Levitan Endoscope F 30000-GLS Operators Manual

Clarus Medical 30000-GLS Endoscope

Table of Contents

Page

Symbol Descriptions

3

Warnings and Cautions

3-4

Intended Use, Indications and Contraindications

4

Product Description

4

Features and Connections

5

Accessory Components

6

Compatible Endo-tracheal Tubes

7

Use with External Equipment

7

Unpacking, Inspection, and Maintenance

8

Verifying Operation

8-9

Setup for Performing a Procedure

10-13

Instructions for Cleaning, Disinfecting and Sterilization

14-17

Disposal of Waste

17

Troubleshooting and Service

17

Warranty

17

Specifications

18

Contact Information: Manufacturer: Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, MN 55427 USA www.clarus-medical.com Tel (763) 525-8403

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Authorized European Representative: MPS Medical Product Services GmbH, Borngasse 20 35619 Braunfels, Germany

Clarus Medical 30000-GLS Endoscope

Symbol Descriptions WARNING: Read this operating manual for additional warnings and instructions for use. Type BF equipment

Date of manufacture

Single use only.

WARNINGS 1. Follow the cleaning, disinfecting, and sterilization instructions provided in this manual. 2. Physicians must be trained before using this device. 3. Federal USA law restricts the use of this device to sale by or on order of a physician. 4. Do not advance the endoscope forcefully or blindly. 5. Do not attempt to service any part of this product. 6. To ensure patient and operator safety, read and understand this manual before using the 30000–GLS endoscope. 7. If the 30000–GLS endoscope is connected to electrically operated, endoscopically-used accessories, a system has been formed and patient leakage currents may be additive. The user is then responsible to assure that the electrical isolation and grounding requirements of IEC60601-1 have been met. 8. Use the 30000-GLS only with ISO 7376-1 compatible battery operated light sources that meet the requirements of IEC 60601-1 safety standards. 9. Do not use in the presence of flammable anesthetics. 10. Follow the instructions regarding disposal or reuse of accessories. Do not reuse accessories that are intended for single patient use. 11. The 30000-GLS endoscope is not Defibrillation Proof and is not intended for use in conjunction with a cardiac defibrillator.

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Clarus Medical 30000-GLS Endoscope 12. The 30000-GLS endoscope emits visible light energy from its distal end when connected to a light source. Avoid looking directly at this emitted light or directing it toward others whenever the endoscope is withdrawn from the patient. 13. Carefully inspect the external contact surfaces of the 30000-GLS and any endoscopically used accessories to assure they are smooth and free of any protrusions or sharp edges which might cause injury to the patient or user.

Intended Use The 30000-GLS is an endoscope intended for use in placement of an endo-tracheal tube. The physical shape of the endoscope is similar to that of a traditional endo-tracheal tube placement stylet with the added advantage of providing visualization. The endoscope is thus designed to be inserted into the air passage of an endo-tracheal tube and can be shaped to the user’s preference.

Indications for Use Visualization of airway anatomy to aid in placing and confirming placement of an endotracheal tube.

Contraindications for Use There are no known contraindications.

Product Description The 30000-GLS endoscope is a fiberoptic endoscope for placement through an endotracheal tube. This allows visualization of critical anatomical landmarks and aids in the placement of the endo-tracheal tube. The endoscope is constructed with a malleable stainless steel shaft that can be shaped by hand to varying angles. This allows the user to adjust to shape of the endoscope to their preference. An eyepiece is integrated into the endoscope for direct use with the eye. No focusing is required. The light source connection is compatible with ISO 7376-1 (Green-Line) battery operated fiberoptic sources with integrated lamp. A receptacle is provided at the proximal end of the endoscope’s stainless steel shaft to act as a stop to secure the Endo-tracheal tube into place. This assures that the endo-tracheal tube is held into place during patient use. A port is available on the side of the endoscope’s body near the proximal shaft to allow connection of an oxygen source. The Clarus model 30410 is a barbed fitting that, when plugged into the port, provides a means of connection of an oxygen source.

