ICP EXPRESS Monitor Instruction Manual Rev R Feb 2020

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3

EN – ENGLISH

ICP EXPRESS MONITOR DISPLAY

A. Alarm Suspend B. Mean ICP C. Low Battery Alert D. Alarm Limits (HIGH Alarm engaged) E. Alarm ON/OFF status F. Systolic and Diastolic ICP

FR – FRANÇAIS

ÉCRAN DU MONITEUR ICP EXPRESS A. Suspension d’alarme B. PIC moyenne C. Alerte de batterie faible D. Limites d’alarme (alarme HAUTE activée) E. Statut d’alarme marche/arrêt F. PIC systolique et diastolique

DE – DEUTSCH

PT (EU) – PORTUGUÊS

ICP EXPRESS MONITOR ANZEIGE

ECRÃ DO MONITOR ICP EXPRESS

A. Alarm-Stumm B. Mittelwert ICP C. Batterieende-Alarm D. Alarmgrenzwerte (HÖCHST-Alarm [HI] aktiviert) E. Alarm ON/OFF-Status F. Systolischer und diastolischer ICP

A. Suspensão de alarme B. PIC média C. Alerta de bateria fraca D. Limites de alarme (Alarme ALTO [HI] ativado) E. Posição ON/OFF do alarme F. PIC sistólica e diastólica

IT – ITALIANO

ES – ESPAÑOL

A. Sospensione allarme B. Pressione intracranica media C. Allarme batteria scarica D. Limiti allarme (allarme ALTO [HI] inserito) E. Stato allarme ON/OFF F. Pressione intracranica sistolica e diastolica

A. Suspensión de la alarma B. PIC promedio C. Alerta de batería insuficiente D. Límites de la alarma (Alarma ALTA [HI] activada) E. Estado ON/OFF de la alarma F. PIC sistólica y diastólica

DISPLAY DEL MONITOR ICP EXPRESS

PANTALLA DEL MONITOR ICP EXPRESS

4 IT – ITALIANO

CONFIGURAZIONE DEL MONITOR ICP EXPRESS

EN – 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

FR – FRANÇAIS

CONFIGURATION DU MONITEUR ICP EXPRESS A. Moniteur patient B. Câble d’interface du moniteur Codman C. Moniteur ICP EXPRESS D. Câble de l’ICP EXPRESS E. Capteur de PIC du Codman Microsensor

DE – DEUTSCH

A. Monitor paziente B. Cavo di interfaccia per monitor Codman C. Monitor ICP EXPRESS D. Cavo ICP EXPRESS E. Trasduttore per la pressione intracranica Codman Microsensor

PT (EU) – PORTUGUÊS

CONFIGURAÇÃO DO MONITOR ICP EXPRESS A. Monitor do paciente B. Cabo de interface do monitor Codman C. Monitor ICP EXPRESS D. Cabo ICP EXPRESS E. Transdutor de PIC Codman Microsensor

ES – ESPAÑOL

ICP EXPRESS MONITOR SETUP

CONFIGURACIÓN DEL MONITOR ICP EXPRESS

A. Patientenmonitor B. Codman Monitor-Schnittstellenkabel C. ICP EXPRESS Monitor D. ICP EXPRESS Kabel E. Codman Microsensor ICP-Wandler

