FLEX-XC series Flexible Video-Uretero-Renoscope Instruction Manual

Important Information for Users of KARL STORZ Instruments Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this product is the result of years of experience and great care in manufacture. You and your organization have decided in favor of a modern, high-quality piece of equipment from KARL STORZ. This instruction manual is intended to serve as an aid in the proper handling, cleaning and sterilization of the Flexible Video-Uretero-Renoscope. All essential details of the equipment and all actions required on your part are clearly presented and explained. We thus ask that you read this manual carefully before proceeding to work with the instrument. Keep this manual readily available for reference. CAUTION: Federal (USA) law restricts this device to sale by/or on the order of a physician. KARL STORZ is constantly working on the further development of all products. Please appreciate that changes to the scope of supply in form, equipment and technology are possible for this reason. Therefore, no claims may be derived from the information, figures and descriptions in this manual.

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Contents

Important information for users of KARL STORZ instruments______________________________________________________________ 2 Illustrated description__________________________________________________________________________________________________________ 5 General information for the safe use of the Flexible Video-Uretero-Renoscope___________________________________________ 6 Specifications______________________________________________________________________________________________________________ 6 Operating conditions______________________________________________________________________________________________________ 6 Equipment classification__________________________________________________________________________________________________ 6 User qualification__________________________________________________________________________________________________________ 7 Warnings and cautions____________________________________________________________________________________________________ 7 Definitions__________________________________________________________________________________________________________________ 7 Device description_________________________________________________________________________________________________________ 8 Indications for use_________________________________________________________________________________________________________ 8 Contraindications__________________________________________________________________________________ 8 Safety precautions when using the Flexible Video-Uretero-Renoscope_______________________________________________ 8 Warnings and cautions____________________________________________________________________________________________________ 9 Unpacking the device___________________________________________________________________________________________________ 10 Basic equipment and accessories ____________________________________________________________________________________ 10 Handling instructions_________________________________________________________________________________________________________ 11 Handling__________________________________________________________________________________________________________________ 11 Operating________________________________________________________________________________________________________________ 11 Holding the Flexible Video-Uretero-Renoscope correctly____________________________________________________________ 11 Handling the shaft_______________________________________________________________________________________________________ 11 Handling the deflection mechanism____________________________________________________________________________________ 12 Handling the accessories_______________________________________________________________________________________________ 13 Directions for use_____________________________________________________________________________________________________________ 14 Compatible camera control units_______________________________________________________________________________________ 14 Connection to the camera control unit_________________________________________________________________________________ 14 Control buttons__________________________________________________________________________________________________________ 15 Default button settings__________________________________________________________________________________________________ 15 Program head buttons__________________________________________________________________________________________________ 15 Inspection prior to use__________________________________________________________________________________________________ 16 Inspecting the surfaces_________________________________________________________________________________________________ 16 Checking the deflection_________________________________________________________________________________________________ 17 Inspecting the LED function____________________________________________________________________________________________ 18 Inspecting the instruments and the instrument channel______________________________________________________________ 18 3

Contents

Cleaning and sterilization instructions______________________________________________________________________________________ 19 General information_______________________________________________________________________________ 19 Water quality requirements_____________________________________________________________________________________________ 20 Cleaning equipment and accessories__________________________________________________________________________________ 21 Bedside pre-cleaning (at point of use)_________________________________________________________________________________ 21 Leakage test_____________________________________________________________________________________________________________ 22 Manual cleaning_________________________________________________________________________________________________________ 24 Detergent cleaning________________________________________________________________________________ 24 Water rinsing_____________________________________________________________________________________ 25 Drying __________________________________________________________________________________________ 26 Inspection________________________________________________________________________________________ 26 Sterilization_______________________________________________________________________________________ 26 STERRAD® sterilization__________________________________________________________________________________________________ 27 Amsco V-PRO maX sterilization_____________________________________________________________________ 28 STERIS System 1/1E (SS1/SS1E) Liquid Chemical Sterilant Processing System____________________________________ 28 Reference for cleaning and sterilization_______________________________________________________________ 29 Storage________________________________________________________________________________________________________________________ 30 Endoscope return instructions______________________________________________________________________________________________ 31 Appendix______________________________________________________________________________________________________________________ 32 Troubleshooting______________________________________________________________________________________________________________ 32 Shipping_______________________________________________________________________________________________________________________ 33 Return policy__________________________________________________________________________________________________________________ 33 Repair program_______________________________________________________________________________________________________________ 34 Warranty policy_______________________________________________________________________________________________________________ 34 Limitation of liability__________________________________________________________________________________________________________ 35 Software ownership and licensing__________________________________________________________________________________________ 36

