ZOLL E Series User Manual

October 2007 9650-1212-01 Rev. E

End Tidal Carbon Dioxide (EtCO

)

The issue date or revision level for this Operator’s Guide is shown on the front cover. ZOLL and E Series are registered trademarks of ZOLL Medical Corporation. CAPNOSTAT is a registered trademark and LoFlo and CAPNO

Novametrix LLC. Cidex is a registered trademark of Advanced Sterilization Products, a Johnson & Johnson Company.

Nafion is a registered trademark of DuPont. System 1 is a registered trademark of the Steris Corporation.

mask are trademarks of Respironics

END-TIDAL CARBON DIOXIDE (EtCO2)

General Information

Product Description

ESeries® units equipped with software revision 2.00.000 or higher support two End Tidal Carbon Dioxide (EtCO2) monitoring options for the continuous measurement of respiratory carbon dioxide (CO2) and respiration rate. These options use the same connector on the E Series unit and may be used interchangeably.

The first option uses a unique, mainstream, solid-state, infrared sensor called the CAPNOSTAT® 5 Mainstream CO2 Sensor. The CAPNOSTAT 5 CO2 sensor is attached to an airway adapter that connects to an endotracheal (ET) tube or other airway and measures gases flowing through these breathing circuit components. A disposable mouthpiece may be connected to the adapter for monitoring non-intubated patients. A CAPNO with non-intubated patients. This option provides for O

The second option is a sidestream sampling system called the LoFlo™ CO2 Module. The LoFlo module contains a gas sampling pump, which draws small samples of gas from the patient’s airway via a nasal/oral cannula or airway adapter, and passes these gases through a solid state infrared sensor (located away from the patient’s airway) that measures

. While the sidestream system is typically used on non-intubated patients, it can also be used for EtCO2

measurement on intubated infant, pediatric and adult patients. The sidestream system should not be used, however, on patients who cannot tolerate the 50ml/min removal of the sample gases from their breathing circuit. The sidestream module uses specially designed cannulas and airway adapters for sampling airway gases and passing them through an integrated sample cell, which connects to the LoFlo module’s CO sample cell, providing maximum filtration of fluids and contaminants, and protecting the system from aspiration of these fluids.

In both systems, the CO2 sensor generates infrared light and beams it through the airway adapter or sample cell to a detector on the opposite side. CO2 from the patient, flowing through the mainstream airway adapter or sample cell, absorbs some of this infrared energy. The ESeries unit determines CO measuring the amount of light absorbed by gases flowing through the airway or sample cell.

The E Series unit disp lays EtCO numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, the unit can display a capnogram. This capnogram is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal (ET) tube placement. The unit calculates respiration rate by measuring the time interval between detected peaks of the CO those caused by cardiogenic oscillations and artifact.

(the concentration of carbon dioxide detected at the end of each exhalation) as a

waveform. The technology differentiates between waveforms caused by breathing and

delivery while monitoring expired CO2.

sensor. These cannulas incorporate a filter and

concentration in the breathing gases by

mask™ is also available for use

How to Use This Manual

This section explains how to set up and use the E Series End Tidal Carbon Dioxide option. Important safety information relating to general use of the E Series End Tidal Carbon Dioxide monitor appears in the “Safety Considerations” section of this manual.

The E Series Operator’s Guide provides information operators need for the safe and effective use and care of the ESeries unit. It is important that persons using this device read and understand all the information contained therein.

Please read both safety considerations and warnings sections thoroughly before operating your E Series unit. All CAPNOSTAT 5 sensor, LoFlo module, airway adapter and cannula questions with regards to the Declaration of

Conformity with European Union Directives should be directed to the authorized representative for Respironics Novametrix LLC:

Respironics Novametrix LLC Authorized European Contact

Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany +49 8152 93060

9650-1212-01 Rev. E 1

E Series - End Tidal Carbon Dioxide (EtCO2) Option Insert

Safety Considerations

WARNINGS

General

• Carefully read the E Series Operator’s Guide and these operating instructions before operating the

monitoring option.

EtCO

• Ensure that the E Series EtCO2 option is operated by qualified personnel only.

• Do not use the E S eries EtCO2 option as an apnea monitor.

• Do not immerse the E Series unit, patient cables, or sensors in water, solvents, or cleaning solutions.

• If the accuracy of any reading is suspect, first check the patient’s vital signs by alternate means and then check the E Series EtCO

option for proper

operation.

• If an alarm condition occurs while the alarms are suspended, the suspended alarm indications will only be visual displays and symbols. No audio alarm indications will occur.

CAPNOSTAT and Accessories

• Always ensure the integrity of the patient breathing circuit after insertion of the airway adapter by verifying a proper CO

waveform (capnogram) on

the monitor display.

• Elevated oxygen levels, nitrous oxide, or halogenated agents contained in the breathing gases may degrade the accuracy of measurements made with the E Series EtCO oxygen compensation if O are introduced. Activate N

option. Activate

levels in excess of 60%

O compensation if nitrous

oxide is introduced into the airway circuit. The presence of Desflurane beyond 5% may positively bias the carbon dioxide reading by up to 3 mmHg.

