Irrigation device GN090

Contents 1. 2. 2.1 2.2 2.3 2.4 3. 3.1 3.2 3.3 3.4 3.5 4. 4.1 4.1.1 4.1.2 4.1.3 4.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9 4.3.10 4.3.11 4.3.12 4.3.13 5. 5.1 5.2 5.3 5.4 5.5 5.5.1 5.5.2 5.6 5.7 5.8

Safe handling Product description Scope of supply Components required for operation Intended use Operating principle Preparation and setup First use Stacking of units Moving stacks of units Dismantling stacks of devices Presetting the correct voltage Working with the GN090 irrigation device System set-up Connecting the accessories Connecting the power supply Start-up Function checks Safe operation Factory settings Switching on the device Insert tube set Set the drip frequency Set the drip volume Set the lead time Switching the drip release on/off during HF Set follow-up time Combining drip release with the “CUT”/”COAG” operating modes Activate the JET function Activate device Storing the settings Taking the irrigation device out of service Validated reprocessing procedure General safety instructions General information Preparations at the place of use Preparation before cleaning Cleaning/disinfection Product-specific safety instructions for the reprocessing procedure Validated cleaning and disinfection procedure Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Storage and transport

3 4 4 4 4 4 4 4 5 5 5 5 6 6 6 6 7 7 8 8 8 8 8 8 8 9 9 9 9 9 9 9 10 10 10 10 10 11 11 11 11 11 11

6. 6.1 7. 7.1 8. 9. 10. 10.1 11. 12.

1.

Maintenance Safety inspection Troubleshooting list Fuse replacement Technical Service Accessories/Spare parts Technical data Ambient conditions Disposal Distributor in the US/Contact in Canada for product information and complaints

12 12 13 13 14 14 14 15 15 15

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician! Note These instructions for use only describe the setup, function and operation of the GN090 irrigation device and is not suitable for initiating a newcomer to high-frequency surgery. A general description of the application of highfrequency electrosurgery can be found in the respective O.R. manuals and other relevant literature.

DANGER

DANGER

Risk of death by electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. Risk of injury to patients due to inappropriate application! ► The product and accessories should only be operated by qualified or trained and experienced personnel.

► Transport the product only in its original box. ► Prior to use, check that the product is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see

TA022454. ► To prevent damage caused by improper setup or operation, and in order

not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. – Adhere to application instructions according to relevant norms. ► Inspect the accessories regularly: Electrode cables and endoscopic accessories, in particular, must be checked for possible damage to the insulation.

3

Aesculap® Irrigation device GN090

► Ensure that the device does not come in direct contact with the patient

or in the sterile area respectively. ► Ensure that the user does not come into direct contact with the patient and HF device at the same time. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards.

2.

Product description

2.1

Scope of supply

Designation

Art. no.

Irrigation device

GN090

GN090 HF device connection cable

GN090830

Bottle holder

GD412804

GN090 irrigation device instructions for use

TA021676

2.2

Components required for operation

Instruments with an incorporated flushing canal as well as an Aesculap pedal switch and an Aesculap HF device are required for operating the GN090 irrigation device. The following combinations of Aesculap foot switches and Aesculap HF devices are possible: Unit

Foot control switch

GN060, GN160

GK226, GN161

GN300, GN640

GN324, GN325, GK226, GN161

2.4

Operating principle

When using the instruments without supplying irrigation fluid, the transition resistance between the instrument and the tissue may fluctuate greatly. To achieve consistently good results, the GN090 irrigation device supplies defined doses of sterile fluid to the instrument tip and thereby reduces the transition resistance to a defined level. Moistening of the application reduces the degree of deposits and results in less “sticking” at the instrument tip. The fine instrument tips are also cooled by the liquid. This increases the durability of the instrument. The application site and the instrument can also be flushed using the JET function.

3.

Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national regulations on fire and explosion protection. Note For the safety of patients and users it is essential that the mains power cord and, especially, the protective earth connection are intact. In many cases defective or missing protective earth connections are not registered immediately. ► Connect the device via the potential equalization terminal at the rear

panel of the device to the potential equalization system of the room used for medical purposes. Note The potential equalization lead can be ordered from the manufacturer as art. no. GK535 (4 m length) or TA008205 (0.8 m length).