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Clarus Medical 30000-GLS Endoscope

30000-GLS Endoscope Features and Connections The user features and connections are shown in the following illustration. 2

1

3

4

7

6

8

5

9

Figure 1: 30000-GLS Features

#

Name

1

Eye Cup

2

Eyepiece

3

Green Line Compatible Hub

4

35 Degree Bend

5

Distal Lens

6

Green Line Lock

7

Illumination Fibers

8

Oxygen Port

9

Endo-tracheal tube Stop

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Function DIN 58105:2000-06 standard eyecup for direct viewing with the eye. The eyepiece converts the image from the fiber optic section of the endoscope to an image useable to the eye. The eyepiece can correct for most variations in the vision of the user. The hub comprises the center section of the endoscope. The 30000-GLS hub is compatible with ISO 7376-1 Green-Line series of battery operated light sources. This bend is an ergonomic feature the user can adjust. It allows improved handling of the 30000-GLS and the endo-tracheal tube. The objective lens on the distal end of the endoscope. The Green line compatible hub that captures the mating part of an ISO 7376-1 (Green-Line) battery operated fiberoptic light source. Point of entry for light used for illumination. The illumination fibers pass from this connection to the distal tip of the endoscope. Point of entry for the Oxygen port. The oxygen introduced into this port is routed to the proximal endo-tracheal tube stop where it can then flow into and through the endo-tracheal tube. A green dot marks the location to connect the oxygen port Receptacle for the endo-tracheal tube allowing it to be anchored to the endoscope. Compatible with 15mm ASTM F 1243-89 conical fittings.

Clarus Medical 30000-GLS Endoscope

Accessory Components The following components are intended for use with the 30000-GLS endoscope. They are either supplied with the endoscope or sold separately. 1. Clarus model 30410 Oxygen port. (2 supplied with 30000-GLS) 2. Green-Line ISO 7376-1 compatible battery light source. (sold separately) 3. User Instruction Manual. (supplied with 30000-GLS) 4. Endo-tracheal tube (sold separately)

Clarus Model 30410 Oxygen Port

Packaged endo-tracheal tube (Typical)

ISO 7376-1 “Green-Line” light source (Typical)

Clarus 601221-003 User Instruction Manual

Figures 2A,B,C,D: Accessory Components Page 6 of 18 601221-003 Rev. F

Clarus Medical 30000-GLS Endoscope

Compatible 30000-GLS Endo-tracheal Tubes An endo-tracheal tube is not supplied with the 30000-GLS but rather must be acquired separately by the user. The 30000-GLS is compatible with a variety of endo-tracheal tubes manufactured by others. These tubes are normally supplied in single use sterile packages. An endo-tracheal tube with a minimum inside diameter of 5.5mm or larger is compatible with the 30000-GLS. In addition the tube must have a 15mm conical fitting per ASTM F 1054-87 and -01 (Conical Fittings) and ASTM F 1243-89 Tracheal Tube Connectors. These standards specify the proximal connection to an endo-tracheal tube and the 30000GLS is compatible with tubes that meet these standards. WARNING: Do not attempt to use the 30000-GLS with improperly fitted endo-tracheal tubes. The use of poorly fitting tubes will degrade patient safety or performance. The associated endo-tracheal tube required for an intubation procedure is intended for single patient use only. Re-use could result in hazardous conditions. Clarus Medical assumes no responsibility for complications resulting from reuse or improper use of an Endo-tracheal tube. WARNING: An endo-tracheal tube cannot be cleaned or sterilized. WARNING: This instruction manual describes how to connect the 30000-GLS

endoscope and achieve normal operation. This manual does NOT provide information for performing a patient procedure. Only trained physicians can perform patient procedures.

Use of 30000-GLS with External Imaging Equipment The 30000-GLS endoscope utilizes a DIN 58105:2000-06 standard endoscope eyecup and is therefore compatible with a variety of video imaging and photographic equipment. It is beyond the scope of this Instruction Manual to define the varieties and the use of this type of equipment. The user is advised to seek information from the manufacturer or the Instructions Manuals of the specific equipment being used. WARNING: If the 30000–GLS endoscope is connected to electrically operated endoscopically-used accessories a system has been formed and patient leakage currents may be additive. The user is then responsible to assure that the electrical isolation and grounding requirements of IEC60601-1 have been met.