• Do NOT use the LoFlo module on patients who cannot tolerate the removal of 50ml/min of breathing gases from the airway.

• Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

• Do not touch the bed, patient, or any equipment connected to the patient during defibrillation. A severe shock can result. Do not allow exposed portions of the patient’s body to come in contact with metal objects, such as a bed frame, as unwanted pathways for defibrillation current may result.

• Do not use CAPNOSTAT 5 or LoFlo sensors in the presence of flammable anesthetics or other flammable gases.

• Do not attempt to open the sensor. An electrical shock hazard exists internally. Refer servicing to qualified personnel.

2 9650-1212-01 Rev. E

Safety Considerations

CAUTIONS

• CAUTION: Federal (U.S.A.) law restricts this device to sale, or use by or on the order of a licensed medical practitioner.

• Use only ZOLL/Respironics Novametrix CAPNOSTAT 5 sensors and LoFlo modules, airway adapters, nasal and nasal/oral cannula sets with the E Series EtCO

option.

• The device is protected against interference from

radio frequency emissions typical of two-way radios and cellular phones (digital and analog) used in emergency service/public safety activities. Users should assess the device’s performance in their typical environment of use for the possibility of radio frequency interference from high-power sources. Radio Frequency Interference (RFI) may be observed as shifts in monitor baseline, trace compression, display brightness changes or transient spikes on the display.

• Do NOT sterilize or immerse the CAPNOSTAT 5 CO

sensor or LoFlo module.

• Do NOT reuse or sterilize the disposable airway adapter, airway adapter with mouthpiece, CAPNO sets, or airway adapters, as system performance will be compromised. These items are intended for single patient use only.

• Do NOT use a damaged sensor or airway adapter.

• Do NOT use the device if it fails to operate properly.

• Do NOT place the mainstream or sidestream airway adapters between the ET tube and the breathing circuit elbow, as this may allow patient secretions to accumulate in the adapter.

• Position airway adapters with windows in a vertical, NOT a horizontal, position. This helps keep patient secretions from pooling on the windows.

• Do NOT insert any object other than the sample cell into the sample cell receptacle on the LoFlo module.

mask, nasal or nasal/oral sampling cannula

• Remove the LoFlo sample cell from the sample cell receptacle when not in use.

• Clean or replace the airway adapter if excessive secretions are observed.

• ZOLL Medical Corporation recommends that the airway adapter be removed from the circuit whenever aerosolized medication is delivered. The increased viscosity of the medications may contaminate the adapter windows, requiring premature cleaning or replacement of the adapter.

• In order to eliminate the potential build up of CO

inside the storage bag, ensure that the LoFlo module exhaust tube vents gases away from the module environment.

• To avoid injury to the patient, remove the nasal/oral cannula from the patient before cutting the oral cannula tip.

• Do NOT apply tension to the sensor cable.

• Periodically inspect the sampling tubing for the absence of kinks.

• Monitor the capnogram for an elevated baseline. If an elevated baseline is observed, verify patient condition first. If the care giver determines that the patient condition is not contributing to the elevated baseline, follow the instructions for zeroing the sensor or module detailed in this manual.

• Do NOT store sensors, modules, airway adapters, or cannula sets at temperatures less than -40° C or greater than 70° C.

• Do not operate CAPNOSTAT sensors at temperatures less than 0° C or greater than 45° C. Do not operate LoFlo modules at temperatures less than 0° C or greater than 40° C.

• Refer servicing to qualified personnel.

• Do not use the LoFlo module on E Series units that have a software version lower than 2.00.000.

9650-1212-01 Rev. E 3

E Series - End Tidal Carbon Dioxide (EtCO2) Option Insert

Proper Grasp

Improper Grasp

Figure 1

EtCO2 Indications for Use

The ZOLL E Series EtCO2 option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, or anesthesia. The E Series

option with Respironics Novametrix technology

EtCO

supports two methods for continuous measurement of end tidal carbon dioxide (EtCO

The first method uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece.

The second method uses the LoFlo CO2 module to monitor both non-intubated and intubated patients using specially designed sampling cannulas and airway adapters.

The E S eries EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.

The following substances can influence CO measurements made with the CAPNOSTAT 5 CO sensor:

• elevated oxygen levels

• nitrous oxide

• halogenated agents

The E Series EtCO nitrous oxide compensation. Halogenated anesthetic agents alter CO2 readings, but the E Series unit will monitor CO

present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5-6%) may positively bias measured carbon dioxide values by up to an additional 2-3 mmHg.

The E S eries EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream CO mainstream airway adapters, nasal and nasal/oral sampling cannula sets, and sidestream on-airway adapters.

option allows high oxygen and/or

within specifications when these agents are

Sensor and the LoFlo CO2 Module,

) and respiration rate.

back of the E Series unit by matching the key on the cable to the key on the connector (Figure 1).

Note T o remove the sensor cable from the E Series unit,

grasp the collar surrounding the cable’s E Series connector and pull up.

Selecting a Mainstream Airway Adapter

Select an airway adapter based on the patient's size, ET tube diameter and monitoring situation. For more information refer to the following table or contact ZOLL Medical Corporation.

