Safety Notes

ManualsBrandsFluid Control Lap 2216 ManualsElectronicsMedical Pump with RFID technology

General Safety Notes

CAUTION!

Use of other accessories, other transducers and cables

The use of accessories, transducers, and cables other than those specified, with

the exception of transducers and cables sold by the MANUFACTURER of the ME

EQUIPMENT or ME SYSTEM (see Chapter 22 "Glossary") as replacement parts for

internal components, may result in increased EMISSIONS or decreased IMMUNI-

TY of the ME EQUIPMENT or ME SYSTEM.

CAUTION!

ME Device in Rack

The ME device may not be used when stacked or stored directly adjacent to or

with other devices. If it should be necessary to operate the device close to

stacked with other devices, the ME device or ME system should be monitored to

ensure it works properly as configured.

CAUTION!

ME systems (Medical Electrical System)

The medical electrical device is suitable for integration in ME equipment systems

(see Chapter 22 Glossary). Operation of the ME device in vicinity of non-ME de-

vices may result in voiding the intended use of the ME device.

CAUTION!

The device may not be used in conjunction with a defibrillator since it is not

equipped with corresponding safety elements. The manufacturer accepts no

liability in this case for ensuing damage.

CAUTION!

Do not reach into the area of the roller wheel during operation. There is a risk of

jamming.

OBJ_DOKU-0000006143-008.fm Seite 11 Mittwoch, 11. November 2020 2:29 14

Summary of content (112 pages)

