2D Camera Heads Instructions for Use

Aesculap® 2D camera heads PV481, PV482, PV485

2D camera heads PV481, PV482, Aesculap PV485®

Legend 1 2 3 4 5

Manufacturer

Endocoupler Focus ring Zoom ring Camera head buttons Lock

Date of manufacture

Federal Law (US) restricts this device to sale to or on behalf of a physician. Marking of electric and electronic devices according to directive 2002/96/EC (WEEE). see Disposal

Symbols on product and packages Indicates a hazard. If not avoided, the hazard can result in death or serious injury. WARNING Indicates a potential hazard. If not avoided, this hazard may result in injury and/or damage to the product.

Contents

CAUTION Follow the instructions for use

Caution (IEC 60601-1 3rd edition) / Attention, please take note of the accompanying document (IEC 606011 2nd edition) Defibrillation-proof type CF rated part according to IEC 60601-1 Permissible storage temperature

Permissible relative air humidity during storage

Permissible atmospheric pressure during storage

Not permitted for use in a magnetic resonance environment Caution, fragile

2

REF

Article number

SN

Serial number

1. 2. 3. 3.1 3.2 3.3 3.4 4. 4.1 4.2 4.3 5. 5.1 5.2 5.3 5.4 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 7.

Applicable to... Safe handling... Product description... Scope of supply... Components required for operation... Intended use... Operating principle... Preparation... Combination with medical electrical equipment... Inspections... First use... Working with the camera heads... General notes on use... System set-up... Function checks... Safe operation... Reprocessing procedure... General information... Dismantling prior to carrying out the reprocessing procedure. Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Manual cleaning and disinfecting... Mechanical cleaning/disinfecting with manual pre-cleaning . STERRAD sterilization... Material-compatible cleaning and disinfecting agents... Inspection, maintenance and checks... Storage... Service...

3 3 5 5 5 5 5 6 7 7 7 8 8 8 9 9 10 11 11 11 11 11 12 14 15 16 16 16 16

8. 9. 9.1 10. 11. 12. 12.1 13. 14.

1.

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

16 17 17 17 18 18 18 19

2.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

19

Risk to user and patient from non-observance of instructions, warnings and precautions! ► Use the product only according to these instructions for use. ► Check the product is in good working order before use. ► Carry out function checks before each use. ► Do not use the product if irregularities are observed during inspections and checks.

Applicable to

These instructions for use apply to the following devices: Designation

Art. no.

Full HD CMOS camera head with pendulum coupler

PV481

Full HD CMOS camera head with zoom coupler

PV482

Full HD 3CMOS camera head with zoom coupler

PV485

WARNING

These instructions for use are an integral component of the device and contain all the information required by users and operators for safe and proper use. Target group

WARNING

These instructions for use are intended for physicians, medical assistants, medical technicians and employees of sterile services who are entrusted with the installation, operation, maintenance and reprocessing of the device. CAUTION Using and storing this document These instructions for use must be stored in a defined location so that it may be accessed at all times by the target group. In the event of the sale of this device or its relocation, this document must be handed over to the new owner.

Risk to patient due to incorrect application! ► Use the product only after instruction by the manufacturer or by an authorized person. ► The instructions for use enclosed with the individual components and all products used (e.g. high frequency surgery) must be observed. ► Endoscopic procedures may only be carried out by specialists who have the necessary medical training, knowledge and experience. Risk to patient and user due to premature wear! ► Handle and maintain the product properly. ► Use the product only in accordance with the intended purpose. Possible restricted function if third party devices are used! ► Use the product with the recommended components and accessories. ► The full functionality of the product can only be guaranteed if the recommended accessory components are used.

Supplementary documents For the use and assignment of the camera head buttons and the related options and possible functions, observe the instructions for use of the camera control unit concerned. The instructions for use of the camera head used and instructions for use of all other devices used must be observed to ensure the safe use of the device. ► For item-specific instructions for use and information regarding material compatibility, see Aesculap Extranet at https://extranet.bbraun.com

3

Aesculap® 2D camera heads PV481, PV482, PV485

WARNING

WARNING

WARNING

WARNING

CAUTION

4

Risk of injury due to electric shock! ► When installing a medical electrical system, there is a risk of fire, short-circuit or electric shock. Installation must be performed by qualified personnel only. ► If a number of electrical devices are being used in combination, observe Annex I of IEC 606011:2006. Non-medical devices that comply with the applicable IEC safety standards can be connected only via a medical isolating transformer. Do not connect any additional non-medical devices to a medical electrical system. ► Signal lines from devices with a functional connection, which are connected to different branches of the mains power supply, must be galvanically isolated at both ends. ► Connect the devices only to a power supply with a protective earth conductor. ► After installing a medical electrical system, it must be inspected according to IEC 62353. Risk to the patient if the product is not used gently/a damaged product is used! ► Handle the product with appropriate care. ► Do not use the product if it has been subjected to strong mechanical stress or if it has been dropped, and send the product to the manufacturer or an authorized repair center for inspection. Risk to patient if the device power fails! ► Use the device only with an uninterruptible power supply. ► To guarantee a continuous power supply a medical emergency supply (USP) is suggested. Device failure due to incorrect storage and usage conditions! ► Store and operate the product only within the specified environmental conditions. Restricted function if third party devices are used! ► Use the product only with the recommended components and accessories. ► Full functionality is only guaranteed if the recommended components and accessories are used.