Airway Adapter Type ET Tube Diameter

* Pediatric/Adult > 4.0 mm

SPU Adult Reusable > 4.0 mm

* Neonatal/Pediatric ≤ 4.0 mm

SPU Neonatal Reusable ≤ 4.0 mm

*SPU = Single Patient Use

Mainstream EtCO2 Setup

There are several steps involved with mainstream EtCO2 setup. These steps include:

• Attaching the CAPNOSTAT sensor cable.

• Selecting a mainstream airway adapter.

• Attaching the airway adapter to the CAPNOSTAT

sensor.

• Zeroing the CAPNOSTAT sensor/airway adapter .

• Attaching the airway adapter to the airway circuit.

• Applying an airway adapter with mouthpiece.

Attaching the CAPNOSTAT 5 CO

To attach the CAPNOSTAT 5 CO2 sensor cable, plug the cable’s connector into the yellow CO

Sensor Cable

connector at the

Attaching the Airway Adapter to the CAPNOSTAT 5 CO

Before attaching the airway adapter to the CAPNOSTAT 5 CO adapter windows are clean and dry. Clean or replace the adapter if necessary.

CAUTION! The disposable (SPU) Pediatric/Adult and

the Neonatal/Pediatric airway adapters are intended for single patient use. Do NOT reuse or sterilize these adapters as system performance will be compromised.

Attach the airway adapter to the CAPNOSTAT sensor, as follows:

1. Align the arrow on the bottom of the airway adapter with the arrow on the bottom of the sensor.

Sensor

sensor, verify that the airway

4 9650-1212-01 Rev. E

Mainstream EtCO2 Setup

Figure 2

CAPNOSTAT

CO2 Sensor

To Patient

Reusable Adult

Airway Adapter

Ventilator Wye

2. Press the sensor and airway adapter together until they click.

3. Turn the Selector switch on the E Series unit to MONITOR (ON for AED units).

4. Wait for the airway adapter and sensor to warm up. The unit will display a WARM UP message for

approximately one minute while the sensor and adapter warm to operating temperature. The message disappears when the sensor is ready to use.

Note Warm up time varies with ambient temperature of

the sensor.

5. If the unit displays th e CHECK CO2 ADAPTER message, follow steps a through c.

a. Verify proper connection of the adapter to the

sensor.

b.Verify that the airway adapter windows are clean

and dry.

c. If the adapter is properly connected, and the

windows are clean and dry, then zero the adapter as described in the next section, “Zeroing the Mainstream CAPNOSTAT 5 CO

Sensor/Airway

Adapter.”

Zeroing the Mainstream CAPNOSTAT 5 CO2 Sensor/Airway Adapter

Adapter zeroing compensates for the optical differences between airway adapters and should be performed after switching between single patient use and reusable airway adapters, in order to obtain accurate readings.

Zeroing is also recommended the first time a particular CAPNOSTAT 5 CO

1. Place the sensor with the adapter installed away from all sources of CO own – exhaled breath and ventilator exhaust valves).

2. Press the Param. softkey and select the EtCO2 menu item, then press Enter.

3. Press the Zero softkey. The unit zeroes the adapter and displays the

ZEROING CO2 ADAPTER message for 15 to 20 seconds.

The unit displays the message ZERO DONE upon completion of the zeroing.

Note Do not attempt zeroing for 20 seconds after

removing the adapter from the patient’s airway. This time allows any CO to dissipate before zeroing. Do not attempt to zero the adapter while it is connected to the patient’s airway. Zeroing with CO inaccurate measurement and/or other error

sensor is connected to the unit.

(including the patient’s – and your

remaining in the adapter

in the adapter can lead to

conditions. If you attempt zeroing while CO

remains in the adapter, the time required to zero the adapter may be increased. If zeroing cannot be completed, the message ZERO FAILED wil l be displayed. If this occurs, clear any occlusion in the adapter, remove any source of CO

, wait 20

seconds, and try zeroing again.

Attaching the Airway Adapter to the Airway Circuit

If you have not yet done so, you must attach the airway adapter to the CAPNOSTAT 5 CO2 sensor before attaching the airway adapter to the airway circuit. Refer to “Attaching the Airway Adapter to the CAPNOSTAT 5 CO2 Sensor” on page 4 if necessary.

Attach the airway adapter to the airway circuit as follows:

1. Place the CAPNOST AT 5 CO assembly at the proximal end of the airway circuit between the elbow and the ventilator circuit wye. Do NOT place the airway adapter between the ET tube and the elbow, as this may allow patient secretions to accumulate in the adapter.

Position the airway adapter with its windows in a vertical, NOT a horizontal, position. This helps keep patient secretions from pooling on the windows. If pooling does occur, the airway adapter may be removed from the circuit, rinsed with water and reinserted into the circuit. To prevent moisture from draining into the airway adapter, do NOT place the airway adapter in a gravity dependent position. See Figure 2.

2. Check that connections have been made correctly by verifying the presence of a proper CO the E Series display.

3. The sensor cable should face away from the patient.

sensor/airway adapter

waveform on

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