Storz S-PILOT User manual

Instructions for use
S-PILOT®
en

Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of
KARLSTORZSE&Co.KG.
All rights reserved.
02-2021

Table of contents
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................5
1.1 Read the instructions for use.................................................................................................................... 5
1.2 Read the instructions for use of combinable products............................................................................. 5
1.3 Scope........................................................................................................................................................5
1.4 Free RTOS Licensing ................................................................................................................................5
1.5 Description of warning messages.............................................................................................................5
2 Normal use....................................................................................................................................................7
2.1 Intended use .............................................................................................................................................7
2.2 Indications.................................................................................................................................................7
2.3 Contraindications......................................................................................................................................7
2.4 Target user populations ............................................................................................................................ 7
2.5 Patient groups...........................................................................................................................................7
2.6 Intended conditions of use .......................................................................................................................7
3 Safety ............................................................................................................................................................9
3.1 Serious incidents ......................................................................................................................................9
3.2 Unsterile product ......................................................................................................................................9
3.3 Contaminated products ............................................................................................................................9
3.4 Single-use product ...................................................................................................................................9
3.5 Combination with other components .......................................................................................................9
3.6 Damaged products .................................................................................................................................10
3.7 Dangers from electrical current...............................................................................................................10
3.8 Damage due to ingress of liquid in electrical components..................................................................... 10
3.9 Electromagnetic interference ..................................................................................................................11
3.10 Failure of devices ....................................................................................................................................11
3.11 Observing ambient conditions ................................................................................................................12
3.12 Safety features ........................................................................................................................................12
3.12.1 Self-test ....................................................................................................................................... 12
3.12.2 Motor current monitoring............................................................................................................. 12
4 Product description ....................................................................................................................................13
4.1 Description of operation .........................................................................................................................13
4.2 Product overview ....................................................................................................................................13
4.3 Possible combinations............................................................................................................................15
4.3.1 Combination with high frequency surgical units.......................................................................... 15
4.3.2 Combination with UNIDRIVE® S III .............................................................................................. 15
4.3.3 Combination with CALCUSON.................................................................................................... 15
4.4 Technical data.........................................................................................................................................16
4.5 Symbols employed .................................................................................................................................16
4.5.1 Symbols on the packaging .......................................................................................................... 16
4.5.2 Symbols on the product .............................................................................................................. 17
4.5.3 Symbols on the type plate........................................................................................................... 18
4.5.4 Symbols on the tube set.............................................................................................................. 18
4.6 Ambient conditions .................................................................................................................................19
5 Preparation..................................................................................................................................................20
5.1 Unpacking the product ...........................................................................................................................20
5.2 Testing the product.................................................................................................................................20
5.3 Setting up the product ............................................................................................................................20
5.4 Connecting the product ..........................................................................................................................20
5.5 Connecting the footswitch......................................................................................................................21
5.6 Connection for automatic smoke evacuation ......................................................................................... 21
5.6.1 Connecting the product in the OR1™ system............................................................................. 21
5.6.2 Connecting the product as a stand-alone solution ..................................................................... 22

Table of contents
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 4
5.7 Connecting the product for suctioning fluid ...........................................................................................22
5.8 Putting the product into operation..........................................................................................................23
5.9 Functional test ........................................................................................................................................23
5.9.1 S-PILOT® with UNIDRIVE® S III.................................................................................................... 23
5.9.2 S-PILOT® with CALCUSON ......................................................................................................... 24
5.9.3 S-PILOT® with AUTOCON® II 400................................................................................................ 24
5.9.4 S-PILOT® with AUTOCON® III 400............................................................................................... 25
6 Application ..................................................................................................................................................26
6.1 Inserting and connecting the tube set ....................................................................................................26
6.2 Closing the application ........................................................................................................................... 28
6.3 Acoustic signals ......................................................................................................................................28
6.3.1 Availability signal ......................................................................................................................... 28
6.3.2 Information signal ........................................................................................................................ 28
7 Maintenance, servicing, repairs, and disposal............................................................................................29
7.1 Maintaining the product.......................................................................................................................... 29
7.1.1 Maintenance ................................................................................................................................ 29
7.2 Safety inspection in accordance with IEC 62353 ................................................................................... 29
7.2.1 Visual inspection.......................................................................................................................... 29
7.2.2 Electric measurements ................................................................................................................ 29
7.2.3 Functional test ............................................................................................................................. 29
7.3 Repairs to the product ............................................................................................................................ 29
7.4 Disposing of the product ........................................................................................................................30
8 Accessories and spare parts ......................................................................................................................31
8.1 Accessories.............................................................................................................................................31
9 Electromagnetic compatibility.....................................................................................................................32
9.1 General notes on the operating environment .........................................................................................32
9.2 Accessories and cables .......................................................................................................................... 32
9.3 Table 1 – Compliance level for immunity tests ....................................................................................... 33
9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 34
9.5 Table 3 – Test levels for radiated and conducted immunity tests .......................................................... 35
9.6 Table 4 – Emission class and group .......................................................................................................36
9.7 Table 5 – Recommended separation distances between portable and mobile HF communications
devices and the product .........................................................................................................................37
10 Faults and messages ..................................................................................................................................38
10.1 Troubleshooting ......................................................................................................................................38
11 Subsidiaries.................................................................................................................................................39

