Mindary Module-3 Operating Instructions

Operating Instructions

™

Gas Module

DRYLINE™ is a trademark of Artema Medical AB

Passport 2

Spectrum

Spectrum OR

is a U.S. registered trademark of Mindray DS USA, Inc.

™

is a U.S. trademark of Mindray DS USA, Inc.

orm without permission of Mindray DS USA, Inc.

0070-10-0696-02 Gas Module 3 Operating Instructions

Table of Contents

Foreword....................................................................................................................................................... ii

Patents........................................................................................................................................................... ii

Warnings, Cautions and Notes ........................................................................................................................ii

Warnings ......................................................................................................................................................iii

Cautions ........................................................................................................................................................ v

Notes ............................................................................................................................................................v

Indication For Use........................................................................................................................................... v

Unpacking .....................................................................................................................................................v

Symbols and Descriptions ................................................................................................................................ vi

General Product Description.............................................................................................. 1 - 1

Front Panel.....................................................................................................................................................1 - 1

Rear Panel .....................................................................................................................................................1 - 2

Operations ....................................................................................................................... 2 - 1

Gas Monitoring with Gas Module 3..................................................................................................................2 - 1

Pre-use Test ............................................................................................................................................. 2 - 3

Gas Monitor Calibration - Passport 2

Passport 2 Spectrum OR

Gas Module Troubleshooting ............................................................................................................ 2 - 8

/Spectrum®....................................................................................................................2 - 4

™

................................................................................................................................. 2 - 6

/Spectrum®/Spectrum OR™...............................................................2 - 4

User Maintenance.............................................................................................................3 - 1

Care and Cleaning of Gas Module...................................................................................................................3 - 1

Accessories ....................................................................................................................... 4 - 1

Appendix ......................................................................................................................... 5 - 1

Environmental and Safety Characteristics........................................................................................................... 5 - 1

Agency Compliance........................................................................................................................................5 - 2

Electromagnetic Capability ..............................................................................................................................5 - 3

Warranty Statements.......................................................................................................................................5 - 7

Phone Numbers and How To Get Assistance......................................................................................................5 - 9

Mindray DS’s Responsibility .............................................................................................................................5 - 9

Gas Module 3 Operating Instructions 0070-10-0696-02 i

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Gas Module 3 Operating Instructions 0070-10-0696-02 1 - ii

Foreword Introduction

Foreword

The Gas Module 3 Operating Instructions manual is intended to provide information for proper operation.

General knowledge of monitoring of airway gases and an understanding of the features and functions of the Mindray DS Gas Module 3 are prerequisites for its proper use.

NOTE: Do not operate this device before reading these instructions.

Information for servicing this instrument is contained in the Gas Module Service Manual Addendum, part number 0070-00-0522. For additional information or assistance, please

contact an authorized Mindray DS representative in your area.

CAUTION: U.S. Federal Law restricts this device to sale by or on the

NOTE: Figures in this manual are provided for reference purposes

order of a physician or other practitioner licensed by state law to use or order the use of this device.

only. Screens will likely differ based on the monitoring device configuration, licenses available, parameters selected and patient configuration of the bedside monitor.

Patents

This device is covered under one or more of the following U.S. Patents: 6,589,028, 6,896,713, and foreign equivalents. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Warnings, Cautions and Notes

Please read and adhere to all Warnings, Cautions and Notes listed here and in the appropriate areas throughout this manual.

A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user.

A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects.

A NOTE is provided when additional general information is applicable.

Gas Module 3 Operating Instructions 0070-10-0696-02 ii

Introduction Warn ings

Warnings

WARNING: Internal Electrical Shock Hazard - This unit does not contain

any user-serviceable parts. Do not remove instrument covers. Refer servicing to qualified personnel.

WARNING: Trace Gas Hazard - When using the Gas Module 3, a health

WARNING: Do not use this device during MRI (Magnetic Resonance

WARNING: For continued protection against a fire hazard, replace all

WARNING: Observe extreme caution when a defibrillator is used on a

WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e.

WARNING: Do not connect other equipment to the same MPSO with the

WARNING: Reliably attach Potential Equalization connector to the safety

hazard exists when trace amounts of vaporized anesthetic agents are chronically inspired by operating room personnel. See Appendix A in NFPA 56A on Inhalation Anesthetics. During any procedure where such agents are employed, the Gas Module 3 exhaust output should be connected to a medical gas-scavenging system.

Imaging) scanning. Induced current could potentially cause burns. Accuracy of measurements on this unit and the MRI unit may also be affected.

fuses with the specified type and rating.

patient. Do not touch any part of patient, table, or monitor when a defibrillator is in use.

Multiple outlet extension cords) used with the Gas Module 3 on the floor. Connect only a bedside monitor to the same MPSO as the Gas Module 3. Do not overload the MPSO.

Gas Module 3, as it may increase system leakage current.

ground when interconnecting the Gas Module 3 with other medical or non-medical electrical equipment to minimize the risk of excessive leakage current and/or shock hazard.

WARNING: Do not reuse disposable devices.

WARNING: Compressed gasses are considered Dangerous Goods/

Hazardous Materials per I.A.T.A. And D.O.T. regulations. It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and/or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information.

WARNING: Do not use a damaged or broken unit or accessory.