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

5 DE – DEUTSCH

PATIENTENMONITORSENSITIVITÄTSWAHLSCHALTER

INTERRUPTOR DE SELEÇÃO DE SENSIBILIDADE DO MONITOR DE PACIENTE

A. 5 µV-Position B. 40 µV-Position C. SENSITIVITÄT D. SENSITIVITÄT

A. Posição 5 µV B. Posição 40 µV C. SENSIBILIDADE D. SENSIBILIDADE

IT – ITALIANO

ES – ESPAÑOL

A. Posición 5 µV B. Posición 40 µV C. SENSIBILIDAD D. SENSIBILIDAD

EN – ENGLISH

FR – FRANÇAIS

INTERRUPTEUR DE SÉLECTION DE LA SENSIBLITÉ DU MONITEUR DU PATIENT

INTERRUTTORE PER LA SELEZIONE DELLA SENSIBILITÀ DEL MONITOR PAZIENTE

A. Position 5 µV B. Position 40 µV C. SENSIBILITÉ D. SENSIBILITÉ

A. Position 5 µV B. Position 40 µV C. SENSIBLITÉ D. SENSIBLITÉ

A. Posizione 5 µV B. Posizione 40 µV C. SENSIBILITÀ D. SENSIBILITÀ

SÉLECTEUR DE SENSIBILITÉ DU MONITEUR PATIENT

ii

PT (EU) – PORTUGUÊS

INTERRUPTOR DE SELECCIÓN DE SENSIBILIDAD DEL MONITOR DEL PACIENTE

6

EN – ENGLISH

FUSE REPLACEMENT

FR – FRANÇAIS

REMPLACEMENT DES FUSIBLES

DE – DEUTSCH

AUSWECHSELN DER SICHERUNG

IT – ITALIANO

SOSTITUZIONE DEI FUSIBILI

PT (EU) – PORTUGUÊS

SUBSTITUIÇÃO DOS FUSÍVEIS

ES – ESPAÑOL

REEMPLAZO DE LOS FUSIBLES

7

EN – ENGLISH

AC POWER CORD RETAINER

FR – FRANÇAIS

DISPOSITIF DE RETENUE DU CORDON D’ALIMENTATION SECTEUR

DE – DEUTSCH

WECHSELSTROMKABELHALTERUNG

IT – ITALIANO

DISPOSITIVO DI FISSAGGIO PER CAVO DI ALIMENTAZIONE CA

PT (EU) – PORTUGUÊS

RETENTOR DO CABO DE ALIMENTAÇÃO DE CORRENTE ALTERNADA

ES – ESPAÑOL

RETENEDOR DEL CABLE DE ALIMENTACIÓN DE CA

EN – ENGLISH

8

ICP EXPRESS Cable

FR – FRANÇAIS

Câble ICP EXPRESS

DE – DEUTSCH

ICP EXPRESS Kabel

IT – ITALIANO

Cavo ICP EXPRESS

PT (EU) – PORTUGUÊS Cabo ICP EXPRESS

ES – ESPAÑOL

CABLE ICP EXPRESS

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EN – ENGLISH

Codman

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.

ICP EXPRESS® Monitor

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

®

Patient connections are electrically isolated Type CF. Do not let patient connections contact other conductive parts, including earth. Routinely inspect all electrical plugs and connections. Do not use if damaged.

Instruction Manual

Maintain strict sterile technique when connecting the ICP EXPRESS Cable to the Codman Microsensor.

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

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.

Introduction This manual is intended to provide instructions on the proper use of the ICP EXPRESS® Monitor (REF 82-6634). 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.

Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.

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 Codman 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 may be interfaced directly to the pressure channel input on most patient monitoring systems. The ICP EXPRESS Monitor is 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 three hours on its own internal rechargeable battery. Key features provided by the ICP EXPRESS Monitor include:

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. The use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause damage to the ICP Codman Microsensor and/or ICP EXPRESS Monitor. This could lead to permanent or temporary disabling of either device.

CAUTIONS 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.).

• Digital display of mean, systolic, and diastolic ICP • One-touch transducer zero function • User programmable mean ICP alarms • Compatibility with most patient monitoring systems for full ICP waveform analysis and integration of ICP data with other patient information

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.

• 0, 20 and 100 mmHg patient monitor reference signals • Integral pole clamp

Use only the ICP EXPRESS Cable (Catalog No. 82-6636) to connect the Codman Microsensor to the ICP EXPRESS Monitor.

Included with the ICP EXPRESS Monitor is one 3 m long ICP EXPRESS Cable (Catalog No. 82‑6636). The ICP EXPRESS Cable is used to connect the Codman Microsensor to the ICP EXPRESS Monitor. During the transducer zeroing process the ICP EXPRESS Monitor automatically stores the Codman Microsensor’s zero reference value in a nonvolatile 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 (EtO) gas. Refer to the Sterilization section for details.

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 US, contact your local Integra representative for full details. Outside the US, contact your local Integra representative.