General information
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 5
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
This instruction manual is valid for:
Product name Article number
S-PILOT®UP501
Control cable, length 100cm 20701070
Control cable for combination with
UNIDRIVE®SIII, length 100cm
27610070
1.4 Free RTOS Licensing
The product uses the FreeRTOS.org real time kernel. The FreeRTOS.org source code can be
obtained by visiting: http://www.FreeRTOS.org.
The FreeRTOS source code is licensed by the GNU General Public License (GPL) with an
exception. The full text of the GPL is available from this URL: http://www.freertos.org/
license.txt. http://www.FreeRTOS.org /license.txt. The text of the exception is available on
FreeRTOS official FreeRTOS.org website.
The exception permits the source code of applications that use FreeRTOS solely through the
API published on this website to remain closed source. This allows the use of FreeRTOS in
commercial applications without the need for the application as a whole to be open sourced.
1.5 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warning messages describe the following levels of
danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

General information
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 6
ATTENTION
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
Valves
Valves are used to regulate the volume flow during diagnostic or therapeutic interventions.
Cable
The connecting cable is used for electrical signal transmission.
2.2 Indications
Valves
Valves with corresponding accessories are suitable for all diagnostic and therapeutic
procedures that require controlled fluid removal in order to be performed successfully.
Cable
The connecting cable is used for electrical signal transmission. It does not depend on special
indications.
2.3 Contraindications
Use is contraindicated if, in the opinion of the responsible physician, the device is not
compatible with successful completion of the planned procedure due to its technical design.
The accessories must only be used with the intended devices. In general, medical devices
must not be used on patients who are not part of the defined patient group, or if the operation
itself is contraindicated. The use of pump systems is contraindicated if, in the opinion of the
responsible physician, the surgical method is contraindicated or the patient is not able to
undergo surgery or anesthesia due to his or her general condition. Pump systems (pump +
associated tube set) must not come into direct contact with the central nervous system (CNS)
or the central cardiovascular system.
2.4 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
2.5 Patient groups
There are no restrictions in terms of patient groups for this product.
2.6 Intended conditions of use
The product may only be used in hospitals and doctors’ offices in suitable ambient conditions.
Condition Application
Frequency of use One or more times a day
Length of use Several minutes to several hours a day
Place of installation Positioning on a level, vibration-free surface
Mobility Can be moved if placed on a cart.

Normal use
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 8
Condition Application
Combination Can be used on the patient at the same time as other devices.
Control Can be controlled via the KARLSTORZ SCB.
Site Placed outside of the sterile area.

Safety
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 9
3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, Art.2, No.65[1]):
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.3 Contaminated products
Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Observe the guidelines of the Employer’s Liability Insurance Association and equivalent
organizations.
3.4 Single-use product
The product must only be used once. Using the product more than once exposes patients,
users, and third parties to a risk of infection and injury.
Dispose of the product properly after using it once. Do not continue to use it.
3.5 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards. Furthermore, all configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or Clause 16 of the 3rd edition of IEC 60601-1).
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Connect only devices that comply with IEC 60601 to signal inputs and signal outputs.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
The product should not be used immediately adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the product should be observed to verify normal
operation in the configuration in which it will be used.
Comply with national and local regulations.