Note Accessories and/or peripheral devices which are connected to the interfaces of the medical device must be verified to comply with the relevant specifications (e.g. IEC 60601-1). Note The medical electrical device may not be modified in any way. Note To guarantee optimal function of the product, use in controlled environmental conditions is recommended (e.g. air-conditioned operating room). Note Always handle the medical device very carefully as it contains sensitive optic, mechanic and electronic components. Do not strike or drop the camera head. Note Ensure that all devices operated in the vicinity meet their relevant EMC requirements. Note The camera components are used to visualize the inside of the body during minimally invasive procedures. Do not use the components for diagnostic purposes. This applies in particular with the use of image optimization algorithms. Note Before putting into operation, check the compatibility of all components using the accessories list. Note All accessories and spare parts must only be procured from the manufacturer. ► Remove the transport packaging and clean the new product, either

manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see

TA022130. ► 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. – Follow the application advisories acc. to standard, see Extracts from relevant standards. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards.

3.

Product description

3.1

Contraindications

Scope of supply

Designation

Art. no.

Full HD CMOS camera head with pendulum coupler – or – Full HD CMOS camera head with zoom coupler – or – Full HD 3CMOS camera head with zoom coupler

PV481

Instructions for use

TA014624

3.2

PV482 PV485

Components required for operation

CAUTION

If the recommended components are not used, the following errors/complications may occur, among others:

■ Incorrect color display ■ No/incorrect display of the camera menu ■ Restricted operating function from the camera head

■ Increased fogging on the optics The camera head (PV481/PV482/PV485) is used for visualization during endoscopic surgical procedures. The camera head is intended for use with the following components: ■ Camera control unit PV480 or PV630 ■ Disposable sterile cover JG904 ■ LED light source OP950 These components are optimally aligned with one another and therefore offer the best possible quality and unlimited functionality.

3.3

The use of the Full HD CMOS camera components and its accessory is contraindicated if endoscopic procedures are contraindicated for any reason. As is appropriate with any surgical procedure, consideration must be given to patient size and workspace volume when using the Full HD CMOS camera components. Depending on the patient’s disease, there may exist contraindications that rely on the general condition of the patient or the specific disease pattern. The decision to perform an endoscopic procedure rests with the responsible surgeon and should be made on the basis of an individual risk-benefit analysis.

3.4

Operating principle

The camera heads within the scope of these instructions for use can be used with the PV480 and PV630 camera control units and may only be connected to this unit. The combination of camera control unit and camera head result in a camera based on CMOS technology. In combination with a suitable monitor, the camera provides two-dimensional images. The camera head features four configurable camera head buttons that can be used to control image display, record images and video, or to navigate and change the settings in the configuration menu of the camera control unit. The camera heads are intended for use with the applicable sterile cover. (B. Braun JG904). Camera head buttons The camera head buttons have different functions depending on the operating mode. The assignment of the buttons is always synchronous with the assignment of the buttons on the front of the camera control unit. Different functions can be assigned for a short press of the button (<2 sec.) and a long press of the button (≥2 sec.). The procedure for changing the assigned functions is described in the instructions for use of the respective camera control unit.

Intended use

The Full HD CMOS camera control unit (PV480) serves the 2D HD visualization of the interior of the body during minimally invasive surgical procedures and endoscopic examinations. The application in combination with a camera head serves 2D visualization of the intracorporal surgical area during endoscopic diagnostic and surgical procedures. The Full HD CMOS camera control unit is only used for visualizing and not for diagnosis. Endoscopic indications

■ Minimal invasive surgery ■ Surgery ■ General endoscopy 5

Aesculap® 2D camera heads PV481, PV482, PV485

Button assignment in live mode

Button assignment when on-screen keyboard is active The button assignment in live mode depends on whether a standard profile or user profile is set. If a user profile is set, the buttons can be assigned individually, however the assignment for entering the camera control unit menu cannot be changed. In standard profile, the buttons are assigned as follows: Short press of button

Long press of button

not working

Open menu

Zoom

White balance

Light source on

Light source on/off

Single frame image

Video recording start/stop

Button assignment when on-screen display is active When on-screen display is active, the buttons are used to navigate the menu until the menu is left. Short press of button

Long press of button

up / control +

Leave the menu

When the on-screen keyboard is active, the buttons are used to navigate the keyboard until the keyboard is left.

