ENDO stratus GI Endoscopy CO2 Insufflator Instruction Manual

Table of Contents

I. Unpacking and Inspection...3 II. Introduction...3 Definitions...3 Indications for use...3 Contraindications...3 III. Warnings and Cautions...4 IV. Product Features...6 Safety Features...6 Theory of Operation...6 V. Technical Specifications...6 Electrical...6 Mechanical...7 CO2...7 Environmental requirements...8 Accessories...8 Replacement parts...8 VI. Front Panel Controls/Connections...9 VII. Rear Panel Connections...10 VIII. Setup and Operation...11 Initial Setup...11 Air hose attachment...11 Pre-procedure setup...11 Water warming...12 Operation...12 Shutdown...12

IX. Care and Maintenance...13 Cleaning...13 Maintenance...13 X. EMC Tables...14

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Instruction Manual

I. Unpacking and Inspection: Upon receiving the ENDO STRATUS® CO2 insufflator, ensure that the following items are included in the shipping box: • • • •

Base tray and water bottle holder Hardware for assembling water bottle holder Operator’s manual Power cord

READ THIS MANUAL THOROUGHLY BEFORE PROCEEDING WITH THE OPERATION OF THIS EQUIPMENT. The user manual is written at a level such that it can be understood by the intended users and is consistent with the education and training of users. These instructions should be stored and used for reference as needed. If there are any questions, please contact Customer Service - Service Department at 800-444-4729 / International: 01-782-594164

II. Introduction: Definitions: • • • • • • •

Throughout this document the ENDO STRATUS CO2 insufflator may be referred to as “unit” or “device” L/min – Liters per minute (flow) kPa – kilo Pascal (pressure) VAC – Volts Alternating Current (electrical potential) W – Watts Hz – Hertz (frequency) PSI – Pounds Per Square Inch (pressure)

Indications for Use: The ENDO STRATUS CO2 insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The ENDO STRATUS CO2 insufflator contains a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 to the patient that has been warmed to a target temperature 37°C.

Contraindications: The ENDO STRATUS CO2 insufflator should only be used by or under the direct guidance of a physician experienced in the standard practices of gastrointestinal endoscopy procedures. It should only be used for procedures where insufflation of the gastrointestinal tract is necessary to support navigation of the GI endoscope and performance of any necessary evaluation procedures. The device should not be used in any other method or for any other treatments or procedures. The device is contraindicated for laparoscopic or hysteroscopic insufflation. It must not be used for intrauterine distension. The device is contraindicated for CT colonography. Also, the device is not intended for use with or exposure to magnetic resonance imaging (MRI) systems. Do not use the device in an environment where it could be exposed to MRI systems.

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III. Warnings and Cautions SIGNAL WORDS: WARNING: Indicates a potentially hazardous situation which if not avoided, could result in death or serious injury. CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Safety Symbols:

Attention

Refer To Operating Instructions

Warning: Dangerous Voltage

Equipotentiality

DO NOT Allow Fingers To Contact Moving Parts.

Hot Surface

MR MR Unsafe

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WARNINGS A. To reduce risk of electrical shock, do not remove cover. Refer servicing to qualified service personnel. B. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. C. The ENDO STRATUS® CO2 insufflator is not suitable for use in the presence of a flammable anesthetic mixture with oxygen. D. The ENDO STRATUS CO2 insufflator shall be sold only by prescription for use by physicians/clinicians who are trained and qualified. E. Only qualified medical personnel in an acceptable medical facility should operate the ENDO STRATUS CO2 insufflator. F.

The ENDO STRATUS CO2 insufflator should be connected to a properly grounded receptacle marked “Hospital Grade” or “Hospital Only,” otherwise grounding reliability cannot be achieved.

G. Extreme precaution must be taken when handling liquids around electrical equipment. DO NOT operate the ENDO STRATUS CO2 insufflator if liquid has been spilled on the unit. H. Never place or stack the ENDO STRATUS CO2 insufflator on other electrical equipment other than the ENDO STRATUS irrigation pump. Electromagnetic or other interference may occur between the ENDO STRATUS CO2 insufflator and other electronic devices. The equipment or system should be observed to verify normal operation in the configuration in which it will be used. I.

The ENDO STRATUS CO2 insufflator should only be used in conjunction with other equipment whose safety against leakage currents has been established.

J.