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Illustrated Description

⑤ ④

⑦

③

⑨ Leakage Tester

② ⑥

①

5

⑧

⑩ Pressure Compen­sation Cap

General Information for the Safe Use of the Flexible Video-Uretero-Renoscope ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩

Control Buttons Supply Connector Connection for Leakage Tester or Pressure Compensation Cap Distal Tip Shaft Handpiece Working Channel with Luer Lock Connectors Deflection Lever Leakage Tester 13242 XL Pressure Compensation Cap 11025E

Specifications:

11278 V

Direction of view:

0°

Field of view:

90°

Depth of field:

4–60 mm

Tip deflection:

270° up 270° down

Working shaft diameter:

2.9 mm

Working channel diameter:

1.2 mm

Working shaft length:

675 mm

Total length:

980 mm

Operating Conditions Ambient temperature: Humidity:

15° C – 37° C (59° F – 98.6° F) 15% – 80%

Equipment Classification Type of protection against moisture: Ordinary Degree of protection against electric shocks: CF-type Mode of operation: Continuous

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General Information for the Safe Use of the Flexible Video-Uretero-Renoscope Equipment test certificates: Equipment is certified and manufactured in accordance with IEC 60601-1 (3rd Edition), IEC 60601-2-18 (2nd Edition), CSA 22.2 No. 601 (3rd Edition). Electromagnetic compatibility: This instrument has been tested and complies with the EMC limits as per EN/IEC 60601-1-2: 2007 CISPR 11 Class A.

User Qualification The KARL STORZ Flexible Video-Uretero-Renoscopes may only be used by persons with an appropriate medical qualification and who are acquainted with the technique of uretero-renoscopy. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible Video-Uretero-Renoscope. It is not intended as an introduction to the technique of renoscopy. Please read these safety instructions carefully before using this instrument and ensure that you are very familiar with its operation and control.

Warnings and Cautions Please read this manual carefully and follow the instructions exactly. The words Warning, CAUTION and Note convey special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and effective operation of this product.

Definitions Warning: A Warning indicates that the personal safety of the patient or physician may be involved. Disregarding a Warning could result in injury to the patient or physician. CAUTION: A Caution indicates that particular service procedures or safety precautions must be followed to avoid any damage to the product.­­

 Note: A Note indicates special information about operating the product, or clarifies important information.

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General Information for the Safe Use of the Flexible Video-Uretero-Renoscope

Device Description The KARL STORZ Flexible Video-Uretero-Renoscope has a working length of 675 mm with an outer diameter of 2.9 mm. The shaft consists of a working channel, 1.2 mm in diameter, that can be used for insertion of various flexible instruments. The distal tip houses a CMOS imaging sensor for capturing images and videos. The handle encloses a LED light source, deflection lever and control buttons. The LED light source provides the illumination for visualization of the anatomy under examination. The deflection lever deflects the distal tip 270 degrees in an UP/DOWN direction. The control buttons can be programmed to perform functions such as white balance, Image Capture, zoom and to provide access to the setup menu. The KARL STORZ Flexible Video-Uretero-Renoscope when used with compatible Camera Control Unit (CCU) and accessories from the KARL STORZ Flexible Ureteroscope System. There are three different system configurations possible. Please refer to the system configuration matrix shown under Compatible Camera Control Units section of this instruction manual. Please refer to the proper CCU manual for instructions on how to use the Camera Control Unit. Videoscopes are applied parts which should only be used with supply units (camera control units) specified for this purpose by KARL STORZ.

