”OrthoPilot® operating system, operation, software”. The passive transmitters do not have any cables or wires and do not require external voltage supply.  For intraoperative application, fit the appropriate, sterile, single-use marker spheres on the transmitters.

Aesculap Orthopaedics

OrthoPilot® FS101

7. Validated processing procedure

Residues containing chlorine or chlorides, ( e.g. surgical residues or remnants of medicines or saline solutions in the service water used for cleaning, disinfection and sterilization, will cause corrosion damage (pitting, stress corrosion) and destruction of stainless steel products remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly.)

Note: Adhere to national statutory regulations, international standards and directives, and local, clinical hygiene instructions for sterile processing. Note: For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of the products. Note: Since it produces better and more reliable cleaning results, mechanical processing must be preferred over manual cleaning. Note: Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net Note: Successful processing of this medical product can only be ensured if processing is performed through a validated processing procedure. The user/processor is responsible for the validation. Due to process tolerances, the manufacturer’s specifications can only serve as an approximate guide for assessing the processing procedures applied by the individual user/processor.

•

Only use process chemicals that have been tested and approved (e.g. VAH/ DGHM or FDA approval or CE mark) and which are recommended by the chemicals’ manufacturers as compatible with the product’s materials. All process parameters specified by chemicals’ manufacturers, such as temperatures, concentrations and exposure times, must be strictly observed. Failure to do so can result in the following problems: Optical changes to the material, e.g. fading or discoloration of titanium or aluminum. For aluminum, pH >8 in the application/process solution can cause visible surface changes. Material damage such as corrosion, cracks, fracturing, premature aging or swelling.  Do not use process chemicals that cause stress cracking or brittleness of plastic materials.  Further detailed advice on hygienically safe and material-/valuepreserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

7.2 Preparations at the place of use  Remove visible residues as completely as possible, using a lint-free, single-use cleaning wipe.

7.1 General notes Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of stainless steels. Therefore, the time interval between application and processing should not exceed 6 hour and neither fixating pre-cleaning temperatures >45 °C nor fixating disinfectants (active ingredients: aldehyde, alcohol) should be used. Excessive application of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of machine-readable laser markings.

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Aesculap Navigation Platforms

Aesculap Orthopaedics OrthoPilot FS101 Navigation Platform Instructions for Use Rev 1 July 2016