The instructions contained in the operating manuals of any equipment to be used in conjunction with the ENDO STRATUS CO2 insufflator must be followed to avoid any possible hazard from incompatibility.

K. The instructions for use described in this manual MUST be followed. Otherwise, compromised safety, malfunction, injury to the operator and/or patient, or costly damage to the unit and other equipment may occur. L.

The ENDO STRATUS CO2 insufflator must be connected to an appropriate power source when loss of power source would result in an unacceptable risk.

CAUTION A. If emergency or abnormal function occurs, immediately turn off the power to the unit. B. Use only medical USP medical grade CO2 from a “D” or “E” size CO2 tank. C. Read and understand all warnings that come with your commercially available “D” or “E” sized CO2 tanks. D. Field-servicing of the ENDO STRATUS CO2 insufflator is limited to the replacement of the power cords, high pressure hoses, yoke adapters, water bottle holder and heater assemblies, and fuses. E. Remove power from the device before initiating any field servicing of the replacement parts. F.

There are no user serviceable parts inside this unit. Repairs to the ENDO STRATUS CO2 insufflator should only be performed by qualified service personnel. No user modification of this equipment is allowed.

G. When the low pressure warning indicator illuminates, exchange the CO2 tank as soon as possible to avoid loss of function. H. Always keep a spare full tank of CO2 nearby for quick access. I.

Always keep the CO2 tank in an upright position to avoid fluid entering the unit.

J.

Do not use the device if the enclosure is damaged or enclosure integrity has been compromised.

K. Do not attempt to operate the device before reading and understanding all sections of this manual. L. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in section X. M. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Do not expose the device to sources of electromagnetic interference such as CT equipment, diathermy equipment, cellular phones, RFID tags and metal detectors.

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IV. Product Features • • • • • • • •

Internal CO2 warmer eliminates cold CO2 Includes control for optional water bottle warmer to maintain water at close to body temperature Stackable with the ENDO STRATUS® irrigation pump Standard male luer lock output Uses standard “D” or “E” size CO2 cylinders Accepts input from wall CO2 with standard DISS type connection U  sable at CO2 input pressures lower than most comparable units, making efficient use of tank supply W  orks with disposable ENDO SMARTCAP® and ENDOGATOR® hybrid tubing for safety and compliance

Safety Features • • • • •

Dual inline pressure regulators ensure a constant pressure Additional mechanical pressure relief at ≤12 PSI prevents overpressure Low CO2 input pressure is indicated by a yellow light on the front panel On initial power up, gas flow is off until the flow knob is turned on CO2 warmer will not operate unless flow is initiated

Theory of Operation The ENDO STRATUS CO2 insufflator works by regulating CO2 from a tank source to a preset pressure and then controlling the output of CO2 to an GI endoscope system for ultimate delivery as a distention media in the gastrointestinal tract. The clinician will use the air/water valve on the GI endoscope and visual feedback of the GI endoscopic system to manually distend the gastrointestinal tract with CO2. The ENDO STRATUS CO2 insufflator contains a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 to the patient that has been warmed to a target temperature of 37°C with an upper tolerance of +3°C. Warming is achieved as CO2 flows across a heating element which can be switched on or off by the user, depending on if warming of the CO2 is desired. The heating of the CO2 is accomplished through an internal 20W heating element with dual redundant temperature sensors. The flow rate can be adjusted to low, medium or high settings depending on the desired rate of insufflation, with flow rates of 1.4 L/min, 2.4 L/min and 3.5 L/min maximum, respectively. When the unit is turned on, the CO2 flow and heating function are off by default. To initiate gas flow the user must turn the flow setting knob from the “off” position. The unit will detect gas flow and will not allow the heater to operate unless gas flow is detected. In addition, there is a low gas pressure sensor and the unit will indicate when the input CO2 pressure reaches 25PSI by illuminating a yellow light on the front panel. The unit also has an output to power the water bottle warmer. The water bottle heating element maintains the temperature of the water in a sterile water bottle at 37±3°C. It is controlled by dual temperature sensors for redundancy and safety.

V. Technical Specifications Electrical Specifications Input Voltage:

100-240 VAC

Input Frequency:

50-60 Hz

Power Consumption:

82 VA

Fuse Rating:

M10AL250V

Medium acting, 10 amp, low breaking capacity, 250 volt

Replace fuses only with those of same type and rating

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Certifications:

IEC-60601-1, IEC-60601-1-2, IEC-60601-2-18

Classification:

Class 1 Type B

IP rating (Ingress Protection):

IP24

WARNING: Grounding reliability can only be achieved when connected to a receptacle marked “Hospital Grade”.