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OBJ_DOKU-0000006143-008.fm Seite 11 Mittwoch, 11. November 2020 2:29 14 General Safety Notes CAUTION! Use of other accessories, other transducers and cables The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM (see Chapter 22 "Glossary") as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
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OBJ_DOKU-0000006143-008.fm Seite 12 Mittwoch, 11. November 2020 2:29 14 General Information 3 Intended use The devices PG130/PG145 are multi-indication pumps with irrigation functions for 4 indications: • • • • en General Information Laparoscopy Arthroscopy Hysteroscopy Urology Each indication must be activated individually. Only activated indications can be enabled. Activation is done with a special transponder (see Chapter 6.2 "Activating Indication on New Factory Devices").
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OBJ_DOKU-0000006143-008.fm Seite 13 Mittwoch, 11. November 2020 2:29 14 General Information 3.2 Using the Arthroscopy Indication The devices PG130/PG145 may be used for the distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and surgical procedures such as: • • • • Intended use: Arthroscopy Ligament injuries Meniscus injuries Cartilage injuries Surgical plans and follow-up exams en The user can preset the desired joint pressure.
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OBJ_DOKU-0000006143-008.fm Seite 14 Mittwoch, 11. November 2020 2:29 14 General Information 3.3 Intended use: Hysteroscopy en Using the Hysteroscopy Indication The devices PG130/PG145 may be used for intrauterine distension, aspiration of secretory fluids, and monitoring of fluid deficit during endoscopic procedures. It is used to irrigate the cavum uteri with fluid to prepare for diagnostic and surgical hysteroscopies.
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OBJ_DOKU-0000006143-008.fm Seite 15 Mittwoch, 11. November 2020 2:29 14 General Information • • • • The nominal pressure can be preset to a range of 15 to 90 mmHg. The nominal flow can be preset to a range of 0.025 to 0.5 l/min. The devices feature an instrument recognition function. The pump reacts to pressures greater than the set nominal pressure by emitting warnings. The devices have safety thresholds. 3.5 3.
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OBJ_DOKU-0000006143-008.fm Seite 16 Mittwoch, 11. November 2020 2:29 14 General Information WARNING! Air Embolisms An air embolism can be the result of air contained in the tube set or connected instrument reaching the patient. Make sure that there is always fluid in the bag to prevent air from being aspirated into the patient. en 3.
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OBJ_DOKU-0000006143-008.fm Seite 17 Mittwoch, 11. November 2020 2:29 14 General Information WARNING! Fluid intake and output surveillance Strict fluid intake and output surveillance should be maintained. If a low viscosity liquid distention medium is used, intrauterine instillation exceeding 2 liters should be followed with great care due to the possibility of fluid overload. If a high viscosity fluid is used, the use of more than 500 ml should be followed with great care.
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OBJ_DOKU-0000006143-008.fm Seite 18 Mittwoch, 11. November 2020 2:29 14 General Information WARNING! Fluid volume/sodium concentration The fluid left in the patient and the concentration of sodium in the blood serum must both be monitored. The deficit amount is the entire amount of fluid lost by or to the system. Take note of the measurement tolerance of the system. Estimating the fluid volume remaining in the patient is the doctor’s responsibility.
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OBJ_DOKU-0000006143-008.fm Seite 19 Mittwoch, 11. November 2020 2:29 14 General Information WARNING! Idiosyncratic reactions In rare cases, idiosyncratic reactions such as • intravascular coagulopathy • allergic reaction including anaphylaxis may occur during a surgical procedure if a liquid distention medium is used. en WARNING! Pulmonary edema A surgical procedure has the risk of pulmonary edema, which is formed due a "fluid overload" with isotonic fluids.
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OBJ_DOKU-0000006143-008.fm Seite 20 Mittwoch, 11. November 2020 2:29 14 Initial Device Startup 4 Initial Device Startup Operation of the devices PG130/PG145 is reserved for persons with the relevant professional qualifications and trained to use the device. 4.1 en Delivery Scope • Device PG130/PG145 • Instruction for use • Power cable Delivery inspection Always check all parts and optional accessories of the device immediately after receiving the shipment.
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OBJ_DOKU-0000006143-008.fm Seite 21 Mittwoch, 11. November 2020 2:29 14 Initial Device Startup CAUTION! Equipment should be positioned such that power cord can be easily disconnected. CAUTION! Before switching on the device, sufficient time must have passed to adjust to the indoor climate. en CAUTION! Position the device in such a way that it is easy to operate and switch off. CAUTION! Place the device outside the sterile field.
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OBJ_DOKU-0000006143-008.fm Seite 22 Mittwoch, 11. November 2020 2:29 14 Description of Device 5 Description of Device 5.1 Front of Device Familiarize yourself with the control and display elements of the PG130/PG145. en Fig. 5-1 Device front (1) Touchscreen (2) Tube retainer (3) Roller wheel (4) Mechanical tube set trigger (5) Vacuum pump connection (only PG145) (6) IR interface (7) ON switch (8) OFF switch (1) 5.
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OBJ_DOKU-0000006143-008.fm Seite 23 Mittwoch, 11. November 2020 2:29 14 Description of Device 5.3 Touchscreen The touchscreen connects display and control elements and offers intuitive ease of use. Function fields or symbols are used to control the unit. An acoustic signal (beep) is emitted when pressing a function field or symbol. This beep confirms your input.
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OBJ_DOKU-0000006143-008.fm Seite 24 Mittwoch, 11. November 2020 2:29 14 Description of Device Indication screen Fig. 5-4 en Fig. 5-4 "Indication screen overview" depicts the 6 areas with display and control elements. Indication screen overview (1) Header (2) Suction level (only PG145) (3) Footer (4) Status line (5) Nominal values (6) Actual values (1) ARTHRO Knee ACTUAL PRESSURE (6) (5) 0 50 100 150 2 200 45 mmHg (2) 1.
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OBJ_DOKU-0000006143-008.fm Seite 25 Mittwoch, 11. November 2020 2:29 14 Operating the Device 6 Operating the Device 6.1 Turning the Device On 1. Connect the device with the mains power. 2. Make sure no tube set is inserted into the tube retainer (exception: day set during arthroscopy! See 9.4 "Switching Device on When Using Day Patient Set", item b). Press the ON switch. An acoustic warning signal is emitted. ! en 3. The device performs a device check after being switched on.
