WOM LAP-Pump Model PP110 Irrigation and Suction Instructions for Use April 2019

Symbols/Bildzeichen/Symboles/Symbolen/Символ

Description

Beschreibung

Description

Beschrijving

Описание

Authorized for Sale or use by Physician only

Nur für authorisiertes Vertriebspersonal oder Arzt

Autorisé seulement pour la vente par un personnel autorisé ou l’utilisation par un médecin

Uitsluitend voor bevoegd personeel of arts

Только для врача или авторизованного персонала

Consult instructions for use

Gebrauchsanweisung beachten

Respecter les instructions d’utilisation

Gebruiksaanwijzing opvolgen

Соблюдать инструкцию по применению

en

de

fr Follow instructions for use (white image on a blue background)

Gebrauchsanweisung befolgen (weißes Bild auf blauem Grund)

Respecter le mode d’emploi (image blanche sur fond bleu)

Gebruiksaanwijzing opvolgen (witte afbeelding op blauwe ondergrond)

Соблюдать инструкцию по применению (белое изображение на синем фоне)

Caution

Vorsicht; Achtung

Prudence; Attention

Voorzichtig; Let op

Осторожно; внимание

Type BF applied part

Gerät des Typs BF

Symbole pour un appareil type BF

Apparaat van het type BF

Прибор типа BF

Degrees of protection provided by enclosures (IP-Code)

Gehäuseschutzklasse (IP-Code)

Degrés de protection procurés par les enveloppes (Code IP)

Beschermingsklasse (IPcode) behuizing

Класс защиты корпуса (IP-код)

Equipotentiality

Potentialausgleich

Connexion équipotentielle

Potentiaalvereffening

Выравнивание потенциалов

Alternating current

Wechselstrom

Courant alternatif

Wisselstroom

Переменный ток

Service

Service

Service

Service

Сервис

Catalogue number

Artikelnummer

Numéro d’article

Artikelnummer

Артикул

Do not reuse

Nicht wiederverwenden

Ne pas réutiliser

Niet voor hergebruik

Не для повторного применения

Do not resterilize

Nicht resterilisieren

Ne pas restériliser

Niet opnieuw steriliseren

Не стерилизовать

Contains DEHP

Enthält DEHP

Contient du phtalate de diéthylhexyle (DEHP)

Bevat DEHP

Содержит DEHP

Not made with phthalates

Enthält keine Phthalate

Ne contient pas de phtalate

Bevat geen ftalaten

Не содержит фталатов

Sterilized using ethylene oxide

Sterilisiert mit Ethylenoxid

Stérilisé à l’oxyde d’éthylène

Gesteriliseerd met ethyleenoxide

Стерилизовано этиленоксидом

Batch code

Chargencode

Codes de lot

Chargecode

Код партии

nl

ru

Table of Contents 1

Important User Notes ... 3

2

Safety Information... 4

3

General Information ... 5 3.1 Device Description ... 5 3.2 Intended Use and Contraindications ... 5 3.2.1 Intended Use... 5 3.2.2 Contraindications ... 5 3.3 General Warnings and Precautions ... 5 3.3.1 General Warnings ... 5 3.3.2 Precautions... 9

4

Initial Device Startup ... 11 4.1 Scope of Delivery ... 11 4.2 Setting up and Connecting the Device... 12 4.2.1 Mounting on Stand... 14 4.2.2 Positioning in Device Rack ... 15 4.3 Switching Device Off ... 15

5

Operating the Device ... 16 5.1 Device Front ... 16 5.2 Device rear... 16 5.3 Overview of Usable Tube Sets ... 17 5.4 Using the Tube Sets ... 18 5.5 Irrigation Tube Set Connection... 19 5.6 Inserting the Suction/Irrigation Set... 21 5.7 Inserting a Day Patient Tube Set (NOT FOR SALE IN USA AND CHINA)... 22 5.7.1 Replacing the Patient Tube after Surgery... 25 5.8 Connecting the Fluid Bags ... 26 5.9 Irrigation ... 26 5.10 Suction... 27 5.11 Replacing the Suction Container ... 28 5.12 Removing a Vacuum Tube... 28