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

Connect the Patient Monitor Interface Cable connector to only certified patient monitors. 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. Discontinue use if the patient monitor can not 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 can not be properly calibrated to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

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).

2

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.

EN – ENGLISH 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 Codman Microsensor must be zeroed at atmospheric pressure, prior to implantation. The Codman Microsensor transducer tip must remain wet during the zeroing process. Do not submerge the tip of the Codman 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. 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 Codman Microsensor connector housing or the patient’s chart. The mean ICP alarms will reset to default values (LO: 0 mmHg; HI: 20 mmHg) whenever the ICP EXPRESS Monitor power is turned OFF.

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

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

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

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

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.

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.

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

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

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

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.

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.

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.

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

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.

ON (CIRCUITS)/STANDBY (CIRCUITS) Type CF equipment, floating input protected against defibrillator discharge.

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.”

ICP EXPRESS Monitor Description 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

0

Pole Clamp Used for mounting the ICP EXPRESS Monitor to standard pole diameters from 1/2" to 1-1/2" (1.3 to 3.8 cm). Handle Used for hand transport.

PATIENT MONITOR ZERO KEY-Initiates an electronic 0 mmHg reference

 signal for zeroing an externally connected patient monitor.

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

 PATIENT MONITOR 100 mmHg CALIBRATION KEY-Initiates an electronic

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.

Display (See Figure 3) Intracranial Pressure The ICP EXPRESS Monitor 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 and Diastolic ICP values are displayed with smaller characters in the bottom right portion of the screen.

100 mmHg reference signal for calibrating an externally connected patient monitor.



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

3

EN – ENGLISH 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 HI and LO alarms will engage whenever the mean ICP exceeds the HI or falls beneath the LO user programmable limits. When the alarm is OFF, the HI and LO alarms will not engage, regardless of the mean ICP level.

Zeroing and Calibrating the Patient Monitor

Alarm Limits The HI and LO 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 HI and 0 mmHg for LO. Both limits can be adjusted by using the MENU system.

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 can not be properly zeroed to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

Alarm Indicators HI and LO Mean ICP: The HI and LO 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 HI or falls beneath the LO user programmable limits. An audible tone is cycled on and off once per second when the alarm condition is triggered.

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).

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.

LOW BATTERY: The BAT. LOW message will appear in reverse video 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.

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 may 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 can not be properly calibrated to the ICP EXPRESS Monitor. Consult with appropriate technical personnel.

Wrong Key Press: The ICP EXPRESS Monitor will sound a triple audible tone whenever an incorrect key is pressed. Alarm SUSPEND The Alarm SUSPEND symbol, , 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.

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

Operating Instructions

key to proceed.

Connecting the Transducer

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.

CAUTION: Read all instructions included with the Codman Microsensor ICP Transducer Kit regarding proper operation prior to use. CAUTION: Use only Codman Microsensor ICP Transducers for intracranial pressure measurements.

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 installation instructions). Plug the other end of the power cord into a power supply providing the appropriate voltage (120/127 VAC for Catalog No. 82-6634; refer to rear panel label for proper voltage). The front panel AC and BATTERY CHARGING indicators will illuminate.

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. CAUTION: Do not autoclave the ICP EXPRESS Cable. Sterilize the ICP EXPRESS Cable using ethylene oxide (EtO) 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. 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.

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 onequarter turn clockwise while withdrawing.)

3.A few seconds will elapse as the ICP EXPRESS Monitor performs a series of selfdiagnostic 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 self-test period the ICP EXPRESS Monitor will display an error message. Discontinue use and consult with appropriate technical personnel.

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

Connecting the Patient Monitor

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

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.

CAUTION: The Codman Microsensor transducer tip must remain wet during the zeroing process. 1. Lay approximately three inches of the tip of the Codman 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 Codman Microsensor or ventricular catheter. CAUTION: Do not submerge the tip of the Codman 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.

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.

2. While keeping the tip of the Codman 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.

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.