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Clarus Medical 30000-GLS Endoscope

Unpacking the Endoscope The 30000-GLS has been thoroughly inspected and carefully packaged for shipping. Once the unit has been removed from its container, it should be carefully inspected for shipping damage. If there is any damage, contact the shipping carrier and Clarus Medical, LLC immediately. WARNING: Do not attempt to use the endoscope if it appears to be damaged. WARNING: The 30000-GLS endoscope and 30410 oxygen port are NOT sterile as supplied from Clarus Medical LLC. The user must follow their institutions protocol for cleaning, disinfecting or sterilization.

Inspection Prior to use, inspect the 30000-GLS endoscope for signs of wear or damage. Operation can be verified by following the steps in the Verifying Operation section of this manual. WARNING: Carefully inspect the external contact surfaces of the 30000GLS endoscope and any accessories to assure they are smooth and free of any protrusions or sharp edges which might cause injury to the patient or user.

Routine Maintenance There are no user serviceable parts within the 30000-GLS endoscope. No user maintenance is required. Refer all service or replacement needs to Clarus Medical LLC. The contact information is listed at the end of this manual.

Verifying Operation Following the steps listed below will help ensure the proper use and performance of the 30000-GLS endoscope. This will confirm the operation of the endoscope prior to a patient procedure or anytime the endoscope needs to be checked. WARNING: The 30000-GLS endoscope requires no external source of electrical power. DO NOT connect the 30000-GLS to a source of electrical power.

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Clarus Medical 30000-GLS Endoscope IMAGE QUALITY 1. The 30000-GLS can, for the most part, be checked by simply viewing through it with the eye and observing for a visual defect. When viewing with the eye the image should be immediately in focus. The 30000-GLS does not have a focus adjustment. 2. Make sure enough light is available before verifying an image with the 30000-GLS. Bright room lighting is usually enough light to produce a good image. 3. Normal operation will produce a focused discernable image to the user. The image should appear round and will include a grid pattern created by the characteristics of the fiberoptics of the endoscope. The grid like pattern is normal and should not be confused with being out of focus or the cause of a cloudy image. The 30000-GLS cannot clearly focus on an object closer than 5mm but will focus to infinity. 4. Image defects will appear as, no discernable image and complete darkness, no image but uneven light, or a view that is partially obstructed by dark or discolored spots. These defects are a result of damaged fiberoptics or eyepiece lenses and cannot be corrected by the user. See the Troubleshooting and Service section of this manual to obtain repair service. ILLUMINATION 1. The illumination capability of the 30000-GLS can be verified by attaching the endoscope to an ISO 7376-1 “Green-Line” battery operated light source. Once connected, the distal tip of the endoscope will cast visible light from its tip and can be observed on any surface to which the endoscope is directed. 2. Normal illumination will disperse a uniform circular field of light onto the target surface. Figure 3: Typical light emitting from 30000-GLS when connected to an ISO 7376-1 “Green Line” light source

The design of a 30000-GLS fiberoptic endoscope was undertaken to assure maximum durability. It is important to note that the nature of glass fiber optics is such that when repeatedly used some fibers will be stressed and eventually broken. Endoscopes with broken fibers are not necessarily at the end of their useful life and can still provide useful service. The user must judge when an endoscope is no longer adequate for use but as a guide, when 10% of the image or illumination has been degraded or lost it is recommended that a replacement be acquired.

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Clarus Medical 30000-GLS Endoscope

Setup for Performing an Intubation Procedure Following the steps listed below will help ensure the proper use and best performance of the 30000-GLS endoscope. Follow these steps prior to a patient procedure. WARNING: This manual does NOT provide information for performing a patient procedure nor is it intended to replace physician training. Only trained, licensed, and certified physicians can perform patient procedures. WARNING: Precautions for intubation, such as proper positioning, suctioning, and pre-oxygenation should be observed when using the 30000-GLS. Determination of the proper placement of the Endo-tracheal tube in the trachea requires medical judgment and skill. Follow the steps below to setup the 30000-GLS endoscope in preparation for a procedure. Figure 4 below shows the 30000-GLS fully connected and ready for use.

