ICP EXPRESS Instruction Manual Rev K May 2012

PPE Specification Labeling Specification ICP EXPRESS INSTRUCTION MANUAL

IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

Operating Instructions ...5 Power Up ...5 Connecting the Patient Monitor...5

ENGLISH

Zeroing and Calibrating the Patient Monitor ...5 Connecting the Transducer ...6

ICP EXPRESS® Monitor (Catalog No. 82-6635)

Zeroing the Transducer ...6

Instruction Manual

Alarm Functions...6 Changing Alarm Limits ...6 Changing Alarm On/Off Status ...6 Manual Functions ...6 Adjusting the Transducer Zero Reference Value...6

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IMPORTANT: Please read entire Instruction Manual before attempting to operate this unit.

Re-Zeroing the Patient Monitor ...7 Re-Calibrating the Patient Monitor ...7

Changing System Components During Monitoring ...7

TABLE OF CONTENTS

Warnings ...3

Selecting Operating Language ...8

Precautions ...3

Setting Patient Monitor Sensitivity ...8

International Symbols ...4

Battery Operation...8

Classification ...4

Fuse Replacement ...8

ICP EXPRESS Monitor Description...4 Front Panel Controls...4 ON/OFF Key ...4 Patient Monitor Zero Key ...4 Patient Monitor 20 mmHg/100 mmHg Calibration Keys ...4 Transducer Zero Key ...4 MENU/ENTER Key ...4 Up Arrow Key ...4 Down Arrow Key ...4 Alarm Suspend Key ...4 Front Panel Indicators ...4 AC Indicator ...4 Battery Indicator ...4 Battery Charging Indicator...4 Front Panel Connector ...4

AC Power Cord Retainer...8

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Introduction...3

Switching to a New Patient Monitor ...7 Switching to a New ICP EXPRESS Unit ...7 Switching ICP EXPRESS Cables ...7

ICP EXPRESS Cable ...8 Technical Specifications ...9 Safety ...9 Cleaning ...10 User Maintenance ...10 Preventive Maintenance ...10 Sterilization ...10 Service and Repair ...10 Accessories...10 Warranty...10

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Appendix A – Tables ... 11 Table 1 Manufacturer’s Declaration – Emissions All Equipment and Systems ... 11 Table 2 Guidance and Manufacturer’s Declaration Regarding Electromagnetic Immunity ... 11 Table 3 Guidance and Manufacturer’s Declaration Regarding Electromagnetic Immunity – Non-life Supporting ... 12

ICP Input ...4 Rear Panel Controls...4 Display Backlight ON/OFF Switch ...4 Patient Monitor Sensitivity Selection Switch ...4 Rear Panel Connectors ...4

Table 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model 82-6635 ICP EXPRESS Monitor ... 12

Patient Monitor Interface Connector ...4 AC Power Entry Module ...5 Pole Clamp ...5

Illustrations ... i

Handle ...5 AC Power Cord Retainer ...5

Display ...5 Intracranial Pressure ...5 Alarm ON/OFF Status ...5 Alarm Limits ...5 Alarm Indicators...5 Alarm SUSPEND...5

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PPE Specification Labeling Specification ICP EXPRESS INSTRUCTION MANUAL

IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

Introduction

If the integrity of the protective earthing system is in doubt, operate the ICP EXPRESS Monitor from its internal battery.

This manual is intended to provide instructions on the proper use of the ICP EXPRESS Monitor (catalog no. 82-6635). It is the responsibility of the user to ensure that any applicable regulations regarding the installation and operation of the ICP EXPRESS Monitor are observed.

Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual.

The ICP EXPRESS Monitor (see Figure 1) is intended to serve as an interface between the CODMAN® MICROSENSOR® ICP Transducer and compatible patient monitoring systems. When connected to a MICROSENSOR, the ICP EXPRESS Monitor provides a continuous numeric display of the mean, systolic and diastolic intracranial pressure. For detailed waveform analysis the ICP EXPRESS Monitor generates an output signal that can be interfaced directly to the pressure channel input on most patient monitoring systems.

Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. The use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause damage to the ICP MICROSENSOR and/or ICP EXPRESS Monitor. This could lead to permanent or temporary disabling of either device. The monitor must not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor must be observed to verify normal operation in the configuration in which it will be used.

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The ICP EXPRESS Monitor was designed for use wherever ICP monitoring is appropriate, such as emergency rooms, operating rooms, and intensive care units. The small profile and light weight of the ICP EXPRESS Monitor make it ideal for monitoring ICP during patient transport, with or without a separate transport monitor. The ICP EXPRESS Monitor operates continuously on AC power, or for up to 3 hours on its own internal rechargeable battery. Key features provided by the ICP EXPRESS Monitor include: Digital display of mean, systolic and diastolic ICP

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One-touch transducer zero function

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User programmable mean ICP alarms

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Compatibility with most patient monitoring systems for full ICP waveform analysis and integration of ICP data with other patient information

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0, 20 and 100 mmHg patient monitor reference signals

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Integral pole clamp

Read all instructions included with the appropriate CODMAN MICROSENSOR ICP Transducer Kit regarding proper operation prior to use. Read all instructions provided with the external patient monitoring system prior to use. This device can be damaged by exposure to high levels of Electrostatic Discharge (ESD) energy. Unusually high levels can damage the electronic components, which could cause the unit or an attached sensor to be rendered inoperable. Take all precautions to reduce the build-up of electrostatic energy during the use of this product. Provide patient grounding at all times and avoid the use of materials that can generate ESD during patient movement and transport (e.g., avoid the use of nylon transfer boards and bedding; use grounding straps on gurneys, etc.).

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PRECAUTIONS

Patient leakage current is limited internally by the ICP EXPRESS Monitor to less than 10 μA. However, additional leakage current can be caused by other equipment used on the patient at the same time as the ICP EXPRESS Monitor.

Included with the ICP EXPRESS Monitor is one ICP EXPRESS Cable (catalog no. 82-6636). The ICP EXPRESS Cable is used to connect the MICROSENSOR to the ICP EXPRESS Monitor. During the transducer zeroing process the ICP EXPRESS Monitor automatically stores the MICROSENSOR’s zero reference value in a non-volatile memory element embedded in the ICP EXPRESS Cable. This feature allows the physician to transfer a patient to another ICP EXPRESS unit without having to manually adjust the zero reference value. The reusable ICP EXPRESS Cable can be sterilized by ethylene oxide (EO) gas. Refer to the Sterilization section for details.

Use only the ICP EXPRESS Cable (catalog no. 82-6636) to connect the MICROSENSOR to the ICP EXPRESS Monitor. Use only CODMAN MICROSENSOR ICP Transducers for intracranial pressure measurements. Use CODMAN Patient Monitor Interface Cables only with the patient monitors for which they are specifically designed and designated.

CODMAN Patient Monitor Interface Cables are available separately for connecting the ICP EXPRESS Monitor to a variety of compatible patient monitoring systems. Inside the U.S., contact your local Codman & Shurtleff sales representative for full details. Outside the U.S., contact your local Codman representative.

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WARNINGS

Verify compatibility between the ICP EXPRESS Monitor and the external patient monitor prior to use. Compatibility can be verified using the 0, 20, and 100 mmHg reference signals provided by the ICP EXPRESS Monitor. Failure to verify compatibility between the ICP EXPRESS Monitor and the patient monitor can result in inaccurate ICP readings on the patient monitor.

Read the entire operating manual before attempting to operate this unit.

Discontinue use if the patient monitor cannot be properly zeroed to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

Do not attempt to bypass the grounding prong on the ICP EXPRESS Monitor by using a three-prong to two-prong adapter. The unit must be properly grounded to ensure operator and patient safety. Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.”

Discontinue use if the patient monitor cannot be properly calibrated to the ICP EXPRESS Monitor. Consult with appropriate technical personnel. The signal processing algorithms used to detect and display physiological pressure data can vary among patient monitors of different make and model. Therefore, pressure data displayed by the ICP EXPRESS Monitor may not always be consistent with the data displayed on an externally connected patient monitor. Refer to the patient monitor manufacturer’s instruction manual for specific details regarding signal processing, calibration and accuracy.

Do not touch outer surfaces of monitor and patient simultaneously. No modification of this equipment is allowed.

Explosion Hazard: Do not use in the presence of flammable materials (i.e., anesthetics, solvents, cleaning agents and endogenous gases). Electrical Shock Hazard: Do not remove side, front or rear panels. Send to qualified personnel for servicing. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

The MICROSENSOR must be zeroed at atmospheric pressure, prior to implantation.