4.

Long press of button

up

not working

right

Confirm/enter

down

not working

left

not working

Preparation

If the following instructions are not observed, the manufacturer assumes no responsibility for possible consequences. Before installation and use, ensure that the: ■ electrical installations comply with the relevant technical regulations, ■ relevant regulations concerning fire and explosion protection are observed. Note For the safety of the user, 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.

right / next level / across / save control setting down / control – / on WARNING left / back a level / save control etting WARNING

6

Short press of button

Risk to patient from misdirected leakage current due to incorrect or defective earthing! ► Do not touch the product and patient at the same time. Risk to patient due to failure of a device! ► Keep an operationally ready replacement device on hand and if necessary change to conventional surgical methods.

WARNING

WARNING

WARNING

WARNING

WARNING

CAUTION

CAUTION

CAUTION

Danger of explosion from a device that is improperly set up! ► Make certain that the power plug is connected to the power supply outside of any areas where there is a risk of explosion. ► Do not use the product in potentially explosive areas or close to highly flammable or explosive gases (e.g. oxygen, anesthetic gases). Risk to patient and user due to condensation and short-circuit! ► Before putting into operation make sure that all components used have enough time to adjust to the changed environmental conditions. Risk of injury to the eyes! ► Do not insert the light guide into the light source during the check of the fibers. Risk of infection and injury! ► Do not use products with damaged fiber optics, damaged glass surfaces or stubborn deposits which cannot be removed by cleaning. Risk to patient due to use of damaged products! ► Do not use products if they have sharp edges or other hazardous surface damage. Risk to persons and risk of damage to equipment due to improper cable routing! ► Lay all cables and leads so that they do not present a tripping hazard. ► Do not place objects on the cables. Risk to patient due to poor/lack of vision! ► Adjust the monitors and display elements so that they are highly visible to the user. Interference of high frequency energy with the device! ► Do not use any mobile or portable equipment that emit high-frequency energy (e.g. mobile phones, cell phones, GSM phones) in the vicinity of the product.

Note The product including the camera cable is fragile when bent, kinked, twisted, pulled, or pressed. Note Handle the camera head and camera cable with care. Do not exert any mechanical forces and avoid mechanical impacts. Note Connect the equipotential bonding terminals of all equipment used with the equipotential bonding strip see IEC 60601-1-1 / EN 60601-1-1 or in accordance with national standards. Note Ensure that the corresponding interconnection conditions, standards and respective national deviations are observed.

4.1

Combination with medical electrical equipment

The product can be combined with components from other manufacturers provided that all components are compliant with the medical electrical equipment safety requirements according to IEC 60601-1. It is the operator’s responsibility to check and make sure that the system is and remains fully operational. When using devices from different manufacturers and when operating an endoscope and/or endoscopic accessories together with medical electrical equipment, it must be ensured that the applied part is properly isolated: Type CF, defibrillation-proof.

4.2

Inspections

Carry out the following inspection steps before reprocessing and immediately before use of the device: Inspection of the glass surfaces ► Before each use, inspect the camera head for damage such as rough

surfaces, sharp edges or protrusions to avoid injuries to the patient. ► Perform a visual inspection of the glass surfaces. The surfaces must be

clean and smooth. If there are impairments/damage, see Troubleshooting list.

4.3

First use

WARNING

Risk of injury and/or product malfunction due to incorrect operation of the medical electrical system! ► Follow the instructions for use of all products required.

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Aesculap® 2D camera heads PV481, PV482, PV485

5.

Working with the camera heads

5.1

General notes on use

The camera cable is fragile when bent, kinked, twisted, pulled, or pressed. Observe the maximum bend radius of 7 cm and handle the cable with care. Do not make any changes to the cable and do not load with sharp-edged objects.

5.2

System set-up

WARNING

WARNING

WARNING

WARNING

WARNING

CAUTION

8

Risk of infection due to unsterile parts! ► Ensure that unsterile components do not enter the sterile area. ► Process products and accessories that are delivered unsterile before use and only use them with sterile accessories. Risk of infection due to unsterile, soiled or contaminated products! ► Only use the camera head in the sterile area if it is in sterile condition. To do so, use the camera head with the correctly applied sterile cover or after sterilization process. Risk to patient due to addition of leakage currents! ► If the product is used with medical electrical equipment and/or power-driven endoscope accessories, the leakage currents can multiply. Risk to patient and user from burns, sparks or explosion! ► When using a high frequency surgical device during an endoscopic procedure, observe the safety instructions of the corresponding instructions for use. Risk of injury due to improper use! ► Observe the intended use of the product. ► Do not use the endoscope as a lever. Interference of electromagnetic emissions with the image quality (e.g. minor banding, minor color changes on the monitor image)! ► Check the image quality if used in combination with additional peripheral devices (e.g. monitor, video equipment).

