PaediScope: Endoscope PF01A, eyepiece PF011A

Function check

Aesculap® PaediScope: Endoscope PF010A, eyepiece PF011A Legend

► Check that the image projected on the eyepiece window 4 is clear and distinct. ► Hold the endoscope with the Aesculap-Storz optical cable connection 2 against the light source and check that

the four points of the light bundle 10 at the endoscope tip 13 are evenly illuminated. ► Ensure that the eyepiece window 4, the window of the image channel 9 at the endoscope tip 13 and the input

surface at the Aesculap-Storz optical cable connection 2 are not dull or dirty.

Use of the endoscope

1 Endoscope 2 Aesculap-Storz optical cable connection 3 Eyepiece 4 Eyepiece window 5 Eyepiece cup 6 Focus 7 Eyepiece cover class 8 Fiberoptic light guide end of endoscope 9 Image channel 10 Light bundle 11 Irrigation and overflow channel 12 Working channel 13 Endoscope tip 14 Luer lock connectors for irrigation and overflow channel 15 Silicone sealing cap 16 Endoscope shaft

WARNING

Risk of burns from the hot tips of fiberoptic bundles on the instrument side! ► Make certain the instrument-side end of the fiberoptic bundle does not touch human tissue or highly combustible materials while the light source is active. WARNING

WARNING

Symbols on product and packages Symbol

Danger to patients due to inappropriate use of the irrigation channel! ► Feed the irrigation channel of the endoscope only by a passive gravitational (drip) system. ► Set the height difference of the gravitational system to not more than 50 cm.

Explanation Caution, general warning symbol Caution, see documentation supplied with the product

Risk of burns to patient and user, caused by high-intensity light! ► Make certain the distal end of the endoscope or optical cable connection does not touch human tissue or any flammable or heat-sensitive materials while the light source is active. ► Do not put down the endoscope on the patient. ► Do not touch the distal end of the endoscope and the optical cable connection. ► Adjust the light source to the minimum required power for optimal illumination of the endoscopic image. ► Only use light sources of a power rating of up to 300 W. Damage to the endoscope by bending the endoscope shaft! ► Do not bend the endoscope shaft 16. ► Use endoscopes with their appropriate sheaths and working trocars only.

CAUTION Date of manufacture

Product supplied in unsterile condition

Intended use The PaediScope is used for intraventricular procedures in neurosurgery. Its small size makes it particularly suitable for pediatric indications. When the endoscope 1 and eyepiece 3 are mounted, the field at the tip of the endoscope can be seen through the eyepiece window 4. Instruments can be inserted into the endoscope through the working channel 12.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! This manual contains instructions for the preparation, reprocessing, and disposal of the endoscope. It does not contain information on the actual application of the endoscope.

► Avoid kinking the flexible parts of the endoscope 1. ► Do not place any heavy objects on the endoscope 1. ► Insert the endoscope 1 distal end (of the endoscope) first, avoiding any strong impact. ► Turn the focusing ring 6 until the eyepiece window 4 shows a sharp image. ► To enhance the view through the endoscope: Feed the irrigation channel 11 of the endoscope by a passive grav-

itational (drip) system without pressure sleeve. – Do not employ active pumps. – Allow liquid to drain through the overflow channel, against atmospheric pressure. – Do not employ suction devices or vacuum pumps. – Ensure that the overflow channel 11 is not closed during irrigation. ► Push additional instruments through the silicone sealing cap 15 in order to insert them into the working channel 12 of the endoscope 1. ► To remove instruments, pull the latter out of the working channel 12 at the silicone sealing cap 15. ► To avoid burns caused by heating up of the distal end of the product: Adjust the light source to the minimum required power for optimal illumination of the endoscopic image.

Using the endoscope with additional instruments The working channel 12 allows instruments to be inserted and applied with the endoscope 1. Risk of injury due to application of products outside the field of view! ► Apply instruments only under visual control.

Risk of injury from defective endoscopes! ► Only use an endoscope if it is in perfect condition. WARNING

WARNING

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► When using the endoscope with an electromedical device, adhere to rules for the use of high-frequency devices. ► Clean the new product thoroughly, by hand, after removing its transport packaging and prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar). ► Replace the product if its image quality is degrading. ► Do not, under any circumstances, put down the product on the patient or on the surgical drape covering the patient. ► To avoid burns caused by heating up of the distal end of the product: Prior to putting down the product, turn down the power of the light source. To avoid HF burns: ► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated. ► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories. ► Prior to each use, visually inspect the product for: damage or surface changes to the insulation. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device. ► Follow the instructions for use of the HF device.