Disconnect the ICP EXPRESS Monitor from all external AC power sources before changing fuses.

The MICROSENSOR transducer tip must remain wet during the zeroing process.

Patient connections are electrically isolated Type CF. Do not let patient connections contact other conductive parts, including earth.

Do not submerge the tip of the MICROSENSOR or ventricular catheter vertically in a cup of sterile water or saline during the zeroing process. Doing so will impose pressure on the transducer diaphragm that is higher than atmospheric zero, resulting in an inaccurate zero reference value.

Routinely inspect all electrical plugs and connections. Do not use if damaged. Maintain strict sterile technique when connecting the ICP EXPRESS Cable to the MICROSENSOR. 3

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The ICP EXPRESS Monitor transducer zero reference value setting must only be adjusted manually if the displayed value differs from the value recorded on the MICROSENSOR connector housing or the patient’s chart.

PATIENT Monitor ZERO KEY-Initiates an electronic 0 mmHg reference signal for zeroing an externally connected patient monitor.

The mean ICP alarms will reset to default values (LOW ( ): 0 mmHg; HIGH ( ): 20 mmHg) whenever the ICP EXPRESS Monitor power is turned OFF.

PATIENT Monitor 20 mmHg CALIBRATION KEY-Initiates an electronic 20 mmHg reference signal for calibrating an externally connected patient monitor.

Do not autoclave the ICP EXPRESS Cable. Sterilize the ICP EXPRESS Cable using Ethylene Oxide (EO) gas only.

PATIENT Monitor 100 mmHg CALIBRATION KEY- Initiates an electronic 100 mmHg reference signal for calibrating an externally connected patient monitor.

Do not immerse the ICP EXPRESS Cable in any liquid, or allow liquid to enter the plug or connectors. Do not use cable if connectors become wet. Erratic results can occur.

TRANSDUCER ZERO KEY-Zeroes the attached MICROSENSOR transducer. The zero reference value of the transducer is automatically stored in the non-volatile memory of the attached ICP EXPRESS Cable.

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Always disconnect the ICP EXPRESS Monitor from its power supply before cleaning. Do not sterilize the ICP EXPRESS Monitor.

MENU/ENTER KEY-Accesses the ICP EXPRESS Monitor MENU, or ENTERS a selected display parameter value such as an alarm limit or a zero reference value.

Verify ICP EXPRESS Cable integrity prior to use. Do not use any cable that fails to meet the pin-to-pin resistance or electrical leakage specifications.

UP ARROW KEY-Moves the cursor on the MENU screen in the UP direction, or INCREASES the value of a display parameter such as an alarm limit or a zero reference value.

The ICP EXPRESS Monitor and external patient monitor pressure displays may be inaccurate if used simultaneously with radiofrequency electrosurgical equipment.

DOWN ARROW KEY-Moves the cursor on the MENU screen in the DOWN direction, or DECREASES the value of a display parameter such as an alarm limit or a zero reference value.

The rear panel sensitivity selection switch must be set in the appropriate position prior to connecting to the patient monitor. Do not adjust the sensitivity selection switch while connected to a patient monitor, as inaccurate pressure readings can result.

ALARM SUSPEND KEY-Silences the audible portion of the mean ICP alarm for a period of approximately two minutes.

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Discontinue use of any ICP EXPRESS Cable that continues to yield a “–99” transducer zero reference value (as displayed on the ICP EXPRESS Monitor screen) during manual zeroing or zero reference verification procedures.

Front Panel Indicators

International Symbols

AC Indicator Lights whenever the ICP EXPRESS Monitor is connected to an AC power supply.

The international symbols on the ICP EXPRESS Monitor are defined as follows: Refer to instructions for use

BATTERY Indicator Lights whenever the ICP EXPRESS Monitor is running only on its own internal battery power.

On/Standby

Alternating Current

BATTERY CHARGING Indicator Lights whenever the ICP EXPRESS Monitor is connected to an AC power supply and the internal battery charger is operating. The Battery Charging indicator will remain lit even when the battery is fully charged.

Replace fuse, as marked.

Type CF equipment, floating input protected against defibrillator discharge.

Classification

Front Panel Connector ICP Input The ICP EXPRESS Cable connects to this receptacle for direct interface with the CODMAN MICROSENSOR ICP Transducer.

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Electric Shock Protection: Class I-protectively earthed when powered from supply mains

Degree of Protection Against Electric Shock: Type CF protected against defibrillator discharge

, floating inputs

Rear Panel Controls (See Figure 2) Display Backlight ON/OFF Switch Used to turn the front panel liquid crystal display backlight ON and OFF. When operating the ICP EXPRESS Monitor on battery, the display backlight can be turned off to conserve power.

Power Requirements: 200–260 VAC, 50/60 Hz or internally powered rechargeable battery Mode of Operation: Continuous when supplied by mains. Three hours on battery power.

Patient Monitor Sensitivity Selection Switch Used to set the sensitivity of the ICP EXPRESS Monitor external patient monitor output signal to either 5 μV/V/mmHg or 40 μV/V/mmHg. This switch is preset to 5 μV/V/mmHg at the time of manufacture. Refer to the patient monitor manufacturer’s instructions to verify the pressure channel sensitivity requirements of a specific patient monitor.

External Fuses: 2X T125 mA 250 V, 5 mm x 20 mm Moisture Protection: Not classified.

Flammable Atmosphere: Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.

ICP EXPRESS Monitor Description

Rear Panel Connectors Patient Monitor Interface Connector Compatible patient monitors can be connected to this receptacle using the appropriate CODMAN Patient Monitor Interface Cable. CAUTION: CODMAN Patient Monitor Interface Cables must be used only with patient monitors for which they are specifically designed and designated.

Front Panel Controls (See Figure 1) ON/OFF KEY-Turns the ICP EXPRESS Monitor operating system ON and OFF. NOTE: When ON, the ICP EXPRESS Monitor can be powered either from an AC power supply or from its internal battery. The ICP EXPRESS Monitor will automatically switch to battery operation if no AC power is available. 4

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AC Power Entry Module Connects with the AC power cord and provides access to the internal fuses. WARNING: Do not attempt to bypass the grounding prong on the ICP EXPRESS Monitor by using a three prong to two prong adapter. The unit must be properly grounded to ensure operator and patient safety. Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.”

installation instructions). Plug the other end of the power cord into a power supply providing the appropriate voltage (230 VAC nominal for catalog no. 82-6635; refer to rear panel label for proper voltage). The front panel ) and BATTERY CHARGING ( ) indicators will illuminate. AC ( 2. Press the key to turn the ICP EXPRESS Monitor ON. An audible tone will sound and the LCD screen will turn dark for a few seconds permitting verification of the display. The ICP EXPRESS Monitor will then display the introductory screen.

Pole Clamp Used for mounting the ICP EXPRESS Monitor to standard pole diameters from 1.3 to 3.8 cm.

3. A few seconds will elapse as the ICP EXPRESS Monitor performs a series of self-diagnostic tests. Upon successful completion of all tests the ICP EXPRESS Monitor will display the message, “NO TRANSDUCER DETECTED (CHECK CONNECTIONS).” This message will be maintained on the screen until a patient monitor or transducer is connected to the ICP EXPRESS Monitor. NOTE: If any errors are detected during the selftest period the ICP EXPRESS Monitor will display an error message. Discontinue use and consult with appropriate technical personnel.

Handle Used for hand transport.

Display (See Figure 3)

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AC Power Cord Retainer Used to secure the AC power cord to the ICP EXPRESS Monitor and to prevent inadvertent disconnection of the AC power cord.

Connecting the Patient Monitor

Intracranial Pressure The ICP EXPRESS Monitor display contains the digital values of the Mean, Systolic and Diastolic ICP in units of millimeters of mercury (mmHg). The Mean ICP is the large value displayed in the center of the screen. The Systolic (SYS) and Diastolic (DIAS) ICP values are displayed with smaller characters in the bottom right portion of the screen.

1. Verify that the sensitivity selection switch on the rear panel of the ICP EXPRESS Monitor is set to the correct position, according to the sensitivity of the patient monitor. The sensitivity is preset to the 5 μV position at the time of manufacture. See the Setting Patient Monitor Sensitivity section for full details. CAUTION: The rear panel sensitivity selection switch must be set in the appropriate position prior to connecting to the patient monitor. Do not adjust the sensitivity selection switch while connected to a monitor, as inaccurate pressure readings can result.