WARNING: When using the Gas Module 3, the maximum sampling rate

at the nasal cannula is 200 ml/min with an Adult/Pediatric water trap and 120 ml/min with a Neonatal water trap. This device should not be used on patients whose breathing could be impaired by this vacuum flow rate.

iii 0070-10-0696-02 Gas Module 3 Operating Instructions

War nin gs Introduction

WARNING: Connection of the Gas Module 3 exhaust port to the

hospital’s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. Vacuum (negative pressure) should not exceed 1 mmHg at the Gas Module Pump Exhaust fitting. Excessive scavenge vacuum may result in damage to the Gas Module’s internal pump.

WARNING: The use of gas sampling accessories in Gas Module 3 other

than specified by Mindray DS may cause significant measurement errors and patient risk.

WARNING: Use of accessories, transducers and cables other than those

specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Gas Module 3.

WARNING: With the exception of stacking under a bedside monitor

with the appropriate mounting brackets, the Gas Module 3 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Gas Module 3 should be observed to verify normal operation in the configuration in which it will be used.

WARNING: If the water trap breaks or becomes damaged during

operation, there is a risk that bacteria and/or mucus may contaminate the Gas Module.

WARNING: Do not use Adult/Pediatric type water traps and/or

sampling lines with neonates to avoid high sampling flow.

WARNING: The Gas Module must not be used with flammable

anesthetic agents.

WARNING: The Gas Module water trap, sampling line and airway

adapter should be disposed of in accordance with local regulations for contaminated and biologically hazardous items.

WARNING: Do not clean the Gas Module while it is on and/or plugged

in.

WARNING: Connect only DRYLINE

™

gas sampling lines to the water trap. Note that there may be other compatible tubes present that must not be used, e.g. IV lines.

WARNING: Do not use DRYLINE

lock nuts) with DRYLINE

™

Neonatal sampling lines (blue Luer

™

Adult/Pediatric water traps as this

could result in incorrect measurement data.

™

WARNING: Do not use DRYLINE

(colorless Luer lock nuts) with DRYLINE

Adult/Pediatric sampling lines

™

Neonatal water

traps as this could result in incorrect measurement data.

WARNING: The contents of the water trap should be handled as a

potential infection hazard.

™

WARNING: Do not use other cleaning methods for the DRYLINE

water traps. Do not clean or wash the filter housing of the water trap. Never allow alcohol to enter the filter housing. Never force air through the water trap.

Gas Module 3 Operating Instructions 0070-10-0696-02 iv

Introduction Cautions

Cautions

CAUTION: Use recommended Mindray DS supplied power cords. If a

substitute is necessary use only hospital grade power cords.

CAUTION: The internal sampling system of the Gas Module does not

need to be cleaned or sterilized. There is no reverse flow back to the patient. If the internal sampling system is suspected to be clogged or dirty, the module should be serviced by an authorized service person only.

CAUTION: To avoid permanent damage, do not expose metal

components (pins, sockets, snaps) to disinfectants, soaps or chemicals.

CAUTION: Gas Module 3 must be moisture protected whenever

CAUTION: Contamination with CO

transported. This can be done with a protective plastic bag in which water-absorbing materials (e.g. silica gel) have been included.

, N2O or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors.

Notes

NOTE: Potential hazards due to errors in software or hardware

have been minimized by actions taken in accordance with IEC 60601-1-4.

Indication For Use

The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

Unpacking

Remove the instrument from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Mindray DS Service Department at (800) 288-2121 or (201) 995-8237 for prompt assistance in resolving shipping problems.

v 0070-10-0696-02 Gas Module 3 Operating Instructions

Symbols and Descriptions Introduction

Symbols and Descriptions

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Dangerous Voltage Gas Port Input

Equipotentiality Gas Port Output

Alternating Current (AC) Direct Current (DC)

Data Input / Output

Type BF Equipment

Interference may occur in the vicinity of equipment marked with this symbol

Crossed out wheelie bin indicates separate treatment from general waste at end of life

For single-patient use only, do not reuse.

For Neonatal use Serial number

Not for Neonatal use Software Version

Conformité Européenne (CE) Marking of Conformity to European Medical Device Directive. CE

represents the Notified Body number

XXXX

Manufacturer’s reference/catalogue number

Manufacturer’s batch number

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Gas Module 3 Operating Instructions 0070-10-0696-02 vii

1.0

General Product Description

1.1 Front Panel

FIGURE 1-1 Gas Module 3 - Front Panel

1. Input Port

This port is used to connect the sampling tubing to the Gas Module 3.

2. Water Trap Assembly (includes Water Trap Reservoir)

(Adult/Pediatric P/N 0202-00-0182-10, Neonate P/N 0202-00-0181-10)

The Water Trap Assembly is used to capture moisture drawn in with the patient sample. The Water Trap Reservoir must be emptied and rinsed (with water only) whenever more than half full or whenever changing patients. Refer to section 3.1 for more details.

3. Power Indicator Lamp

This lamp illuminates when the Power Switch is in the ON position.

4. Power Switch

A switch used to power the unit ON and OFF.

Gas Module 3 Operating Instructions 0070-10-0696-02 1 - 1

Rear Panel General Product Description

1.2 Rear Panel

Mindray DS USA Inc.,

FIGURE 1-2 Gas Module 3 - Rear Panel

5. AC Power Input

This input is used to attach the special “Y” Shaped Power Cord.

6. Exhaust Port

This panel mount coupling is used for attaching a gas scavenging system (P/N 0997-00-0923 or P/N 0997-00-0984) to the Gas Module 3.

7. External Interface Port

A communication interface port used to connect the Gas Module 3 to a Mindray DS bedside monitor (Passport 2®, Spectrum®, and Spectrum OR™).

8. Equipotential lug

Provides Equipotential grounding of hospital equipment.

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