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OBJ_DOKU-0000006143-008.fm Seite 26 Mittwoch, 11. November 2020 2:29 14 Operating the Device Fig. 6-1 Inserting transponder into tube retainer (1) Tube retainer (2) Transponder ! en Language English Español 1.Italiano Français (1) ARTHRO Deutsch (2) 1. Switch device on. The touchscreen of the device depicts the language selection if an indication has not yet been activated. Press the desired language. 2. Press [Save] to save the language. 3.
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OBJ_DOKU-0000006143-008.fm Seite 27 Mittwoch, 11. November 2020 2:29 14 Operating the Device 6.4 Indication Activation Overview en 6.5 Using the Tube Sets The transponder technology detects the tube type, the validity and reliability of a tube set automatically and a corresponding message is output in the status line of the touchscreen. This eliminates virtually all "operating errors" since non fitting, invalid, and not allowed tube sets are reliably detected.
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OBJ_DOKU-0000006143-008.fm Seite 28 Mittwoch, 11. November 2020 2:29 14 Operating the Device device is switched off or in case of a power failure, the current use cycle is invalidated. Once the last use cycle has been invalidated, irrigation can no longer be started. If this is the case, you must insert a new, valid, and allowed day tube. Transponder signal loss The device stops and cannot be restarted if the transponder loses its signal during current operation (e.g. defective electronic component).
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OBJ_DOKU-0000006143-008.fm Seite 29 Mittwoch, 11. November 2020 2:29 14 Operating the Device WARNING! Reprocessing of sterile disposable products Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! Do not reprocess the product. 6.7 en Inserting a Standard Tube Set (1) (2) (3) (4) (11) (5) (10) (6) Fig.
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OBJ_DOKU-0000006143-008.fm Seite 30 Mittwoch, 11. November 2020 2:29 14 Operating the Device Fig. 6-3 en Inserting the tube set (12) Irrigation fluid bags (12) (13) Tap spikes/Care lock (13) (14) Tube retainer (15) Inflow tube/irrigation tube (16) Roller wheel (17) Mechanical tube release (18) Instrument tube (14) ! (15) (16) (17) (18) In order to separate sterile from non-sterile areas, assign the following tasks to the "sterile" or "non-sterile" nurse or medical technician.
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OBJ_DOKU-0000006143-008.fm Seite 31 Mittwoch, 11. November 2020 2:29 14 Operating the Device 6.8 Inserting the Day Patient Tube Set The day patient set consists of two tube sections comprised of the day tube and the patient tube. The day tube establishes the tube connection between the irrigation fluid bags and the patient tube. The day tube is inserted into the tube retainer of the device and not replaced for the duration of one day between surgeries and/or surgical procedures.
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OBJ_DOKU-0000006143-008.fm Seite 32 Mittwoch, 11. November 2020 2:29 14 Operating the Device such as a trocar, for example, is fitted to the other side. Connect the hygiene connector (13) of the patient tube with the matching piece on the day tube (Fig. 6-4 (10)). en Fig.
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OBJ_DOKU-0000006143-008.fm Seite 33 Mittwoch, 11. November 2020 2:29 14 Operating the Device  Connect the luer lock connector (15) with the instrument (e.g., inflow cannula). Open inflow valve at instrument. 3. To be carried out by non-sterile technician: Insert new day tube  Connect the hygiene connector (13) with the patient connector (10).  Switch the device on and select the arthroscopy indication (see Chapter 9.4 "Switching Device on When Using Day Patient Set").
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OBJ_DOKU-0000006143-008.fm Seite 34 Mittwoch, 11. November 2020 2:29 14 Operating the Device 6.8.1 Replacing the Patient Tube After Surgery WARNING! The day tube remains connected to the device after each surgery. The patient tube must be disposed of immediately after surgery. A new sterile cap (included with the patient tube) must be screwed onto the hygiene connector at the day tube after each surgery. This sterile protector remains connected to the day tube until the next surgery. en 1.
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OBJ_DOKU-0000006143-008.fm Seite 35 Mittwoch, 11. November 2020 2:29 14 Operating the Device h (1) Fig. 6-7 (2) (1) Irrigation fluid bags (2) Tap spikes (3) Tube clamps (4) Inflow tube Hanging the irrigation fluid bags en (3) ! (4) To be carried out by non-sterile technician:  The inflow tube (4) can take irrigation fluid from 2 fluid bags (1). Connect both tube clamps (3) to the branches of the inflow tube.
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OBJ_DOKU-0000006143-008.fm Seite 36 Mittwoch, 11. November 2020 2:29 14 Operating the Device ARTHRO Knee need of replacement. ACTUAL PRESSURE 0 50 100 150 This procedure must be carried out each time a fluid bag is replaced. 200 45 mmHg en 1.5 l/min SET PRESSURE SET FLOW 6.12 Replace fluid bag STOP  Replace the almost empty fluid bag with a full one.  Keep the tube clamp of the new, full fluid bag closed until this bag is also in Switching Device Off • Press the OFF switch.
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OBJ_DOKU-0000006143-008.fm Seite 37 Mittwoch, 11.
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OBJ_DOKU-0000006143-008.fm Seite 38 Mittwoch, 11. November 2020 2:29 14 Operating the Device 1. Using a screwdriver, open the cover on the back of the remote control. 2. Remove the old batteries and insert the new batteries in the orientation indicated by the symbols on the remote control housing. 3. Replace the cover and tighten with screw. WARNING! Never switch polarity and make sure that the plus (+) and minus (-) poles are aligned correctly to prevent short circuits.
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OBJ_DOKU-0000006143-008.fm Seite 39 Mittwoch, 11. November 2020 2:29 14 Operating the Device 6.15 Using a Foot Pedal (Optional) CAUTION! The foot pedal can be disinfected by wiping off and must not be sterilized. en Fig.
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OBJ_DOKU-0000006143-008.fm Seite 40 Mittwoch, 11. November 2020 2:29 14 Using Suction Function (Only Pg145) 7 Using Suction Function (Only Pg145) The device PG145 is equipped with a vacuum pump. The vacuum pump is used to suction off secretions of a patient by using a suction tube and a secretion container. A suction tube can be used with all 4 indications.
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OBJ_DOKU-0000006143-008.fm Seite 41 Mittwoch, 11. November 2020 2:29 14 Using Suction Function (Only Pg145) Fig. 7-3 Connecting the suction system (1) Secretion container tube with filter (vacuum tube) (2) Secretion container (3) Suction instrument tube (4) Suction instrument ! (3) en ! (1) (2) (4) WARNING! Filter The vacuum tube with integrated filter PG139 is designed for max. 28 days. In case the PG139 is not used, please use a new/sterile filter for each patient.