Figure 4: 30000-GLS with O2 Port, endo-tracheal tube and Light Handle connected

1. Attach an ISO 7376-1 “Green Line” light handle to the Green Line Lock of the endoscope’s body. This connection is the same familiar connection used for most laryngoscope blades. Once connected and locked in place the light source will automatically turn on and light will emit from the distal tip of the endoscope.

Figures 5A and B: 30000-GLS and Green Line light handle Page 10 of 18 601221-003 Rev. F

Clarus Medical 30000-GLS Endoscope WARNING: The 30000-GLS endoscope emits visible light energy from its distal end when connected to a light source. Avoid looking directly at this emitted light or directing it toward others whenever the endoscope is withdrawn from the patient. WARNING: The endoscope and the Green Line light handle are free to separate when the handle is in the UN-LOCKED position. DO NOT lose control of either the light handle or the 30000-GLS endoscope when separating them. Dropping either device can cause damage and possibly incur patient injury. 2. The stainless steel shaft of the 30000-GLS is malleable and can be shaped to accommodate the patient anatomy and the preferences of the user. It is supplied with a 35 degree bend as this is often thought to be the optimal angle for an endo-tracheal tube placement stylet. Re shape the 30000-GLS by grasping with both hands and bend to the desired angle. The 30000-GLS has the durability to be bent multiple times. WARNING: Do not bend the 30000-GLS into a sharp radius of less than 32mm (1.25in). Avoid frequent or unnecessary bending.

Figure 6A: Stylet with nominal 35° bend as supplied from Clarus Medical

Figure 6B: Stylet bent to a user’s preference.

3. Acquire an endo-tracheal tube with a minimum inside diameter of 5.5mm. Make a determination of the length of the endo-tracheal tube and its fit onto the 30000-GLS. The tube most often requires its length to be adjusted by cutting the tube.

Figure 7: Cutting the ET Tube to the correct length

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Clarus Medical 30000-GLS Endoscope 4. Once the endo-tracheal tube is cut you must remove the proximal conical fitting and remove the remaining stub of tube. The conical fitting is then replaced onto the main tube.

Figures 8A and B: Replace the Conical fitting onto the main tube 5. After the endo-tracheal tube length is adjusted it is ready to be placed onto the 30000GLS. Slide the tube over the stainless steel shaft of the endoscope and press it securely into the “tube stop” of the endoscope. The “tube stop” is a receptacle for the conical fitting and is located at the proximal end of the endoscope’s stainless steel shaft. The use of a medical grade lubricant is recommended to aid in sliding the endotracheal tube onto the endoscope’s shaft. Apply an anti-fogging agent onto the distal lens of the endoscope.

Figure 9: Conical fitting of the endo-tracheal tube as it is about to be pressed into the 30000-GLS tube stop

Figure 10: Proper position of the endo-tracheal tube with respect to the 30000-GLS distal tip

6. You can confirm the proper tube length by observing the position of the end of the tube with respect to the endoscope’s distal tip. Proper alignment of the 30000-GLS into the endo-tracheal tube will provide optimal viewing of the patient anatomy and reduce the potential for trauma by avoiding direct contact of the endoscope with the mucosa. Figure 10 illustrates the correct positioning. Page 12 of 18 601221-003 Rev. F

Clarus Medical 30000-GLS Endoscope WARNING: Do not let the 30000-GLS endoscope extend beyond the distal end of the Endo-tracheal tube. 7. Application of patient Oxygen can be provided by using the endo-tracheal tube as a pathway while placed over the 30000-GLS. Attach the provided O2 port connector to the mating “hole” type receptacle on the side of the 30000-GLS main body. The hole is marked with a green dot. See Figure 11. The O2 port is pressed into the mating hole. The O2 Port is a barbed type fitting and can accept a wide range of tubes for supplying Oxygen.