3.1

First use

The instrument tips can be flushed with the optional JET foot switch GN092. WARNING

2.3

Intended use

The GN090 irrigation device is used to control the supply of liquid to the tip of a HF cutting or coagulation instrument.

4

Risk of injury and/or product malfunction due to incorrect operation of the electromedical system! ► Adhere to the instructions for use of any medical device.

3.2

Stacking of units

3.4

The GN090 JET irrigation device can be installed and fixed on an HF device using the integrated stacking device. ► Make certain the system is set up on a sufficiently stable support (e.g. a table, ceiling support, equipment cart, etc.).

Dismantling stacks of devices

Dismounting a stack of products fitted with stacking devices:

B

Note The GN090 irrigation device must be located at the highest position on the stack of devices due to the holding arm for the sterile liquid bottle. Stacking products fitted with stacking devices:

A

Fig. 1

C

B

Dismantling stacks of devices

Legend B Locking screw ► Apply a screwdriver on locking screw B and turn it counterclockwise to the positive stop. ► Remove the topmost device. ► Screw back on the feet of the device, either by hand or using a screwdriver.

Stacking of units

Legend A Accessory device, e.g. JET irrigation device GN090 B Locking screw C Stacking cone ► Do not exceed a stack height of 475 mm. ► Remove the caps from stacking cones C. ► Unscrew the feet of the product that will be on top. ► Adjust the stacking cones to the correct mounting position by turning the locking screw B counterclockwise as far as it will go, using a screwdriver. ► Place the upper device on the one below it. ► Securing the device: Turn locking screw B clockwise to the positive stop. ► Slightly lift the units to check that they are safely connected to each other. ► Place the units in a stable position.

3.3

Fig. 2

Moving stacks of units

3.5

Presetting the correct voltage

The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. The correct voltage for the control unit is indicated in the window located at the back of the device. The standard voltage for the unit in Europe is: 230 V. Risk of death by electric shock! ► Unplug the device before changing the fuses! DANGER ► If the indicated voltage does not correspond to the actual mains volt-

age, change the setting at the rear panel of the power unit: – Release clip B using a suitable screwdriver A and remove the fuse holder 32. – Pull out the voltage selection element 31 under the fuse holder. – Reinsert the voltage switching element so that the desired voltage C is legible. – Reinsert the fuse holder 32.

► Always lift stacks from underneath the bottommost unit.

5

Aesculap® Irrigation device GN090

Voltage range

Imprint C

100 V to 120 V (+/- 10 %)

110

220 V to 240 V (+/- 10 %)

230

4.

Working with the GN090 irrigation device

4.1

System set-up

4.1.1

Connecting the accessories

30 DANGER

A

31 C B

Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices). All configurations must comply with basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

32 4.1.2 Fig. 3

Device connection with fuse holder and voltage selection element

Legend 30 Device connector 31 Voltage selection element 32 Fuse holder A Screwdriver B Clip C Voltage switching element imprint

6

Connecting the power supply

DANGER

Risk of death by electric shock! ► Connect the product only to a grounded power supply. ► Set up the device in such a way that a separation from the network cable is easily possible.

Note Before operating the device, make certain that that the supply voltage marked on the plug of the device matches that of the supply voltage being used. To change the setting, see Presetting the correct voltage. The GN090 irrigation device must only be operated with an alternating current from 50 Hz to 60 Hz. The mains voltage must be between 100 V and 120 V or between 220 V and 240 V. The voltage is preselected on the mains voltage connector on the rear side of the device. Insert the power cord only in a properly mounted schuko power socket (for this see VDE 0107).

Note The isolation of the power cable from the device must also be treated as secure isolation from the mains in the sense of the IEC norm. When aligning the device, ensure that an isolation of the mains plug is possible without any problems.

4.2

4.1.3

► Prepare the device, see System set-up.