6

Safety Functions... 29 6.1 Pressure Limitation at 450 mmHg ... 29 6.2 Motor Cutout at 600 mmHg ... 29 6.3 Device Self-Test ... 29

7

Functional Test ... 30 7.1 Preparing the Function Test ... 30 7.2 Irrigation Test ... 30 7.3 Suction Test... 31

8

Using the Device during Surgery ... 32

9

Care and Maintenance... 33 9.1 Cleaning the Device... 33 9.2 Maintenance Intervals... 33 9.3 Maintenance by Authorized Service Technician... 33 9.4 Replacing the Fuse ... 34 9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA) ... 35 9.5.1 General Notes... 35 9.5.2 Reprocessing ... 37

10

Annual Inspection ... 43 10.1 Electrical Safety Test ... 43 10.2 Irrigation Test ... 44 10.3 Suction Test... 44

11

Technical Data ... 45

12

Accessory list... 47

13

Electromagnetic Compatibility... 48 13.1 Electrical Connections... 48 13.2 Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions ... 49 13.3 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity ... 50

14

Error and Warning Messages... 52

15

Test Log... 54 15.1 Test Log... 54 15.2 Return Form ... 55

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Index... 56

1

Important User Notes 1

Important User Notes

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Read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing staff or service personnel, or • to damage or malfunction of device and/or accessories. The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of its products.

Subject to technical changes

The words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be given special attention.

Please note

WARNING! The safety and/or health of the patient, user, or a third party are at risk. Comply with this warning to avoid injury to the patient, user, or third party.

CAUTION! These paragraphs include information provided to the operator concerning the intended and proper use of the device or accessories.

NOTE! These paragraphs contain information to clarify the instructions or provide additional useful information.

3

Safety Information

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2

Safety Information

Federal Law (only for U.S. market)

CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

Exclusion of liability

The manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if: • the device and/or the accessories are improperly used, prepared, or maintained; • the instructions and rules in the instructions for use are not adhered to; • unauthorized persons perform repairs, adjustments, or alterations on the device or accessories; • unauthorized persons open the device; • the prescribed inspection and maintenance schedule is not adhered to. The handing over of technical documents does not constitute authorization to make repairs or alterations to the device or accessories. WARNING: Modifying the PP110 is not permitted.

Authorized service technician

Only authorized service technicians are permitted to repair, change settings, or modify the device or associated accessories and equipment. Any violation will void the manufacturer's warranty. Authorized service technicians are only trained and certified by the manufacturer.

Care and maintenance

The service and maintenance of the device and its accessories has to be carried out as per instructions to ensure the safe operation of the device. For the protection of the patient and the operating team, check that the device is complete and functional before each use. NOTE: Service or maintenance work may not be carried out during surgery.

Contamination

Before shipping, decontaminate device and accessories in order to protect the service personnel. Follow the instructions listed in this manual. If this is not possible, • the product must be clearly marked with a contamination warning and • is to be double-sealed in safety foil. The manufacturer has the right to reject contaminated products for repair.

Waste management This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. For disposal of the device and its accessories, please consult the manufacturer or an authorized disposal company, in compliance with legal or national regulations.

4

General Information 3

General Information

3.1

Device Description

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The device PP110 is a pump providing an irrigation and suction function for laparoscopy. The device itself is non-invasive and designed for use in multi-unit racks (nonsterile area). It pumps medical sterile irrigation fluid through a sterile tube. This flushes the corresponding fluids into the body cavity. The device can be used with electrolyte-free media (such as glycine 1.5 % or sorbitol 3.0 %) and with isotonic electrolyte-containing media (such as saline 0.9 % or Ringer's Lactate solution). The device is equipped with a vacuum suction function used to suction off secreted fluids. The secretion liquid is sucked through a tube into the container. The device functions only with the tube sets described in the accessory list (see chapter 12 "Accessory list").