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OBJ_DOKU-0000006143-008.fm Seite 42 Mittwoch, 11. November 2020 2:29 14 Using Suction Function (Only Pg145) 7.3 Stopping Suction Stop suction ARTHRO Knee ACTUAL PRESSURE en 0 50 100 150 2 200 45 mmHg Close the inflow valve of the instrument. On the indication screen, press the [0] symbol to deactivate suction level 1 or 2. 1.5 l/min SET PRESSURE SET FLOW 0 Start pump START 7.
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OBJ_DOKU-0000006143-008.fm Seite 43 Mittwoch, 11. November 2020 2:29 14 Using the Laparoscopy Indication 8 Using the Laparoscopy Indication The devices PG130/PG145 may serve as irrigation pump for use in minimally invasive laparoscopic surgery (keyhole surgery). The optional suction function can be used to siphon off secretions. The optional suction function can be used to extract and remove waste gas when using laser or RF surgical devices.
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OBJ_DOKU-0000006143-008.fm Seite 44 Mittwoch, 11. November 2020 2:29 14 Using the Laparoscopy Indication between 1.0 and 2.5 l/min. The user can switch between the [STANDARD] flow level and the higher [HIGH FLOW] level (up to 3.5 l/min). WARNING! Check all factory settings Factory settings are not mandatory settings for the physician. The physician is responsible for all settings affecting the surgical procedure. en 8.
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OBJ_DOKU-0000006143-008.fm Seite 45 Mittwoch, 11. November 2020 2:29 14 Using the Laparoscopy Indication 8.6 Stopping Irrigation 1. Press the [STOP]. unction field. The roller wheel stops. The irrigation process is canceled or ended. 2. Irrigation can also be stopped with the remote control (see Chapter 6.13 "Using the Remote Control (Optional)"). 8.
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OBJ_DOKU-0000006143-008.fm Seite 46 Mittwoch, 11. November 2020 2:29 14 Using the Laparoscopy Indication 8.7.1 Set the flow level Standard/flow level High Menu Flow level Standard en 1,5 l/min 3. 4. 5. 6. Setting the Flow Level Standard/Flow Level High 1. In the user menu, press the [LAP settings] function field. This opens the laparoscopy user menu. 2. Press the [Flow level Standard]/[Flow level High] function field. You can set values between 1.0 and 2.
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OBJ_DOKU-0000006143-008.fm Seite 47 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9 Using the Arthroscopy Indication The devices PG130/PG145 may be used for the distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and surgical procedures such as: • • • • Intended use: Arthroscopy Ligament injuries Meniscus injuries Cartilage injuries Surgical plans and follow-up exams en The user can preset the desired joint pressure.
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OBJ_DOKU-0000006143-008.fm Seite 48 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.1 Device-inherent Dangers: Arthroscopy Indication WARNING! The height difference between the device and the patient must be adjusted correctly in order to ensure exact pressure measurement. en WARNING! Fluid irrigation pumps used in Arthroscopy may cause fluid extravasation into the surrounding tissue.
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OBJ_DOKU-0000006143-008.fm Seite 49 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication For additional information see 6.5 "Using the Tube Sets", 6.7 "Inserting a Standard Tube Set", 6.8 "Inserting the Day Patient Tube Set" and 6.9 "Removing a Tube Set". 9.3 Switching Device on When Using Standard Tube Set 1. Make sure no tube set is inserted into the tube retainer before switching the device on. 2. Press the ON switch. The device turns on.
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OBJ_DOKU-0000006143-008.fm Seite 50 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.4 Switch device on with inserted day tube en Remove tube set Switching Device on When Using Day Patient Set a. If the device is switched on and a new day set is inserted, the status field of the display depicts the following: Remove tube set. The day tube must be removed. b.
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OBJ_DOKU-0000006143-008.fm Seite 51 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.5 Selecting Joint Type After pressing the [ARTHRO] function field, the following joint selection function fields are displayed on the touchscreen: Select a joint ARTHRO • • • • • • Knee Shoulder Small joint Hip User 1 User 2 Knee Shoulder Small joint Hip User 1 User 2 en Enter and save your own user profiles into the function fields [User 1] and [User 2]. 1.
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OBJ_DOKU-0000006143-008.fm Seite 52 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.5.1 Fig.
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OBJ_DOKU-0000006143-008.fm Seite 53 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication • Briefly press the [-] symbol to decrease the nominal pressure in increments of 5 mmHg. Pressing the [-] symbol longer than 1.5 seconds activates scrolling of the values in increments of 10 mmHg. The nominal pressure can also be reduced with the help of the remote control (see Chapter 6.13 "Using the Remote Control (Optional)").
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OBJ_DOKU-0000006143-008.fm Seite 54 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.6 ARTHRO Knee ACTUAL PRESSURE en 0 50 100 150 200 45 mmHg 1.5 l/min SET PRESSURE SET FLOW Start pump START ARTHRO Knee ACTUAL PRESSURE 0 50 100 150 200 45 mmHg SET PRESSURE STOP 1.5 l/min SET FLOW WASH 1. 2. 3. 4. 5. 6. Insert the tube set/day set as described in Chapter 9.2 "Inserting a Tube Set". The status line depicts the following: Start pump or Day tube inserted.
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OBJ_DOKU-0000006143-008.fm Seite 55 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.8.1 Using WASH Function via Touchscreen Follow these steps to activate the WASH function via touchscreen while operating the device: 1. Press the [WASH] function field to start the Wash function. Please note that the Wash function stops automatically after 10, 20, or 30 seconds and the device returns to the previously specified nominal values.
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OBJ_DOKU-0000006143-008.fm Seite 56 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication WARNING! Before every surgery, make sure the remote control does not affect other devices within the surgical field. en Starting and stopping the WASH function via infrared remote control 56 PRESSURE FLOW START STOP WASH . 1. The infrared remote control is operational and points towards the front of the device. 2. Press the [WASH] function field to start the Wash function.