Alarm ON/OFF Status The Alarm ON/OFF status ( ) is displayed in the top center portion of the screen. When the alarm is ON ( ), the HIGH ( ) and LOW ( ) alarms will engage whenever the mean ICP exceeds the HIGH ( ) or falls beneath the LOW ( ) user programmable limits. When the alarm is OFF, the HIGH ( ) and LOW ( ) alarms will not engage, regardless of the mean ICP level.

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2. Plug the appropriate CODMAN Patient Monitor Interface Cable into the nine pin D-type connector located on the rear panel of the ICP EXPRESS Monitor. Secure the two locking screws on the cable to prevent inadvertent disconnection from the ICP EXPRESS Monitor.

Alarm Limits The HIGH ( ) and LOW ( ) limits for the mean ICP alarm are displayed in the top right portion of the screen. The default values for these limits are 20 mmHg for HIGH ( ) and 0 mmHg for LOW ( ). Both limits can be adjusted by using the MENU system.

3. Plug the other end of the Patient Monitor Interface Cable into the appropriate pressure channel input located on the patient monitor. CAUTION: Use CODMAN Patient Monitor Interface Cables only with the patient monitors for which they are specifically designed and designated.

Alarm Indicators HIGH ( ) and LOW ( ) Mean ICP: The HIGH ( ) and LOW ( ) alarm limits located in the top right portion of the screen will flash in reverse video approximately once per second whenever the mean ICP exceeds the HIGH ( ) or falls beneath the LOW ( ) user programmable limits. An audible tone is cycled on and off once per second when the alarm condition is triggered.

Zeroing and Calibrating the Patient Monitor 1. Upon detection of a new patient monitor, the ICP EXPRESS Monitor will automatically prompt the user to zero the patient monitor. The user must proceed to do so according to the monitor manufacturer’s instructions.

2. Once the patient monitor displays 0 mmHg, press the key on the ICP EXPRESS Monitor to proceed. CAUTION: Discontinue use if the patient monitor cannot be properly zeroed to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

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LOW BATTERY: The LOW BATTERY icon, , will appear at the bottom center portion of the screen whenever the battery has less than approximately 15 minutes of life remaining. An audible tone is sounded once per minute to further alert the user of the low battery condition.

3. Next, the ICP EXPRESS Monitor will automatically display instructions for calibrating the patient monitor. Following the ICP EXPRESS Monitor prompt, start by pressing the or key to send a 20 mmHg or 100 mmHg electronic reference signal to the patient monitor. Use the 20 mmHg calibration reference whenever the patient monitor pressure display scale is set to less than 100 mmHg (i.e., –10 to 20 mmHg or 0 to 40 mmHg). The 100 mmHg reference is best suited for calibration when the range is greater than 100 mmHg (i.e., 0 to 120 mmHg).

Wrong Key Press: The ICP EXPRESS Monitor will sound a triple audible tone whenever an incorrect key is pressed. Alarm SUSPEND The Alarm SUSPEND icon, , is displayed in the top left portion of the screen whenever the SUSPEND key is pressed. In the SUSPEND mode, the audible portion of the mean ICP alarm is silenced for a two minute period. The audible alarm will automatically re-activate upon expiration of the two minute period. The user can choose to manually re-activate the audible alarm any time prior to the expiration of the suspend period by pressing the SUSPEND key again.

4. If the key is selected, verify that the patient monitor displays exactly 20 mmHg. If the key is selected, verify that the patient monitor displays 98 to 102 mmHg. There can be a short delay (10–15 seconds) while the patient monitor’s digital display stabilizes. If the patient monitor displays a value outside of the specified range, refer to the monitor manufacturer’s instructions for information on how to adjust the pressure channel calibration or gain (some patient monitors do not have this feature). CAUTION: Discontinue use if the patient monitor cannot be properly calibrated to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

Operating Instructions

The following instructions describe all necessary steps required to set-up and operate the ICP EXPRESS Monitor with the CODMAN MICROSENSOR ICP Transducer and an external patient monitor. See Figure 4.

Power Up 1. Plug a hospital grade AC power cord into the power entry module located on the rear panel of the ICP EXPRESS Monitor. NOTE: An optional AC Power Cord Retainer is provided to prevent inadvertent disconnection of the AC power supply (refer to the AC Power Cord Retainer section for detailed

5. Once the patient monitor calibration is complete, press the to proceed.

key

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Connecting the Transducer

5. After recording the zero reference value on the MICROSENSOR connector housing and the patient’s chart, press the key to proceed.

CAUTION: Read all instructions included with the CODMAN MICROSENSOR ICP Transducer Kit regarding proper operation, prior to use.

6. The ICP EXPRESS Monitor is now in standard display mode. The MICROSENSOR is now ready for placement.

CAUTION: Use only CODMAN MICROSENSOR ICP Transducers for intracranial pressure measurements.

Alarm Functions Changing Alarm Limits

CAUTION: Verify ICP EXPRESS Cable integrity prior to use. Do not use any cable that fails to meet the pin-to-pin resistance or electrical leakage specifications.

The HIGH ( ) and LOW ( ) mean ICP alarm limits have default values of 20 mmHg and 0 mmHg, respectively. The following instructions describe the correct procedure for changing these limits.

CAUTION: Do not autoclave the ICP EXPRESS Cable. Sterilize the ICP EXPRESS Cable using ethylene oxide (EO) gas only. 1. Connect the four pin end of the ICP EXPRESS Cable, catalog no. 82-6636, to the white connector on the CODMAN MICROSENSOR ICP Transducer.

2. Use the or keys to move the cursor to the SET ALARM LIMITS line, then press the key. The HIGH ( ) alarm limit will be displayed above the mean ICP value.

2. Line up the white indicator marks on the ICP EXPRESS Cable plug and ICP EXPRESS Monitor front panel receptacle. Guide the plug into the receptacle until a visible flick of the plug and an accompanying audible “click” occur. This confirms that the connectors are fully mated and locked. (NOTE: To release the cable from the ICP EXPRESS Monitor, grasp the plug near the white indicator arrow and twist one-quarter turn clockwise while withdrawing.)

Zeroing the Transducer

key to bring up the main

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1. From the standard display mode, press the menu screen.

3. Use the or keys to increase or decrease the displayed HIGH ( ) alarm limit to the desired value. Press the key to enter the value. The LOW ( ) alarm limit will be displayed above the mean ICP value. 4. Use the or keys to increase or decrease the displayed LOW ( ) alarm limit. Press the key to enter the value and return to the standard display mode.

Upon detection of a new transducer, the ICP EXPRESS Monitor will automatically display instructions regarding the zero balancing procedure.

NOTE: The HIGH ( ) and LOW ( ) alarm limits will reset to their original default values (HIGH ( ) = 20 mmHg; LOW ( ) = 0 mmHg) whenever the ICP EXPRESS Monitor power is turned OFF.

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CAUTION: The MICROSENSOR must be zeroed at atmospheric pressure, prior to implantation.

Changing Alarm ON/OFF Status

CAUTION: The MICROSENSOR transducer tip must remain wet during the zeroing process.

1. From the standard display mode, press the main menu.

1. Lay approximately three inches (7.6 cm) of the tip of the MICROSENSOR or ventricular catheter flat in the marked well of the sterile blister. Pour sufficient sterile water or saline into the well to just barely cover the MICROSENSOR or ventricular catheter. CAUTION: Do not submerge the tip of the MICROSENSOR or ventricular catheter vertically in a cup of sterile water or saline. Doing so will impose pressure on the transducer diaphragm that is higher than atmospheric zero, resulting in an inaccurate zero reference value.

key to bring up the

2. Use the or keys to position the cursor on the TURN ALARM ON or TURN ALARM OFF line item.

3. Press the key to enter the new alarm condition and return to the standard display mode. The new alarm status will be displayed at the top center of the screen.

Manual Functions

The following additional functions are available while ICP monitoring is in progress.

2. While keeping the tip of the MICROSENSOR or ventricular catheter flat in the sterile water or saline, press the key on the ICP EXPRESS Monitor front panel. The message “TRANSDUCER ZEROING IN PROCESS (PLEASE WAIT)” will appear on the ICP EXPRESS Monitor screen while the zeroing process takes place.

Adjusting the Transducer Zero Reference Value

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The following instructions describe the procedure for manually adjusting the zero reference value for the attached MICROSENSOR. CAUTION: The ICP EXPRESS Monitor transducer zero reference value setting must only be adjusted manually if the displayed value differs from the value recorded on the MICROSENSOR connector housing or patient’s chart.