Figure 11: Attachment of the O2 connector port. A green dot marks the location.

WARNING: The pressure and flow rate of Oxygen must be monitored to ensure that its application falls within a medically safe range. WARNING: Verify that adequate space exists for Oxygen egress between the outer wall of the endo-tracheal tube and the trachea. Failure to assure egress could result in a pneumothorax condition. WARNING: Awareness of the possibility of a gas embolism is required whenever compressed gases are used in a patient procedure. To minimize this risk, you must verify that adequate space exists for the egress of any patient applied gases. WARNING: Verify that the 30000-GLS endoscope has reached a temperature suitable for a patient procedure. If the endoscope is substantially below patient body temperature fogging of the optical surfaces will occur.

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Clarus Medical 30000-GLS Endoscope

Instructions for Cleaning, Disinfecting and Sterilization WARNING: The Clarus 30000-GLS and its accessories are provided nonsterile from Clarus Medical LLC. Before initial use and after each procedure, the external surfaces of the 30000-GLS should be cleaned. The 30000-GLS can be immersed in liquids and washed with mild cleaning agents. To clean, disinfect or sterilize the 30000-GLS follow CHART 1 below.

CHART 1 Compatible Cleaning, Disinfecting and Sterilization Methods

Method Emzymatic cleaning solutions Neutral pH soap and water Cidex™ 2.4% glutaraldehyde solution Cidex PA™ 0.08% peracetic acid solution Cidex OPA™ Tristel™ Chlorine Dioxide Sporox™ 0.85% phosphoric acid solution Ethylene Oxide gas (EtO) Steris ® process Sterrad ® process Autoclave, steam or heat

30000-GLS

30410 O2 Port

YES YES YES NO YES YES NO YES YES YES NO

YES YES YES YES YES YES YES YES YES YES NO

WARNING: Cleaning does not disinfect or sterilize the 30000-GLS or its accessories. Be sure to follow your institution’s specific cleaning and sterilization procedures in consultation with this manual. The user is responsible to ensure that their procedures result in disinfection or sterilization, whichever is required. WARNING: Do not use cold soak disinfecting or sterilization solutions that are not listed above without first contacting Clarus Medical, LLC to ensure compatibility. WARNING: Do not use caustic or harsh detergents to clean the 30000-GLS. The optical surfaces of the endoscope will be damaged from exposure to aggressive cleaning agents. WARNING: Do not reprocess the 30000-GLS using steam sterilization, autoclave, or dry heat. Use of these processes will result in damage to the instrument, and void its warranty. WARNING: The optics of the 30000-GLS will be damaged or degraded if left exposed to cleaning or disinfecting solutions for extended periods of time. Do not exceed the disinfectant solution manufacturer’s recommended exposure times for cleaning and disinfecting. Page 14 of 18 601221-003 Rev. F

Clarus Medical 30000-GLS Endoscope

WARNING: Do not allow liquids to dry on the proximal eyepiece window or the distal endoscope lens tip. Dried liquids are difficult to remove and will leave deposits that obscure the image of the endoscope. WARNING: Do not clean, disinfect, or sterilize the 30000-GLS or its accessories using an ultrasonic cleaner, washer sanitizer, washer pasteurizer, washer sterilizer, steam autoclave, or any method with a processing temperature above 60°C (140°F). WARNING: An endo-tracheal tube is intended for single use and cannot be effectively cleaned or sterilized. Do not attempt to re-use.

Compatible Cleaning Methods Enzymatic Cleaning Solutions Neutral pH soap and water Instructions for Cleaning 1. Follow the cleaning agent manufacturer’s instructions for use and precautions regarding health hazards, dispensing, measuring, and storage of cleaning agents. 2. If accessories such as a video camera or remote light source are being used, turn them OFF and then disconnect them from the 30000-GLS. 3. Remove the model 30410 O2 Port if present. 4. Place the components in a bath of enzymatic detergent that has been prepared according to the manufacturer’s instructions. Follow the detergent manufacturer’s recommended soaking cycle. 5. Use clean cotton gauze pads that are saturated with the detergent solution to wipe down all surfaces of the 30000-GLS and its accessories. Use soft brushes with the detergent solution to remove any residues from areas that cannot be reached with the gauze pads. 6. Rinse all components in cool (not cold) flowing de-ionized water for 45 to 60 seconds. 7. Blot dry the components using an individual sterile surgical towel.