Mechanical Specifications Physical Dimensions: Height Width Depth Weight

4 ¾” inches 121 mm 7 ¾” inches 13 ¾” inches 349 mm 10.5 pounds 4.8 kg

197 mm

CO2 Specifications Free Flow rates (maximum unrestricted output to GI endoscope system): Front panel setting Low: Medium: High:

1.4 L/min 2.4 L/min 3.5 L/min

GI Endoscopic Flow rates (approximate flow rate at GI endoscope output): Front panel setting Low: Medium: High:

0.6-0.9 L/min* 1.2-1.4 L/min* 1.5-1.8 L/min*

*These values are approximate and are based on testing with respective models of GI endoscopes. User results may vary depending on GI endoscope used, channel diameter, and channel length.

Output Connection: Male luer lock Input Connection:

¼” male flare fitting.

CO2 Heater:

20W, internal, flow through, with dual redundant temperature sensors.

CO2 Output temperature: 37°C (+3°C) Operating Pressure: Input Pressure

1900 PSI Maximum 25 PSI Minimum*

*The low pressure warning light will illuminate at 25 PSI or less, although the unit may still flow. It is recommended to replenish the CO2 supply when the light illuminates. Pressure regulator set point

8 PSI Maximum

Internal safety relief valve

≤12 PSI

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Environmental requirements: Operating Temperature: Operating Relative Humidity: Operating Pressure:

16° to 24°C (+61° to 75°F) 30% to 75% non-condensing 70 kPa-106 kPa_(10.2 PSI -15.4 PSI)

Storage Temperature: Storage Relative Humidity: Storage Pressure:

0° to 40°C (32° to 104°F) 10% to 95% non-condensing 70 kPa-106 kPa_(10.2 PSI -15.4 PSI)

Altitudes below 3000m

Accessory Items The ENDO STRATUS® CO2 insufflator is intended to be used only with the specific models of compatible tubing sets, connectors and accessories identified in the table below and/ or officially recommended by Medivators. Use of the device with accessories not identified in the table below or officially recommended by Medivators may result in incompatibility and/ or the risk of cross contamination and infection transmission.

Order Number

Description

100145CO2, 100145CO2U ENDO SMARTCAP® tubing for OLYMPUS®140/240, 160/260, 180/280 (24 hr Use) series GI Endoscopes 100150CO2, 100150CO2U (24 hr Use)

ENDO SMARTCAP tubing for OLYMPUS 100/200, 130/230 Series GI Endoscopes and PENTAX® GI Endoscopes

100165CO2, 100165CO2U (24 hr Use)

ENDO SMARTCAP tubing for FUJIFILM™ GI Endoscopes

100141 ENDO SMARTCAP™ adaptor for FUJIFILM™ 530 Series Colonoscopes (Single Use) 100605, 100605S ENDOGATOR® hybrid tubing for OLYMPUS 140/160/180 (24 hr Use) Series GI Endoscopes with OLYMPUS OFP or ENDOSTAT™ II Pump Irrigation Units 100606, 100606S ENDOGATOR hybrid tubing for OLYMPUS 140/160/180 (24 hr Use) Series GI Endoscopes with OLYMPUS AFU-100, OLYMPUS OFP or EGP-100 irrigation Units 100551 CO2 Source Tubing

Replacement parts Order Number

Description

EGA-7014

Power cord (E.U.)

EGP-042

Power cord (U.K.)

EGA-7011

High pressure hose

EGA-7012 Yoke adapter EGA-7010

Water bottle holder and warmer assembly

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VI. Front panel controls/connections NOTE: Note: All status indicator lights will be green during normal operation. 1.  On/Off push button Turns main power on or off to the unit

2.  Water warmer On/Off Push to turn water warmer on or off

3.  CO2 Flow control

Controls flow rate of CO2 output. The three levels are represented by three green indicators of “L”, “M”, and “H” which are illuminated to indicate the flow rate setting. The ability to quickly turn off CO2 flow is available by pressing the flow control knob in. This will immediately turn the flow of CO2 off and extinguish the CO2 flow light indicator. By turning the CO2 flow control knob off and then back to your desired flow rate setting (“L”, “M”, “H”) will restart the flow of CO2. The flow rates are as follows*:

Low – 1.4L/min Medium – 2.4L/min High – 3.5L/min

*Flow rates shown are maximum free flow measurements at output of unit Low gas pressure is indicated by the words “LOW PRESSURE” flashing to notify the user that the gas input pressure has fallen below 25PSI.