Note In combination with the camera control unit, PV480 or PV630, the endoscope is classed as a type CF defibrillation-proof applied part. Note Before application of endoscopic high frequency surgery (HF surgery) prepare the patient accordingly. Note Take measures to remove or avoid formation of combustible gases (e.g. gastro-intestinal tract/colonoscopy, urinary bladder/transuretheral resection). Connecting the accessories

DANGER

Risk of injury due to unapproved configuration using additional components! ► For all components used, ensure that their classification matches that of the applied part (e.g. type CF defibrillation-proof) 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. Any equipment connected at the interfaces must also demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, and IEC/DIN EN 60601-1 medical electrical equipment). All configurations must meet the basic standard IEC/DIN EN 60601-1. The person connecting the devices is responsible for the configuration and must ensure that the basic standard IEC/DIN EN 60601-1 or the corresponding national standards are met. ► Please contact your B. Braun/Aesculap partner or Aesculap Technical Service, (address: see Technical Service) with any inquiries in this respect.

5.3

Function checks

WARNING

WARNING

Risk to patient due to incorrectly displayed image! ► Remove any contaminations on the optical surfaces (camera head) before and during the procedure. Clean the endoscope tip with a cloth soaked in alcohol (70 % ethanol) or with a neutral cleaning agent. ► Prior to application and after changing the settings, check the correct display of the live image. If necessary, perform white balance. Risk to patient and user from functional failure or electric shock! ► Use only dry components (e.g. plug connector for camera control unit, optical lens).

Note Only perform the surgical procedure if all of the components being used are in a flawless condition. Note Before each use, after a power failure or any interruption, the functionality of all connected devices must be checked and all connections must be checked to see they are correct. Note The endoscope image must be focused, bright and clean at an appropriate working distance. Note Do not continue to use damaged products.

5.4

Safe operation

WARNING

Risk of burns due to development of heat at the tip of the endoscope! ► Do not put down the endoscope on the patient during use. ► In the patient's abdominal cavity, always leave a sufficient distance between the optical lens and the tissue surfaces and mucous membranes of the patient. ► Use automatic light intensity control or set the light source so that a bright, well-lit image is visible with the lowest possible light intensity. ► Switch off the light source if the illumination is no longer needed or if the endoscope is out of the patient for a longer period of time.

Excessive temperatures in combination with light sources Light sources, especially high-power light sources, emit large amounts of light energy and thermal energy. The light guide connector and the distal end of the endoscope may therefore become extremely hot.

WARNING

Risk of injury due to excessive temperature! ► Do not touch the light guide connector or distal end of the endoscope during use or immediately after use.

Risks from use of light sources: ■ Irreversible tissue damage or unwanted coagulation to the patient or user ■ Burns or thermal damage to surgical equipment (e.g. surgical drapes, plastic materials, etc.) ■ If the light source fails during use, this may endanger the patient. Therefore keep an operationally ready replacement light source on hand. Safety precautions ► Do not illuminate the inside of the patient for longer than necessary with the light source. ► Use the automatic light intensity control or set the light source so that a bright, well-lit image is visible with the lowest possible light intensity. ► Do not allow the distal end of the endoscope or light guide connector to come into contact with patient tissue or with combustible or heatsensitive materials. ► Do not touch the distal end of the endoscope. ► Remove contaminations on the distal end surface or light emission surface.

WARNING

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

WARNING

Risk of injury from burns and unwanted deep penetration and risk of damage to product! ► Only switch on high frequency current when the corresponding applied part (electrode) can be seen through the endoscope and there is no contact between the two.

WARNING

Risk of infection due to contamination of the sterile area! ► Fix the camera cable (unsterile) with sterile cover (sterile) sufficiently nearby in the operation area.

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Aesculap® 2D camera heads PV481, PV482, PV485

WARNING

WARNING

WARNING

WARNING

WARNING

CAUTION

Risk of injury due to misdirected leakage currents! ► Before thoracic or cardiothoracic surgery, deactivate implanted defibrillators (ICD). ► Before any kind of defibrillation, remove the used camera head from the patient.

6.

Reprocessing procedure

WARNING

Risk of infection/injury to patients and users! ► Only use the sterile cover once. ► Do not clean the sterile cover with ultrasound. ► Do not reprocess the sterile cover. Risk to patient from gas embolism! ► Avoid overinsufflation (e.g. with air or inert gas) before high frequency surgery. Risk to patient from damage to the optical lens! ► Withdraw the endoscope slowly from the used trocar. ► If a trocar with a manual opening valve is being used, only withdraw the endoscope from the trocar when the valve is open. Risk of infection due to unsterile cover or medical device! ► Replace the sterile cover or the camera head if it falls on the ground or if it is touched by unsterile objects/persons.