Start-up

► Connect the GN090 irrigation device to the power supply with the

power cord. The LED display 25 lights up. ► Insert the sterile liquid bottle 34 into the pressure cuff and suspend it on the holding arm, see Fig. 4. ► Using clips, fasten the GN094 tube set to the electrode cable. When doing so, ensure that conditions remain sterile. ► Switch on the irrigation device. ► Activate the “Device on/off” button 24. LED displays 23 and 25 light up. ► Connect foot switch to the socket 12. When doing so, ensure that the markings on the plug and the socket 12 agree. ► Optional: connect JET foot switch to the socket 7. The system is ready for operation.

Function checks

► Always carry out function checks before using the product. ► Make certain that the accessories used for the function tests do not

show any visual damage. ► Prepare and set up the unit, see Preparation and setup. ► Check the functionality of the following elements, one after the other,

in the following sequence: User action

Device action

Activate the “Device on/ off” button 24.

The “device on” 23 LED display lights up

Repeatedly press the button for setting the drip frequency 1

One to five light fields light up, one after the other, in the “drip frequency” bar graph 2

Repeatedly press the button for setting the drip volume 3

One to five light fields light up, one after the other, in the “drip volume” bar graph 4

Repeatedly press the button for setting the lead time 22

Zero to six light fields light up, one after the other, in the “lead time” bar graph 21

Repeatedly press the button for setting the follow-up time 18

Zero to six light fields light up, one after the other, in the “follow-up time” bar graph 17

Activate and release the JET foot switch

When activating the JET foot switch, the LED display 8 lights up and the tappet in the hose clamp device opens Releasing the JET foot switch closes the tappet with a clearly audible "click"

“Activate the CUT” or “COAG” function using the connected foot switch

The “HF foot switch activated” 10 LED display lights up After the expiry of the lead time, the HF device is activated and the “HF device activated” LED display 11 lights up

34 35 GN090

Fig. 4

Complete system configuration

Legend 34 Sterile liquid bottle 35 HF device

7

Aesculap® Irrigation device GN090

4.3

Safe operation

WARNING 4.3.1

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Factory settings

The following settings are preset when the GN090 irrigation device is delivered:

Note The amount of liquid delivered correlates directly with the pressure of the pressure cuff. If the amount of liquid delivered is too low or too high, the pressure can be slightly increased or reduced. Note If a very large amount of liquid is taken out of the sterile liquid bottle, the air must be pumped into the pressure cuff afterwards in some cases in order to recreate the nominal pressure. 4.3.4

Setting

Value

Drip frequency

Level 3

Drip volume

Level 3

Lead time

Level 3

Follow-up time

Level 3

Drip release during HF

switched on

Combining the drip release with the “CUT”/“COAG” operating modes

combined with “COAG”

4.3.2

Set the drip frequency

The drip frequency, i.e. the number of drips per unit of time, can be set in five steps. The set value is displayed via the "Drip frequency" 2 bargraph. The more light fields of the bar are lit up, the higher the selected drip frequency. Note A drip frequency of zero cannot be set. The drip release can however be partly or entirely switched off using the button for combining the drip release with the “CUT” and “COAG” operating modes 16, see Combining drip release with the “CUT”/”COAG” operating modes. ► Activate the button for setting the drip frequency 1 as often as is nec-

essary so that the desired number of light fields is displayed in the "Drip frequency" bargraph 2.

Switching on the device

In order to be able to switch on the irrigation device it must be connected to the mains voltage. The green LED 25 lights up. ► Activate the “Device on/off” button 24 in order to switch on the irrigation device. The “device on” 23 LED display lights up.

4.3.5

4.3.3

Note A drip volume of zero cannot be set. The drip release can however be partly or entirely switched off using the button for combining the drip release with the “CUT” and “COAG” operating modes 16, see Combining drip release with the “CUT”/”COAG” operating modes.

Insert tube set

Note The tube set is intended for single use. ► When inserting the tube set, ensure that sterile conditions are

observed. ► Activate the button for opening the hose clamp device 5.

The hose clamp device 9 opens and the “Hose clamp device open” LED display 6 lights up. ► Insert the silicone tube of the tube set into the hose clamp device. The hose clamp device closes automatically after approximately 10 seconds. The “Hose clamp device open” LED display 6 starts to blink shortly before the expiry of ten seconds. ► Inflate the pressure cuff to 150 mmHg up to a maximum of 300 mmHg using the pair of bellows.