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OBJ_DOKU-0000006143-008.fm Seite 57 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.9 Opening and Configuring the User Menu for the Arthroscopy Indication Device parameters are displayed and changed in the [ARTHRO settings] menu. The following chart provides an overview over the possible settings. User menu overview en Menu General settings ARTHRO settings Service 1. In the user menu, press the [ARTHRO settings] function field. This opens the arthroscopy user menu. 2.
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OBJ_DOKU-0000006143-008.fm Seite 58 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication 9.9.2 Set the height differential Menu en Height differential 0 cm 20 cm 3. 40 cm 4. 5. 6. Setting the Height Difference 1. In the user menu, press the [ARTHRO settings] function field to open the Arthroscopy user menu. 2. Press the [Height differential] function field. Select 0, 20, or 40 cm. 3.
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OBJ_DOKU-0000006143-008.fm Seite 59 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication If the actual pressure exceeds the nominal pressure by more than 30 mmHg (example: nominal pressure = 45 mmHg, actual pressure = 76 mmHg), the following safety mechanisms are automatically triggered by the device: Actual pressure +30 mmHg > nominal pressure • After a few second: a pressure relief function is activated consisting of turning the roller wheel backwards.
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OBJ_DOKU-0000006143-008.fm Seite 60 Mittwoch, 11. November 2020 2:29 14 Using the Arthroscopy Indication side of the joint. Actual pressure > 300 mmHg ARTHRO Knee • Immediately: The roller wheel stops. • A continuous acoustic signal is emitted. The status line depicts Critical overpressure! in red letters. • If the overpressure actually occurs inside of the joint, the pump triggers a pressure relief function consisting of turning the roller wheel backwards.
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OBJ_DOKU-0000006143-008.fm Seite 61 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10 Using the Hysteroscopy Indication The devices PG130/PG145 may be used for intrauterine distension, aspiration of secretory fluids, and monitoring of fluid deficit during endoscopic procedures. It is used to irrigate the cavum uteri with fluid to prepare for diagnostic and surgical hysteroscopies.
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OBJ_DOKU-0000006143-008.fm Seite 62 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication WARNING! Hyponatremia Some distension fluids may lead to fluid overload and, consequently, hyponatremia with its attending sequelae. This can be affected by the distending pressure, flow rate, and duration of hysteroscopic procedure. It is critical to closely monitor the input and outflow of the distending liquid at all times.
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OBJ_DOKU-0000006143-008.fm Seite 63 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication WARNING! The pressure should be kept as low as possible to allow for a sufficient intrauterine distension and to reduce the forces that could allow fluid, ambient air, and/ or gas into the circulatory system. en WARNING! Fluid Overload There is a risk of irrigation fluid reaching the circulatory system of the patient's soft tissue.
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OBJ_DOKU-0000006143-008.fm Seite 64 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.3 Screen Displays of the Hysteroscopy Indication The hysteroscopy indication should always be used with a connected scale to measure the differential volume. In case a scale is not connected, the screen display changes as depicted below. en Fig.
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OBJ_DOKU-0000006143-008.fm Seite 65 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication Once the scale is connected to the device, the differential volume (deficit volume) is displayed by the device instead of the consumed amount of fluid (volume display (3)). (1) (2) (3) Fig. 10-2 Hysteroscopy indication screen displays with connected scale (4) HYS HYS (5) 100 INFLOW VOLUME ACTUAL PRESSURE DEFICIT [ml] % 0 50 100 1.
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OBJ_DOKU-0000006143-008.fm Seite 66 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.5 Switching device on without standard tube set en Device check Switching Device on When Using Standard Tube Set 1. Make sure no tube set is inserted into the tube retainer before switching the device on. 2. Press the ON switch. The device turns on. The touchscreen displays the following in succession: Company logo/Device check/Device OK 3.
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OBJ_DOKU-0000006143-008.fm Seite 67 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.6 Using a Scale WARNING! In accordance with its design purpose, the pump may be used without balancing system only for diagnostic purposes. When using a scale, the fluid volume remaining in the patient during the procedure and not drained and collected is depicted in the volume display of the device.
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OBJ_DOKU-0000006143-008.fm Seite 68 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.6.1 Installing and Connecting the Scale CAUTION! The scale to be connected must be attached to the device before the device is switched on or the device does not detect the scale. en Fig. 10-3 Connecting the scale (1) Connection cable (2) Instrument (3) Apron (4) Secretion container (5) Scale h (1) ! (2) (3) (4) (5) Connect scale 68 1.
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OBJ_DOKU-0000006143-008.fm Seite 69 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication If the weight of the connected scale exceeds the value of 7 kg, the status line depicts Scale overloaded! in red letters and a continuous acoustic signal is emitted. Stop the pump and remove the weight. Weight > 7 kg HYS HYS 100 INFLOW VOLUME ACTUAL PRESSURE DEFICIT [ml] 1.
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OBJ_DOKU-0000006143-008.fm Seite 70 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication Decreasing nominal pressure HYS HYS 100 INFLOW VOLUME ACTUAL PRESSURE DEFICIT [ml] 1.0 52 % 0 50 100 150 0 en 80 45 mmHg mmHg SET PRESSURE 0 • Briefly press the [-] symbol to decrease the nominal pressure in increments of 5 mmHg. Pressing the [-] symbol longer than 1.5 seconds activates scrolling of the values in increments of 10 mmHg.
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OBJ_DOKU-0000006143-008.fm Seite 71 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.9 Resetting the Differential Volume You can reset the differential (deficit) volume to the value 0. • Press the [->0<-] symbol (reset) to reset the differential (deficit) volume to the value 0. The status line depicts the following: Deficit reset. Reset differential volume HYS HYS 100 INFLOW VOLUME ACTUAL PRESSURE DEFICIT [ml] 1.
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OBJ_DOKU-0000006143-008.fm Seite 72 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 3. 4. 5. 6. en Container change not allowed 72 Replace the full secretion container with an empty one. Close the inflow valve of the instrument. Press the [START] function field. Measurement of the differential (deficit) volume is continued.