4

EN – ENGLISH 3. Upon successful completion of the zeroing process, the ICP EXPRESS Monitor will display the Codman Microsensor’s three digit zero reference value. Record the displayed zero reference value on the Codman Microsensor connector housing and on the patient’s chart for future use. NOTE: When zeroing is complete, the Codman 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 Monitor 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 Codman Microsensor connector housing or the patient’s chart. 4. If the transducer zeroing process is unsuccessful, the message “TRANSDUCER ZEROING ERROR” will appear. Verify that the tip of the Codman 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, and consult with appropriate technical personnel. 5. After recording the zero reference value on the Codman Microsensor connector housing and the patient’s chart, press the key to proceed. 6. The ICP EXPRESS Monitor is now in standard display mode. The Codman Microsensor is now ready for placement.

or 3. Use the line, then press the

keys to position the cursor on the ADJUST REFERENCE key.

4. Use the or keys to change the three digit zero reference value until it matches the value recorded on the Codman 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.

Re-Zeroing the Patient Monitor The following instructions describe the procedure for manually re-zeroing the patient monitor. 1. From the standard display mode, press the front panel.

0

key on the ICP EXPRESS Monitor

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 can not be properly zeroed to the ICP EXPRESS Monitor. Consult with appropriate technical personnel. 3. Press the

key to resume patient monitoring.

Re-Calibrating the Patient Monitor The following instructions describe the procedure for manually re-calibrating the patient monitor.

Alarm Functions

1. Press the

Changing Alarm Limits

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 may 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 HI and LO 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. 1. From the standard display mode, press the screen. 2. Use the or then press the value.

key to bring up the main menu

keys to move the cursor to the SET ALARM LIMITS line, key. The HI alarm limit will be displayed above the mean ICP

3. Use the or keys to increase or decrease the displayed HI alarm limit to the desired value. Press the key to enter the value. The LO alarm limit will be displayed above the mean ICP value. 4. U  se the Press the

or keys to increase or decrease the displayed LO alarm limit. key to enter the value and return to the standard display mode.

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

Changing Alarm ON/OFF Status 1. From the standard display mode, press the

key to bring up the main menu.

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.

Adjusting the Transducer Zero Reference Value The following instructions describe the procedure for manually adjusting the zero reference value for the attached Codman 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 Codman Microsensor connector housing or patient’s chart. 1. From the standard display mode, press the 2. Use the or then press the

key to bring up the main menu.

keys to position the cursor on the MANUAL ZERO line, key.

3. P ress the

or the

key on the ICP EXPRESS Monitor panel.

key to resume patient monitoring.

Changing System Components During Monitoring 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.

Switching to a New Patient Monitor 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). 1. Disconnect the Codman Patient Monitor Interface Cable from the original patient monitor. 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. 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.

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EN – ENGLISH

Battery Operation

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

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

Switching to a New ICP EXPRESS Unit The following instructions describe the procedure for switching the patient to a new ICP EXPRESS unit while patient monitoring is in progress (i.e., 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).

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. 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. 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.

The ICP EXPRESS Monitor 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 BAT. LOW message 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 Codman Microsensor. NOTE: The HI and LO mean ICP alarms will reset to the default values (HI: 20 mmHg; LO: 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.

3. Follow the instructions for Zeroing and Calibrating the patient monitor as previously described in the Operating Instructions section. 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 Codman 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. 5. If the displayed zero reference value does not match the zero reference value previously recorded on the Codman 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 Codman Microsensor housing or the patient’s chart, then press the key to enter the zero reference value. The new reference is automatically updated in the ICP EXPRESS Cable memory.

IMPOR­TANT BATTERY MAIN­TE­NANCE INFOR­MA­TION! To main­tain the ICP EXPRESS Monitor recharge­able battery in optimum con­di­tion: 1. Charge for at least 12 hours within seven days of a com­plete dis­charge. 2. Charge for at least 12 hours once every six 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.

Switching ICP EXPRESS Cables Integra 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:

Fuse Replacement 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.

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

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.

2. Connect the new ICP EXPRESS Cable to the Codman 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.

3. Remove the fuses by pulling them straight out of the fuse holder. 4. Replace the fuses with the same type and rating as indicated on the rear panel label. For model 82-6634 use 5 x 20 mm, 0.25 A, 250 V, time delay (SB or T) type fuses.

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.

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.