Indications for Use The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Contraindications There are no known contraindications relating directly to the product. The Flexible Video-Uretero-Renoscope must not be used if, in the opinion of a qualified physician, such an application would endanger the patient, or if the endoscopic method as such is contraindicated.

Safety Precautions When Using the Flexible Video-Uretero-Renoscope The Flexible Video-Uretero-Renoscope must be used according to the recognized medical rules and procedures of endoscopy.­­ The patient leakage current limit of the CF applied parts may be exceeded if CF applied parts (application on  Note: heart) are used in combination with other BF applied parts. In this case, the patient leakage current can be reduced by using only CF applied parts. 8

General Information for the Safe Use of the Flexible Video-Uretero-Renoscope The video endoscope does not offer any electric insulation against high frequency (HF) currents. Protection  Note: against high frequency currents should be ensured through the use of correct HF instruments. Please read the instructions for use in the instruction leaflet supplied with the HF applied part for more information.

Warnings and Cautions Warning: Every time the Flexible Video-Uretero-Renoscope is used, it, and any accessories used in combination, must be inspected to ensure that they are in perfect condition. A damaged Flexible Video-Uretero-Renoscope or damaged accessories must not be used. Warning: Combinations of medical devices can only be considered safe if: • they are identified as such in the respective instruction manual • the intended purpose and the interface s­ pecifications of the ­combination of devices permit this. Pay careful attention to the instructions and i­nterface specifications of medical devices used in combination. Warning: The videoscope is delivered non-sterile and must be cleaned and sterilized according to validated reprocessing instructions before the i­nitial use as well as before any further application. CAUTION: The pressure compensation cap must be removed from the vent port for: • endoscopic interventions • immersion in liquids Warning: Do not point the light of the Flexible Video-Uretero-Renoscope into the eyes. Looking into the light may cause eye damage. Warning: Only use accessories (guide wires, cleaning brushes etc.) that are specifically intended for use with videoscopes and can be operated with generally accepted technical standards and occupational safety guidelines. Warning: Explosion may occur if flammable gases are used in the immediate proximity of the Flexible Video-UreteroRenoscope. The Flexible Video-Uretero-Renoscope must not be used in the presence of flammable or combustible media. Warning: As a result of the light emitted by the Flexible Video-Uretero-Renoscope, the tip may heat up. Prolonged direct contact of the light-emitting surfaces on tissue can lead to burns, and must therefore be avoided. CAUTION: The pressure compensation cap must be in place on the vent port for: • plasma sterilization • shipping Warning: Always unplug the Flexible Video-Uretero-Renoscope before carrying out any maintenance and/or cleaning. 9

General Information for the Safe Use of the Flexible Video-Uretero-Renoscope Warning: The Flexible Video-Uretero-Renoscope may only be repaired by personnel authorized by KARL STORZ. Unauthorized repairs may impair functioning and safety, and are therefore strictly forbidden. KARL STORZ gives no warranty for Flexible Video-Uretero-Renoscope that are repaired by unauthorized personnel. Warning: If a malfunction should occur during application on a patient, stop the application immediately. Place the distal tip of the videoscope in the neutral, nondeflected position and remove the v­ ideo endoscope slowly and carefully from the patient. CAUTION: Do not expose the Flexible Video-Uretero-Renoscope to direct sunlight or excessive heat, to avoid damage to the device. CAUTION: Do not steam sterilize (autoclave) the Flexible Video-Uretero-Renoscope. CAUTION: The maximum permissible temperature for decontamination, sterilization and storage is 65° C (149° F). CAUTION: Do not hit the distal tip of the Flexible Video-Uretero-Renoscope against hard objects, and never use a sharp object to remove dirt. CAUTION: Never lay heavy objects on the Flexible Video-Uretero-Renoscope. CAUTION: When using the Flexible Video-Uretero-Renoscope with the AIDA HD-Connect, a brief loss of video (2-3 sec) may occur when the zoom function is used. The image will be restored without the need for additional user interaction. Refer to the AIDA HD-Connect Instruction Manual for instructions for use.

Unpacking the Device Check for missing items and evidence of shipping damage. File any complaints immediately with KARL STORZ or the supplier.

