Gas Module 3 Operating Manual Rev C Sept 2010

DRYLINE™ is a trademark of Artema Medical AB Passport 2® is a U.S. registered trademark of Mindray DS USA, Inc. Spectrum® is a U.S. registered trademark of Mindray DS USA, Inc. Spectrum OR™ is a U.S. trademark of Mindray DS USA, Inc.

Copyright © Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.

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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®/Spectrum®/Spectrum OR™ ...2 - 4 Passport 2®/Spectrum® ...2 - 4 Spectrum OR™ ...2 - 6 Gas Module Troubleshooting ...2 - 8

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

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

NOTE:

Figures in this manual are provided for reference purposes 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.

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Introduction

Warnings

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 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. WARNING: Do not use this device during MRI (Magnetic Resonance Imaging) scanning. Induced current could potentially cause burns. Accuracy of measurements on this unit and the MRI unit may also be affected. WARNING: For continued protection against a fire hazard, replace all fuses with the specified type and rating. WARNING: Observe extreme caution when a defibrillator is used on a patient. Do not touch any part of patient, table, or monitor when a defibrillator is in use. WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e. 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. WARNING: Do not connect other equipment to the same MPSO with the Gas Module 3, as it may increase system leakage current. WARNING: Reliably attach Potential Equalization connector to the safety 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.

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Warnings

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™ Neonatal sampling lines (blue Luer lock nuts) with DRYLINE™ Adult/Pediatric water traps as this could result in incorrect measurement data. WARNING: Do not use DRYLINE™ Adult/Pediatric sampling lines (colorless Luer lock nuts) with DRYLINE™ 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.

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

CAUTION:

Contamination with CO2, 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.

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Gas Module 3 Operating Instructions

Symbols and Descriptions

Introduction

Symbols and Descriptions SYMBOL DESCRIPTION

SYMBOL

DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Type BF Equipment

Dangerous Voltage

Gas Port Input

Equipotentiality

Gas Port Output

Alternating Current (AC)

Direct Current (DC)

Data Input / Output

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

Manufacturer’s reference/catalogue number

For single-patient use only, do not reuse.

Manufacturer’s batch number

For Neonatal use

Serial number

Not for Neonatal use

Software Version

Conformité Européenne (CE) Marking of Conformity to European Medical Device Directive. CEXXXX represents the Notified Body number

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1.0

General Product Description

1.1

Front Panel 2 4

1

3

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

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Rear Panel

1.2

General Product Description

Rear Panel Mindray DS USA Inc.,

8

7

5

6

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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Gas Module 3 Operating Instructions

2.0

Operations

The menus shown in the following sections are from Mindray DS Passport 2®, Spectrum®, and Spectrum OR™ bedside monitors.

2.1

Gas Monitoring with Gas Module 3 The Gas Module option in Mindray DS bedside monitors allows for the measurement of anesthetic gases, O2, N2O and CO2 levels. Measurement can be acquired via a nasal cannula (non-intubated) for oxygen and CO2 only or through a sampling line connected to a breathing circuit (intubated).

FIGURE 2-1 Gas Menu NOTE:

Gas Module 3 Operating Instructions

The bedside monitor will interface to the Gas Module 3 via the Serial Port Connector on the Comm-Port that is mounted in the rear of the bedside monitor.

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Gas Monitoring with Gas Module 3

Operations

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. NOTE:

The Gas Module 3 is equipped with automatic barometric pressure compensation.

NOTE:

The Gas Module 3 uses a fixed correction of 11 hPa to compensate for the influence of water vapor in the gas sample, when converting the gas readings to ATPD. An increase in the ambient H20 partial pressure to 30 hPa (i.e. 28 °C, 80% RH or 33 °C, and 60% RH) will cause a general error for all gases of only -2% REL.

Monitoring Anesthetic Gases, O2, N2O and/or CO2 NOTE:

To prevent moisture from entering the pneumatic system, ensure that the Gas Module 3 is always installed and operated in the horizontal orientation shown in all graphical depictions.

1. Turn on the Gas Module 3 and the bedside monitor, and configure the bedside monitor serial port to be used with the Gas Module. Hold the DISCHARGE key in while powering unit on. Set alarms as desired.

Spectrum

™

7 Foot Nasal Cannula, CO2/O2 P/N 0683-00-0452-10

Patient

Monitor Setup

Print Setup

Parameters

Functions

05/09/02

13.35

JONES , ERIC

II

E C G

1 mV Mon

I S T

1 mV Mon

140

A R T

mmHg 60 40

Adult

HR

60

Lead II I V Sys

bpm

mm +2.2 - 2.1 - 3.0 Dia

0

Mean

121 / 81 94 21 / 12 14 10 mmHg

Sys

P A

mmHg

170 V A S 55 Source:Auto PVC/min: 45

Mean

Dia

mmHg

Mean

20

C V P

mmHg 0 10

I C P

mmHg -10

40

C O 2

mmHg 0

S P O 2 T T1 e m p

37.0

T2

CO

T

0.1

36.9

C

C O

CI

5.2

l / min

2.2

l / min / m 2 Source:Modul

N I B P

e

mmHg Sys/Dia (14/16)

Mean

4 Insp

Sys/Dia (5/2)

CPP

90

Exp

0/ 3 8 SpO2

mmHg mmHg

Source:CO2 Resp 14 rpm PR

97 Sys

60

% bpm Dia

180 / 120 Interval: ON

Off 94 MAP

122

mmHg ET: 13min

NIBP: Idle ECG

NIB P

A L A RM S

D I SP L A Y

PRIN T

LE AD

S TA RT

ZERO ALL IBP

LIMITS

STRIP

S TANDB Y

TRENDS

S IZE

INTERVAL

C.O.