4.  CO2 gas output connector

Connect to tubing and GI endoscope. Standard male luer lock connector.

5. CO2 gas heater On/Off

Push to toggle CO2 gas heater On or Off 2

1

3

4

5

(The appearance of your device may differ slightly from picture shown above)

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VII. Rear Panel Connections 1.

Water bottle warmer connection Power connection for water bottle warmer Refer to section VIII for warmer explanation

2.

CO2 input connection For connecting a “D” or “E” sized CO2 tank. Use only pre-filtered medical grade CO2 gas.

3.

Equipotentiality (Earth Ground)

4.

AC power connection AC power input 100-240 VAC, 50-60HZ

WARNING: Use only the hospital grade power line cord supplied with this unit. Connect only to a power receptacle marked as hospital grade.

5.

Fuse receptacle

WARNING: 6.

Replace only with type and rating marked M10AL250V

Water bottle holder The water bottle holder contains the warming system for the water bottle and connects to the main ENDO STRATUS® CO2 insufflator by means of an electrical cable which plugs into the receptacle marked “water warmer”.

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2

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3

4

5

(The appearance of your device may differ slightly from picture shown above)

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VIII. Setup and Operation Initial Setup 1. Place the ENDO STRATUS® CO2 insufflator on a flat surface such as an accessory cart or other suitable working surface. 2. Before beginning, inspect the ENDO STRATUS CO2 insufflator for any signs of damage. 3. Connect the power cord to the back of the device. 4. Before connecting the power cord to the hospital grade wall receptacle, make sure the power is off, and no accessories are connected. Then plug the power cord into the wall receptacle. 5. Assemble the water bottle holder and warmer assembly in the following manner: A. The following supplies are necessary and can be found in a bag attached to the water bottle holder:

a.) Short Screws (2) b.) Long Screws (2) c.) Large Hex Key d.) Small Hex Key

B. Attach the water bottle holder to the base tray using the (2) small screws and small hex key.

C. Place the ENDO STRATUS CO2 insufflator on the base tray and install the (2) long screws using the large hex key.

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D. Adjust the water bottle hold-down bracket to fit the water bottles used by your facility. This is done by loosening the nut on the back and sliding the bracket up or down so it contacts the water bottle and then re-tightening the nut. 6.

Plug the water warmer cable into the receptacle marked “water warmer” on the back of the unit.

Air hose attachment Tools required: (not included) 9/16” open-end wrench ¾” open-end wrench

Accessories required: “D” or “E” size CO2 tank filled with medical grade CO2 (not included) High pressure hose Yoke adapter 1.

Assemble the high pressure hose and the yoke by tightening the hose with the 3/4” wrench while holding the yoke with the 9/16” open-end wrench.

2.

Unscrew the T-handle on the yoke to allow it to slip over the top post of the CO2 tank. The correct orientation is so that the two pins on the yoke line up with the two alignment holes on the tank. (CO2 tank is not included with system, purchase separately)

3.

After aligning the two pins, tighten the T-handle firmly.

4.

Tighten the other end of the high pressure hose and yoke assembly to the back of the ENDO STRATUS® CO2 insufflator. Hold the brass fitting with wrench and use a second wrench to

tighten the hose nut. DO NOT USE TEFLON TAPE OR THREAD SEALANT ON THE FITTINGS.

Pre-Procedure setup 1.

Open the valve on the CO2 tank approximately 1 turn.

2.

Turn the power switch to “On”

3.

Test the setup by turning the flow control knob position clockwise. Verify that there is CO2 flowing out the front output of the unit. If there is no CO2 observed out the front of the unit verify that the CO2 tank is full and check the connection outlined in air hose attachment above.

4.

Turn off the flow control knob.

5.

Connect the tubing to the front output of the device. Use only ENDO SMARTCAP® tubing or ENDOGATOR® hybrid tube set manufactured by MEDIVATORS.

6.

When using ENDO SMARTCAP™ CO2 source tubing, attach ENDO SMARTCAP source tubing to ENDO SMARTCAP tubing or ENDOGATOR hybrid tube set. Attach ENDO SMARTCAP tubing or ENDOGATOR hybrid tube set to the GI endoscope according to the manufacturer’s instructions.