WARNING

Malfunction in connection with magnetic resonance! ► Do not use the product in a magnetic resonance environment.

Note The current assignment of the buttons is displayed on the screen as "Camera head information" after opening the camera menu.

CAUTION

Connection to camera control unit

CAUTION

► Insert the connection plug fully into the connection socket of the cam-

era control unit until it engages in place.

10

Risk of infection due to an incorrectly reprocessed product! ► Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. ► For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. ► The camera head is not autoclavable. Therefore, the camera head and corresponding sterile cover must not be used in patients suspected of having Creutzfeldt-Jakob disease or who have already been diagnosed with Creutzfeldt-Jakob disease. ► Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. ► Successful reprocessing of this medical device can only be ensured through a validated reprocessing procedure. The operator/reprocessing technician is responsible for this. Risk of infection for patients and/or user due to: ► Residues of cleaning and disinfectants at the product. ► Insufficient or incorrect cleaning and disinfection of the product and accessories. Risk of damage to and malfunction of the device due to incorrect reprocessing! ► Do not autoclave the product. Risk of defects, consequential damage or a shortened product service life! ► Follow and observe the manufacturer's requirements for reprocessing.

6.1

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 reprocessing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non 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 damage to the products in case of non stainless steel. 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 reprocessing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical material changes (e.g. fading or discoloration) in titanium or aluminum. For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage (e.g. 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.

WARNING

Damage to the product due to improper reprocessing! ► Do not, under any circumstances, clean or disinfect the product in an ultrasonic cleaning bath. ► Use cleaning and disinfecting agents which are suitable and approved for the present product. ► Observe the manufacturer’s cleaning and disinfecting instructions regarding concentration, temperature and exposure time. ► Only reconnect the system to power when all cleaned parts are completely dry. ► Never autoclave the product.

6.2

Dismantling prior to carrying out the reprocessing procedure

► Unplug the camera plug from the camera control unit. ► Remove the sterile cover from the camera head and dispose of it

according to regulations. The sterile cover is only intended for single use. ► Remove the endoscope, light guide and all detachable parts.

6.3

Preparations at the place of use

► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth. Use a soft cloth for this to avoid scratching the optical lens. ► Pre-clean all used parts of the fully disassembled product at the operating table at the conclusion of the surgery by wiping with a lint-free wipe wetted with an enzymatic cleaning solution until visibly clean. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

6.4

Preparation before cleaning

► Non-fixating/NaCl-free pre-cleaning is mandatory immediately after

use.

6.5

Cleaning/disinfection

The effectiveness of the following procedures: ■ Manual cleaning and manual disinfection ■ Automated cleaning and thermal disinfection ■ Sterilization As described in this document, has been fully validated. It is the operator’s responsibility to introduce, document, implement, and maintain a validated reprocessing procedure. Make sure that the equipment used for reprocessing is properly maintained. The reprocessing procedure described in this document consists of the following steps: ■ Pre-cleaning immediately after use ■ Cleaning and disinfection (manual or automated) and ■ Sterilization.

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Aesculap® 2D camera heads PV481, PV482, PV485

Product-specific safety instructions for the reprocessing procedure

DANGER

CAUTION

Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. 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. The cleaning and disinfecting agent must be approved for plastics and high-grade steel, and it must not attack softeners (e.g. silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 100 °C.

Note There may be significant discoloration of the camera head when using Cidex OPA. However, this discoloration has no influence on the functionality or safety of the product.

6.6

Manual cleaning and disinfecting

Post use and pre-cleaning activities ► Pre-clean the device immediately after use. ► Remove and discard the sterile drape, if present. ► Decouple the endoscope from the optocoupler. ► Uncouple the camera head from the controller. ► Pre-clean all used parts of the fully disassembled product at the oper-

ating table at the conclusion of the surgery by wiping with a lint-free wipe wetted (i.e. wetted but not dripping; squeeze out excess solution) with an enzymatic cleaning solution until visibly clean. Before wetting the lint-free wipe with the enzymatic clean solution, the solution should be prepared according to the manufacturer’s instruction. ► Arrange for reprocessing, ensuring that all of the device components are reprocessed within 6 hours.

12

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Cleaning

as per manufacturer’s instruction

2-5

Tap water

Enzymatic cleaning agent (Cidezyme/Enzol)

II

Rinse 2x

<45/113

2x ≥1

Tap water

–

III

Disinfection1)

as per manufacturer’s instruction

12

as per manufac- 0.55 % Orthophtaldehyde solution (Cidex OPA) turer’s instruction

IV

Rinse 2x1)

<45/113

2x ≥1

Tap water

–

V

Final Rinse

<45/113

≥1

FD-W

–

VI

Drying

–

–

–

–

FD-W 1)

Fully desalinated water (demineralized, low microbiological contamination, max. 10 germs/ml and low in endotoxins, max. 0.25 Endotoxin units/ml) Phase does not apply to US market ► Thoroughly rinse all hidden crevices, lumens or complex geometry at least three times. – Use a disposable 50ml syringe. – Use fresh water for each rinse. Damage to the product due to improper handling! – Allow water to drip off for a sufficient length of time. Scratch-sensitive surface.