3.2

Intended Use and Contraindications

3.2.1

Intended Use

WARNING! To be used only with appropriate training The device may only be used by surgeons or operating room personnel with the necessary training in the corresponding indication. The device PP110 is a suction and irrigation pump intended for use during diagnostic and/or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

3.2.2

Intended use

Contraindications

Do not use this device PP110 for procedures where a specific pressure has to be preset and reached such as a hysteroscopy or an arthroscopy.

3.3

General Warnings and Precautions

3.3.1

General Warnings

Contraindications

WARNING! Technique and procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.

WARNING! Original accessories For your own safety and that of your patient, use only original accessories.

WARNING! Not explosion-proof The device is not explosion-proof. Do not operate the device in the vicinity of explosive anesthetic gases and not in the vicinity of oxygen-enriched environments.

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General Information WARNING! Falls and crashes Place the device on a stable and level surface. Cables must be laid safely. Tubes between the device and the patient must not create any obstruction.

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WARNING! Device defect Do not use this device if a defect is suspected or detected during the function check. This also applies to obvious defects, especially defects and damage of the power plug and power cable.

WARNING! Risk of electrical shock To avoid the risk of electrical shock, only use this device when connected to a properly grounded power supply network.

WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicing to qualified service personnel.

WARNING! Function test The function test must be performed prior to each device use.

WARNING! Sterile media and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated.

WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating see Chapter 12 "Accessory list".

WARNING! Unplug the power cable from the device before checking the fuse.

WARNING! Maintenance and calibration Do not open the device. The device may not be opened or calibrated by the user. Only authorized service technicians are permitted to repair, calibrate, or modify the device or its equipment.

6

General Information WARNING! Condensation / Water penetration Protect device from moisture. Do not use if moisture has penetrated the device.

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WARNING! The device is only intended for use with flexible fluid bags. Do not use glass containers as they might break. Fluid cannot flow quickly enough due to the vacuum being generated inside of the bottle. Risk of implosion.

WARNING! Keep full fluid bags ready for use Always keep a full fluid bag on hand to replace an empty one. This avoids having to interrupt surgery due to a lack of irrigation fluid.

WARNING! Contamination Do not use device or vacuum tube if signs of contamination are detected. Fluid that has penetrated can be detected, for example, by dirt encrustations on the connections for the suction or at the exit of the vacuum pump. Make sure the device or/and accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

WARNING! Different default settings of the warning message for identical or similar devices in the operating room may cause a risk due to conflicting acoustic signals.

WARNING! Preventing infections Sterilize reusable instruments before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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.

WARNING! ME System (Medical Electrical System) Use only parts and/or devices from ME systems (see chapter 13 Electromagnetic Compatibility) in patient environments in compliance with the standard IEC60601-1 in the respective currently valid version.

WARNING! Make sure the tubes for the suction-irrigation instrument do not have any kinks when installed. Make sure the tubes are not crimped or clamped off.

7

General Information WARNING! Filter The vacuum tube with integrated filter is designed for max. 30 days. Replace the vacuum tube if it is obviously contaminated. The filter prevents that body fluids enter the interior of the device. Please note that the filter may reduce the suction capacity.

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WARNING! The vacuum tube sets for this device contain diethylhexylphthalate (DEHP), which is classified as toxic to reproduction according to the EU Directive 1272/ 2008/EEC on Classification, Labeling and Packaging of Dangerous Substances. DEHP may impair fertility and may cause harm to the unborn child. Therefore, this product must not be used for unauthorized applications. When applied within the intended use, the potential risk to pregnant or breastfeeding women as well as to children resulting from the DEHP contained in this product is not critical.

WARNING! Cleaning of reusable tube set The reusable tube set (NOT FOR SALE IN USA) is made of silicone, polysulfone (PSU), and stainless steel. For cleaning and disinfection, use only pH-neutral or slightly alkaline cleaning agents (e.g. neodisher MediClean 2.0 %), disinfectants (e.g. Lysetol V 8 %), and drying and rinsing agents approved for the tube set materials. Using unsuitable agents (e.g. neodisher MediKlar rinsing agent) may damage the tube system and especially the PSU connectors.

WARNING! Remove the membrane before cleaning.

WARNING! Please check the reusable tube (NOT FOR SALE IN THE USA) for any signs of damage after sterilization and before use. Never use a tube showing signs of damage, especially brittleness and perforation.