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Water Pre-Warming 1.

The ENDO STRATUS® CO2 insufflator can be used to control the water bottle warmer system. The warmer system can maintain the temperature of bottles of sterile water at 37°C (±3°C). However, the system is not intended to raise the temperature of the water; therefore, pre-warming of the water bottle is required.

2.

The water bottle must be pre-warmed with a method such as a fluid warmer if warm water is desired. Water bottle pre-warming should be performed according to the following instructions: Place sterile water bottle in a fluid warming oven set to 37°±3°C. Do not exceed this temperature. If warm water is not desired, turn the water warmer on the pump off and place a bottle of room temperature sterile water on the water bottle holder.

NOTE: If the water warmer has been enabled and has exceeded the upper temperature set point limit, the water warmer’s switch indicator light will turn blue and the warmer will automatically shut off. If the switch indicator light is flashing blue, ensure the water warmer cable is plugged into the back of the unit. If it is connected and the light is flashing, this may indicate a problem with the unit. Contact technical service at 800-444-4729.

Read and become familiar with all manufacturer’s instructions on warming ovens and water bottles regarding maximum fluid temperatures. Never exceed 40°C during water pre-warming. Never use a microwave oven to warm a water bottle, as this could heat the water to a dangerously high temperature or could result in uneven warming.

CAUTION: The surface of the water bottle warmer may be hot to the touch.

Operation 1.

After the pre-procedure setup has been completed as outlined in section VIII, flow can be initiated.

2.

Turn the flow control knob to the first position. “L” will illuminate for “LOW”. If a higher flow rate is desired, turn the knob to the next position for “MEDIUM” and one more position for “HIGH”. “M” will illuminate for “MEDIUM” and “H” will illuminate for “HIGH”. The knob will turn freely in each direction, and will increase or decrease the flow rate accordingly. The ability to quickly turn off CO2 flow is available by pressing the flow control knob in. This will immediately turn the flow of CO2 off and extinguish the CO2 flow light indicator. By turning the CO2 flow control knob off and then back to your desired flow rate setting (“L”, “M”, “H”) will restart the flow of CO2. See section V for flow rates.

3.

If warming of the CO2 is desired, press the button for the CO2 heater. The button will illuminate green.

4.

If the device is attached to a water bottle warmer, and water warming is desired, press the button for water bottle warmer. The button will illuminate green.

5.

Use the appropriate air/water valve on the GI endoscope and visual feedback of the GI endoscopic system to manually distend the gastrointestinal tract with CO2.

Shutdown 1.

When the procedure is over, turn the knob counter clockwise until all lights are off, turn off the water bottle warmer (if attached) and turn off the CO2 heater.

2.

Turn off the main power switch and disconnect the tubing from the front of the unit.

3.

Discard the tubing according to the manufacturer’s instructions for proper disposal.

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IX. Care and Maintenance Cleaning •

Before cleaning ensure the power to the unit is turned off and the electrical cord unplugged.

•

The outside surface of the unit can be cleaned with a damp cloth, 70% isopropyl alcohol solution, or a 10% bleach with water solution as often as deemed necessary.

•

To disinfect the outside surface, use a mild disinfectant as needed according to the manufacturer’s instructions.

•

Do not use abrasive or harsh cleaners.

•

Do not allow liquid to enter the unit.

•

Do not sterilize the unit by any means.