8

Set the drip volume

The drip volume, i.e. the amount of liquid that is let through for each opening of the tappet, can be set in five steps. The set value is displayed via the “Drip volume” 4 bargraph. The more light fields of the bar are lit up, the greater the selected drip volume.

► Activate the button for setting the drip volume 3 as often as is neces-

sary so that the desired number of light fields is displayed in the "Drip volume" bargraph 4. 4.3.6

Set the lead time

The lead time, i.e. the time between the activation of the “CUT” or “COAG” pedal and the HF activation can be set in six steps between 0 s and 1.5 s. The set value is displayed via the “Lead time” 21 bargraph. The more light fields of the bar are lit up, the longer the selected lead time. ► Activate the button for setting the lead time 22 as often as is necessary so that the desired number of light fields is displayed in the “Lead time” bargraph 21.

4.3.7

Switching the drip release on/off during HF

The “Drip release during HF” LED display 19 shows the status of the drip release during HF activation: ■ The LED indicators light up: Drip release during HF is activated ■ The LED indicators are not lit up: Drip release during HF is deactivated ► Activate button for switching drip release on/off during HF 20. 4.3.8

Set follow-up time

The follow-up time, i.e. the time between the release of the “CUT” or “COAG” pedal, in which drips are still released, can be set in six steps between 0 s and 1.5 s. The set value is displayed via the “follow-up time” 17 bargraph. The more light fields of the bar are lit up, the longer the selected follow-up time. ► Activate the button for setting the follow-up time 18 as often as is necessary so that the desired number of light fields is displayed in the "Follow-up time" bargraph 17. 4.3.9

Combining drip release with the “CUT”/”COAG” operating modes

Drip release can be combined with the “CUT” or “COAG” operating modes, or with both. The 14 (“CUT”) and 15 (“COAG”) LED indicators show which operating mode the drip function is combined with. ► Repeatedly press the button for combining drip release with the “CUT”/ “COAG” operating modes 16 until the desired combination is displayed in the LED displays 14 (“CUT”) and 15 (“COAG”). 4.3.10 Activate the JET function If the JET foot switch is activated, the hose clamp device is opened for the duration of the activation, and liquid is therefore supplied to the instrument tip with full pressure. Note If the JET function is activated for longer than 10 s, the clamp device closes automatically. This should prevent the entire contents of the bottle being emptied in the event that the JET foot switch is activated unintentionally. The JET foot switch must then be released again in order to perform activation again.

4.3.11 Activate device If the “CUT” or “COAG” foot switches are activated, the lead time starts initially and the LED display “HF foot switch activated” 10 lights up. During the lead time, drips are released in the set drip frequency and volume. After the expiry of the lead time, the HF release is activated and the “HF device activated” LED display 11 lights up. If drip release is activated during HF, drips continue to be released and the “Drip release during HF” LED display 19 lights up. The HF activation ends with the release of the foot switch and the set follow-up time is started. During the follow-up time, drips are again released in the set drip frequency and volume. It is possible to set the JET function at any time. Note If the foot switch is released again before the expiry of the lead time, highfrequency is not activated and no follow-up time is started. Note If the foot switch “CUT” or “COAG” is activated for too long a period, a permanent activation error may be triggered, depending on the HF device used. For this, see the instructions for use for the HF device used. 4.3.12 Storing the settings The set values are stored if the device is switched off with the “Device on/ off” button 24. When the device is switched back on, the most recently set values are preselected again. Note If the device is switched off by disconnecting the mains voltage, the set values are not stored and the values set when the device was most recently switched off using the “Device on/off” button 24 are set instead when the device is next switched on. 4.3.13 Taking the irrigation device out of service ► Activate the “Device on/off” button 24 in order to switch off the irri-

gation device. The “Device on” LED display 23 stops being illuminated. LED 25 lights up, and the irrigation device is still ready for switching on. ► Withdraw mains cable. The irrigation device is completely disconnected from the power supply.

9

Aesculap® Irrigation device GN090

5.

Validated reprocessing procedure

5.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

5.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary.