CAUTION

► Handle the device with appropriate care. ► Do not use metal brushes, metal objects or abra-

sive cleaners. Phase I: Cleaning ► Prepare the cleaning solution according to the manufacturer’s instruc-

tions. ► Fully immerse all parts of the fully disassembled device that were used

in the cleaning solution bath for two (2) to five (5) minutes. All accessible surfaces must remain immersed in the cleaning solution bath throughout the entire cleaning time. ► After soaking in the cleaning solution, clean all external surfaceswhile the items are fully emerged in the cleaning solution – using a clean, lint-free, soft, non-sterile cloth or a soft bristled brush until all visible soiling is removed: – Brush for at least one (1) minute or until no more residues can be removed. – During cleaning, move non fixed components 3 times in each direction and as far as possible. ► Thoroughly rinse all surfaces of products with hidden crevices, lumens with working channels, or complex geometry five (5) times. Use a disposable 50 ml syringe.

Phase III: Disinfection ► Immerse all parts completely in disinfectant solution for at least

12 minutes. All accessible surfaces must remain immersed in the disinfectant solution bath throughout the entire disinfecting time. ► Remove all adherent air bubbles from the component surfaces ► Thoroughly rinse all surfaces of products with hidden crevices, lumens with working channels, or complex geometry five (5) times. Use a disposable 50 ml syringe. ► Move non fixed components 3 times in each direction and as far as possible. Phase IV: Rinse ► Fully immerse all parts in a tap water bath (< 45 °C/113 °F) and thor-

oughly rinse all accessible surfaces twice for a minimum of one minute each. ► Move non fixed components 3 times in each direction and as far as possible. ► Thoroughly rinse all hidden crevices, lumens or complex geometry at least three times: – Use a disposable 50ml syringe. – Use fresh water for each rinse. – Allow water to drip off for a sufficient length of time.

Phase II: Rinse ► Fully immerse all parts in a tap water bath (<45 °C/113 °F) and thor-

oughly rinse all accessible surfaces twice for a minimum of one (1) minute each. ► Move non fixed components 3 times in each direction and as far as possible.

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Aesculap® 2D camera heads PV481, PV482, PV485

Phase V: Final rinse

Phase VI: Drying

► Fully immerse all parts in a fully desalinated water bath

► Thoroughly dry all parts with a clean, lint-free wipe or a lint-free sur-

(<45 °C/113 °F) and thoroughly rinse all accessible surfaces for a minimum of one minute. ► Move non fixed components 3 times in each direction and as far as possible. ► Thoroughly rinse all hidden crevices, lumens or complex geometry at least three times: – Use a disposable 50 ml syringe. – Use fresh water for each rinse. – Allow water to drip off for a sufficient length of time.

6.7

gical towel. ► Dry all accessible surfaces, especially the channels with medical-qual-

ity filtered compressed (pmax = 0,5 bar). ► Visually inspect the device in a well-lit area; they should be completely

clean and dry. If necessary please use a magnifying glass and repeat the manual cleaning performance. This concludes the manual cleaning and disinfection process.

Mechanical cleaning/disinfecting with manual pre-cleaning

Post use and pre-cleaning activities ► If applicable, flush not observably surfaces primarily with deionized

water e.g. with a single use syringe. ► Remove as far as possible visible residues with a moist lint free wipe.

Use an enzymatic cleaning solution to moisten the cloth that was prepared in accordance with the instructions of the manufacturer. ► Place the device in a dry and closed disposable container and transport it within 6 hours to cleaning and disinfection.

Manual pre-cleaning Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Cleaning

<45/113

10-30

Tap water

Enzymatic cleaning agent (Cidezyme/Enzol)

II

Rinse 2x

<45/113

2x ≥1

Tap water

–

Phase I: Cleaning ► Fully immerse all parts of the fully disassembled device that were used

in a cleaning solution bath (<40°C) for ten (10) to thirty (30) minutes. ► Immerse all accessible surfaces in the cleaning solution bath through-

out the entire cleaning time. ► While the components soak in the solution, use a soft wipe or soft

brush to remove all visible residues from all exterior surfaces of the components. ► Move non fixed components 5 times in each direction and as far as possible. Phase 2: Rinse ► Fully immerse all parts in a tap water bath (<45 °C/113 °F) and thor-

oughly rinse all accessible surfaces twice for a minimum of one (1) minute each: – Use fresh water for each rinse. – Move non fixed components 5 times in each direction and as far as possible. – Allow water to drip off for a sufficient length of time. 14