Basic Equipment and Accessories Flexible Video-Uretero-Renoscope 11278 V with the following accessories:

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1

Short cleaning brush 9990/50

1

Long cleaning brush 11276CL2/10

1

Luer plug 29100-BK

1

Flat cleaning brush 27652/3

1

Pressure compensation cap 11025E

Handling Instructions

Handling Damage to the Flexible Video-Uretero-Renoscope resulting from incorrect operation­is not covered by the  Note: manufacturer’s warranty.

Operating The following instructions outline the correct operation of the Flexible Video-Uretero-Renoscope and the corresponding accessories. Suitable accessories for your Flexible Video-Uretero-Renoscope, such as biopsy forceps, can be found in the UROLOGY catalog or excerpts from this manual.

Holding the Flexible Video-Uretero-Renoscope Correctly Grip the handle of the Flexible Video-Uretero-Renoscope in your left or right hand, as shown in the picture. With this kind of control grip, the Flexible Video-Uretero-Renoscope can be operated with one hand.

Handling the Shaft CAUTION: Do not carry the Flexible Video-Uretero-Renoscope by the shaft. Do not pull, clamp or twist the shaft of the Flexible Video-Uretero-Renoscope. CAUTION: The shaft of the Flexible Video-Uretero-Renoscope must never be kinked or coiled up too tightly. It is best to suspend the shaft of the Flexible Video-Uretero-Renoscope by securely holding the handle in a vertical position. Warning: Applying lubricant to the lens may cloud the image and interfere with normal scope operation. Use a suitable water-soluble lubricant (e.g. Surgilube) for the distal section of the insertion shaft.­­Observe the lumen the entire time during use. If you lose your orientation, pull the shaft back slightly, in the neutral position, until vision is restored. If during use the image fails, is disturbed, becomes blurred, or if vision in general is impeded, put the deflection mechanism into the neutral position and slowly pull the shaft of the Flexible Video-Uretero-Renoscope out of the patient’s body. If the Flexible Video-Uretero-Renoscope is used in the patient after the image has failed or when there is interference, this may result in a serious injury to the patient.

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Handling Instructions

Handling the Deflection Mechanism

 Note: The neutral position of the distal tip is straight, without any deflection. Warning: Accessories must only be inserted into the instrument channel of the Flexible Video-Uretero-Renoscope with the distal tip in the neutral, non-deflected position. The deflection lever must never be operated with force or abruptly to avoid injuring the patient or damaging the device. Warning: Before removing the Flexible Video-Uretero-Renoscope from the patient, the distal tip of the Flexible Video-Uretero-Renoscope must be put into the neutral position, otherwise injuries to the patient or damage to the instrument may occur. Warning: If the distal tip can no longer be properly controlled via the deflection lever, or if the deflection mechanism develops any other fault, the Flexible Video-Uretero-Renoscope must not be used. Warning: If a functional defect occurs during use on the patient, discontinue use immediately. Put the distal tip of the Flexible Video-Uretero-Renoscope into the neutral, non-deflected position and remove the Flexible Video-UreteroRenoscope slowly and carefully from the patient. CAUTION: The resistance that can be felt when deflecting the tip using the deflection lever increases as the angle of deflection increases. Actuate the deflection gently, without any sudden movements, as far as the limit stop allows. CAUTION: Do not use force to actuate the deflection lever, to avoid either injuring the patient or damaging the instrument. The distal tip can be deflected 270° upward or downward by continuously actuating the deflection lever slowly and carefully. The distal end will deflect in accordance with the direction of actuation. Before use, the user must always have full control over the deflection and must develop a feel for the deflection mechanism and in particular for the neutral position.