MUTE ALL

CO NT E CG

DISCHARGE

FREEZE

V IE W

S TO P

PA WP

MUTE

P RINT TREND

MA RK EV ENT

NORMAL SCREEN

or

7 Foot Nasal Cannula, CO2 P/N 0683-00-0424-10

Adapter, Straight Tee ET P/N 0683-00-0242-22

2.5 Meter Sample Line, Patient Adult/Pediatric P/N 0683-00-0525-25 Neonate P/N 0683-00-0524-25

Gas Scavenging Adapter Assy. P/N 0997-00-0923 or P/N 0997-00-0984

Adapter, Mask Elbow ET P/N 0683-00-0242-12

FIGURE 2-2 Gas Module 3 Airway Adapter NOTE:

DRYLINE™ Sample Lines are for use with Gas Module 3 only.

2. For non-intubated patients, apply the nasal cannula to the patient. For intubated patients connect the sample line to the breathing circuit. Refer to instruction provided in the sample line packets. 3. Connect the other end of the nasal cannula or sample line to the Gas Module at the input port. Ensure all tubing connections are tight.

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Operations

Gas Monitoring with Gas Module 3

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. CAUTION:

Contamination with CO2, N2O or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors.

4. Check for a clean water trap. 5. Select CO2 or AUTO as the Resp Source in the Resp Menu. 6. Observe the capnogram on the monitor’s display. On bedside monitor powerup, O2, Agent and N2O numbers will display. CO2 numbers will be displayed when a valid breath is detected. NOTE:

The Gas Module 3 must be warmed up a minimum of 45 seconds for ISO accurate CO2, O2, N2O, and agent readings.

7. If not already set, use the Display Setup Menu to select the gas waveforms to be displayed. 8. If desired, the gas waveform speed can be changed via the Monitor Setup Menu and the scale can be changed in the Gas Menu.

2.1.1

Pre-use Test Prior to each use, perform the following test with the Gas Module 3 to verify that the gas analyzer and sample system are functioning properly: 1. Verify that the appropriate water trap is properly installed and that the appropriate sampling line is connected. • DRYLINE™ Adult/Pediatric water trap used with DRYLINE™ Adult/Pediatric sampling line (colorless Luer lock nut) • DRYLINE™ Neonatal water trap used with DRYLINE™ Neonatal sampling line (blue Luer lock nut) 2. Verify that the water trap container is less than half full. 3. Occlude the sampling line and verify that the occlusion alarm functions properly. 4. Breathe into the sampling line and verify that a CO2 waveform is correctly displayed on the monitor. 5. Sample room air for 30 seconds and verify that the monitor oxygen output is 20.95% (± sensor inaccuracy).

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Gas Monitoring with Gas Module 3

2.1.2

Operations

Gas Monitor Calibration - Passport 2®/Spectrum®/Spectrum OR™ Accuracy verification of the Gas Module 3 is recommended at one (1) year intervals or whenever gas readings appear to be in error. The date of the last successful mixture calibration appears at the bottom of the gas Calibration Menu. During the calibration session gas readings and all other gas functions are not available. Span calibration is a set of prompted commands that enables the operator to align the gas display(s) to specific gas concentration(s) within the Mindray DS Calibration Gas canister. Span calibration can be initiated by the operator any time the gas module’s readings are suspected to be inaccurate. Always verify accuracy using a full canister of Mindray DS approved precision calibration gas, after calibration is performed. Never use calibration gas that has expired, has a different concentration, or a canister that is indicating low pressure. The pressure indicator on the Mindray DS gas regulator must operate in the green zone during the entire calibration session. NOTE:

2.1.2.1

The Gas Module 3 must be fully warmed up before performing a gas calibration. For maximum accuracy, a warm-up time of 10 minutes is recommended.

Passport 2®/Spectrum® 1. Select Calibrate from the Gas Menu. The Calibration Menu opens. 2. Select Gas Selection from the Calibration Menu and choose the calibration gas type. Choices are: Mixture, 5% CO2, 55% O2, 33% N2O and 2% Des. 3. Select Start to begin calibration. 4. At the start of the calibration, the Gas Module will zero the gas channels. After successful zeroing, the Gas Module will request the calibration gas.