WARNING! Make sure to connect tubes as indicated by the matching connectors.

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.

WARNING! Do not touch Avoid touching the roller wheel. Risk of injury!

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General Information WARNING! Do not touch patient and the ON/OFF switch at the same time.

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WARNING! The fluid bags must not be stored on the device or hung up directly above the device.

WARNING! Replacement device and accessories In case the device or any of the accessories fail during surgery, a replacement device and replacement accessories should be kept within close proximity to be able to finish the operation with the replacement components.

3.3.2

Precautions

CAUTION! Cleaning the device Do not sterilize the device.

CAUTION! Endoscope The device may only be connected with endoscopes designed for and featuring the technical specification permitting such a combined use. Any utilized endoscopes must comply with the most recent versions of IEC 60601-2-18 and ISO 8600. Combining/connecting with other devices generates a medical electrical system (MES). The system configurator is responsible for compliance with the standard IEC 60601-1 / EN 60601-1 in its latest version.

CAUTION! Electrical Interference (See chapter 13 "Electromagnetic Compatibility"). Care was taken during the development and testing of this device that electrical interference from this device or other devices or instruments was practically eliminated. However, if you still detect or suspect such interference, please follow these suggestions: • Move this, the other or both devices to a different location • Increase distance between used devices • Consult an electro-medical expert

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 13 "Electromagnetic Compatibility") as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.

9

General Information CAUTION! Ventilation of the device • Avoid device overheating. • Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm).

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CAUTION! Incorrect voltage Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device.

CAUTION! Indoor climate Before switching on the device, sufficient time must have passed to adjust to the indoor climate.

CAUTION! Power cables Any power cables employed by the user that are not provided by the manufacturer must meet the safety requirements of the national standards in the respective current valid version.

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Initial Device Startup 4

Initial Device Startup

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WARNING! The product may be used only by doctors or health care professional in accordance with the intended use. Personnel must have training that qualifies them to operate laparoscopy pumps. In addition, personnel must read the instruction for use and operating instructions and become familiar with handling the device before first use. Personnel must have mastered handling and operation of the product before first use during a surgery. These instruction for use does not include descriptions or instructions for surgical procedures/techniques. It is also not intended to introduce to or train physicians in the use of surgical techniques.

4.1

Scope of Delivery

• Device PP110 • Instructions for Use • Power cord WARNING! Check for defects Check the product and the packaging for defects prior to use. Do not use if package is damaged.

CAUTION! Premature unpacking Do not premature unpack the devices, sufficient time must have passed to adapt to the room climate. Always check all parts and accessories of the device immediately after receiving the shipment. The manufacturer considers only replacement claims that have been immediately submitted or reported to a sales representative or an authorized service company.

Delivery inspection

If it becomes necessary to return the device, always use the original packaging. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging.

Returning the device

Please fill out the return form enclosed at the end of the instructions. Enclose the manual with the device. Please make sure that all required information has been supplied: • Name of owner • Address of owner • Device type and model • Serial number (see identification plate) • Description of defect

11

Initial Device Startup 4.2

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Setting up and Connecting the Device

WARNING! Always hold on to the power plug when disconnecting the device from the power supply. Never pull on the cable itself.

NOTE! Locations The device may be used only in the hospital or operating rooms. Setting up

Place the device on a flat surface free of vibration located in a dry environment. The ambient temperature and humidity must meet the requirements mentioned in chapter 11 "Technical Data" . CAUTION! ME systems (Medical Electrical System) The medical electrical device is suitable for integration in ME equipment systems (see chapter 13 "Electromagnetic Compatibility"). Operation of the ME device in vicinity of non-ME devices may result in voiding the intended use of the ME device.

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! Device Setup • Equipment should be positioned such that power cord can be easily disconnected. • Position the device in such a way that it is easy to use and switch off and on. • Place the device outside the sterile area.

CAUTION! Ventilation of the device • Avoid device overheating. • Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm).

CAUTION! Before switching on the device, sufficient time must have passed to adjust to the indoor climate.