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OBJ_DOKU-0000006143-008.fm Seite 73 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.13 Opening and Configuring the User Menu for the Hysteroscopy Indication Device parameters are displayed and changed in the [HYS settings] menu. The following chart provides an overview over the possible settings. User menu overview en Menu 1. Switch device on. 2. Press the [HYS] function field. This opens the screen display of the hysteroscopy indication. 3.
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OBJ_DOKU-0000006143-008.fm Seite 74 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication 10.13.1 Setting the Nominal Flow Level LO Set nominal flow level LO Menu Flow level LO en 100 ml/min 3. 3. 4. 6. 5. 1. In the user menu, press the [HYS settings] function field. This opens the hysteroscopy user menu. 2. Press the [Flow level LO] function field. The nominal flow level LO can be set in a range of 50-200 ml/min. 3.
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OBJ_DOKU-0000006143-008.fm Seite 75 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication Hysteroscopy device parame- Hysteroscopy factory settings ters Nominal pressure 45 mmHg Flow level LO 100 ml/min Flow level HI 300 ml/min Deficit threshold en 2000 ml Table 10-2 1. Press the [Factory settings] function field to reset the HYS device parameters to the factory settings. Reset to factory settings Menu HYS settings Flow level LO Flow level HI Deficit threshold 1.
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OBJ_DOKU-0000006143-008.fm Seite 76 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication Differential volume > threshold value If the differential (deficit) volume exceeds the set threshold value, a short warning beep is emitted 3 times and the screen depicts the following: Deficit exceeded!. Every additional 100 ml the value exceeds the threshold value is indicated with the same warning signal.
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OBJ_DOKU-0000006143-008.fm Seite 77 Mittwoch, 11. November 2020 2:29 14 Using the Hysteroscopy Indication CAUTION! The message "Critical Overpressure!" overwrites all other possible messages. Overpressure warnings serve as information for the attending physician to respond appropriately to the existing excess pressure. The intrauterine pressure can be reduced by opening the outflow cannula, for example. If possible, the attending physician should perform this task.
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OBJ_DOKU-0000006143-008.fm Seite 78 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11 Intended use: Urology en Using the Urology Indication The devices PG130/PG145 may be used for the distention and/or irrigation of the lower and upper urinary tract, fluid aspiration and monitoring of fluid deficit during diagnostic and surgical procedures. The optional suction function can be used to siphon off secretions.
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OBJ_DOKU-0000006143-008.fm Seite 79 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11.1 Device-inherent Dangers: Urology Indication WARNING! Instrument replacement Stop the device using the START/STOP switch if replacing the instrument during surgery. en WARNING! Fluid volume/sodium concentration The fluid left in the patient and the concentration of sodium in the blood serum must both be monitored. The deficit amount is the entire amount of fluid lost by or to the system.
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OBJ_DOKU-0000006143-008.fm Seite 80 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication tor the input and outflow of the distending liquid at all times. WARNING! Fluid Overload There is a risk of irrigation fluid reaching the circulatory system of the patient's soft tissue. This can be affected by distention pressure, flow rate, perforation of the distended body cavity and duration of the endoscopic surgery.
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OBJ_DOKU-0000006143-008.fm Seite 81 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11.3 Screen Displays of the Urology Indication (1) (2) Fig. 11-1 Screen displays of the urology indication (3) URO (4) ACTUAL PRESSURE (15) 0 50 100 2 150 45 mmHg (14) 0.3 l/min SET PRESSURE (13) 0 SET FLOW (5) Start pump START (12) 11.
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OBJ_DOKU-0000006143-008.fm Seite 82 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11.5 Switching device on without standard tube set en Device check Switching Device on When Using Standard Tube Set 1. Make sure no tube set is inserted into the tube retainer before switching the device on. 2. Press the ON switch. The device turns on. The touchscreen displays the following in succession: Company logo/Device check/Device OK 3.
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OBJ_DOKU-0000006143-008.fm Seite 83 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication the values in increments of 10 mmHg. The nominal pressure can also be reduced with the help of the remote control (see Chapter 6.13 "Using the Remote Control (Optional)"). URO ACTUAL PRESSURE 0 50 100 150 45 mmHg 0.3 l/min SET PRESSURE en SET FLOW Start pump START 11.7 Preselecting the Nominal Flow CAUTION! The nominal pressure cannot be reached if the nominal flow is set too low.
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OBJ_DOKU-0000006143-008.fm Seite 84 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication URO ACTUAL PRESSURE 0 50 100 150 45 mmHg en 0.3 l/min SET PRESSURE SET FLOW Start pump START pressure display shows the current measured value. The roller wheel starts to turn and the device begins to run the instrument detection function. The [START] function field can also be controlled with the help of the remote control (see Chapter 6.13 "Using the Remote Control (Optional)"). 6.
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OBJ_DOKU-0000006143-008.fm Seite 85 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11.12 Opening and Configuring the User Menu for the Urology Indication Device parameters are displayed and changed in the [URO settings] menu. The following chart provides an overview over the possible settings. User menu overview en 1. Switch device on. 2. Press the [URO] function field. This opens the screen display of the urology indication. 3. Press the [User menu] symbol (see Fig.
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OBJ_DOKU-0000006143-008.fm Seite 86 Mittwoch, 11. November 2020 2:29 14 Using the Urology Indication 11.13.2 Exceeding Nominal Pressures When Using Standard Tube Set Overpressures may occur during device operation. The device features corresponding safety mechanisms that support the physician performing the surgery in deciding on appropriate responses.
