Table of contents Table of contents 1 General information............................ 6 Read the instructions for use ........................ 6 Description of warning messages...................... 6 Abbreviations ............................ 6 2 Intended use .............................. 8 Intended purpose............................ 8 Other intended conditions ........................ 8 Indications.............................. 8 Contraindications............................ 8 Target user populations .......................... 9 Target patient groups .......................... 9 2.6.1 Intended application areas on the patient ..................
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Table of contents Unpacking the product ........................... 25 Product installation .......................... 25 Connecting the product .......................... 25 Test the product............................ 26 Putting the product into operation...................... 26 Selecting discipline and procedure...................... 28 Installing the tubing set........................... 29 Combined operation with CALCUSON (art. no. 27 6100 20).............. 32 5.8.1 Install the bottle holder ........................ 32 5.8.2 Putting the CALCUSON into operation ..................
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Table of contents Table 1 – Compliance level for immunity tests .................. 59 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....... 61 Table 3 – Test levels for radiated and conducted immunity tests ............ 61 Table 4 – Emission class and group ....................... 63 Table 5 –...
General information 1 General information 1.1 Read the instructions for use These instructions for use are intended to aid you in the proper installation, connection, and operation of this product. If the instructions for use are not followed, patients, users, or third parties may be injured. In addition, the product may be damaged.
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General information Abbreviation Explanation Laparoscopy Medical Device Regulation (European Union) NEURO Neurosurgery Pressure-controlled Percutaneous nephroscopy Resection SURG Surgery Urology Ureterorenoscopy Veterinary medicine ® Instructions for use • ENDOMAT SELECT • 96326003EN-US • V 1.0...
Can be moved if positioned on a cart Combination Can be used on the patient at the same time as other devices re- quired for the operations Control Can be controlled via the KARL STORZ SCB 2.3 Indications ® ENDOMAT SELECT is intended to: –...
Training may only be provided by persons equipped to do so on the basis of their knowledge. Your local representative or responsible KARL STORZ member of staff is available to provide training and information on other training alternatives.
Safety 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 –...
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.
Observe the information on electromagnetic compatibility; see chapter Electromagnetic compatibility [p. 59]. 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 integration of the product in an IT network can interfere with the function of the product or other devices in the IT network. Do not connect the product with an IT network or other devices. Only the KARL STORZ Service may use the interfaces for USB and Ethernet.
1.5% and sorbitol 3.0%) and isotonic, electrolyte-containing media (e.g., saline solution 0.9%). ® Automated fluid measurement system – EQUIMAT ® For the automated fluid measurement system, we recommend the KARL STORZ EQUIMAT device or the appropriate devices from other manufacturers. 4.2 Product overview ®...
SCB connectors Power cord socket Connection socket, e.g., for footswitch The KARL STORZ SCB interface, which is based on the CAN fieldbus, permits remote control of device functions and remote display of device parameters. Fig. 3: Tubing set for single use 4.3 Touch screen The user interface of the touch screen is subdivided into the following areas: ®...
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Product description Name of the discipline or Boost pressure increase the area of use Parameters that can be set Reduce set value Increase set value Irrigation/suction display Limitation of flow or pressure Parameters that can be set The parameters that can be set depend on the tubing set used and the installed software packages: –...
Product description 4.3.1 User interface symbols Symbol Meaning Start/stop standby / pump activated Start/stop Suction using footswitch Alarm audio on Alarm audio paused (30 s) Call up menu Cancel Reject changes Confirm Accept changes ® Instructions for use • ENDOMAT SELECT • 96326003EN-US • V 1.0...
Local regulations take precedence over IEC and ISO standards. If you have any questions, please contact your local KARL STORZ representative or technical customer support.
Product description 4.6 Operating modes Fig. 4: Operation as irrigation pump From the irrigant solution bag To the instrument Fig. 5: Operation as suction pump From instrument/patient To the collection container 4.7 Technical data General specification ® ENDOMAT SELECT UP 210 Power supply voltage 100 – 240 V∼...