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 Codman Microsensor housing or the patient’s chart. To adjust the zero reference value, move the cursor to the ADJUST REFERENCE line and press the key. Use the or keys to adjust the zero reference value to match the zero reference value recorded on the Codman Microsensor housing or patient’s chart, then press the key to enter the zero reference value and proceed patient monitoring.

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.

Setting Patient Monitor Sensitivity

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.

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 and turn one position counterclockwise. See Figure 5.

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.

6

EN – ENGLISH 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 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 Codman Microsensor to the ICP EXPRESS Monitor. The ICP EXPRESS Cable is also available separately (Catalog No. 82-6636).

Pressure Display Accuracy:

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

Pressure Display Resolution:

1 mmHg

Isolation:

Isolated from ground related circuits by >4000 Vrms.

Leakage Current:

<10 µA at 120/127 VAC, 60Hz

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 (EtO) gas only.

Alarms Alarm Parameter:

Mean ICP

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 Codman 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.

Low (LO) Limit, Default:

0 mmHg (user adjustable)

High (HI) Limit, Default:

20 mmHg (user adjustable)

Low (LO) Limit Range:

–50 to +249 mmHg; 1 mmHg steps

High (HI) Limit Range:

–49 to +250 mmHg; 1 mmHg steps

External Patient Monitor Interface

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 Codman Microsensor is zeroed, or when the user chooses to adjust the 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 may 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.

Output Signal Sensitivity:

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

Output Signal Accuracy:

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

Reference Signals:

0, 20 and 100 mmHg

Input Impedance:

350–500 Ω

Source Impedance:

350 Ω

Frequency Response:

0 to 200 Hz (–3 dB)

Recommended External Patient Monitor Specifications Excitation Voltage Range:

0.5 to 10.0 VDC or VAC rms

Excitation Voltage Frequency:

DC to 5000 H

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.

Transducer Sensitivity (Gain):

5 µV/Vex/mmHg or 40 µV/Vex/mmHg

Drift:

<0.1 mmHg/°C

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.

Zero Range:

at least ±100 mmHg

Frequency Response:

at least 10 Hz

Leakage:

<10 µA at 120 VAC, 60 Hz

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.

Isolation:

Isolated from ground related circuits by 4000 Vrms.

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.

Display

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.

Technical Specifications Pressure Channel

Type:

Liquid Crystal Display (LCD)

Active Viewing Area:

2.215 in. x 1.51 in. (5.6 x 3.8 cm)

Matrix Size:

128 x 64 pixels

Backlight:

Blue-Green Electroluminescent (EL) ±30°

Operating Range:

–50 to 250 mmHg

Viewing Angle:

Transducer Excitation Voltage:

5 VDC, ±2.6%

Environmental

Transducer Sensitivity (Gain):

5 µV/V/mmHg

Operating Temperature Range:

5°C to 45°C

Input Impedance:

10 MΩ

Non-Operating Temperature Range (Storage and Transportation):

–40°C to 60°C

Frequency Response:

0 to 200 Hz (–3 dB) ±100 mmHg (auto pushbutton

Operating/Non-Operating Humidity Range:

5% to 90% (non-condensing)

Zero Range: Drift:

<0.1 mmHg/°C (exclusive of ransducer)

Operating Atmospheric Pressure Range:

700 hPA to 1060 hPA

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End of Useful Life

Mechanical Size:

6.1 in. H x 3.5 in. W x 6.2 in. D

Weight:

4.75 lbs (2.15 kg)

The ICP Express Monitor contains electrical components. Consider recycling at the end of service life. The product can be returned to Integra for recycling. Dispose of the equipment in accordance with local ordinances.

Accessories

Power Requirements

Use only Codman Microsensor ICP Transducers for intracranial pressure measurements. The Codman Microsensor is available in kits tailored for different applications including subdural, intraparenchymal and intraventricular ICP patient monitoring. Please contact your local sales representative

Internally Powered Equipment Mode of Operation is Continuous Rated Input:

120/127VAC, 0.2A

Supply Frequency:

60 Hz

Supply Voltage:

120/127 VAC

The following ICP patient monitoring accessories are available: Description

Codman Catalog No.