3. Upon successful completion of the zeroing process, the ICP EXPRESS Monitor will display the MICROSENSOR’s three digit zero reference value. Record the displayed zero reference value on the MICROSENSOR connector housing and on the patient’s chart for future use.

1. From the standard display mode, press the main menu.

NOTE: When zeroing is complete, the MICROSENSOR’s zero reference value is automatically stored in the memory element embedded in the attached ICP EXPRESS Cable. By storing the zero reference value in the cable, the user has the ability to move the patient to a different ICP EXPRESS unit without having to manually adjust the zero reference value on the new unit. This feature can only be utilized if the original ICP EXPRESS Cable remains with the patient whenever he/she is moved to another patient monitoring system. If the original cable does not remain with the patient, the user will be required to manually adjust the zero reference value on the new ICP EXPRESS Monitor to the zero reference value previously recorded on the MICROSENSOR connector housing or the patient’s chart.

key to bring up the

or keys to position the cursor on the MANUAL 2. Use the ZERO line, then press the key. 3. Use the or keys to position the cursor on the ADJUST REFERENCE line, then press the key. 4. Use the or keys to change the three digit zero reference value until it matches the value recorded on the MICROSENSOR connector housing or patient’s chart. 5. Press the key to enter the zero reference value and return to the standard display mode. The new zero reference value is automatically updated in the internal memory of the ICP EXPRESS Cable.

4. If the transducer zeroing process is unsuccessful, the message “TRANSDUCER ZEROING ERROR” will appear. Verify that the tip of the MICROSENSOR or ventricular catheter is still laying flat in the sterile water or saline, then press the key to clear the error and reinitiate the zeroing process. Discontinue use if the transducer zeroing error persists. Consult with appropriate technical personnel. 6

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Re-Zeroing the Patient Monitor

Switching to a New ICP EXPRESS Unit

The following instructions describe the procedure for manually re-zeroing the patient monitor.

The following instructions describe the procedure for switching the patient to a new ICP EXPRESS unit while patient monitoring is in progress (Example: Patient was originally set-up with an ICP EXPRESS unit in the operating room. Patient is now being moved to the intensive care unit where the original ICP EXPRESS Monitor will be exchanged with a new unit dedicated to the ICU).

1. From the standard display mode, press the ICP EXPRESS Monitor front panel.

key on the

2. Wait for the external patient monitor display to stabilize. If the monitor displays a value other than 0 mmHg, proceed to zero balance the patient monitor per the monitor manufacturer’s instructions. CAUTION: Discontinue use if the patient monitor cannot be properly zeroed to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

2. Reconnect both cables to the new ICP EXPRESS Monitor. If the ICP EXPRESS Monitor is also being connected to a new patient monitor, verify that the Patient Monitor Interface Cable is appropriate for the new patient monitor.

key to resume patient monitoring.

Re-Calibrating the Patient Monitor

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3. Press the

1. Disconnect both the Patient Monitor Interface Cable and the ICP EXPRESS Cable from the front and rear panel receptacles of the original ICP EXPRESS Monitor.

The following instructions describe the procedure for manually re-calibrating the patient monitor. 1. Press the

or the

3. Follow the instructions for Zeroing and Calibrating the patient monitor as previously described in the Operating Instructions section.

key on the ICP EXPRESS Monitor front panel.

4. The new ICP EXPRESS Monitor will prompt the user to ACCEPT or ADJUST the zero reference value stored in the attached ICP EXPRESS Cable. Compare the three digit zero reference value displayed on the screen with the value previously recorded on the MICROSENSOR connector housing or the patient’s chart (the zero reference values must match if the original ICP EXPRESS Cable has remained with the patient). If the values do match, position the ICP EXPRESS Monitor screen cursor on the ACCEPT REFERENCE option and press the key to proceed.

2. If the is selected, verify that the patient monitor displays exactly 20 mmHg. If the key is selected, verify that the patient monitor displays 98 to 102 mmHg. There can be a short delay (10–15 seconds) before the patient monitor display stabilizes. If the patient monitor does not display the correct value, refer to the monitor manufacturer’s instructions for information on how to adjust the pressure channel calibration or gain (some patient monitors do not have this feature). CAUTION: Discontinue use if the patient monitor cannot be properly calibrated to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

The following procedures must be followed whenever any component of the original ICP patient monitoring system (i.e., ICP EXPRESS Monitor, ICP EXPRESS Cable, patient monitor) is changed or substituted while patient monitoring is in progress.

5. If the displayed zero reference value does not match the zero reference value previously recorded on the MICROSENSOR housing or the patient’s chart, move the ICP EXPRESS Monitor screen cursor to the ADJUST REFERENCE option and press the key. Use the or keys to adjust the displayed zero reference value to match the zero reference value recorded on the MICROSENSOR housing or the patient’s chart, then press the key to enter the zero reference value. The new zero reference value is automatically updated in the ICP EXPRESS Cable memory.

Switching to a New Patient Monitor

Switching ICP EXPRESS Cables

The following instructions describe the procedure for switching the ICP EXPRESS Monitor to a new patient monitor while patient monitoring is in progress (Example: ICP EXPRESS Monitor was originally set-up with a patient monitor in the operating room. Patient is now being moved to the intensive care unit where the ICP EXPRESS Monitor must be connected to a new patient monitor).

Codman & Shurtleff, Inc. recommends that the ICP EXPRESS Cable used during the original transducer zeroing procedure remain with the patient at all times. However, if replacement of the original cable is necessary, the following procedure must be followed:

key to resume patient monitoring.

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3. Press the

Changing System Components During Monitoring

1. Unplug the original ICP EXPRESS Cable from the MICROSENSOR and ICP EXPRESS Monitor. The ICP EXPRESS Monitor will display the message “NO TRANSDUCER DETECTED (CHECK CONNECTIONS).”

1. Disconnect the CODMAN Patient Monitor Interface Cable from the original patient monitor.

2. Connect the new ICP EXPRESS Cable to the MICROSENSOR and ICP EXPRESS Monitor. CAUTION: Verify ICP EXPRESS Cable integrity prior to use. Do not use any cable that fails to meet the pin-to-pin resistance or electrical leakage specifications.

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2. If the original Patient Monitor Interface Cable is not compatible with the new patient monitor (i.e., the new patient monitor is of different make and model from the original patient monitor) disconnect the cable from the rear panel of the ICP EXPRESS Monitor and replace it with the appropriate compatible cable. CAUTION: Use CODMAN Patient Monitor Interface Cables only with the patient monitor for which they are specifically designed and designated.

3. If connected to a patient monitor, the ICP EXPRESS Monitor will prompt the user to Zero and Calibrate the patient monitor as described in the Operating Instructions section. 4. The ICP EXPRESS Monitor will prompt the user to ACCEPT or ADJUST the zero reference value as read from the newly attached ICP EXPRESS Cable. Since this is a new ICP EXPRESS Cable, the displayed zero reference value will not match the zero reference value recorded on the MICROSENSOR housing or the patient’s chart. To adjust the zero reference value, move the cursor to the ADJUST REFERENCE line and press the or keys to adjust the zero key. Use the reference value to match the zero reference value recorded on the MICROSENSOR housing or patient’s chart, then press the key to enter the zero reference value and proceed patient monitoring.

3. Verify that the sensitivity selection switch on the rear panel of the ICP EXPRESS Monitor is set to the correct position, according to the sensitivity of the new patient monitor. The sensitivity is preset to the 5 μV position at the time of manufacture. CAUTION: The rear panel sensitivity selection switch must be set in the appropriate position prior to connecting to the patient monitor. Do not adjust the sensitivity selection switch while connected to a patient monitor, as inaccurate pressure readings can result. 4. Connect the Patient Monitor Interface Cable to the appropriate pressure channel input on the new patient monitor. 5. Follow the instructions for Zeroing and Calibrating the new patient monitor as previously described in the Operating Instructions section.

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IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

Selecting Operating Language

Fuse Replacement

The ICP EXPRESS Monitor can be configured to operate in English, German, French, Italian, Portuguese or Spanish. To change the operating language, select the key to display the menu screen. Use the keys to position the cursor on the “SELECT LANGUAGE” item, or then press the key. Use the or keys to position the cursor on the language of choice, then press the key again. The ICP EXPRESS Monitor will immediately switch to the newly selected operating language. The ICP EXPRESS Monitor stores the selected language in non-volatile memory, and will always run in the last selected language, even after a power down. The language may be reconfigured at any time.

1. Turn the ICP EXPRESS Monitor OFF and remove the power cord from the rear panel AC power entry module. WARNING: Disconnect the ICP EXPRESS Monitor from all external AC power sources before changing fuses.