Check the maximum permissible load of a multiple socket outlet in connection with a KARL STORZ isolation transformer depending on the model used. If the isolation transformer is connected to the system via a multiple socket outlet, the isolation transformer is part of the medical electrical system.
Product description 4.8.6 Reprocessing The instructions for reprocessing the system components can be found in the respective instructions for use. Further instructions are not intended for the system. 4.8.7 Maintenance Required maintenance work can be found in the instructions for use of the system components.
Product description Symbol Meaning In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Medical device CE mark. The CE mark is a label required for certain marketable industrial products in accordance with EU law.
Product description Symbol Meaning Separate collection of electrical and electronic devices. Do not dispose of in household refuse. Manufacturer Date of manufacture 4.11 Ambient conditions Storage/transport conditions Temperature -10 °C ... +60 °C (14 °F ... 140 °F) Relative humidity 15 – 95% (non-condensing) Air pressure 500 – 1,080 hPa Usage conditions Temperature 10 °C ... 40 °C (50 °F ... 104 °F) Relative humidity 15 – 80%...
Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessory from the packaging. Check the delivery for missing items and evidence of shipping damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.
S III. Connect the SCB cable. Connect the other end of the SCB cable with a KARL STORZ control device or other SCB devices; see KARL STORZ SCB control NEO system instructions for use. To remove the SCB cable, pull on the plug, since the SCB cable is equipped with a protection device against accidental pulling out.
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Preparation ð The green control lamp lights up, the product starts up and carries out a self-test. ð When the startup is complete and the self-test is successful, the following start screen appears: ð Alternatively, the following start screen appears: Tap the button Please press here to continue to start the product.
Preparation The height difference between the product and cavity (patient) can only be set with the Advanced software package. 5.6 Selecting discipline and procedure Start the product; see chapter Putting the product into operation [p. 26]. ð The screen for selecting the discipline appears: Fig. 6: Human medicine Fig. 7: Veterinary medicine Select the discipline.
Preparation Fig. 8: Human medicine Fig. 9: Veterinary medicine Select the procedure. Follow the animation for installing the tubing set. 5.7 Installing the tubing set WARNING Disposable products! Risk of infection! The reprocessing of disposable products can lead to infections in patients, users and third parties as well as damage to the product.
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Preparation WARNING Expiry date passed! Risk of infection! Check the expiry date. Check the packaging for damage. Never use products that have passed the expired expiry date or have damaged or accidentally opened packaging but dispose of them properly. ü The product is switched on. Install the tubing set.
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Preparation Select the desired discipline and procedure; see chapter Selecting discipline and procedure [p. 28]. Turn the pump lever of the tubing set counter clockwise. Connect the tubing ends with the irrigation bag (puncture needle) or with the irrigation connector on the instrument (LUER-Lock). ð...
Preparation To remove the tubing set, turn the pump lever clockwise to the 9 o'clock position. 5.8 Combined operation with CALCUSON (art. no. 27 6100 ® The CALCUSON is suitable for combined operation with the ENDOMAT SELECT. The products can be installed next to each other or at different levels on an equipment cart. ®...
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Preparation Mark the surface of the suspension on the right side of the product (as seen from the front) with a pencil. Keep a distance of 2 cm from the side rail. Apply the adhesion promoter thinly and evenly to the marked area. Apply the adhesion promoter only to surfaces that are completely covered, as the adhesion promoter contains a UV indicator that can be visible on treated surfaces.
Preparation Allow the adhesive to dry sufficiently, as the adhesive develops its full bond strength only after several hours. 10. Hang the bottle holder in the suspension. 5.8.2 Putting the CALCUSON into operation ® Connect ENDOMAT SELECT and CALCUSON with the optional control cable (art. no. 20 7010 70).
Preparation Actuate the first position of the footswitch (art. no. 20 0142 30) to start the suction of the ® ENDOMAT SELECT. Actuate the second position of the footswitch to activate the CALCUSON. ð The green pilot lamp (1) lights up when ultrasonic energy is emitted. The function is being performed correctly.