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

WARNING

Burns caused by high-frequency current (HF current)! ► When using an endoscope and HF electrodes at the same time, be cautious to activate the HF current under visual control only. ► Ensure that the active electrode is never in the immediate vicinity of electrically conductive components (e.g. trocar, endoscope).

► Follow the user instructions of any additional instruments used. ► Only use instruments that can be easily inserted into the working channel 12 (maximum outer diameter of the

instrument used: 1 mm or 3 french). ► When using HF electrodes: only activate HF electrodes if their insulation is visible in the eyepiece window 4. ► Observe the respective manufacturer’s instructions when using the endoscope in combination with other equip-

ment, instruments, or optical cables.

Disassembling ► Unscrew the optical cable from the Aesculap-Storz optical cable connection 2. ► Remove the tubes from the Luer lock connectors of the irrigation and overflow channel 14. ► Rotate the eyepiece 3 counterclockwise and remove it from the endoscope 1. ► Remove the silicone sealing cap 15 from the endoscope 1. ► Remove the sealing caps from the Luer lock connectors 14.

Assembling ► Make certain that the tip of the fiberoptic light guide 8 on the endoscope and the cover glass 7 on the eyepiece 3

are not dirty. ► Screw the eyepiece 3 (by rotating it clockwise) into the fiberoptic light guide end 8 of the endoscope until slight

resistance can be felt. Then rotate the eyepiece 3 by an additional one-quarter clockwise turn. The threaded connection between the endoscope and eyepiece is now watertight. ► Attach the irrigation and overflow tubes to the irrigation and overflow channel 14 at the Luer lock connectors. ► Connect the optical cable to the Aesculap-Storz optical cable connection 2.

Validated reprocessing procedure

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Disinfecting cleaning

RT (cold)

>15

1.0

D–W

B. Braun Cleaner N

II

Intermediate rinse

RT (cold)

3x1

-

D–W

-

III

Disinfection

RT (cold)

15

1.5

FD-W

B. Braun Helipur H Plus N

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Dry

RT

-

-

-

-

General safety notes 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 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 For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological Max. 10 microorganisms/ml, low endotoxin: Max. 0.25 endotoxin units/ml Room temperature

contamination:

General information

RT:

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 pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive dosages of neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking on stainless steel becoming unreadable either visually or by machine. 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. Perform additional drying, if necessary. 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 in 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 surface and could cause corrosion ► For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Check that all accessible surfaces are moistened and all lumens, channels and complex geometries are bubble-free and filled with cleaning solution. ► Clean the outer surfaces of the immersed product with a soft, lint-free, disposable wipe. ► Brush through all areas not accessible to visual inspection, e.g. in products with hidden crevices, lumens (e.g. open/working/irrigation channel) or complex geometries, for at least 1 minute or until no more residues can be removed. ► During cleaning, mobilize non-rigid components, such as set screws, joints, etc., 3 times in each direction to the positive stop. ► Clean open/working/irrigation channels with the cleaning brush supplied with the product (PF893800) for at least 1 minute. ► To clean with the brush, insert the brush with its metal tip into the channel and slowly extract it from the other end as soon as it emerges there. ► After cleaning, use the cleaning solution and a 20-ml disposable syringe to thoroughly rinse these parts of the product at least 5 times.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use. ► Remove the covers from the Luer lock connectors and the sealing cap from the working channel. ► Open all valves/faucets.

Preparations at the place of use ► If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),

using a disposable syringe, for example. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure Risk to patient due to cross contamination! ► Do not clean contaminated products together with uncontaminated products in a tray. DANGER

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – be approved for flexible endoscopes, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 55 °C.