Safety
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 10
Only make changes to the product if these changes are approved by KARLSTORZ.
3.6 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
3.7 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third
parties. All electrical installations of the operating room in which the product is connected and
used must meet the applicable IEC standards.
Use either the power cord supplied by KARLSTORZ or a power cord which has the same
properties and which bears a national mark of conformity.
The product may only be operated with the line voltage stated on the rating plate.
Position the product appropriately so that the power cord can be unplugged at any time.
The product is only voltage-free when the mains plug has been disconnected.
The product’s ground line should be installed by a qualified electrician.
Ensure potential equalization according to the applicable national rules and regulations.
To ensure reliable protective earth grounding, connect the product to a properly installed
socket that is approved for use in the operation room. Routinely inspect the electrical plug
and cord and do not use if the inspection reveals damage.
Connect the product to a power supply with protective conductor.
Do not use any additional multiple socket outlets or extension cables.
Do not use freely accessible multiple socket outlets.
Multiple socket outlets must not be placed on the floor.
In the case of electrical products, individual components or the product itself may be live. Live
parts can cause electric shocks in the event of contact and injure patients, users, and third
parties.
Do not open the product.
Have servicing carried out by KARLSTORZ or a company authorized by KARLSTORZ.
Failure to observe this will void the guarantee.
Do not touch the output jacks of the product and the patient at the same time during use.
Always pull out the mains plug before carrying out any cleaning and maintenance work.
During use, explosive anesthetic gases are used. If sparks occur, this may trigger explosions.
Only connect or disconnect the power plug to or from the power supply outside explosive
atmospheres.
3.8 Damage due to ingress of liquid in electrical
components
In the case of electrical products, individual components or the product itself may be live.
Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer
of current. The product is damaged as a result and patients, users and third parties may be
injured.
Do not store liquids near the product or on the product.
If liquid has entered the product, pull out the plug and allow the product to dry completely.

Safety
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 11
3.9 Electromagnetic interference
Medical electrical products are subject to special precautions regarding electromagnetic
compatibility and must be installed and commissioned according to the tables on
electromagnetic compatibility. If other products (e.g. for MRT, CT, diathermy, electrocautery, or
RFID) emit electromagnetic radiation, the function of the product may be impaired. High-
frequency communication equipment can affect electrical medical products and impair their
performance.
Do not use the product in the vicinity of a magnetic resonance tomograph (MRT).
Do not use the product next to or together with other devices. If such use is required,
monitor the product and the other devices, and follow the relevant instructions for use in
the event of malfunctions.
Portable RF communications equipment including peripheral devices (e.g., antenna cables
and external antennas) should be used no closer than 30cm from the product, including
cables specified by the manufacturer.
Observe the information on electromagnetic compatibility; see chapter Electromagnetic
compatibility [p.32].
In case of uncertainties, seek expert advice from KARLSTORZ.
Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc
test of the electromagnetic radiation.
The use of accessories and cables other than those specified in the instruction manual may
result in increased emissions or decreased immunity of the product. When using other
accessories and cables, the operator is responsible for checking compliance with IEC
60601-1-2 for this particular product.
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
3.10 Failure of devices
The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.

Safety
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 12
3.11 Observing ambient conditions
If the device is operated in an environment which is not suitable, patients, users and third
parties may be injured.
Always operate the product in the prescribed ambient conditions.
When using explosive narcotic gases: Operate the product outside of the hazard zone.
Do not use the product in the presence of flammable anesthetics.
The product must not be operated in oxygenated environments.
3.12 Safety features
3.12.1 Self-test
During power-up the product performs a self-test. The tube squeeze valve is checked during
this self-test. If the self-test proves negative, the LED of the power switches flashes and an
alarm signal sounds. The product may only be used for its intended purpose.
3.12.2 Motor current monitoring
The motor drive control of the tube squeeze valve includes a temperature and current monitor
that switches off when the motor is overheated or overloaded.

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 13
4 Product description
4.1 Description of operation
The S‑PILOT® tube squeeze valve with integrated SCB module is used to clamp off or release
a suction tube connected to a vacuum reservoir. The underpressure is generated by a suction
pump or via the central vacuum supply of the hospital.
The tube squeeze valve can be operated directly or indirectly.
When operated directly, the footswitch is connected to the socket of the S-PILOT®. When the
footswitch is activated, the valve opens. The valve closes when the activation signal stops.
Alternatively, the tube squeeze valve can be opened and closed using the switch on the S-
PILOT®, e.g. by unsterile OR staff.
When operated indirectly, the tube squeeze valve is activated via a device connected to the S-
PILOT®. The S-PILOT® is connected to the device either via the footswitch socket, the
KARLSTORZ SCB interface or via a connecting cable.
4.2 Product overview
123
S-PILOT® – Front view
1 Power switch 3 Tube squeeze valve
2 Open/close tube squeeze valve switch

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 14
4
123 5 6
S-PILOT® – Rear view
1 Serial port, e.g. for footswitch 4 SCB sockets
2 Serial port for connecting cable, dia.
3.5mm
5 Power socket
3 Slot for SD memory card 6 Potential equalization connector
Example of a workstation – LAP
Example of a workstation – URO