Setting Patient Monitor Sensitivity

4. Replace the fuses with the same type and rating as indicated on the rear panel label. For model 82-6635 use 5 x 20 mm, 0.125 A, 250 V, time delay (SB or T) type fuses.

2. To remove the fuse holder, place a small screwdriver, or fine pointed object, in the slot at either side of the panel and gently press the tab so that the holder pops partially out. Pull the fuse holder straight out to expose the fuses. See Figure 6. 3. Remove the fuses by pulling them straight out of the fuse holder.

Battery Operation

ED

The ICP EXPRESS Monitor is capable of interfacing with external patient monitors having invasive piezoresistive pressure transducer sensitivities of 5 μV/Vex/mmHg or 40 μV/Vex/mmHg. Most patient monitors are designed for a transducer sensitivity of 5 μV, therefore the sensitivity selection switch on the rear panel of the ICP EXPRESS Monitor is pre-set to the 5 μV setting at the time of manufacture. To change the monitor output signal to the 40 μV level (in order to interface with a monitor requiring a 40 μV transducer sensitivity), insert a small flat head screwdriver into the slotted switch and turn one position clockwise. To change back to the 5 μV setting, insert a small flat head screwdriver into the slotted switch and turn one position counterclockwise. See Figure 5.

5. Replace the fuse holder by inserting it into the receptacle and pushing firmly until the fuse holder pops back into place on both sides. The fuse holder is keyed to prevent improper installation. NOTE: If the fuses continue to blow, contact appropriate technical personnel.

AC Power Cord Retainer

A removable AC power cord retainer is included for optional use. When properly installed, the retainer will prevent inadvertent disconnection of the AC power cord. WARNING: Disconnect the AC power cord from the AC power supply before installing or removing the AC power cord retainer.

The battery is continuously charging whenever the ICP EXPRESS Monitor is connected to the appropriate AC power supply, even when the operating system is OFF. The BATTERY CHARGING indicator, located in the lower right corner of the ICP EXPRESS Monitor front panel, illuminates to verify that the battery is charging. Approximately 12 hours is required to recharge a fully discharged battery. Less time is required to recharge the battery if it has not been fully discharged. NOTE: The Battery Charging indicator will remain lit even when the battery is fully charged.

1. Use a Phillips screwdriver to remove the screw located directly underneath the AC power entry module on the rear panel of the ICP EXPRESS Monitor (refer to Figure 7-1). DO NOT discard the screw; it will be reinstalled in Step 4.

VIS

The ICP EXPRESS Monitor is equipped with an internal battery which allows the unit to operate for approximately 3 hours under its own power.

2. Plug the AC power cord into the power entry module as shown in Figure 7-2. 3. Place the “U” shaped arm of the retainer around the shoulder of the power cord plug, as shown in Figure 7-3. Align the hole in the retainer with the screw hole located directly beneath the AC power entry module.

The ICP EXPRESS Monitor automatically switches to battery operation during a loss of AC power without any effect on the operating mode. When less than 15 minutes of battery life remain, the LOW BATTERY icon, , is displayed in reverse video in the bottom center portion of the screen. An audible tone sounds once every minute to further alert the user of the low battery condition. The user must connect the ICP EXPRESS Monitor to an appropriate AC power supply as soon as possible once the low battery alert is engaged. The ICP EXPRESS Monitor will automatically shut down when the battery is fully discharged. If automatic shutdown occurs while ICP monitoring is in progress, simply plug the ICP EXPRESS Monitor into an appropriate AC power supply and press the key to turn the unit back on. The ICP EXPRESS Monitor will prompt the user to zero and calibrate the patient monitor, and to verify the transducer offset of the attached MICROSENSOR. NOTE: The HIGH ( ) and LOW ( ) mean ICP alarms will reset to the default values (HIGH ( ): 20 mmHg; LOW ( ): 0 mmHg) after a battery discharge shut down. The ICP EXPRESS Monitor must remain connected to the AC power supply for at least 12 hours to fully recharge the battery.

4. Reinstall the previously removed screw through the hole in the retainer and into the screw hole located directly beneath the AC power entry module. Once the retainer is installed, the AC power cord cannot be removed from the ICP EXPRESS Monitor without first removing the retainer.

ICP EXPRESS Cable

RE

The ICP EXPRESS Monitor is supplied with one ICP EXPRESS Cable for connecting to CODMAN MICROSENSOR ICP Transducers. See Figure 8. CAUTION: Use only the CODMAN ICP EXPRESS Cable to connect the MICROSENSOR to the ICP EXPRESS Monitor. The ICP EXPRESS Cable is also available separately (catalog no. 82-6636). The ICP EXPRESS Cable is reusable and is supplied nonsterile. Refer to the Sterilization section for details. CAUTION: DO NOT AUTOCLAVE the ICP EXPRESS Cable. Sterilize the ICP EXPRESS Cable using ethylene oxide (EO) gas only.

IMPORTANT BATTERY MAINTENANCE INFORMATION!

The ICP EXPRESS Cable has a non-volatile memory element (EEPROM) embedded in-line which is used to store the transducer zero reference value of any attached MICROSENSOR. The ICP EXPRESS Monitor automatically stores the zero reference value in the cable when the transducer zeroing process is complete. By storing the transducer zero reference value in the cable, the user will not have to manually adjust the offset if the patient is moved to another monitor or to another ICP EXPRESS unit, as long as the original ICP EXPRESS Cable is retained with the equipment in use. If the original ICP EXPRESS Cable is not retained when switching to new equipment, the user will be required to manually adjust the stored zero reference value via the manual zero referencing function of the ICP EXPRESS Monitor.

To maintain the ICP EXPRESS Monitor rechargeable battery in optimum condition: 1. Charge for at least 12 hours within 7 days of a complete discharge. 2. Charge for at least 12 hours once every 6 months when unit is not in regular use. Charging occurs automatically whenever the unit is connected to AC power. Failure to maintain the battery as described can result in reduced battery life.

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Output Signal Accuracy:

±1 mmHg or 1%, whichever is greater (exclusive of transducer)

Reference Signals: Input Impedance:

0, 20, and 100 mmHg 350–500 Ω

Source Impedance: Frequency Response: Recommended External Patient Monitor Specifications

350 Ω 0 to 200 Hz (–3 dB)

Excitation Voltage Range: Excitation Voltage Frequency: Transducer Sensitivity (Gain):

0.5 to 10.0 VDC or VAC rms DC to 5000 Hz 5 μV/Vex/mmHg or 40 μV/Vex/mmHg

ED

The ICP EXPRESS Monitor will erase the previously stored zero reference value and store a new zero reference value in the ICP EXPRESS Cable whenever a new MICROSENSOR is zeroed, or when the user chooses to adjust the zero reference manually. The memory element in the cable is designed to perform over one million erase/write cycles and will retain data for several years. NOTE: A transducer zero reference value of “–99,” as displayed by the ICP EXPRESS Monitor during a manual zeroing or zero reference verification procedure, is an indication of an ICP EXPRESS Monitor EEPROM read failure. This may be a result of a simple random timing error by the ICP EXPRESS Monitor and can be corrected by selecting the ADJUST REFERENCE menu item and manually adjusting the displayed zero reference value to the correct zero reference value. However, this error can also be an indication of a failure in the ICP EXPRESS Cable EEPROM circuit due to deterioration associated with age or mechanical abuse. CAUTION: Discontinue use of any ICP EXPRESS Cable that continues to yield a “–99” transducer zero reference value (as displayed on the ICP EXPRESS Monitor screen) during the manual zeroing or zero reference verification procedures. CAUTION: DO NOT immerse the ICP EXPRESS Cable in any liquid, or allow liquid to enter the plug or connectors. Do not use cable if connectors become wet. Erratic results can occur.

Drift: Zero Range: Frequency Response:

<0.1 mmHg/°C at least ±100 mmHg at least 10 Hz

Leakage: Isolation:

<10 μA at 230 VAC, 50/60 Hz Isolated from ground related circuits by 4000 Vrms.

Display Type: Active Viewing Area: Matrix Size: Backlight:

CAUTION: Verify cable integrity prior to use. Do not use any cable that fails to meet the pin-to-pin resistance or electrical leakage specifications.

The ICP EXPRESS Cable integrity must be evaluated by qualified technical personnel. The cable must be routinely inspected for pin-to-pin resistance and electrical leakage.