10

Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

5.3

Preparations at the place of use

► Remove any visible surgical residues to the extent possible with a

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

5.4

Preparation before cleaning

► Keep the product separate from the power supply. ► Remove accessories.

5.5

Cleaning/disinfection

5.5.1

Product-specific safety instructions for the reprocessing procedure

DANGER

Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product.

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances.

CAUTION

5.5.2

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. ► Observe specifications regarding concentration, temperature and exposure time.

Validated cleaning and disinfection procedure

Validated procedure

Special features

Wipe disinfection for – electrical devices without sterilization

Reference Chapter Wipe disinfection for electrical devices without sterilization

5.6

Wipe disinfection for electrical devices without sterilization

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Wipe disinfection

RT

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

RT:

Room temperature

5.8

Phase I

Storage and transport

► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable

disinfectant wipe. ► Observe the specified application time (1 min minimum).

5.7

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Inspect all cables, and in particular electrode cables, for any damage to their insulation. ► Set aside the product if it is damaged. ► Perform a safety inspection annually, see Maintenance.

CAUTION

Damage to the product caused by switch-on to early after storage/transport at temperature below +10 °C! ► Allow the irrigation device to acclimate at room temperature for about 3 hours.

► Transport the product only in its original box. ► Observe storage and transport conditions, see Ambient conditions.

11

Aesculap® Irrigation device GN090

6.

Maintenance

6.1

The GN090 irrigation device requires no maintenance. Note Maintenance must only be carried out by authorized personnel. If necessary, the circuit diagrams and the service manual, which contains all the necessary documents, are provided for this.

Safety inspection

A safety inspection must be carried out annually. ► Only have the product and its accessories inspected by persons who possess the requisite training, knowledge and experience and who are authorized to do so. ► If the maximum values stated in the accompanying checking protocol for safety inspection are exceeded, the device must be sent in. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5

PASS

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Fig. 5

12

Checking protocol for safety inspection

7.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

No supply voltage available

Check current

–

Fuse blown

Replace the fuse, see Fuse replacement

Tappet not moving

–

Hose clamp device contaminated Clean hose clamp device

Amount of liquid released is too small or too large

–

Too little or too much pressure in the pressure cuff

Increase pressure through extra pumping or reduce by deflating

–

Incorrect settings or drip volume selected

Change setting, see Set the drip volume

Drip release switched off

Switch on drip release for the desired operating type, see Combining drip release with the “CUT”/”COAG” operating modes

Unit cannot be switched on –

No drips are being released –

7.1

Fuse replacement Risk of death by electric shock! ► Unplug the device before changing the fuses!

30

DANGER Specified fuses: TA020112 (T 1.25 AH/250 V) ► Unlatch clip B with a suitable screw driver A. ► Remove fuse holder 32. ► Replace both fuse sets 33. ► Reinsert fuse holder 32 so that it audibly snaps into place.

A

33

B

32 Fig. 6

Device connector with fuse holder and voltage switching element

Legend 30 Device connector 32 Fuse holder 33 Fuse sets A Screwdriver B Clip Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical Service. 13

Aesculap® Irrigation device GN090

8.

Technical Service

Irrigating coagulation forceps

Risk of injury and/or malfunction! ► Do not modify the product.

Note Information concerning the instruments is available on request and can be found in Aesculap brochure C-304-81.

WARNING Spare parts ► For service and repairs, please contact your national B. Braun/

Aesculapagency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

9.

Art. no.

Designation

TA020112

Fuses that can be used with this unit

GN090830

GN090 HF device connection cable

GN094

Remove the tube set

GN092

JET foot switch

GN093

Pressure cuff with manometer

Note Information on other accessories and replacement parts is available on request and can be found in Aesculap brochure C-304-81.

10. Technical data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GN090

Irrigation device

IIa

Accessories/Spare parts

Power cord Art. no.

Approvals

Length [m]

TE730

Europe

5.0

TE734

United Kingdom and Ireland

5.0

TE735

USA, Canada, Japan

3.5

Mains voltage ranges

100-120 V +/- 10 % 220-240 V +/- 10 %

Frequency

50–60 Hz

Current consumption

0.30–0.40 A (for 100–120 V) 0.13-0.20 A (for 220-240 V)

Protection class (acc. to IEC/ I DIN EN 60601-1)

Art. no.