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OBJ_DOKU-0000006143-008.fm Seite 87 Mittwoch, 11. November 2020 2:29 14 User Menu 12 User Menu The following is possible in the user menu: • • • • Change the general device parameters Change the indication-specific parameters Activate new indicators Call the service menu (only for authorized service personnel!) en The following chart provides an overview over the possible settings. 12.
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OBJ_DOKU-0000006143-008.fm Seite 88 Mittwoch, 11. November 2020 2:29 14 User Menu 12.2 Open General settings menu en LAP ARTHRO HYS URO General Settings 1. Switch device on. 2. Press the function field of an indication (e.g., [HYS]). This opens the screen display of the indication. If you have selected the indication ARTHRO, then press one of the displayed function fields (e.g., [Knee]) to then access the arthroscopy screen display. 2. 3. Press the [User menu] symbol. The user menu opens.
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OBJ_DOKU-0000006143-008.fm Seite 89 Mittwoch, 11. November 2020 2:29 14 User Menu Setting the Bag Volume 1. In the user menu, press the [Fluid bags] function field. 2. In the user menu, press the [Volume] function field. 3. Press the [+] or [-] symbol to set the volume of the irrigation fluid bags to a value between 1 and 10 l. You can now do the following: 4. Press [Save] to save the setting. After saving, the previous menu level is automatically opened. 5.
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OBJ_DOKU-0000006143-008.fm Seite 90 Mittwoch, 11. November 2020 2:29 14 User Menu 12.2.4 Setting the (Display) Brightness Setting the brightness Menu Brightness en 20 % 2. 2. 3. 5. 4. 1. In the user menu, press the [Brightness] function field. 2. Press the [+] symbol or [-] symbol to set the desired brightness to a value between 20 and 100 %. Pressing the [+] or [-] symbol longer than 1.5 seconds activates scrolling of the values in increments of 10 %. You can now do the following: 3.
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OBJ_DOKU-0000006143-008.fm Seite 91 Mittwoch, 11. November 2020 2:29 14 User Menu 3. Press the [User menu] symbol. The user menu opens. HYS HYS 100 INFLOW VOLUME ACTUAL PRESSURE DEFICIT [ml] 1.0 52 % 0 50 100 150 0 80 45 mmHg mmHg SET PRESSURE 0 100 ml/min LO SET FLOW en HI Start pump START STOP 00STOP 3. 4. Press the [Service] function field. Menu General settings HYS settings Service 4. 5.
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OBJ_DOKU-0000006143-008.fm Seite 92 Mittwoch, 11. November 2020 2:29 14 Safety Functions 13 Safety Functions The electronic components continuously monitor the proper function of the device. Device malfunctions are indicated with audible warning signals (beeps), error messages, and/or by blocking device functions. A table listing a summery of possible error and warning messages is provided in Chapter 18 "Error and Warning Messages". en 13.
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OBJ_DOKU-0000006143-008.fm Seite 93 Mittwoch, 11. November 2020 2:29 14 Functional Test 14 Functional Test WARNING! Functional test The functional test must be performed prior to each surgery. en WARNING! Checking the warning signals The warning signals must be checked prior to each operation. The system is to be set up so that all warning signals can be perceived. WARNING! Sterilize the reusable instruments and tubes before surgery to prevent infections.
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OBJ_DOKU-0000006143-008.fm Seite 94 Mittwoch, 11. November 2020 2:29 14 Functional Test  Open the tube clamp and the inflow valve.  Press the [START] function field.  The roller wheel starts to turn. Wait until tube set and instrument are completely filled with water.  Press the [STOP] function field. The roller wheel stops. en Check user menu  Check the settings in the user menu (see Chapter 12.2 "General Settings"). 14.2 Performing the Device Function Test (Only for Laparoscopy Indication) 1.
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OBJ_DOKU-0000006143-008.fm Seite 95 Mittwoch, 11. November 2020 2:29 14 Functional Test "Aesculap Technical Service"). 7. Exit the user menu by pressing [Exit]. 8. Remove weight from scale. The function test of the scale is successfully completed when the permissible tolerance of < 100 g is maintained. 14.6 en Function Control of Foot Pedal (Only for Indication Arthroscopy) 1. A foot pedal is connected to the switched-on device. 2. Press the foot pedal to test the functions described in Chapter 6.
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OBJ_DOKU-0000006143-008.fm Seite 96 Mittwoch, 11. November 2020 2:29 14 Care and Maintenance 15 Care and Maintenance Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories. 15.1 en Cleaning the Device 1. Use the ON/OFF button to turn the device off. 2. Remove the power cable. 3.
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OBJ_DOKU-0000006143-008.fm Seite 97 Mittwoch, 11. November 2020 2:29 14 Care and Maintenance 15.4 Aesculap Technical Service Technical service address Aesculap Technical Service Am Aesculap-Platz 78532 Tuttlingen/Germany en Phone: +49 7461 95-1601 Fax: +49 7461 14-939 Email: ats@aesculap.de Please contact the address above for additional service addresses. 15.5 Replacing the Fuse CAUTION! Before replacing the fuse, check the values of the fuse to be inserted acc. to Chapter 19 Technical Data.
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OBJ_DOKU-0000006143-008.fm Seite 98 Mittwoch, 11. November 2020 2:29 14 Care and Maintenance 5. 6. 7. 8. A Undo the latch of the fuse holder with a small screwdriver. B Remove the fuse holder. C Check fuses. Insert a new fuse. Use only the specified type of fuse (see Chapter 19 Technical Data). 9. Insert the fuse holder until it can be heard snapping into place. 10. Use the power cable to reconnect the shockproof safety socket with the rear mains socket. en 15.6 Cleaning the Accessories 1.
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OBJ_DOKU-0000006143-008.fm Seite 99 Mittwoch, 11. November 2020 2:29 14 Care and Maintenance No special requirements. Storage and transport It is recommended to recondition the tube set as soon as possible after use. 15.8 Cleaning the Reusable Tube Set Dismantle the tube set into its individual parts. Preparing for cleaning en It is recommended to recondition the tube set as soon as possible after use. Machine cleaning and disinfecting with the Miele disinfector.
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OBJ_DOKU-0000006143-008.fm Seite 100 Mittwoch, 11. November 2020 2:29 14 Annual Inspection 16 en Annual Inspection Manufacturer's instructions The manufacturer stipulates that a specialist or a hospital technician must regularly inspect the device and its accessories with regard to function and safety. These inspections have to be carried out on an annual basis. Regular inspections will assist in early detection of possible malfunctions.