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Handling Instructions

Handling the Accessories CAUTION: Only use flexible accessories (forceps, cleaning brushes etc.) from KARL STORZ. Accessories from other manufacturers may damage the Flexible Video-Uretero-Renoscope. CAUTION: Only introduce the instruments into the proximal port of the Flexible Video-Uretero-Renoscope. Warning: When HF electrodes or laser probes are used, it must be ensured that power is not applied until the active parts have emerged from the instrument channel and are in the user’s field of view, and the site of the operation is clearly recognizable. Activation in the instrument channel may lead to serious injury to the patient and damage the Flexible Video-Uretero-Renoscope. Warning: When HF electrodes or laser probes are used, it must be ensured that power is only applied when there are no flammable gases in the operating field or in the proximity of the Flexible Video-Uretero-Renoscope. CAUTION: Do not force accessories through the working channel to avoid damaging the device. It should be possible to move the accessory easily, without any hindrance through the entire channel. CAUTION: Do not introduce any accessory into the Flexible Video-Uretero-Renoscope when the distal tip is deflected. CAUTION: Inserting sharp-tipped accessories into the instrument channel may damage the Flexible Video-Uretero-Renoscope. CAUTION: The instrument channel is not designed for removal of tissue and/or foreign bodies. Remove the tissue or foreign bodies from the patient by removing the entire endoscope.

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Directions for Use

Compatible Camera Control Units KARL STORZ Flexible Ureteroscope System Configurations System Name

Flexible Video-Uretero-Renoscope with Image 1 HD Hub CCU System

Material Numbers

Description

11278 V

Flexible Video-Uretero-Renoscope

22201011-U1, 22201011-U102, 22201011-U104, 22201011U110, 22201011-U112, 22201015-1, 22201015-102, 22201015-104, 22201015-110 or 22201015-112

Image 1 HD Hub CCU

Warning: The KARL STORZ Flexible Video-Uretero-Renoscope should not be used in combination with Camera Control Units from other manufacturers. The use of non-compatible units may cause injury to the patient or damage to the instrument. It must be ensured that parts of the endoscope that are not electrically insulated do not come into contact with conductive surfaces or electrically live parts of other units, at any time. Please refer to the IMAGE 1 CCU instruction manual for complete instruction on how to use the Camera Control Units.

Connection to the Camera Control Unit Warning: The keyboard of the IMAGE 1 HUB™ HD must not come into contact with patients or be placed in the vicinity of patients. CAUTION: Ensure proper connector alignment before connection to avoid damage.

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Directions for Use

1.

Install the Camera Control Unit on a firm, level surface.

2.

Plug the power cord into the specified power socket.

3.

Plug the Flexible Video-Uretero-Renoscope supply cable into the HD socket of the Camera Control Unit.

4.

Turn on the CCU to power up the endoscope imager and the integrated light source.

IMAGE 1 HD HUB CCU

Control Buttons

Select

The Flexible Video-Uretero-Renoscope has three control buttons which can be assigned specific functions in the camera control unit’s device menu. The assignment is retained after switching off and on again. • Left (Up) • Right (Down) • Select = Menu

Default Button Settings Left (Up)

Right (down)

The factory default button settings are: • Left = Standby • Right = Zoom

Program Head Buttons Refer to the CCU Instruction Manual for instructions on programming the head buttons.

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Directions for Use

Inspection Prior to Use Warning: Every time the Flexible Video-Uretero-Renoscope is used, it, and any accessories used in combination, must be inspected to ensure that they are in perfect condition. A damaged Flexible Video-Uretero-Renoscope or damaged accessories must not be used.

Inspecting the Surfaces Warning: The surface of the Flexible Video-Uretero-Renoscope must be inspected visually and by carefully feeling it, to detect any cracks, cuts, dents, foreign bodies, sharp edges or other forms of damage­. CAUTION: Do not squeeze the distal tip of the Flexible Video-Uretero-Renoscope too tightly.

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Directions for Use

Inspect the supply cable for damage (cut, dents, scratches, etc.) and the supply connector for loose connections.

Checking the Deflection Warning: Actuate the deflection lever gently and carefully as far as the limit stop. The deflection lever must never be operated with force or abruptly, to avoid injuring the patient or damaging the device! Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly. Defective Flexible Video-Uretero-Renoscopes must not be used. The distal tip is deflected by means of the deflection lever. Turn the deflection lever slowly; the end piece should move downward. Turn the deflection lever in the opposite direction to produce an upward movement­­.