FIGURE 2-3 Calibration Menu

2-4

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Operations

Gas Monitoring with Gas Module 3

NOTE:

If the Gas Module cannot zero, a zeroing error will be displayed and the previous calibration data will be restored. Repeat the calibration procedure from step 1. If problems persist, contact Mindray DS Technical Support.

5. The message Feed Calibration Gas will appear. At this point, attach the calibration gas canister to the regulator and turn it on. Increasing gas values will appear in the window as the Gas Module samples the calibration gas.

FIGURE 2-4 Gas Calibration Menu

FIGURE 2-5 Gas Calibration Menu

6. When sampling is complete, the Feed Calibration Gas message will disappear and Adjusting will appear next to each value. An Accept menu item will also appear. If the values are acceptable, select Accept. To cancel calibration and re-install the previous calibration values, select Abort.

FIGURE 2-6 Gas Calibration Menu

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Gas Monitoring with Gas Module 3

2.1.2.2

Operations

NOTE:

To avoid premature emptying of the gas canister, always remove the regulator at the end of the procedure.

NOTE:

If any input data is corrupt or if there are other errors, a “Calibration Error” message will appear after the “Accept” button is selected. The Gas Module 3 will not accept span calibration with errors in any channel.

Spectrum OR™ 1. Select Calibrate from the Gas Menu. The Calibration Menu opens.

FIGURE 2-7 Calibration Menu 2. Select Gas Selection from the Calibration Menu and choose the calibration gas type. Choices are: Mixture, 5% CO2, 55% O2, 33% N2O and 2% Des. 3. Select Start to begin calibration. At the start of the calibration, the message Zeroing… will be initially displayed for each of the gas labels as the Gas Module zeros the gas channels. After successful zeroing, the Gas Module will request the calibration gas as indicated in the next step. NOTE:

2-6

If the Gas Module cannot zero, a zeroing error will be displayed and the previous calibration data will be restored. Repeat the calibration procedure from step 1. If problems persist, contact Mindray DS Technical Support.

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Gas Module 3 Operating Instructions

Operations

Gas Monitoring with Gas Module 3

4. The message Feed calibration gas will be displayed. At this point, attach the calibration gas canister to the regulator and turn it on. Increasing gas values will appear in the window as the Gas Module samples the calibration gas.

FIGURE 2-8 Gas Calibration Menu

FIGURE 2-9 Gas Calibration Menu

5. When calibration is complete, the Feed calibration gas message will be removed from the display and the message Complete will be displayed next to each value that was successfully measured. If at least one gas was successfully measured, the Accept menu choice will become available. If the values are acceptable, select Accept. To cancel calibration and re-install the previous calibration values, select Abort.

FIGURE 2-10 Gas Calibration Menu NOTE:

Gas Module 3 Operating Instructions

When the “Accept” menu choice is selected, the message “Disconnect calibration gas.” will be displayed. To avoid premature emptying of the gas canister, always remove the regulator at the end of the procedure.

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Gas Monitoring with Gas Module 3

NOTE:

2.1.2.3

2-8

Operations

If any input data is corrupt or if there are other errors, a “Calibration Error” message will appear after the “Accept” button is selected. The Gas Module 3 will not accept span calibration with errors in any channel.

Gas Module Troubleshooting MESSAGE/PROBLEM

REASON

SOLUTION

GM: Warming Up

Appears when the system has been turned on, and the sensors have not reached their stable operating temperature.

Wait for the message to go away. It takes up to five minutes for the device to warm up.

GM: Exhaust Blocked

Appears when the system detects a blockage at the exhaust gas outlet, as indicated by an increase in internal pressure.

Remove waste gas scavenging assembly, check if message disappears. Check exhaust line for blockage and clear if possible. If message persists contact Mindray DS Technical Support.

GM: Mixed Agents

Appears when more than one anesthetic agent is detected by the system.

Message will disappear when a single agent is detected again.

GM: Air Leak

Appears when the system detects a pneumatic leak.

Turn Gas Module and bedside monitor Off.

Also may appear when the Gas Module has been turned on without a sample line attached.

Install/check sample lines, filters, water trap and electrical connections.

Gas Module has been on for a long period of time without the bedside monitor being on.

Turn off Gas Module.Turn on Gas Module and bedside monitor.

GM: Replace Trap

Indicates residue build-up on the water trap membrane that is decreasing air flow.

Replace water trap reservoir.

GM: Occlusion

Appears when the system detects an obstruction in the sampling line or the water trap bottle is full.

Empty and rinse water trap. Change water trap if necessary. Check sampling line and filter for blockage, clear sampling line if possible. Replace sampling line and/or filter if necessary. Check exhaust line for blockage and clear if possible. If problem persists, contact Mindray DS Technical Support.

GM: Zero In Progress

Appears when the system is zeroing all of its channels. This appears whether initiated by the user or is automatic.

This is normal operation. Wait for message to clear.

GM: CO2 Zero Error

Appears when the system has been unable to successfully zero the CO2 sensor.

Manually start zeroing the system again. If problem persists, contact Mindray DS Technical Support.

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Gas Module 3 Operating Instructions