VIS

Viewing Angle: Environmental Operating Temperature Range: Non-Operating Temperature Range (Storage and Transportation): Operating/Non-Operating Humidity Range: Mechanical Size: Weight: Power Requirements Internally Powered Equipment Mode of Operation is Continuous Rated Input: Supply Frequency: Supply Voltage:

Pin-to-pin resistance can be measured using an ohmmeter. Resistances between pins 1–1, 2–2, 3–3, and 4–4 must be one ohm or less. See Figure 8. Electrical leakage can be evaluated using an ohmmeter. Measure the open circuit resistance between pins 1, 2, 3, 4 (inclusive) and all other pins accessible on the ICP EXPRESS Monitor connector end. The open circuit resistances must be 300 MΩ or greater.

Technical Specifications

–50 to 250 mmHg 5 VDC, ±2.6% 5 μV/V/mmHg 10 MΩ 0 to 200 Hz (–3 dB) ±100 mmHg (auto pushbutton) <0.1 mmHg/°C (exclusive of transducer) ±1% of reading or 1 mmHg, whichever is larger (exclusive of transducer) 1 mmHg

Battery Operation Type: Operating Time:

RE

Pressure Channel Operating Range: Transducer Excitation Voltage: Transducer Sensitivity (Gain): Input Impedance: Frequency Response: Zero Range: Drift: Pressure Display Accuracy:

Pressure Display Resolution:

Liquid Crystal Display (LCD) 5.6 x 3.8 cm 128 x 64 pixels Blue-Green Electroluminescent (EL) ±30° 5°C to 45°C –40°C to 60°C 5% to 90% (non-condensing) 15.5 cm H x 8.9 cm W x 15.7 cm D 2.15 kg

200–260 VAC 0.1A 50/60 Hz 200–260 VAC Lead Acid, rechargeable 3 hours, nominal (fully charged, new battery)

Charge Time:

<12 hours (for fully discharged battery) <15 minutes life remaining

Isolation:

Isolated from ground related circuits by >4000 Vrms.

Low Battery Alert:

Leakage Current: Alarms

<10 μA at 230 VAC, 50–60 Hz

Safety

Alarm Parameter: Low ( ) Limit, Default: High ( ) Limit, Default: Low ( ) Limit Range:

Mean ICP 0 mmHg (user adjustable) 20 mmHg (user adjustable) –50 to +249 mmHg; 1 mmHg steps

High ( ) Limit Range: External Patient Monitor Interface

–49 to +250 mmHg; 1 mmHg steps

Output Signal Sensitivity:

5 μV/Vex/mmHg or 40 μV/Vex/mmHg (user selected; referenced to excitation voltage of patient monitor)

The ICP EXPRESS Monitor is Class I, CF Type Medical Equipment. The ICP EXPRESS is protected against defibrillator discharge with no interruption to normal functionality. The ICP EXPRESS Monitor meets or exceeds the requirements of the following standards: IEC 60601-1 Medical Equipment (2005), Part 1: General Requirement for Safety IEC 60601-1-2, 2nd Edition, 2001, The Electromagnetic Compatibility Requirements for Medical Electrical Equipment NOTE: When connecting the ICP EXPRESS Monitor to an external patient monitor, compliance with EN55011 is achieved only when using a Codman approved Patient Monitor Interface Cable which has an EMI Suppression Core attached adjacent to the 9-pin D-subminiature plug (the end of the

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Service and Repair

cable that connects to the ICP EXPRESS Monitor). Contact your local Codman sales representative for details regarding Patient Monitor Interface Cables (various product codes available) and EMI Suppression Cores (part number 194208-001).

For service, repair, or replacement outside the United States, contact your local Codman representative. The representative will coordinate the return to:

Cleaning

ELSG – Elektronik Service GmbH Dipl. Ing. Gregory Blufarb Philipp – Reis – Strasse 8 D – 24558 Henstedt – Ulzburg Germany

The ICP EXPRESS Monitor and ICP EXPRESS Cable can be cleaned using a clean cloth dampened with 70% isopropyl alcohol or mild hospital cleaning detergent/bactericide. CAUTION: DO NOT immerse the ICP EXPRESS Monitor or ICP EXPRESS Cable in any liquid, or allow liquid to enter the plug or connections. Do not use cable if connectors become wet. Erratic results can occur.

ED

For service or repairs to the ICP EXPRESS Monitor within the United States, contact your local Codman representative directly or through Codman & Shurtleff Customer Service, 1-800-225-0460.

CAUTION: Always disconnect the ICP EXPRESS Monitor from its power supply before cleaning.

User Maintenance

Accessories

Use only CODMAN MICROSENSOR ICP Transducers for intracranial pressure measurements. The MICROSENSOR is available in kits tailored for different applications including subdural, intraparenchymal and intraventricular ICP patient monitoring. Please contact your local Codman representative or our Customer Service Department at 1-800-225-0460 for ordering information.

With general care and handling the ICP EXPRESS Monitor is virtually maintenance free. The user must observe the following precautions:

Follow the instructions for cleaning, taking care not to stretch the interconnecting cables.

The following ICP patient monitoring accessories are available directly from Codman & Shurtleff, Inc.: Description

MICROSENSOR Basic Kit

82-6631

If the equipment fails to operate refer the equipment for service.

MICROSENSOR Bolt Kit

82-6632

After exposure to transport and storage ambient extremes allow the equipment to come within operating range before use.

MICROSENSOR Catheter Kit

82-6633

VIS

Before each use check the integrity of equipment covers and interconnecting leads. If either the covers or leads are damaged then do not use and refer the equipment for service.

Do not allow the ICP EXPRESS Monitor to stay in transport and storage ambient extremes for more than 15 weeks.

ICP EXPRESS Cable

82-6636

Patient Monitor Interface Cable

Call for product code to match your patient monitor.

EMI Suppression Core

194208-001

Preventive Maintenance

The following preventive maintenance schedule must be carried every 12 months by suitably qualified technical personnel: Earth continuity:

Earth leakage current:

ICP Channel leakage current:

Warranty

Codman & Shurtleff, Inc. warrants that this medical device is free from defects in both materials and workmanship for one year from the date of purchase. Components or products that, in Codman & Shurtleff’s opinion, are found to be defective will be repaired or replaced at Codman & Shurtleff’s option. Fuses and batteries are not covered under this warranty.

Maximum resistance must not exceed 0.2 ohms Maximum leakage current must not exceed 100 μA Maximum leakage current must not exceed 10 μA

Additional warranty information is included in the Codman Catalog and is incorporated here by reference. The foregoing warranty extends to the original purchases only, and will not extend to any assignee, subsequent transferee or other use of the Equipment.

In addition check that:

External fuses correspond to the values prescribed. External equipment markings remain legible. The mechanical condition is sound. The equipment is free of dirt or debris likely to impair safety or performance. The controls and displays function in accordance with the Instruction Manual. The rechargeable battery is charged.

RE

This warranty shall not apply where service is required due to (i) Buyer’s failure to operate or maintain the Equipment according to this Instruction Manual, (ii) Buyer’s use of unauthorized parts or consumables, (iii) accident, abuse, misuse, modification or misapplication, or (iv) improper service. Codman & Shurtleff does not warrant any product component or part not manufactured or distributed by Codman & Shurtleff. EXCEPT FOR THE EXPRESS WARRANTY STATED ABOVE, CODMAN & SHURTLEFF DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THE STATED WARRANTY AND REMEDY PROVIDED ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES AND REMEDIES PROVIDED BY LAW. IN PARTICULAR, THE SUITABILITY FOR USE OF THIS MEDICAL DEVICE FOR ANY PURPOSE OR PROCEDURE SHALL BE SOLELY DETERMINED BY THE USER.

In the event that the ICP EXPRESS Monitor falls outside its specification then it must be submitted for service, refer to the equipment Service Manual.

Sterilization

CAUTION: DO NOT STERILIZE the ICP EXPRESS Monitor. CAUTION: DO NOT AUTOCLAVE the ICP EXPRESS Cable. Sterilize the ICP EXPRESS Cable using ethylene oxide (EO) gas only. The ICP EXPRESS Cable is compatible with ethylene oxide (EO) gas sterilization only. Suggested ethylene oxide sterilization parameters are as follows: Temperature: Exposure Time: Aeration:

Codman Catalog No.

Neither Codman & Shurtleff nor its affiliated companies shall, in any case, be liable for special, incidental or consequential damages arising from breach of warranty, breach of contract, negligence, or any other legal theory. Such damages include, but are not limited to, loss of profits or revenue, loss of use of this medical device or any associated equipment, cost of capital, cost of any substitute equipment, facilities or services, or downtime costs.