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OBJ_DOKU-0000006143-008.fm Seite 101 Mittwoch, 11. November 2020 2:29 14 Annual Inspection Fig. 16-1 Setup of basic function test en h=x cm ! The layout of the test and its setup are depicted in Fig. 16-1 "Setup of basic function test". 1. Switch device on. Wait until the device check has finished. 2. Select one of the possible indications. If you have selected the Arthroscopy indication, then press the [Knee] function field. 3. Insert a disposable tube set into the tube retainer. 4.
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OBJ_DOKU-0000006143-008.fm Seite 102 Mittwoch, 11. November 2020 2:29 14 Annual Inspection of fluid. Laparoscopy indication After 1 minute, press the [STOP] function field and the stop key of the stopwatch at the same time. The measuring cup then contains approx. 1 l (±10 %) of fluid. en The basic function test has been successfully completed once these values have been reached. 16.3 Pressure Measuring Test The layout of the test and its setup are depicted in Fig.
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OBJ_DOKU-0000006143-008.fm Seite 103 Mittwoch, 11. November 2020 2:29 14 Annual Inspection sensor. 9. The actual pressure display should depict approx. 5 mmHg. 10. Hold the instrument tube at a level of approx. 67.5 cm above the roller wheel. Make sure the tube segment between this point and the cartridge is completely filled with fluid. Also make sure that no point of the tube is higher than the indicated value. 11.
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OBJ_DOKU-0000006143-008.fm Seite 104 Mittwoch, 11. November 2020 2:29 14 Electromagnetic Compatibility 17 Precautionary measures Electromagnetic Compatibility Medical devices are subject to special safety and protective measures concerning electromagnetic compatibility (hereafter abbreviated as EMC). This device is to be used only for the purposes described in the manual and has to be installed, set up, and operated in compliance with the EMC notes and instructions.
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OBJ_DOKU-0000006143-008.fm Seite 105 Mittwoch, 11. November 2020 2:29 14 Electromagnetic Compatibility 17.3 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity The PG130/PG145 is intended for use in an electromagnetic environment as described below. The user/operator of the PG130/PG145 must make sure the device is operated within such an environment.
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OBJ_DOKU-0000006143-008.fm Seite 106 Mittwoch, 11. November 2020 2:29 14 Electromagnetic Compatibility 17.4 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity The device PG130/PG145 is intended for operation in an electromagnetic environment as described below. The user of the device PG130/PG145 should make sure the device is operated within such an environment.
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OBJ_DOKU-0000006143-008.fm Seite 107 Mittwoch, 11. November 2020 2:29 14 Electromagnetic Compatibility IMMUNITY TESTS Transients HF IEC 61000-4-3 Test frequency (MHz) Band (MHz) Service Modulation Max. power (W) Distance (m) IMMUNITY TEST LEVEL (V/m) 385 380-390 TETRA 400 Pulse modulation 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 2 0.3 28 2 0.3 28 0.2 0.
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OBJ_DOKU-0000006143-008.fm Seite 108 Mittwoch, 11. November 2020 2:29 14 Electromagnetic Compatibility 17.5 Recommended safety distances between portable and mobile HF telecommunications devices and the PG130/PG145 The PG130/PG145 is intended for use in an electromagnetic environment where HF interferences are controlled.
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OBJ_DOKU-0000006143-008.fm Seite 109 Mittwoch, 11. November 2020 2:29 14 Error and Warning Messages 18 Error and Warning Messages Error and warning messages are indicated by the device acoustically and visually. The visual indication is usually a message in the status line of the touchscreen or a full screen display. Acoustic messages are usually warning signals emitted a certain number of times (beeps). en NOTE! Each warning signal is to be assigned one of the corresponding priorities.
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OBJ_DOKU-0000006143-008.fm Seite 111 Mittwoch, 11. November 2020 2:29 14 Technical Data 19 Technical Data Type designation: PG130/PG145 Production date: AESCULAP AG Am Aesculap-Platz en D-78532 Tuttlingen Germany Software version: See instructions for use to determine software version (Chapter 12.3.1 "Software Version"). Mains voltage range: 100-240 V~ Supply frequency range: 50/60 Hz Fuse designation: 2 x T 3,15 AH, 250 V, UL-recognized, slow blow Internal voltage supply: No Max.
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OBJ_DOKU-0000006143-008.fm Seite 112 Mittwoch, 11. November 2020 2:29 14 Technical Data Adjustable values/ranges Nominal flow range: Arthroscopy: 0.1-2.5 l/min (max. flow) Hysteroscopy: 50-500 ml/min (max. flow) Urology: 25-500 ml/min (max. flow) Laparoscopy: 1.0-3.5 l/min (max. flow) en Suction power: Max. 2.
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OBJ_DOKU-0000006143-008.fm Seite 113 Mittwoch, 11. November 2020 2:29 14 Technical Data Essential Performance Hysteroscopy: Pressure build-up in the body cavity, control and measurement, limit value: max. 150 mmHg (normal state) First error: 200 mmHg for max. 5 seconds Urology: Pressure build-up in the body cavity, control and measurement, limit value: max. 90 mmHg (normal state) en First error: 100 mmHg for max.
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OBJ_DOKU-0000006143-008.fm Seite 114 Mittwoch, 11. November 2020 2:29 14 Article/Accessory List PG130/PG145 20 en Article/Accessory List PG130/PG145 Item No. Description PG130 Multi Flow Without vacuum pump PG145 Multi Flow plus With vacuum pump Table 1: Tube sets Article No.
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OBJ_DOKU-0000006143-008.fm Seite 115 Mittwoch, 11. November 2020 2:29 14 Appendix 21 Appendix 21.
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OBJ_DOKU-0000006143-008.fm Seite 116 Mittwoch, 11. November 2020 2:29 14 Appendix 21.2 en Service and Checklist Date of service: Device type: Serial number: Location of use: Software version: Tester: Company: I: Safety test Mechanical condition Front panel and case: Boards: Cleanness: Mains fuse: Cabling: Labels/identifications: II. Function test (see service manual) III.
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OBJ_DOKU-0000006143-008.fm Seite 117 Mittwoch, 11. November 2020 2:29 14 Glossary 22 Glossary Term Explanation Transponder A RFID transponder is a wireless communication and monitoring device that receives and automatically responds to signals. The term transponder is a mixture of "transmitter" and "responder." Transponders can be active or passive.
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OBJ_DOKU-0000006143-008.fm Seite 118 Mittwoch, 11. November 2020 2:29 14 Glossary Term Explanation Safety test The device safety test is part of the annual inspection. Basic function test The basic function test checks the fundamental operation of the device and is part of the annual inspection.
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