Compatible Disinfecting Methods Cidex™ 2.4% Glutaraldehyde Solution Cidex™ PA 0.08% Peracetic Acid Solution Cidex OPA™ Tristel™ Chlorine Dioxide WARNING: Follow the disinfectant manufacturer’s instructions for disinfecting. WARNING: High level disinfecting does not result in terminal sterilization. Bacterial endospores may still remain viable after high level disinfecting. Page 15 of 18 601221-003 Rev. F

Clarus Medical 30000-GLS Endoscope High Level Disinfecting Using Cold Soaking Solutions 1. Select only the disinfecting solutions listed above in the Compatible Disinfecting Methods section of this manual. 2. Follow all recommendations regarding health hazards, dispensing, measuring and storage from the manufacturer of the cleaning and disinfecting agents. 3. Complete the previously described Instructions for Cleaning section of this manual before proceeding with high level disinfecting. 4. Soak the devices in the selected disinfecting solution per the solution manufacturer’s instructions for high level disinfecting. 5. Rinse the 30000-GLS and its accessories with copious amounts of sterile water, again following the instructions of the disinfecting solution manufacturer. 6. Blot dry the 30000-GLS with a clean and sterile cloth. Ensure that the distal tip and proximal end of the stylet are dried with the cloth. Air drying could leave deposits on these optical surfaces which could result in a degraded image.

Compatible Sterilization Methods Ethylene Oxide (EtO) gas STERIS PROCESS™ via STERIS SYSTEM 1 STERRAD Process™ EtO GAS STERILIZATION Process per your institutions validated procedures and process parameters. Temperatures are not to exceed 60ºC (140ºF). The following parameters are recommended guidelines. Preconditioning Exposure Parameters Temperature: Minimum Relative Humidity: Minimum Time: Maximum time between preconditioning and sterilization:

37.8 ±5.6º C 50% RH 20 Hours

(100 ± 10º F)

30 minutes

EtO Process Cycle Parameters Jacket Temperature: Pre-Vacuum: Humidity Injection Pressure Rise: Minimum Humidity Dwell: Nitrogen Injection: Ethylene Oxide Injection Pressure: Nitrogen Vaporizer Purge: Gas Exposure: Post Vacuum: Nitrogen Dilution: Secondary Post-Vacuum: Air Inbleed:

57.2 ±3.9ºC (135 ±7º F) 51 ±12.5mmHgA (2.0 ±0.5 inHgA) 38 ±12.5mmHg (1.5 ±0.5 inHg) 65 minutes 241 ±12.5mmHgA (9.5 ±0.5 inHgA) 203 ±25.4mmHg (8 ±1 inHg) 737 ±25.4mmHgA (29 ±1 inHgA) 4 +0.5,-0 Hours 63 ±12.5mmHgA (2.5 ±0.5 inHgA) 737 ±25.4mmHgA (29 ±1 inHgA) 63 ±12.5mmHgA (2.5 ±0.5 inHgA) atmosphere

Post Process Aeration parameters Temperature: Time:

43.4 ±5.6º C (110 ±10º F) 24 hours minimum

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(15-60 minutes) (10-20 minutes) (10-20 minutes) (10-20 minutes) (15-120 minutes) (15-120 minutes) (15-120 minutes) (15-120 minutes)

Clarus Medical 30000-GLS Endoscope STERIS SYSTEM 1® The 30000-GLS is compatible with STERIS SYSTEM 1 by STERIS® Corporation. Follow the instructions provided with the STERIS SYSTEM 1 for sterilization processing via this equipment and method. STERRAD® The 30000-GLS is compatible with STERRAD Sterilization System. Follow the instructions provided with the STERRAD Sterilization System for sterilization processing via this equipment and method.