Phase II ► Completely rinse the product (including through all accessible surfaces) 3 times for at least 1 minute, using clean, fresh water for each rinse. ► During rinsing, mobilize non-rigid components, such as set screws, joints, etc., 3 times in each direction to the positive stop. ► For each rinsing process, rinse through lumens and channels with a disposable syringe (20 ml) at least 5 times. ► Drain any remaining water fully. Phase III ► Fully immerse the instrument in the disinfectant solution. Check that all accessible surfaces are moistened and all lumens, channels and complex geometries are bubble-free and filled with disinfectant solution. ► During disinfection, mobilize non-rigid components, such as set screws, joints, etc., 3 times in each direction to the positive stop. ► Rinse the lumens at least five times at the beginning of the contact period using a suitable disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Completely rinse the product (including through all accessible surfaces) 3 times for at least 2 minutes, using clean, fresh water for each rinse. ► During the final rinse, mobilize non-rigid components, such as set screws, joints, etc., 3 times in each direction to the positive stop. ► For each rinsing process, rinse through lumens and channels with a suitable disposable syringe (20 ml) at least 5 times. ► Drain any remaining water fully. Phase V ► Thoroughly dry the external surfaces of the product with a soft, lint-free disposable wipe or with medical compressed air. ► Thoroughly blow-dry lumens and channels with air from a disposable syringe (20ml). Do not use compressed air for this purpose.

Mechanical cleaning/disinfection Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound

Damage to the optical system caused by loosening of connections during ultrasound cleaning! ► Do not clean the endoscope with ultrasound. CAUTION ► For prion inactivation, clean/disinfect the endoscope mechanically using a prion-inactivating cleaning agent. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Ensure that the bend radius of the flexible lines of the product is at least 11 cm. ► Avoid excessive pressure on the product.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

Dr. Weigert neodisher® SeptoClean 1 %* working solution

III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary. ► After manual cleaning: Remove deposits and residues from the cleaning brush and then disinfect.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) ► Connect components with lumens and channels directly to the rinsing port of the injector carriage. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Technical Service

Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

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

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► To remove any residues of cleaning/disinfecting agents, wipe the eyepiece window 4, the window of the image

channel 9 at the endoscope tip 13 and at the input surface of the Aesculap-Storz optical cable connection 2 with a swab moistened with alcohol. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Check for compatibility with associated products.

Packaging ► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. ► Do not store the product in its transport packaging. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the bend radius of the flexible lines of the product is at least 11 cm. ► Avoid excessive pressure on the product. ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization Note The product may only be sterilized when dismantled.

CAUTION

Risk of damage to the optical system through loosening of connections as the result of hot air or flash sterilization! ► Do not sterilize the product with hot air or flash sterilization techniques. ► Do not expose the product to temperatures above 134 °C.

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

opening any valves and faucets). ► Do not sterilize damaged products. ► Make certain the product is cleaned. ► Sterilize the product in the appropriate storage rack (FF373R). ► Avoid knocking or shaking the product. ► Avoid temperature fluctuations after sterilization (e.g. due to cooling with water). ► Aesculap recommends sterilizing the product with steam.

Note Aesculap guarantees steam sterilization of the product up to 15 autoclave cycles at a holding time of 5 min, or 10 autoclave cycles at a holding time of 18 min. ► Validated sterilization process

– Disassemble the product, see Disassembling – Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C, holding time 5 min to 18 min – For prion inactivation: Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.

WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Repairs may be carried out only by persons authorized to do so by AESCULAP FLEXIMED. Any repairs carried out by other persons will void all warranty and guarantee entitlements. ► Prior to dispatching the product for repairs: Have the product cleaned and disinfected or sterilized, and mark it as “disinfected” or “sterilized”, respectively. 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: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Accessories/Spare parts Art. no.

Designation

EJ670202

Silicone sealing cap for working channel

EJ751200

Covers for Luer lock connectors

FH603SU

PaediScope Insertion aid 10 Fr.

PF893800

Cleaning brush

Technical Data ∅ distal end

3.0 mm

∅ working channel

1.2 mm

∅ irrigation/overflow channel

0.03 in

Length of shaft

150 mm

Long flexible component

1 000 mm

Image angle

80°

Viewing direction

0°

Depth of field

3 mm to ∞

To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Make certain that any bending or coiling radius of the endoscope is not less than 11 cm.

Maintenance The product requires no maintenance for the first 15 autoclave cycles at a holding time of 5 min, or the first 10 autoclave cycles at a holding time of 18 min. After that, the image quality of the product can be diminished by normal wear during steam sterilization.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging! ► Put the product away in a dry condition.

Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 010713

2020-03

V6

Änd.-Nr. 62572