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 15
4.3 Possible combinations
4.3.1 Combination with high frequency surgical units
When combined with the following HF surgical units, S-PILOT® can be used for automatic
smoke evacuation:
– KARLSTORZ AUTOCON® III 400
– KARLSTORZAUTOCON® II 400
– COVIDIEN Force Triad
– COVIDIEN Valleylab Force FX
– ConMed System 5000
– ConMed System 2450
There are two possibilities for combining HF surgical units and S-PILOT®:
– The HF surgical unit is integrated into an OR1™ system:
S-PILOT® can be connected to the HF surgical unit via SCB cable. An additional
connecting cable (UP004) is required to connect to AUTOCON® III 400.
– The HF surgical unit and S-PILOT® are used as an independent solution:
Product Accessories
KARLSTORZ AUTOCON® III 400 Connecting cable (UP004)
KARLSTORZAUTOCON® II 400 SCB connecting cable (20090170)
COVIDIEN Force Triad Connecting cable (UP005)
COVIDIEN Valleylab Force FX Connecting cable (UP005)
ConMed System 5000 Connecting cable (UP004)
ConMed System 2450 Connecting cable (UP004)
Smoke gas is produced when operating HF surgical units. If an HF surgical unit is connected to
S-PILOT® via the SCB interface, the tube squeeze valve of the S-PILOT® opens automatically
as soon as the HF surgical unit is activated. Smoke gas is suctioned away and the surgeon has
an excellent view of the operation site. As soon as the HF signal on the tube squeeze valve
stops, the valve closes again after a time delay of 3seconds.
4.3.2 Combination with UNIDRIVE® S III
When combined with the UNIDRIVE® S III motor system, S-PILOT® can be used to suction fluid
from the shaver attachment. The signal from the footswitch is transmitted from UNIDRIVE® S III
to S-PILOT® via the control cable (27610070). If the footswitch is set to the first stage, the valve
on S-PILOT® opens to allow fluid to be suctioned via the vacuum. If the footswitch is set to the
second stage, the motor system is activated in addition. The valve remains open and the tissue
fragments removed from the shaver can be suctioned away along with the irrigant solution.
4.3.3 Combination with CALCUSON
When combined with the CALCUSON ultrasonic generator, S-PILOT® can be used for
suctioning fluid. The signal from the footswitch is transmitted from CALCUSON to S-PILOT®
via the control cable (27610070). If the footswitch is set to the first stage, the valve on S-
PILOT® opens to allow fluid to be suctioned via the vacuum. If the footswitch is set to the
second stage, the CALCUSON is activated in addition. The valve remains open and stone
fragments can be suctioned away along with the irrigant solution.

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 16
4.4 Technical data
Designation Value
Power supply (AC) 100–240V
Operating frequency 50/60Hz
Power input 43VA
Electrical protection class I
Applied part type according to IEC60601-1 CF
Degree of protection acc. to IEC60259 IP21
Dimensions (LxHxW) 356x55x305mm
Weight 1.9kg
4.5 Symbols employed
4.5.1 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Consult instructions for use
Fragile, handle with care
Keep dry

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 17
Symbol Meaning
Temperature limit
Humidity limit
Air pressure limit
Federal (USA) law restricts this device to sale by or on the order of a
physician.
CE marking
With this mark, the manufacturer declares the compliance of the devices
with the applicable standards and directives
The device must not be modified in any way
4.5.2 Symbols on the product
Symbol Meaning
Follow instructions for use
Ready/standby button
Tube squeeze valve switch
Applied part of the type CF
Connection socket, e.g., for footswitch
Remote control
Potential equalization connector

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 18
4.5.3 Symbols on the type plate
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Prevention of pollution by electronic devices
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
4.5.4 Symbols on the tube set
Symbol Meaning
Manufacturer
Article no.
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
Consult instructions for use
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Keep dry

Product description
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 19
4.6 Ambient conditions
Storage/transport conditions
Temperature -10°C...+60°C
Relative air humidity
(non-condensing)
5–95 %
Air pressure 500–1,080hPa
Operating conditions
Temperature 10°C...40°C
Relative air humidity
(non-condensing)
15–85 %
Air pressure 700–1,060hPa
Max. operating altitude 3,000m

Preparation
Instructions for use • S-PILOT® • PYB194_EN_V1.0_02-2021_IFU_CE-MDR 20
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and evidence of shipping damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and
extent and contact the manufacturer or supplier immediately.
4. Keep packaging for further transport.
5.2 Testing the product
1. Inspect the product for visible contamination. Do not use if contaminated.
2. Inspect the product for the following characteristics:
– Good working order
– Functionality
– Correct assembly of the components
– Completeness
5.3 Setting up the product
This product and connected components may only be used in medical rooms with electrical
installations that conform to applicable national regulations.
1. Set the product on a horizontal, flat surface. Make sure that the power cord can be
unplugged at any time.
2. Install the product out of reach of patients.
3. Ensure adequate air circulation.
5.4 Connecting the product
1. Connect the potential equipotential cable.