Disposal of Waste Products The 30000-GLS does not produce any waste materials. However, the use of the 30000GLS endoscope along with a disposable endo-tracheal tube will produce biological waste and the need to dispose of the endo-tracheal tube. The tube must be regarded as containing human biological waste and must be processed and discarded according to your specific institution’s procedures for handling surgical waste. WARNING: Once used, the disposable endo-tracheal tube will contain biological and human tissue matter and must be handled accordingly. Refer to your institution’s specific procedures for proper handling. Do not discard the Endo-tracheal tube into common unmarked waste receptacles.

Troubleshooting and Service See the Verifying Operation section of this manual. This section can help to determine the normal operation of the 30000-GLS endoscope. There is no recommended corrective action for the user to remedy problems with the endoscope. All problems uncovered by the user will require the return of the endoscope to Clarus Medical LLC for repair.

Warranty Clarus Medical, LLC (“Clarus”), warrants this device, when new, to be free of defects in material and workmanship and to perform in accordance with Clarus' specifications when subject to normal use and service for a period of one year from the date of purchase from Clarus or an authorized distributor. Clarus, at its option, will either repair or replace any components found to be defective or at variance from manufacturer's specifications within this time at no cost to the purchaser. It shall be the purchaser's responsibility to return the device directly to Clarus after receiving a Returned Material Authorization Number from Clarus' Customer Service Department. Prior to returning the device, it shall be the purchaser's responsibility to clean and disinfect the device and to package it in a manner that minimizes the possibility of shipping damage. EXCEPT TO THE EXTENT PROVIDED ABOVE, CLARUS MAKES NO REPRESENTATION OR WARRANTY TO THE PURCHASER OR TO ANY THIRD PARTY, WHETHER WRITTEN, ORAL, STATUTORY, EXPRESS OR IMPLIED, CONCERNING THE DEVICE, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL CLARUS BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER FOR BREACH OF ANY WARRANTY, FOR BREACH OR REPUDIATION OF ANY OTHER TERM OR CONDITION OF SALE, OR FOR LIABILITY ON THE BASIS OF NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF CLARUS SHALL HAVE BEEN ADVISED IN ADVANCE OF THE LIKELIHOOD THEREOF. REPAIR OR REPLACEMENT OF THE DEVICE AS PROVIDED ABOVE SHALL BE THE SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF THE WARRANTY GIVEN ABOVE.

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Clarus Medical 30000-GLS Endoscope

Specifications Power Source No source of electrical power is required for the 30000-GLS endoscope Illumination Source ISO 7376-1 compatible “Green Line” battery operated light source Physical Properties Size Stainless steel shaft length 29cm (11.4in) Eyepiece and “Green Line Lock” section length 10.7cm (4.2in) Eyecup diameter 3.18cm (1.25in) Tube Stop 15mm conical fitting Weight Endoscope: 105.5 grams (3.72oz) O2 Port: 1.6 grams (0.06oz) Connectors One ISO ISO 7376-1”Green Line” compatible light source connector. One Clarus model 30410 Oxygen port connector One stylet shaft compatible with a 15mm conical fitting per ASTM F 1054-87 and -01 (Conical Fittings) and ASTM F 1243-89 Tracheal Tube Connectors. One DIN 58105:2000-06 compatible eyecup for direct viewing or attachment of external equipment. Accessories Included 2 30410 oxygen port tube connectors 1 Instruction manual Classifications 30000-GLS Endoscope, Class I Equipment Degree of Protection against Shock Type BF equipment Environmental Conditions Storage and transport Humidity: Temperature: Pressure:

10 to 100% (condensing) -20 deg. C to +60 deg. C 600 hPA to 900 hPA

Normal Operation Humidity: Temperature:

0-100% (condensing) +5 deg. C to +40 deg. C

Manufacturer Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, MN 55427 USA www.clarus-medical.com [email protected] Tel 763-525-8403

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