Designation

Length [m]

Device protection Time-Current characteristic Breaking capacity Construction

GK535

Potential-compensation line

4.0

Weight

4.7 kg

TA008205

Potential-compensation line

0.8

Dimensions (L x W x H)

305 mm x 305 mm x 82 mm

Potential-compensation line

14

T 1.25 AH / 250 V T (time lag) H (1 500 A) 5 mm x 20 mm

EMC

IEC/DIN EN 60601-1-2 CISPR11 Class A

Conforming to standard

IEC/DIN EN 60601-1

Mark of conformity

CSA-CUS

LR 50 151

10.1 Ambient conditions Operation

11. Disposal Adhere to national regulations when disposing of or recycling the product, its components and its packaging! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► Detailed information concerning the disposal of the product is avail-

Storage and transport

able through your national B. Braun/Aesculap agency, see Technical Service.

Temperature

Relative humidity

12. Distributor in the US/Contact in Canada for product information and complaints

Atmospheric pressure

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

Note The atmospheric pressure of 700 hPa corresponds to a maximum operating altitude of 3 000 m.

15

Aesculap® Appareil d’irrigation GN090

6.

Maintenance

6.1

L’appareil d’irrigation GN090 ne demande aucune maintenance. Remarque La révision d’entretien ne doit être confiée qu’à un personnel autorisé. En cas de besoin, consulter les schémas de connexion et le manuel d’entretien, dans lesquels toutes les données nécessaires sont présentées.

Contrôle technique de sécurité

Les contrôles techniques de sécurité doivent être effectués une fois par an. ► Faire contrôler le produit et les accessoires uniquement par des personnes disposant de la formation, des connaissances ou de l’expérience requises et qui peuvent effectuer le contrôle de manière indépendante. ► Si les valeurs maximales mentionnées pour le contrôle technique de sécurité dans le procès-verbal joint sont dépassées, l’appareil doit être renvoyé pour révision. Pour les prestations de service correspondantes, adressez-vous à votre représentation nationale B. Braun/Aesculap, voir Service Technique.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5

PASS

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Fig. 5

40

Procès-verbal de contrôle technique de sécurité

Aesculap® Aparato de irrigación GN090

6.

Conservación

6.1

El aparato de irrigación GN090 no precisa mantenimiento. Nota El mantenimiento debe realizarse exclusivamente por personal autorizado. En caso necesario, se facilitarán los esquemas eléctricos y el manual de servicio técnico, en el que se encuentran todos los documentos necesarios.

Control técnico de seguridad

Someter el aparato a un control técnico de seguridad una vez al año. ► La supervisión del producto y de los accesorios debe confiarse exclusivamente a profesionales independientes con la formación requerida para ello o que dispongan de los conocimientos o experiencia necesarios. ► Si se exceden los valores máximos recogidos en el certificado de revisión de la supervisión técnica de seguridad adjunto, enviar el aparato al fabricante. Si el producto necesita alguna reparación debe dirigirse al representante de B. Braun/Aesculap, ver Servicio de Asistencia Técnica de su país.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.2 2.3 2.4 2.5

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Fig. 5

54

Certificado de revisión de la supervisión técnica de seguridad

Aesculap® Irrigatore GN090

6.

Manutenzione ordinaria

L'irrigatore GN090 non richiede alcuna manutenzione. Nota La manutenzione ordinaria deve essere eseguita solo da personale autorizzato. In caso di necessità sono a disposizione gli schemi elettrici e il manuale di servizio in cui si trovano tutte le documentazioni necessarie.

6.1

Controllo tecnico di sicurezza

I controlli tecnici di sicurezza devono essere eseguiti una volta all’anno. ► Far controllare il prodotto e gli accessori soltanto da personale che disponga della necessaria formazione, conoscenze ed esperienza e che ai fini del controllo sia assolutamente indipendente. ► Se vengono superati i valori massimi indicati nel protocollo di controllo allegato per la verifica di sicurezza, l'apparecchio deve essere spedito all'assistenza. Per i corrispondenti interventi di assistenza rivolgersi alla rappresentanza nazionale B. Braun/Aesculap, vedere Assistenza tecnica.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5

PASS

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Fig. 5

68

Protocollo di prova per il controllo tecnico di sicurezza

Aesculap® Irrigationsenhet GN090

6.