Mechanical alkaline cleaning and thermal disinfecting Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals/Note

I

Prerinse

<25/77

3

Tap water

–

II

Cleaning

55/131

10

Deionized water

Alkaline Detergent Neodisher Mediclean forte 0.5 %

III

Intermediate rinse

>10/50

1

Deionized water

–

IV

Thermal disinfection

90/194

5

Deionized water

–

V

Drying

–

–

–

According to the program of the washer/disinfector

► Use a washer/disinfector that has been validated as effective and

Performing sterilization

meets the performance requirements of ISO 15883-1 (or the respective country specific version thereof) ► For reprocessing, use the camera tray, which is used without a lid. This tray is only suitable for the camera and not for instruments. ► Place the device in the provided reusable camera tray. Avoid areas that cannot be reached during rinsing. ► Place the tray in the automatic washer/disinfector in a suitable carrier that ensures both the protection of the instrument and access to surfaces for cleaning. No lid will be used for the tray. ► Start the cleaning cycle as described (see table) in accordance with the manufacturer’s instructions and instruction for use for the washer/disinfector. ► Remove the tray and the devices from automatic washer. ► Visually inspect the device in a well-lit area; they should be completely clean, dry and undamaged. ► Use a magnifying glass. Repeat the cleaning process if necessary. Immediately set aside any damaged components.

Note STERRAD® sterilization may result in cosmetic device changes that do not necessarily affect the device function.

6.8

STERRAD sterilization

The STERRAD® sterilization systems, manufactured by Advanced Sterilization Products (ASP), use low-temperature, hydrogen peroxide gas plasma technology for terminal sterilization of properly cleaned, rinsed, and dried reusable medical devices. ► Refer to the STERRAD® Sterilization Systems User Guide for detailed instructions for use of any STERRAD® unit and ASP’s STERRAD Sterility Guide (SSG) at www.sterradsterilityguide.com or contact ASP customer service.

CAUTION

Loads containing moisture may cause a cycle cancellation! ► Thoroughly dry the product before loading into the STERRAD® sterilizer.

► Place all parts in a cleaning and storage basket. ► Place a STERRAD® indicator strip in the basket. ► Assemble sterilization container JM441 according to manufacturer’s

instruction. ► Place the basket in the sterilization container JM441. ► Load the container in the sterilizer:

– Position the container such that the plasma can fully surround it. – Load only one container per cycle in the chamber. – Leave the other shelf empty. ► Start the sterilization cycle in accordance with the manufacturer’s instructions and instructions for use for the steam sterilizer. STERRAD® sterilization was validated for the following cycles: – STERRAD® 100S short cycle – STERRAD® NX standard cycle – STERRAD® 100NX standard cycle ► Remove the sterilized products from the sterilizer. ► Ensure that the products remain sterile after reprocessing. This concludes sterilization.

15

Aesculap® 2D camera heads PV481, PV482, PV485

6.9

Material-compatible cleaning and disinfecting agents

■ Wipe disinfection: – Meliseptol HBV tissues 50 % Propan-1-ol (B. Braun) – Chlorine Disinfection (Wetwipe) ■ Manual immersion disinfection: Stabimed Fresh (B. Braun)

7.

Send damaged products to the manufacturer or authorized repair center. Authorized repair centers can be inquired about from the manufacturer.

WARNING

6.10 Inspection, maintenance and checks ► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Check the product for damage or excessive heating. ► Set aside the product if it is damaged.

6.11 Storage

CAUTION

CAUTION

CAUTION

Damage to product due to improper storage! ► Store the product protected from dust in a dry, well ventilated, and temperature-controlled room. ► Store the product protected from direct sunlight, high temperatures, high air humidity or radiation. ► Protect the product from direct UV light, radioactivity or strong electromagnetic radiation. ► Store the product separately or use containers in which it can be fixed in place. ► Always transport the product with care. Damage to product due to improper handling! ► Do not drop the camera head and handle it with care. ► When transporting the camera head over thresholds or uneven ground, store the camera head securely. Damage to the optical lens due to inappropriate transport packaging! ► Use the tray only for the camera head and not for instruments. ► Use the tray for the camera head only within the clinic. ► Only place a disinfected camera head in the tray.

► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

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Service

Risk of infection due to soiled or contaminated products! ► Clean, disinfect and sterilize the product and/or any accessories thoroughly before sending. ► Prior to sending, remove the sterile cover from the camera head. ► Select suitable and safe packaging (ideally the original packaging). ► Package the product in such a way that the packaging does not become contaminated.

Note If for urgent reasons it is not possible to thoroughly clean/disinfect and sterilize the product, reprocess the product as far as possible and label it accordingly. The specialized repair company may refuse to repair soiled or contaminated products for safety reasons. The manufacturer reserves the right to return contaminated products to the sender.

8.