Preparation ® ® Connect ENDOMAT SELECT and UNIDRIVE S III with the optional control cable (art. no. 20 7010 70). ® ® ð The ENDOMAT SELECT can only be controlled with the footswitch of the UNIDRIVE S III. Actuate the footswitch (art. no. 20 0162 30) to the first position to start the suction of the ®...
Preparation ð The Shaver can only be operated via the head buttons of the handpiece. Install the tubing set; see chapter Installing the tubing set. Vent the tubing system; see see chapter Venting the tubing system. Activate the shaver on the handpiece. ®...
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Preparation Fig. 14: Disposable tubing set (art. no. 031647-10) Fill the suction bottle at least ¾ full with water. Place the lid with tube squeeze connecting piece on the suction bottle. Place the suction bottle in the bottle stand on the product; see chapter Install the bottle holder [p. 32].
Preparation Vent the tubing and probe before use; see chapter Venting the tubing system. If there is a height gradient between the patient and the suction bottle, the suction bottle may run full. Therefore, the suction bottle must be placed at the height of the patient. 5.12 Connect the tubing set for direct suction ®...
Application 6 Application 6.1 Menu In the menu, various settings and management fields can be selected. Turn the pump lever of the tubing set to the 9 o'clock position. Tap the menu button to open the menu. ð The Menu screen appears with the following sub-menus: 6.2 Settings In the Menu screen, tap the Settings sub-menu.
Application Select the language and confirm with ð The Settings screen appears. Cancel the selection with Browse back through the screen with 6.2.2 Other settings When the Advanced or VET software package is installed, the following settings can be made in the Other settings screen: Setting Comment...
Application Browse back through the screen with 6.2.3 Set height difference If the Advanced or VET software package is installed, the difference in height between the product and the cavity (patient) can be compensated. Setting the height difference corrects the pressure measurement and pressure control.
Application – Current date – Time – Info ID The event log is backed up in the event of voltage drops and when the device is switched off, and it contains entries relating to switch-on and switch-off times. The entire event log has a capacity of 50,000 entries. If the maximum number of entries is exceeded, the oldest entries are overwritten by new ones.
Application Browse back through the screen with 6.5 Services The Service menu is reserved for the authorized service technicians, and, for this reason, the access is password-protected. The possible settings are described in the service manual. In the Menu screen, tap the Service sub-menu. ð...
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Application ð The displayed actual value of the irrigation flow (white bar) must match the set value (orange marking). Slowly close the filling tap on the instrument. ð The roller pump stops the irrigation. HYS/URO/ART Have a collecting container ready to catch irrigant solution as it runs out. Tap the Start/Stop button and let the roller pump run until all of the air has been released from the tubing system.
Application ® 6.7 Use ENDOMAT SELECT as an irrigation pump WARNING Active roller pump! Risk of crushing! An activated roller pump can start at any time, and the rollers of the pump can cause crushing. Never reach into the pump. Do not wear loose clothing.
Application 6.7.2 Set the irrigation flow (ENT/NEURO) ® In combination with irrigation sheaths, the ENDOMAT SELECT can be used to clean the distal ® lenses (endoscope window) during the CLEARVISION procedure. As long as the footswitch is activated, the pump irrigates the distal objective lens with fluid. The footswitch has 2 different positions: Lens cleaning mode (position 1) The lens cleaning mode starts when the footswitch pedal is pressed halfway down to the first...
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Application Irrigation pressure set value Safety threshold 100 mmHg (URO/GYN) Irrigation pressure set value Flow limit Advanced or VET software package re- quired Percentage pressure increase (boost) (URO/ART/VET ART) Use the plus/minus buttons to set the set value (1) of the irrigation pressure independently of the pump status in 10 mmHg increments: 20...150 mmHg.