Underhåll

6.1

Irrigationsenheten GN090 är underhållsfri. Tips Reparationer får bara utföras av auktoriserad personal. Vid behov ställs kopplingsschema och servicemanualen till förfogande, där alla nödvändiga underlag finns.

Säkerhetsteknisk kontroll

Säkerhetstekniska kontroller ska genomföras en gång per år. ► Produkten och tillbehören får användas endast av personer med erforderlig utbildning, kunskap eller erfarenhet och som är fria från att ta anvisningar. ► Om de i bifogade testprotokoll nämnda maximivärdena för de säkerhetstekniska kontrollerna överskrids, måste enheten skickas in. För service kontakta den nationella representanten för B. Braun/Aesculap, se Teknisk service.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5

PASS

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Fig. 5

110

Testprotokoll för den säkerhetstekniska kontrollen.

Aesculap® Irigační přístroj GN090

6.

Provozní údržba

6.1

Irigační přístroj GN090 je bezúdržbový. Upozornĕní Údržbu smí provádět výhradně autorizovaný personál. V případě potřeby k tomu budou poskytnuta schémata zapojení a servisní příručka, kde naleznete veškeré potřebné podklady.

Technicko bezpečnostní kontrola

Technicko bezpečnostní kontroly je nutno provádět jedenkrát ročně. ► Výrobek a příslušenství nechávejte přezkoušet pouze od osob, které mají patřičné vzdělání, znalosti a zkušenosti a nepotřebují při zkoušce instrukce. ► Pokud dojde k překročení maximálních hodnot, uvedených v přiloženém zkušebním protokolu pro technicko-bezpečnostní kontrolu, je nutno zaslat přístroj ke kontrole. V otázkách servisu se obracejte na své národní zastoupení společnosti B. Braun/Aesculap, viz Technický servis.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5

PASS

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Obr. 5

138

Zkušební protokol pro technicko-bezpečnostní kontrolu

Aesculap® Urządzenie do irygacji GN090

6.

Utrzymanie sprawności urządzenia

Urządzenie do irygacji GN090 jest bezobsługowe. Notyfikacja Konserwację może przeprowadzać wyłącznie upoważniony personel. W razie potrzeby do tego celu udostępnia się schematy elektryczne oraz instrukcję serwisowania, w której znajdują się wszystkie niezbędne dokumenty.

6.1

Kontrola bezpieczeństwa technicznego

Przegląd techniczny urządzenia należy przeprowadzać raz do roku. ► Produkt i akcesoria powinny kontrolować tylko osoby posiadające odpowiednie przeszkolenie, wiedzę i doświadczenie oraz niezwiązane poleceniami i niezależne od innych pracowników. ► Jeżeli wartości maksymalne określone dla kontroli bezpieczeństwa technicznego podane w dołączonym protokole kontroli zostaną przekroczone, urządzenie należy odesłać do producenta. W sprawie konkretnych usług serwisowych proszę się skontaktować z właściwym dla Państwa krajowym przedstawicielstwem firmy B. Braun/ Aesculap, patrz Serwis techniczny.

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year JET Irrigation Unit GN090 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.2 2.3 2.4 2.5

FAIL

Measured value

Verdict PASS / FAIL

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

Protective earth resistance incl. mains cable according IEC62353:2007 Earth leakage current

Rmax= N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Equipment leakage current - alternative method

Imax = 1,00 mA

according IEC62353:2007

Insulation resistance according IEC62353:2007 (Preparation according Service Manual)

2.5.1 Mains against housing 2.6 Function test according to instructions for use Place/Date Inspector/Signature

Imax = 0,50 mA Imax = 1,00 mA Imax = 0,10 mA Imax = 0,50 mA

test voltage = 500 V DC

Rmin = 2 M Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

Rys. 5

152

Protokół kontroli bezpieczeństwa technicznego