Maintenance

This product is maintenance-free. It does not contain components which have to be maintained by the user or manufacturer. However the manufacturer requires that a qualified person or a hospital technician inspects the product regularly in a preventive safety inspection. The product should be inspected at least once every 12 months. In case of preventative safety inspections, no special conditions and measures have to be observed. During the inspection, the following tests have to be done according to section 5 of DIN DIN EN 62353/IEC 62353: ■ 5.2 Visual inspection ■ 5.3.2 Measuring of protective earth resistance (only applicable for devices of protection class I) ■ 5.3.3 Measurement of leakage currents ■ 5.3.4 Measurement of insulation resistance According to section 6 of DIN EN 62353/IEC 62353, the test results must be fully recorded in a test report, which can be taken from Annex G of the standard. After performing the preventive safety inspection, a functional test is to be carried out. For relevant services contact your national B. Braun/Aesculap agency, see Technical Service.

9.

Troubleshooting list

Problem

Possible cause

Remedy

Image cloudy

Glass surfaces soiled

Clean the glass surfaces according to the Cleaning and Disinfection section.

Stubborn residue on the glass surfaces

Remove residues according to the Cleaning and Disinfection section; check water quality.

Glass surfaces soiled

Clean the glass surfaces according to the Cleaning and Disinfection section.

Light guide dirty, defective

Check light guide (e. g. illuminate onto a white surface).

Excessive chloride concentration

Check water quality.

Heavy metal ions and/or silicates, increased content of iron, copper, manganese in water

Check water quality; if applicable, only use deionized (fully desalinated) water.

Image too dark, too little illumination

Too high concentration of mineral substances (e.g. calcium) or organic substances Contaminated cleaning/disinfecting solutions, too fre- The cleaning and disinfecting solutions should be replaced quent use regularly.

9.1

Extraneous rust, (e.g. resulting from previously damaged or non-corrosion-resistant instruments being reprocessed at the same time)

Check supply systems; in case of joint reprocessing, check material compatibility and for existing damage, and avoid mutual contact.

Contact corrosion

Avoid contact with other components.

Repairs

For repairs, contact the manufacturer or authorized repair center. Authorized repair centers can be inquired about from the manufacturer. For a fast processing of your service requests, send in the product indicating: ■ Article number (REF) ■ Serial number (SN) ■ Detailed description of defects

10. Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING

CAUTION Note If a component of the visualization system is replaced (e. g. service, upgrade), the system start-up process must be performed again. It is also recommended to perform a safety inspection after any maintenance or replacement of a device.

Malfunction of the product due to damage in transport! ► Select suitable and safe packaging (ideally the original packaging). ► Keep the original packaging for possible returns in case of service. ► Package the product in such a way that the packaging does not become contaminated.

Note Service and repair work must only be carried out by authorized trained personnel. For service and repairs, please contact your national B. Braun/Aesculap agency. Modifications carried out on medical technical equipment may result in loss of warranty rights and applicable licenses.

17

Aesculap® 2D camera heads PV481, PV482, PV485

Service address 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.

11. Accessories/Spare parts Art. no.

Designation

JG904

Disposable sterile cover, pack of 25

Protection rating

IPX7

Sensor format

Native Full HD 1/3"

Scanning system

Progressive scan

Frequency

50 Hz or 60 Hz

Protection class (according to IEC/DIN EN 60601-1)

I

Weight (excl. cable)

■ PV481: 180 g ■ PV482: 294 g ■ PV485: 380 g

Length of camera cable

3,5 m

Applied part

Type CF, defibrillation-proof (in combination with camera control unit PV480 or PV630)

Dimensions (L x W x H)

■ PV481: 53 mm x 52 mm x 113,9 mm ■ PV482: 149 mm x 52,5 mm x 50,4 mm ■ PV485: 149 mm x 52,5 mm x 50,4 mm

EMC

IEC/EN/DIN 60601-1-2

Conforming to standard

IEC/EN/DIN 60601-1

CISPR 11

In combination with PV480: Class B In combination with PV630: Class A

12.1 Ambient conditions

12. Technical data

Operation

Storage and transport

Temperature

10 °C to 35 °C (PV481) 10 °C to 37 °C (PV482/PV485)

-10 °C to 50 °C

Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

PV481

Full HD CMOS camera head with pendulum coupler

I

Relative humidity

30 % to 90 %

10 % to 90 %

PV482

Full HD CMOS camera head with zoom coupler

I

700 hPa to 1 060 hPa

PV485

Full HD 3CMOS camera head with zoom coupler I

Atmospheric pressure

500 hPa to 1 060 hPa

JG904

Disposable sterile cover, pack of 25

18

IIa

13. Disposal Note The user institution is obliged to process the product before its disposal, see Reprocessing procedure. 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-

able through your national B. Braun/Aesculap agency, see Technical Service. Note Incorrect disposal can lead to environmental damage.

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

19