54.4°C 2 hrs. 48.8°C for 8 hrs

Always refer to the sterilizer manufacturer’s instructions for correct times, temperatures and pressure settings.

® ICP EXPRESS, CODMAN, and CODMAN MICROSENSOR are registered trademarks of Codman & Shurtleff, Inc.

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Appendix A – Tables Note: The EMC tables and other guidelines that are included in this Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment.

Table 1 Manufacturer’s Declaration – Emissions All Equipment and Systems The Model 82-6635 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6635 ICP EXPRESS Monitor must assure that it is used in such an environment. Compliance

Electromagnetic Environment

RF Emissions CISPR 11

Group 1, Class B

The Model 82-6635 ICP EXPRESS Monitor 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.

Harmonic Emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

ED

Emission Test

The Model 82-6635 ICP EXPRESS Monitor is suitable for use in all establishments, including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Reference Table 201 IEC 60601-1-2

Table 2 Guidance and Manufacturer’s Declaration Regarding Electromagnetic Immunity

The Model 82-6635 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6635 ICP EXPRESS Monitor must assure that it is used in such an environment. IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

VIS

Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors must be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity must be at least 30%.

Electrical Fast Transient/burst IEC 61000-4-4

±2 kV on AC Mains ±1 kV I/Os

±2 kV on AC Mains ±1 kV I/Os ±0.5 kV Mains @ 100/120 V, 60 Hz

During EFT testing at 100–120 VAC, 60 Hz the pressure level went out of specification with a deviation of >3 mmHg when a ±1.0 kV disturbance was applied to all line combinations. Codman has provided sufficient justification to disregard this issue (see note 1 below). Mains power quality must be that of a typical commercial or hospital environment. See Note 1.

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

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

>95% dip in UT for 0.5 cycle 60% dip in UT for 5 cycles 30% dip in UT for 25 cycles <5% UT >95% dip in UT for 5 seconds

>95% dip in UT for 0.5 cycle 60% dip in UT for 5 cycles 30% dip in UT for 25 cycles <5% UT >95% dip in UT for 5 seconds

Mains power quality must be that of a typical commercial or hospital environment. If the uses of the Model 82-6635 ICP EXPRESS Monitor requires continued operation during power mains interruptions, it is recommended that the Model 82-6635 ICP EXPRESS Monitor be powered from an uninterruptible power supply or a battery.

3 A/m

3 A/m

Power frequency magnetic fields must be that of a typical location in a typical commercial or hospital environment.

Surge IEC 61000-4-5

RE

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8

UT is the AC mains voltage prior to the application of the test level

Reference Table 202 IEC 60601-1-2

1) Electrical Fast Transient/Burst disturbances greater than ±0.5 kV on the AC Mains can result in erroneous displayed numeric ICP values. In this case, disturbances that are clearly not physiological in origin will be visible on the ICP waveform displayed by the connected patient monitor. The abnormal numeric values may not reflect an accurate account of the treatment and a trained consultant must be notified for confirmation. In the event that the disturbance continues, the user is advised to connect the ICP EXPRESS to a different AC Mains outlet.

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Table 3 Guidance and Manufacturer’s Declaration Regarding Electromagnetic Immunity – Non-life Supporting The Model 82-6635 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6635 ICP EXPRESS Monitor must ensure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Conducted RF IEC 61000-4-6

3 Vrms from 150 kHz to 80 MHz

V1 = 3 Vrms

Portable and mobile communications equipment must be separated from the Model 82-6635 ICP EXPRESS Monitor by no less than the recommended separation distances calculated/listed below:

Radiated RF IEC 61000-4-3

ED

d = [3.5/V1]

3 V/m 80 MHz to 2.5 GHz

E1 = 3 V/m

d = [3.5/E1] 80–800 MHz

d = [7/E1] 800 MHz – 2.5 GHz

Where P is the maximum output power rating in watts and d is the recommended separation distance in meters. Field strength from fixed transmitters as determined by an electromagnetic site survey, must be less than the compliance levels (V1 and E1).

VIS

Interference can occur in the vicinity of equipment containing a transmitter.

Reference Table 204 IEC 60601-1-2

Table 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model 82-6635 ICP EXPRESS Monitor (Equipment and Systems that are NOT Life-Supporting) The Model 82-6635 ICP EXPRESS Monitor is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the Model 82-6635 ICP EXPRESS Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Model 82-6635 ICP EXPRESS Monitor as recommended below, according to the maximum output power of the communications equipment. Recommended Separation Distances for the Model 82-6635 ICP EXPRESS Monitor

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.1667

d = 1.1667

d = 2.3333

RE

Maximum Output Power (Watts)

0.01

0.11667

0.11667

0.23333

0.1

0.36894

0.36894

0.73785

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3785

100

11.667

11.667

23.333

Where P is the maximum output power rating in watts and d is the recommended separation distance in meters.

Reference Table 206 IEC 60601-1-2

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ICP EXPRESS Monitor (Catalog No. 82-6635)

LCN 182937-001/K DEUTSCH

ESPAÑOL

ICP EXPRESS MONITOR VORDERES BEDIENFELD

MONITOR ICP EXPRESS PANEL DELANTERO

A. ON/OFF-Schalter B. Patientenmonitor-Nulltaste C. Patientenmonitor-20 mmHgKalibrierungstaste D. Patientenmonitor-100 mmHgKalibrierungstaste E. Transducer-Nulltaste F. Alarm-Stumm-Taste G. Wechselstrom-Anzeige H. MENU-Taste I. Pfeil-nach-OBEN-Taste J. Pfeil-nach-UNTEN-Taste K. BATTERIE-Anzeige L. BATTERIELADE-Anzeige M. ICP-Eingang

A. Tecla ON/OFF B. Tecla cero del monitor del paciente C. Tecla de calibración a 20 mmHg del monitor del paciente D. Tecla de calibración a 100 mmHg del monitor del paciente E. Tecla cero del transductor F. Tecla de suspensión de la alarma G. Indicador CA H. Tecla MENU I. Tecla flecha hacia ARRIBA J. Tecla flecha hacia ABAJO K. Indicador de BATERÍA L. Indicador de carga de la BATERÍA M. Entrada de PIC

NEDERLANDS

PORTUGUÊS

ICP EXPRESS-MONITOR VOORZIJDE

PAINEL FRONTAL DO MONITOR ICP EXPRESS

A. ON/OFF-toets B. Patiëntmonitor-nulltoets C. Patiëntmonitor 20 mmHg calibratietoets D. Patiëntmonitor 100 mmHg calibratietoets E. Tranductornultoets F. Alarm Pauze-toets G. AC Indicator H. MENU-toets I. Pijl OMHOOG-toets J. Pijl OMLAAG-toets K. BATTERIJ-indicator L. Indicator voor BATTERIJ opladen M. ICP input

A. Tecla ON/OFF B. Tecla para repor a zero o monitor do paciente C. Tecla de calibração de 20 mmHg do monitor do paciente D. Tecla de calibração de 100 mmHg do monitor do paciente E. Tecla para repor a zero o transdutor F. Tecla de suspensão do alarme G. Indicador de CA H. Tecla de MENU I. Tecla com seta ASCENDENTE J. Tecla com seta DESCENDENTE K. Indicador da BATERIA L. Indicador de carga de BATERIA M. Entrada de PIC

ENGLISH

VIS

ED

1

FRANÇAIS

PANNEAU FRONTAL DU MONITEUR ICP EXPRESS

A. ON/OFF Key B. Patient Monitor Zero Key C. Patient Monitor 20 mmHg Calibration Key D. Patient Monitor 100 mmHg Calibration Key E. Transducer Zero Key F. Alarm Suspend Key G. AC Indicator H. MENU Key I. UP Arrow Key J. DOWN Arrow Key K. BATTERY Indicator L. BATTERY Charging Indicator M. ICP Input

A. Touche ON/OFF B. Touche de mise à zéro du moniteur du patient C. Touche d’étalonnage à 20 mmHg du moniteur du patient D. Touche d’étalonnage à 100 mmHg du moniteur du patient E. Touche de mise à zéro du capteur F. Touche de suspension de l’alarme G. Voyant CA H. Touche MENU I. Touche flèche ASCENDANTE J. Touche flèche DESCENDANTE K. Voyant de la BATTERIE L. Voyant du chargement de la BATTERIE M. Entrée de la PIC

