Storz S-PILOT Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Storz Manuals
  4. Medical Equipment
  5. S-PILOT
  6. Instructions for use manual

Storz S-PILOT Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
en
Instructions for use
®
S-PILOT

Advertisement

Table of Contents
loading

Related Manuals for Storz S-PILOT

Summary of Contents for Storz S-PILOT

  • Page 1 Instructions for use ® S-PILOT...
  • Page 2 02-2021 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.

  • Page 3: Table Of Contents

    Connecting the product .......................... 20 Connecting the footswitch........................ 21 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 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 4 Table 4 – Emission class and group ....................... 36 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 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 5: General Information

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

  • Page 7: Normal 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. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 8 Normal use 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. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 9: Safety

    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. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 10: Damaged Products

    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.

  • Page 11: Electromagnetic Interference

    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.

  • Page 12: Observing Ambient Conditions

    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. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 13: Product Description

    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.
  • Page 14 Serial port, e.g. for footswitch SCB sockets Serial port for connecting cable, dia. Power socket 3.5 mm Slot for SD memory card Potential equalization connector  Example of a workstation – LAP  Example of a workstation – URO ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 15: Possible Combinations

    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- ®...

  • Page 16: Technical Data

    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 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 17: Symbols On The Product

    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 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 18: Symbols On The Type Plate

    (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 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 19: Ambient Conditions

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

  • Page 20: Preparation

    Set the product on a horizontal, flat surface. Make sure that the power cord can be unplugged at any time. Install the product out of reach of patients. Ensure adequate air circulation. 5.4 Connecting the product Connect the potential equipotential cable. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 21: Connecting The Footswitch

    Pull the guard off the SCB cable and connect the SCB cable to S-PILOT Connect the other end of the SCB cable with a KARL STORZ control device or other SCB devices; see the instructions for use of the KARL STORZ SCB control system.

  • Page 22: Connecting The Product As A Stand-Alone Solution

    Attach connecting cable (UP004) to AUTOCON III 400 or ConMed System 2450 or 5000 ® and to the remote control connection on S-PILOT Attach connecting cable (UP005) to COVIDIEN Force Triad or Valleylab Force FX and to ® the remote control connection of S-PILOT 5.7 Connecting the product for suctioning fluid...

  • Page 23: Putting The Product Into Operation

    Switch on UNIDRIVE S III and wait until the boot sequence is complete. ® Connect S-PILOT to the power supply. ® ® Connect UNIDRIVE S III and S-PILOT to the control cable (27610070). ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 24: S-Pilot With Calcuson

    Connect the CALCUSON and S-PILOT to the control cable (27610070). ® Switch on the CALCUSON and S-PILOT ð The pilot lamps (1) and (2) on the CALCUSON light up green. Set the first stage on the footswitch to start the suctioning process.

  • Page 25: S-Pilot With Autocon Iii 400

    Activate the HF device. ð The tube squeeze valve remains opens for as long as the activation signal is present (plus shut-off delay of 3 seconds). ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 26: Application

    Make sure that the tube set is not leaking or kinked and that the ends of the tubing are properly secured. Connect the white end of the tube set to the connection socket on the suction receptacle/system in red. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 27 To prevent the cavity from collapsing, the suction flow can be adjusted at any time via the roller clamp attached close to the patient. Fluid and smoke gas can be suctioned simultaneously via the Y-adaptor. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 28: Closing The Application

    The pitch of the information signal is modulated at a frequency of 1.5 Hz by ± 2 Hz at a time. 5 different harmonics are generated and the sound sequence occurs once. Signals indicating the product's safety state are repeated and sound every 15 s.  Information signal ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 29: Maintenance, Servicing, Repairs, And Disposal

    Perform a functional test in line with the instructions for use. Document the results of the safety inspection. 7.3 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. ® Instructions for use • S-PILOT...

  • Page 30: Disposing Of The Product

    Maintenance, servicing, repairs, and disposal Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.

  • Page 31: Accessories And Spare Parts

    Tube set for suctioning 030748-01 Tube set, suctioning, EXTRA-LARGE LL 030547-01 Tube set, suctioning, LUER 030948-01 Tube set, suctioning LAP, S-PILOT 031447-03 Secretion receptacle 1.5 l 030301-01 Secretion receptacle 2.5 l 030302-01 Secretion bag, 1.5 l, single use, pack of 40 030310-40 Secretion bag, 1.5 l, with gelling granulate,...

  • Page 32: Electromagnetic Compatibility

    UP004 Connecting ca- ble between S- ® PILOT and AU- ® TOCON III 400 / ConMed System 2450 or 5000 UP005 Connecting ca- ble between S- ® PILOT and Co- vidien Force ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 33 135°, 180°, 225°, 270°, from an uninterruptible & 315° phase angles & 315° phase angles power supply or a bat- Voltage interruption: Voltage interruption: tery. 100% for 250/300 cy- 100% for 250/300 cy- cles cles ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 34 800 – 960 GSM 800/900, Pulse modula- TETRA 800, tion iDEN 820, 18 Hz CDMA 850, LTE band 5 1,720 1,700 – 1,990 GSM 1800, Pulse modula- CDMA 1900, tion 1,845 GSM 1900, 217 Hz DECT, ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 35 [m]. Field strengths from fixed RF transmitters as deter- mined by an electromag- netic site survey should ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 36 Harmonic emissions acc. to Class A nected to the public low voltage power IEC 61000-3-2 supply network that supplies buildings used for domestic purposes. Voltage fluctuations/flicker emis- Compliant sions acc. to IEC 61000-3-3 ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 37 Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB. ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 38: Faults And Messages

    Contact Service Status LED and buzzer: 1 s/1 s Motor driver: Status LED and buzzer: 1 s/3 s SCB connection lost during Check SCB connection operation, acoustic informa- tion signal every 10 s ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 39: Subsidiaries

    KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com...
  • Page 40 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
  • Page 41 Subsidiaries ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 42 Subsidiaries ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 43 Subsidiaries ® Instructions for use • S-PILOT • PYB194_EN_V1.0_02-2021_IFU_CE-MDR...
  • Page 44 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...

Table of Contents