Application ® ® The boost is activated when the ENDOMAT SELECT is connected with the UNIDRIVE ® S III ARTHRO via the control cable UP 006 and the shaver on the UNIDRIVE S III ARTHRO is activated or the boost button is pressed by a finger. Without the Advanced software package installed, the standard values of the flow limit are 400 ml/min (HYS and URO) and 1,500 ml/min (ART).
Application ® 6.8.1 Setting the suction flow (IBS Shaver/RES/CALCUSON/VET SURG) Suction flow set value Suction flow actual value The suction flow can be set to the following values Suction flow Values ® Shaver 100 – 300 ml/min RES/VET SURG Direct Suction 100 – 1,000 ml/min CALCUSON/VET SURG Bottle Suc- 300 – 1000 ml/min tion Use the plus/minus buttons...
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Application Tap the footswitch button or the start/stop button again to stop the suction process. ® Instructions for use • ENDOMAT SELECT • 96326003EN-US • V 1.0...
Maintenance, repair, and disposal 7 Maintenance, repair, and disposal 7.1 Maintenance Maintenance work may only be carried out by KARL STORZ or a company authorized by KARL STORZ. Interval Maintenance work To be performed by annually Safety inspection KARL STORZ Service techni- cians 7.2 Alarm and information signals...
Maintenance, repair, and disposal Fig. 19: Excess pressure alarm – acoustic signal If an alarm condition is present, at least one complete tone sequence will be output. Tap the bell button to deactivate the signal for 30 seconds. 7.2.1.3 Checking the alarm function Switch on the product.
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Maintenance, repair, and disposal 7.2.2.1 Visual information signal The information signal is displayed with blue writing on a white background in the title line. 7.2.2.2 Acoustic information signal The acoustic information signal is a double tone c-e (263 Hz – 330 Hz) with a duration of 300 ms and a volume of 63 dBA.
Shut down the product. Have the deficiencies repaired by persons authorized by KARL STORZ. Regardless of the national accident prevention regulations and testing intervals for medical devices, for this device safety checks must be performed as repeat inspections according to IEC 62353 and recorded by a qualified electrician at least once a year.
Document the results of the safety test. 7.4 Repairing products If repair work is necessary, an instrument can be loaned from KARL STORZ within Germany for the repair period. As soon as the repaired product is received, the loan equipment must be returned to KARL STORZ.
Accessories and spare parts 8 Accessories and spare parts 8.1 Recommended accessories Item Order no. Metal filter 20 3000 38 Tubing set, irrigation, PC, for single use, 031523-10 sterile, package of 10 Tubing set, suction, BS, for single use, ster- 031647-10 ile, package of 10 Tubing set, suction, DS, for single use, ster-...
Accessories and spare parts Recommended accessories for Advanced package Article Order no. SCB connecting cable, length 100 cm 20090170 8.2 Spare parts list Item Order no. Power cord (grounded) 400A Power cord "hospital grade" (USA) 400B ® Instructions for use • ENDOMAT SELECT •...
Electromagnetic compatibility 9 Electromagnetic compatibility 9.1 General notes on the operating environment The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT).
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Electromagnetic compatibility Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi- munity tests level ronment – guidelines 100 kHz repetition 100 kHz repetition Surges acc. to ± 1 kV voltage outer ± 1 kV voltage outer The power supply qual- IEC 61000-4-5 conductor – outer con- conductor –...
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Electromagnetic compatibility 9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment Test fre- Frequency Radio service Modulation Immunity Compliance quency band test level level 380 – 390 TETRA 400 Pulse modula- tion 18 Hz 430 – 470 GMRS 460, FM ± 5 kHz FRS 460...
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Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi- tests level level ronment – guidelines Radiated HF distur- 3 V/m 3 V/m product, including cables, bances acc. to IEC than the recommended 80 MHz to 2.5 GHz 61000-4-3 separation distance calcu- lated from the equation applicable to the fre- quency of the transmitter.
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Electromagnetic compatibility 9.6 Table 4 – Emission class and group Guidelines and manufacturer’s declaration – electromagnetic emissions The product is intended for use in such an environment as specified below. The customer or user of the device should ensure that it is used in such an environment. Emission measurements Compliance Electromagnetic environment –...