Maintenance Servicing The device is not user serviceable (excluding the replacement parts listed in section V). Please contact Customer Service and obtain a Return Material Authorization (RMA) Number. The RMA number must accompany all units and paperwork for proper service or warranty work. Limited Warranty Subject to the terms below, Medivators Inc. (the “Company”) warrants that its products (the “Products”) will conform to the Company’s written specifications (where applicable) and will be free from defects in material and workmanship under normal use and service for the following periods (the “Warranty Period”): Endoscope reprocessors and associated equipment, and Irrigation Pumps: fifteen (15) months from date of shipment from the Company or one (1) year from the date of installation, whichever occurs first. Consumables, accessories, and Product service parts, including, but not limited to, endoscope hookups, filters, printers, printer supplies, test strips, accessory bags, and service parts for products: ninety (90) days from the date of installation or one hundred and twenty (120) days from the date of shipment, whichever occurs first. Disposable Products: warranted for single use. The Warranty Period will not in any case exceed the expiration date on the Product label. The warranty does not cover, and the Company will have no warranty obligation whatsoever with respect to, any damage to a Product caused by or associated with: (i) external causes, including without limitation, accident, vandalism, acts-of-God, power failure or electric power surges, (ii) abuse, misuse or neglect of the Product by the customer or use of unauthorized third party filters or other consumables and accessories, (iii) usage not in accordance with product instructions, (iv) the customer’s failure to perform required preventive maintenance, or (v) servicing or repair not authorized by the Company. Limitation of Remedy The warranty obligation of the Company hereunder is limited to (at its option) (i) the repair or replacement of the defective Products or any parts it deems defective, or (ii) a refund of the purchase price. This will be customer’s exclusive remedy for a covered defect. In order to recover under the warranty, the customer must notify the Company in the state (if in the U.S.A.) or the country of installation, of the defect (describing the problem in reasonable detail) prior to the expiration of the Warranty Period and within thirty (30) days of discovery of the defect. Upon receiving the Company’s official “Returned Material Authorization” (RMA), the customer must promptly return the defective part or Product to the Company (or the service center indicated on the RMA), freight and insurance prepaid. The Company will not be responsible for any damage during shipment.

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Warranty Disclaimer THE WARRANTY ABOVE IS THE COMPANY’S ENTIRE WARRANTY OBLIGATION TO THE PURCHASER OF PRODUCTS. IT IS IN LIEU OF ALL OTHER WARRANTIES OF THE COMPANY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND THE COMPANY DOES NOT REPRESENT OR WARRANT THAT ANY PRODUCT WILL MEET CUSTOMER’S REQUIREMENTS. THE COMPANY’S RESPONSIBILITY FOR DEFECTS IN A PRODUCT IS LIMITED SOLELY TO REPAIR, REPLACEMENT OR REFUND OF THE PURCHASE PRICE AS SET FORTH IN THIS WARRANTY STATEMENT. TO THE EXTENT PERMITTED BY LAW, THE COMPANY SHALL NOT, UNDER ANY CIRCUMSTANCES, BE LIABLE TO CUSTOMER FOR CONSEQUENTIAL, INCIDENTAL, INDIRECT, PUNITIVE OR SPECIAL DAMAGES OR LOSSES, INCLUDING WITHOUT LIMITATION, DAMAGES ARISING OUT OF OR IN CONNECTION WITH ANY MALFUNCTIONS, DELAYS, LOSS OF PROFIT, INTERRUPTION OF SERVICE, OR LOSS OF BUSINESS OR ANTICIPATORY PROFITS, EVEN IF THE COMPANY HAS BEEN APPRISED OF THE LIKELIHOOD OF SUCH DAMAGES OCCURRING. This Warranty gives the customer of Products specific legal rights, and customers may also have other rights which vary from jurisdiction to jurisdiction. In no event shall the Company’s liability exceed the original purchase price of the covered Product. No representative or agent of the Company has any authority to bind the Company to any other representation or warranty with respect to the Products, and the customer accepts the Products subject to all of the terms above. Disposal No special care is needed when disposing of the device.

X. EMC Tables Table 1 – Guidance And MANUFACTURER’S Declaration ELECTROMAGNETIC EMISSIONS For All ME EQUIPMENT And ME SYSTEMS Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The EGA-501/EGA-501E is intended for use in the electromagnetic environment specified below. The customer or user of the EGA-501/EGA-501E should ensure that it is used in such an environment. Emissions Test

Electromagnetic Environment-Guidance

Compliance

RF Emissions CISPR 11

Group 1

RF Emissions CISPR 11

Class A

Harmonics IEC 61000-3-2

Class A

Flicker IEC 61000-3-3

Complies

The EGA-501/EGA-501E uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The EGA-501/EGA-501E is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Table 2 – Guidance And MANUFACTURER’S Declaration Electromagnetic IMMUNITY For All ME EQUIPMENT And ME SYSTEMS Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The EGA-501/EGA-501E is intended for use in the electromagnetic environment specified below. The customer or user of the EGA-501/EGA-501E should ensure that it is used in such an environment. EN/IEC 60601 Test Level

Compliance Level

ESD EN/IEC 610004-2

±6kV Contact ±8kV Air

±6kV Contact ±8kV Air

EFT EN/IEC 610004-4

±2kV Mains ±1kV I/Os

±2kV Mains ±1kV I/Os

Mains power quality should be that of a typical commercial or hospital environment.