12

Initial Device Startup CAUTION! Position of the user To avoid a malfunction, the user must be positioned correctly • within a display viewing angle of ±50° to operate the device • up to 2 m/6.5 ft from the device front for monitoring the actual values

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CAUTION! Disconnection from the power supply is only guaranteed if the mains plug is pulled from the mains wall socket. Mains connection CAUTION! Mains connection • Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device. • Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The mains connection cable may be plugged only into a properly installed, grounded safety wall socket (shockproof socket) (see DIN VDE 0100-710). • Read the device label located in rear of device (type plate) to determine the operating voltage of the device. The power connection must be equipped with a grounding contact. Use the original power cable (if included in scope of delivery) to establish a connection between the mains wall socket and the non-heating device plug located in the rear of the device.

Grounding contact

Only use a certified (UL-listed), removable mains connection cable, type SJT, minimal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 and IEC 60320-C13. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.

Only for U.S. operators

Integrate the device into the potential equalization system as specified by local safety rules and regulations.

Potential equalization

13

Initial Device Startup 4.2.1

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Mounting on Stand

Mounting on Stand

WARNING! Please read the instruction manual for the stand before mounting the pump on the stand.

WARNING! The position of the device on the stand can affect the stand's stability. If the device is mounted too high on the stand, the stand may tilt or topple. The user/operator of the device is responsible for making sure the device cannot be tipped over or otherwise become unstable. 1. Position the pump on the rod of the stand at the desired height, usually between 80 and 120 cm (example: Base of stand ø = 65 cm, max. height of h < 100 cm recommended). 2. Tighten the toggle screw on the rear of the pump. NOTE! Make sure the toggle screw is tightened sufficiently to fasten the pump securely in place. Also check that the toggle screw remains tightened.

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Initial Device Startup 4.2.2

Positioning in Device Rack

4.3

Switching Device Off

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Ending operation of the pump safely: 1. Press the ON/OFF switch (see Fig. 5-1 "Device front" (11)) 2. Disconnect device from power supply. For this, pull the mains plug from the mains socket (see Fig. 5-2 "Device rear" (17)).

15

Operating the Device

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5

Operating the Device

5.1

Device Front

Familiarize yourself with the control and function elements at the device front.

Fig. 5-1

Device front

(1)

Irrigation START/STOP key

(2)

Irrigation status LED

(3)

Suction START/STOP key

(4)

Suction status LED

(5)

Roller wheel

(6)

Tube retainer

(7)

Irrigation pressure sensor

(8)

LED tube status red

(9)

LED tube status green

(10)

Connection for hygiene filter and vacuum tube

(11)

ON/OFF power switch

(12)

Power switch status LED

(13)

Power LED

(6)

(5)

(1)(2) (3) (4)

(13)

(12) (11)

5.2

(10) (9) (8)

(7)

Device Rear

Familiarize yourself with the connection elements at the device rear.

Fig. 5-2

Device rear

(14)

Service interface

(15)

Non-heating device plug

(16)

Fuse holder(s)

(17)

Metal edge

(18)

Pole mount

(19)

Screw

(20)

Vacuum output

(14)

(15) (16) (17)

(20)

16

(19)

(18)

Operating the Device 5.3

Overview of Usable Tube Sets

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The following table lists the function of each type of tube set depending on the selected indication.

Tube type

Art. No.

Tube category

Disposable (one-time use) (NOT FOR SALE IN USA AND CHINA)

T0500-01

Irrigation day patient tube set

Disposable (one-time use) (NOT FOR SALE IN USA AND CHINA)

T0501-01

Irrigation day tube

Disposable (one-time use)

T0502-01

Suction tube set (1 connection)

Can be used 30 days

T0504-01

Vacuum tube set, incl. filter

Disposable (one-time use)

T0505-01

Irrigation tube set

T0506-01

Irrigation tube set

Reusable (NOT FOR SALE IN USA) Table 5-1

WARNING! This product contains phthalates! Animal experiments have shown that phthalates are potentially endangering reproduction. Based on the latest findings in science, in the case of prolonged exposure, risks for male babies and children cannot be excluded. On and in pregnant women, nursing mothers, babies, and children, medical products containing phthalates should only be used for a short time. (DEHP) Diethylphthalate

WARNING! Preventing infections Sterilize reusable instruments before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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.