ITALIANO

PANNELLO FRONTALE DEL MONITOR ICP EXPRESS A. Tasto ON/OFF B. Tasto azzeramento monitor paziente C. Tasto calibrazione monitor paziente da 20 mmHg D. Tasto calibrazione monitor paziente da 100 mmHg E. Tasto azzeramento trasduttore F. Tasto sospensione allarme G. Indicatore corrente alternata H. Tasto MENU I. Tasto freccia in SU J. Tasto freccia in GIÙ K. Indicatore BATTERIA L. Indicatore ricarica BATTERIA M. Ingresso pressione intracranica

RE

ICP EXPRESS MONITOR FRONT PANEL

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IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

ICP EXPRESS Monitor (Catalog No. 82-6635)

LCN 182937-001/K

4 ENGLISH ICP EXPRESS MONITOR SETUP A. Patient Monitor B. CODMAN Monitor Interface Cable C. ICP EXPRESS Monitor D. ICP EXPRESS Cable E. CODMAN MICROSENSOR ICP Transducer

FRANÇAIS

CONFIGURAZIONE DEL MONITOR ICP EXPRESS A. Monitor paziente B. Cavo di interfaccia per monitor CODMAN C. Monitor ICP EXPRESS D. Cavo ICP EXPRESS E. Trasduttore per la pressione intracranica MICROSENSOR CODMAN

ED

CONFIGURATION DU MONITEUR ICP EXPRESS

ITALIANO

A. Moniteur du patient B. Câble d’interface du moniteur CODMAN C. Moniteur ICP EXPRESS D. Câble ICP EXPRESS E. Capteur de PIC MICROSENSOR CODMAN

DEUTSCH

ICP EXPRESS MONITOR SETUP A. Patientenmonitor B. CODMAN PatientenmonitorSchnittstellenkabel C. ICP EXPRESS Monitor D. ICP EXPRESS Kabel E. CODMAN MICROSENSOR ICP-Transducer

NEDERLANDS

VIS

ICP EXPRESS-MONITOR SETUP A. Patiëntmonitor B. CODMAN monitor-interfacekabel C. ICP EXPRESS-monitor D. ICP EXPRESS-kabel E. CODMAN MICROSENSOR ICP transductor

5

ESPAÑOL

MONITOR ICP EXPRESS CONFIGURACIÓN

A. Monitor del paciente B. Cable de interfase del monitor CODMAN C. Monitor ICP EXPRESS D. Cable ICP EXPRESS E. Transductor de PIC MICROSENSOR CODMAN

PORTUGUÊS

CONFIGURAÇÃO DO MONITOR ICP EXPRESS

A. Monitor do paciente B. Cabo de interface de monitor CODMAN C. Monitor ICP EXPRESS D. Cabo ICP EXPRESS E. Transdutor de PIC MICROSENSOR CODMAN

ENGLISH

PATIENT MONITOR SENSITIVITY SELECTION SWITCH A. 5 μV Position B. 40 μV Position

RE

FRANÇAIS

INTERRUPTEUR DE SÉLECTION DE LA SENSIBLITÉ DU MONITEUR DU PATIENT

ITALIANO

A. Position 5 μV B. Position 40 μV

A. Posizione 5 μV B. Posizione 40 μV

DEUTSCH

ESPAÑOL

WAHLSCHALTER FÜR PATIENTENMONITOR-SENSITIVITÄT A. 5 μV-Position B. 40 μV-Position

NEDERLANDS

INTERRUTTORE SELEZIONE SENSIBILITÀ MONITOR PAZIENTE

INTERRUPTOR DE SELECCIÓN DE LA SENSIBILIDAD DEL MONITOR DEL PACIENTE A. Posición 5 μV B. Posición 40 μV

KEUZESCHAKELAAR VOOR HET INSTELLEN VAN DE GEFOELIGHEID VAN DE PATIËNTMONITOR

PORTUGUÊS

A. 5 μV positie B. 40 μV positie

A. Posição 5 μV B. Posição 40 μV

INTERRUPTOR DE SELECÇAO DE SENSIBILIDADE DO MONITOR DO PACIENTE

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PPE Specification Labeling Specification ICP EXPRESS INSTRUCTION MANUAL

IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

ICP EXPRESS Monitor (Catalog No. 82-6635)

LCN 182937-001/K

6 ENGLISH FUSE REPLACEMENT

FRANÇAIS REMPLACEMENT DES FUSIBLES

DEUTSCH AUSWECHSELN DER SICHERUNG

NEDERLANDS

ED

VERVANGING VAN ZEKERINGEN

ITALIANO

SOSTITUZIONE FUSIBILI

ESPAÑOL

REEMPLAZO DE LOS FUSIBLES

PORTUGUÊS

ENGLISH AC POWER CORD RETAINER

FRANÇAIS DISPOSITIF DE RETENUE DU CORDON D’ALIMENTATION CA

DEUTSCH STROMKABELHALTERUNG

NEDERLANDS AC SNOERHOUDER

ITALIANO DISPOSITIVO DI FISSAGGIO PER CAVO DI ALIMENTAZIONE

ESPAÑOL RETENEDOR DEL CABLE DE CA

RE

7

VIS

SUBSTITUIÇÃO DOS FUSÍVEIS

PORTUGUÊS RETENDOR DO CABO DE ALIMENTAÇÃO DE CA

8

ESPAÑOL CABLE ICP EXPRESS

ENGLISH

FRANÇAIS

DEUTSCH

NEDERLANDS

ITALIANO

PORTUGUÊS

ICP EXPRESS CABLE

CÂBLE ICP EXPRESS

ICP EXPRESS KABEL

ICP EXPRESS-KABEL

CAVO ICP EXPRESS

CABO ICP EXPRESS

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PPE Specification Labeling Specification ICP EXPRESS INSTRUCTION MANUAL

IFU-LCN-182937001 | Rev:K Released: 23 May 2012 Release Level: 4. Production

US Representative

64

Représentant américain US-Vertretung Vertegenwoordiger voor de VS Rappresentante USA Representante en los EE.UU. Representante nos EUA

ED

Authorized European Representative Représentant agréé pour l’Europe Autorisierte Vertretung für Europa Officiële vertegenwoordiging in Europa Rappresentante autorizzato per l’Europa Representante autorizado en Europa Representante autorizado na Europa

Electrical and electronic equipment. Return waste to collection system or treatment and recycling facilities. Applicable in the EU. Follow decontamination instructions before return.

Équipement électrique et électronique. Renvoyez les déchets à l’organisme de collecte ou à une installation de traitement et de recyclage. Applicable dans l’UE. Suivez les instructions de décontamination avant le renvoi. Elektrische und elektronische Geräte. Abfallstoffe an ein Auffangsystem oder an eine Abfallverwertungs- bzw. Recyclinganlage zurückgeben. Für Geräte in der EU. Vor Rückgabe alle entsprechenden Dekontaminierungsanweisungen beachten.

VIS

Elektrische en elektronische apparatuur. Voer afval af volgens het verzamelsysteem en recycle-faciliteiten. Van toepassing in de EU. Volg de ontsmettingsrichtlijnen voordat afvoer plaatsvindt.

Apparecchiature elettriche ed elettroniche. Inviare i rifiuti ad un sistema di raccolta o a strutture di trattamento e riciclaggio. Applicabile nella UE. Prima della restituzione, seguire le istruzioni per la decontaminazione.

Equipo eléctrico y electrónico. Devuelva los desechos a un sistema de recogida o a una planta de tratamiento y reciclaje. Aplicable en la UE. Siga las instrucciones de descontaminación antes de devolver los desechos. Equipamento eléctrico e electrónico. Os resíduos devem ser enviados para o sistema de recolha ou estações de tratamento e reciclagem. Aplicável na U.E. Siga as instruções de descontaminação antes de proceder ao envio.

Refer to instruction manual

RE

Consulter le manuel d’instructions Gebrauchsanleitung beachten Raadpleeg de gebruikershandleiding Fare riferimento al manuale d’istruzioni Refiérase al manual de instrucciones Ver manual de instruções

*

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA 800 225 0460 +1 508 828 3000

*

Medos International SÀRL Chemin-Blanc 38, 2400 Le Locle, Switzerland

* For recognized manufacturer, refer to product label. * Pour le fabricant reconnu, consulter l’étiquette du produit. * Dem Produktetikett ist der anerkannte Hersteller zu entnehmen. * Raadpleeg het etiket op het product voor informatie over de erkende fabrikant. * Per il produttore riconosciuto, fare riferimento all’etichetta del prodotto. * Para el fabricante reconocido, refiérase a la etiqueta del producto. * Para conhecer o fabricante reconhecido, consulte a etiqueta do produto.

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