±1kV Differential ±2kV Common

±1kV Differential ±2kV Common

Mains power quality should be that of a typical commercial or hospital environment.

Immunity Test

Surge EN/IEC 61000-4-5

>95% Dip for 0.5 Cycle

Voltage Dips/ Dropout EN/IEC 610004-11

Power Frequency 50/60Hz Magnetic Field EN/IEC 610004-8

60% Dip for 5 Cycles 30% Dip for 25 Cycles

100% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles

>95% Dip for 5 Seconds

Note 1

3A/m

3A/m

Electromagnetic Environment – Guidance

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%

Mains power quality should be that of a typical commercial or hospital environment. If the user of the EGA-501/EGA-501E requires continued operation during power mains interruptions, it is recommended that the EGA-501/EGA-501E be powered from an uninterruptible power supply or battery.

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

Note 1 The EUT shuts off and must be manually restarted by the operator during a 5 second loss of AC Mains power.

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Table 4 – Guidance And MANUFACTURER’S Declaration Electromagnetic IMMUNITY For ME EQUIPMENT And ME SYSTEMS That Are Not LIFE-SUPPORTING Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The EGA-501/EGA-501E is intended for use in the electromagnetic environment specified below. The customer or user of the EGA-501/EGA-501E should ensure that it is used in such an environment. Immunity Test

EN/IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance Portable and mobile communications equipment should be separated from the EGA-501/EGA-501E by no less than the distances calculated/listed below: D=(3.5/V1)(Sqrt P)

Conducted RF EN/IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated RF EN/IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

D=(3.5/E1)(Sqrt P) 80 to 800 MHz

(3)Vrms)

D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz (3)V/m)

Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.

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Table 6 – Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The EGA-501/EGA-501E EQUIPMENT and SYSTEMS That Are Not LIFE-SUPPORTING Recommended Separations Distances for the EGA-501/EGA-501E The EGA-501/EGA-501E is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the EGA-501/EGA-501E can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the EGA-501/EGA-501E as recommended below, according to the maximum output power of the communications equipment. Max Output Power (Watts)

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

D=(3.5/V1)(Sqrt P)

D=(3.5/E1)(Sqrt P)

D=(7/E1)(Sqrt P)

0.01

.1166

.1166

.2333

0.1

.3689

.3689

.7378

1

1.1666

1.1666

2.3333

10

3.6893

3.6893

7.3786

100

11.6666

11.6666

23.333

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MODELL: EGA-501 MODELL: EGA-501E

CO2-Insufflator für die gastrointestinale Endoskopie - Bedienungsanleitung

Manufactured in the USA by: Medivators 3150 Pollok Drive Conroe, TX 77303 Tel: +1.939.539.0391

Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 USA Toll Free: +1.800.444.4729

Medivators BV Sourethweg 11 6422PC Heerlen The Netherlands Tel: +31.45.5.471.471

www.medivators.com MEDIVATORS®, ENDO STRATUS®, ENDO SMARTCAP®, und ENDOGATOR® sind Marken oder eingetragene Marken von Medivators Inc. FUJIFILM™ ist eine eingetragene Marke der Fujifilm Corporation. OLYMPUS® ist eine eingetragene Marke der Olympus Corporation. PENTAX® ist eine eingetragene Marke der Hoya Corporation. ENDOSTAT™ ist eine Marke der Boston Scientific Corporation.

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MODELO: EGA-501 MODELO: EGA-501E

Manual de instrucciones del insuflador de CO2 para gastroscopia

Manufactured in the USA by: Medivators 3150 Pollok Drive Conroe, TX 77303 Tel: +1.939.539.0391

Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 USA Toll Free: +1.800.444.4729

Medivators BV Sourethweg 11 6422PC Heerlen The Netherlands Tel: +31.45.5.471.471

www.medivators.com

MEDIVATORS®, ENDO STRATUS®, ENDO SMARTCAP® y ENDOGATOR® son marcas comerciales o registradas de Medivators Inc. FUJIFILM™ es una marca registrada de Fujifilm Corporation. OLYMPUS® es una marca registrada de Olympus Corporation. PENTAX® es una marca registrada de Hoya Corporation. ENDOSTAT™ es una marca comercial de Boston Scientific Corporation.

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