190: Cartridge detection error Cartridge detection electron- Switch the product on ics error and off. Contact KARL STORZ Service if the error reoccurs. 191: Cartridge locking error Cartridge locking electronics Switch the product on error and off.
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Information message. Work is possible. Disconnect the USB port. 259: Electronics error BE: Internal error Switch the product on and off. Contact KARL STORZ Service if the error reoccurs. 300: High pressure Stopcock on instrument Observe the surgical closed field. Ensure pressure reduction.
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This text message can also appear in the event of a touch screen short circuit. Switch the product on and off. Contact KARL STORZ Service if the error reoccurs. 501: Touch calibration FE: A touch screen activation The text message is part of...
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Fault correction Message Possible cause Actions Contact KARL STORZ Service if the error reoccurs. 0x763: Motor current offset Electronics error in the motor Switch the product on current measurement and off. Contact KARL STORZ Service if the error reoccurs. 0x764: Peak current...
Possible cause Actions 0x772: PS error (PUST) Error in the monitoring system Switch the product on and off. Contact KARL STORZ Service if the error reoccurs. 0x773: PS error (ST) Error in the monitoring system Switch the product on and off.
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Fault correction Symptom Possible causes Actions Check the seating of the sealing cap. No suction – The plunger ball is Check the fluid level blocking the suction and empty the glass if inlet. necessary. – The bacterial filter on Clean the plunger ball the suction bottle is and check for mobility.
SELECT is not intended to be connected to other devices via the USB or Ethernet interface. These interfaces are reserved for the ® KARL STORZ Service only. Connecting the ENDOMAT SELECT to an IT net- work that contains other devices may cause previously unknown risks for pa- WARNING tients, operators, or third parties.
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WARNING Servicing may only be performed by skilled persons authorized by KARL STORZ. WARNING Test this device prior to each surgical procedure to ensure that it functions cor- rectly. The device should not be used if any damage is evident.
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Overview of risks and warnings Do not open the device! Danger of an electric shock. Have servicing performed exclusively by the manufacturer or by personnel authorized by the manufacturer (cf. §3 of the Medical Device Operator Ordinance). Any opening of the device components by unauthorized personnel will void the warranty.
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WARNING The instrument may only be operated with the power cord delivered by KARL STORZ or a similar power cord which has a national inspection seal. WARNING ® Instructions for use • ENDOMAT...
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The ENDOMAT SELECT is not intended to be connected to other devices via the USB or Ethernet interface. These interfaces are reserved for the KARL STORZ Service. WARNING For safety reasons, the device may only be used if the availability signal was...
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WARNING Risk of infection / product damage: The procedures given in the instructions for use have been validated by KARL STORZ. Only use these procedures. The re- processing method must be validated by the user on site. WARNING...
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Overview of risks and warnings Regardless of the accident prevention regulations or testing intervals for medi- cal devices prescribed in different countries, safety checks / repeat inspections according to IEC 62353 must be carried out on this device and documented at least once a year by a qualified electrician.
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Overview of risks and warnings Multiple socket outlets must not be placed on the floor. WARNING The use of freely accessible multiple socket outlets is not permitted. WARNING The use of additional multiple socket outlets or an extension cable with the sys- tem is not permitted.
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(nonionic) fluids such as glycine 1.5% and sorbitol 3.0%. It is critical to closely WARNING monitor the input and outflow of the distending liquid at all times. Use of the KARL STORZ pumps together with a KARL STORZ morcellator or shaver is not approved for use in the United States. WARNING ®...
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® can be perforated and the ENDOMAT SELECT contaminated. CAUTION Product damage. Only perform reprocessing using chemicals approved by KARL STORZ. A list of approved chemicals can be requested from http://hy- giene@karlstorz.com. CAUTION ® Instructions for use • ENDOMAT SELECT • 96326003EN-US • V 1.0...