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Directions for Use

Inspecting the LED Function Prepare the IMAGE 1 HD CCU as described above and connect to the Flexible Video-Uretero-Renoscope. Emission of light at the distal end should be recognizable. Light intensity is automatically regulated by the camera control unit. Verify that the scope will focus on objects at 5 mm and 50 mm away by pointing the Flexible Video-UreteroRenoscope at a nearby object (5 mm from the distal tip) and verify that the image on the monitor is a clear, high-quality image. Move the distal tip to a distance of approximately 50 mm and verify that the image clarity and brightness on the monitor remains constant. Warning: If the image fails or there is interference during use in the patient, put the distal tip into the neutral position and remove the Flexible Video-Uretero-Renoscope from the patient’s body gently and carefully. If the Flexible VideoUretero-Renoscope is used in the patient after the image has failed or when there is interference, this may result in serious injury to the patient. CAUTION: The Camera Control Unit must be switched off before connecting the videoscope!

Inspecting the Instruments and the Instrument Channel CAUTION: Accessories, such as biopsy forceps, which are bent or twisted, and/or difficult to pass through the channel, may cause serious damage to the channel. Accessories in any of these conditions must be replaced before use. Check the instrument channel by introducing the appropriate instrument into the Luer port. Verify that it passes through the entire channel.

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Cleaning and Sterilization Instructions

General Information Warning: The Flexible Endoscope is delivered non-sterile and must be thoroughly cleaned and sterilized before initial and subsequent uses. Warning: Occupational safety guidelines must be observed and applied when cleaning contaminated Flexible Endoscopes and instruments. Ensure appropriate Personal Protective Equipment (PPE) is used by all staff during reprocessing. Warning: Sterilization can only be performed successfully if: • The instruments are freed of organic materials and residues of pharmaceutical products and cleaning products (i.e. thoroughly cleaned). • The recommended sterilization parameters are maintained. • Sterilization equipment is properly maintained and calibrated. CAUTION: The maximum permitted temperature is 65° C (149° F) for decontamination and sterilization. CAUTION: Personal Protective Equipment (PPE) is required to ensure safety of the operator when cleaning any contaminated medical device. Follow Occupational safety guidelines and your institution’s policies for PPE requirements. CAUTION: The Flexible Endoscope must be protected from objects that could cause damage to the device such as wire bristle brushes, sharp objects etc. Soft, lint-free cloths and/or sponges along with ONLY the correct KARL STORZ cleaning brush(es) should be used to clean the Flexible Endoscope. CAUTION: To prevent biofilm formation it is critical that Flexible Endoscopes be thoroughly dried prior to storage. Biofilm formation will interfere with sterilization of the Flexible Endoscopes and could lead to infection transmission. When preparing cleaning solutions, follow the manufacturer's instructions for proper exposure time, dilution  Note: and temperatures. Note: The soft, lint-free cloths should be disposed of after a single use (i.e. use separate cloths for the detergent cleaning, water rinsing and drying phases).

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Cleaning and Sterilization Instructions

Water Quality Requirements CAUTION: Flexible Endoscopes must never be immersed in normal saline solution, as even brief contact can result in pitting and corrosion. Definitions: Utility Water: Water as it comes from the tap that meets the specifications as defined per the table below. This water is mainly used for flushing, washing, and rinsing. Critical Water: Water that is extensively treated (usually by a multi-step treatment process that could include a carbon bed, softening, DI and RO, or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water; a final sub-micron filtration could also be part of the treatment process. This water is mainly used for the final rinse.

Type of Water Water Use

Utility Water

Critical Water

Flushing/Washing/Rinsing

Final Rinse

Specifications Units Hardness

mg/L

< 150*

<1

Conductivity (mg/L = ppm)

µS/cm

< 500

< 10

6–9

5–7

< 250

<1

pH Chlorides

mg/L

Bacteria

cfu/mL

n/a

< 10**

< 10

Endotoxin

EU/mL

n/a

< 20**

< 10

* If hardness is greater than 150 mg/L, a water softener is recommended unless used for washing and the cleaning chemistry is capable of handling higher levels of hardness ** After high-level disinfection Source: AAMI TIR 34:2014 Water for the Reprocessing of Medical Devices

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