CAUTION! The pressure chamber diaphragm is fragile and can be replaced if damaged. Replacement diaphragms are supplied with reusable tubes. The reusable tube sets must be prepared before each use. See chapter 9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA) for further instructions.

NOTE! Tubes must be stored at room temperature. The shelf life for all tubes is 5 years.

NOTE! Observe applicable hygiene regulations when disposing of the tube set.

17

Operating the Device

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5.4

Using the Tube Sets

RFID technology (transponder technology)

Transponder technology detects the tube type, the validity and reliability of a tube set automatically. This eliminates virtually all "operating errors" since non fitting, invalid, and not approved tube sets are reliably detected. In any approved tube set (see chapter 12 "Accessory list"), the corresponding transponder is located under the tube holder.

Invalidating a tube set

If an approved tube set is located in the device, the transponder technology automatically invalidates this tube set when the device is started. The tube status LED lights up green. Depending on the tube set, this has the following consequences: • Single-use tube set: After inserting the tube set and starting the irrigation cycle, the tube set is invalidated after 10 minutes. If the irrigation cycle is stopped, the device can be restarted within 30 minutes. If the device is switched off or in case of a power failure, the tube set is invalidated. The irrigation cycle can no longer be started. The tube status LED lights up red. If this is the case, you must insert a new, valid, and approved tube set. • Reusable tube set (NOT FOR SALE IN USA): The reusable tube set can be used about 20 times. After inserting the tube set and starting the irrigation cycle, the tube set is invalidated after 10 minutes. If irrigation is stopped during a use cycle, it can be restarted within 30 minutes without the set being invalidated. If the device is switched off or in case of a power failure, the current use cycle is invalidated. If an invalid reusable tube set has been inserted, a warning signal (beep) is emitted. A red LED will be displayed for 8 seconds. • Day patient tube set also day tube set (NOT FOR SALE IN USA AND CHINA): The following description refers only to the day tube (for the patient tube, please see chapter 5.7 Inserting a Day Patient Tube Set (NOT FOR SALE IN USA AND CHINA)). The reusable day tube set can be used for a total of 10 times. After inserting the tube set and starting the irrigation cycle, the tube set is invalidated after 10 minutes. If irrigation is stopped, it can be restarted within 30 minutes without the set being invalidated. After the device is switched off or in the case of a power failure, the current use cycle is invalidated. Irrigation can no longer be started following the last use cycle. The tube status LED lights up red. If this is the case, you must insert a new, valid, and approved day tube.

Transponder signal loss

18

The device stops and cannot be restarted if the transponder loses its signal during current use. If the signal is restored within 20 seconds, it is possible to continue using the tube set.

Operating the Device 5.5

Irrigation Tube Set Connection

en Fig. 5-3

(1) (2) (3) (4)

(5)

(7)

(9)

(6)

Irrigation tube set elements

(1)

Protective caps

(2)

Spikes

(3)

Tube clamps

(4)

Y-connector

(5)

Irrigation tube

(6)

Ring

(7)

Roller tube

(8)

Pressure chamber with membrane and transponder

(9)

Instrument tube

(10)

Luer lock connector

(8)

(10)

The irrigation tube set is available as a disposable or as a reusable tube set (autoclavable) (NOT FOR SALE IN THE USA) (see chapter 12 "Accessory list"). The tube set consists of 3 tube components, (irrigation tube (5), roller tube (7), and instrument tube (9)), a Y-connector (4) and 2 spikes (2). The spikes (2) are used to connect the tube components with the fluid bags. The Luer lock connector (10) connects the instrument tube with the instrument.

(11) (2) (5)

(7)

Fig. 5-4

Inserting the tube set

(2)

Spikes

(5)

Irrigation tube

(7)

Roller tube

(8)

Pressure chamber with membrane and transponder

(9)

Instrument tube

(11)

Fluid bag

(12)

Tube retainer

(8) (9)

(12)

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