Codman Microsensor Basic Kit

82-6631, 626631, 626631US

Codman Microsensor Ventricular Catheter Kit - with Tuohy-Borst Adapter

82-6633, 626633, 626633US

Codman Microsensor Ventricular Catheter Kit

82-6653, 626653, 626653US

Codman ICP Express Cable

82-6636

Codman Microsensor Metal Skull Bolt Kit

82-6638, 626638, 626638US

The ICP EXPRESS Monitor is Class I, CF Type Medical Equipment.

Codman Microsensor Metal Skull Bolt Kit

82-6639 (5 per case)

The input of ICP EXPRESS Monitor is protected against defibrillator discharge with no interruption to normal functionality.

Codman CereLink™ ICP Sensor Basic Kit

82-6850

Codman CereLink ICP Sensor Metal Skull Bolt Kit

82-6851

Codman CereLink ICP Sensor Plastic Skull Bolt Kit

82-6852

Codman CereLink ICP Sensor Ventricular Catheter Kit

82-6854

Cleaning and Maintenance 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.

PRODUCT INFORMATION DISCLOSURE

Battery Operation Type:

Lead Acid, rechargeable

Operating Time:

3 hours, nominal (fully charged, new battery)

Charge Time:

<12 hours (for fully discharged battery)

Low Battery Alert:

<15 minutes life remaining

Safety

The ICP EXPRESS Monitor complies with: IEC 60601-1 (2005) Medical Equipment, Part 1: General Requirements for Safety IEC 60601-1-2 (2001) Electromagnetic Compatibility (EMC) Requirements and Tests

INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE, AND INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.

It is not necessary to perform any yearly maintenance or calibration of the ICP EXPRESS unit. 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. CAUTION: Always disconnect the ICP EXPRESS Monitor from its power supply before cleaning.

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 (EtO) gas only. The ICP EXPRESS Cable is compatible with ethylene oxide (EtO) gas sterilization only. Suggested ethylene oxide sterilization parameters are as follows: Temperature:

130°F (54.4°C)

Exposure Time:

2 hrs.

Aeration:

120°F (48.8°C) for 8 hrs

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

Service and Repair For service, repair, or replacement outside the United States, contact your local sales representative. For service or repairs to the ICP EXPRESS Monitor within the United States, contact your local sales representative directly.

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WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of ICP Express Monitor 82-6634 and its accessories. Otherwise, degradation of the performance of this equipment could result. 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 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6634 ICP EXPRESS Monitor must assure that it is used in such an environment. Emission Test

Compliance

Electromagnetic Environment

RF Emissions CISPR 11

Group 1, Class B

The Model 82-6634 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

The Model 82-6634 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 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6634 ICP EXPRESS Monitor must assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 8 kV contact +/- 2 kV, +/- 4 kV, +/- 8 kV, - +/- 15 kV air

+/- 8 kV contact +/- 2 kV, +/- 4 kV, +/- 8 kV, - +/- 15 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. Integra 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 Note1.

Surge IEC 61000-4-5

±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.

Voltage dips, short interruptions 0 % UT; 0,5 cycle and voltage variations on power At 0°, 45°, 90°, 135°, 180°, supply input lines 225°, 270° and 315° IEC 61000-4-11 0 % UT; 1 cycle at 0° 70 % UT; 25/30 cycles 0°

0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

Mains power quality must be that of a typical commercial or hospital environment. If the uses of the Model 82-6634 ICP EXPRESS Monitor requires continued operation during power mains interruptions, it is recommended that the Model 82‑6634 ICP EXPRESS Monitor be powered from an uninterruptible power supply or a battery.

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

0 % UT; 1 cycle at 0° 70 % UT; 25/30 cycles 0°

0 % UT; for 5 seconds

0 % UT; for 5 seconds

30 A/m

30 A/m

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

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 Monitor 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 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the Model 82-6634 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 82-6634 ICP EXPRESS Monitor by no less than the recommended separation distances calculated/listed below: d = [3.5/V1]

Radiated RF IEC 61000-4-3

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

Reference Table 204 IEC 60601-1-2 For RF Immunity Wireless Communication Equipment refer to test method per Table 9 in IEC60601-1-2 4th ed.

Table 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model 82-6634 ICP EXPRESS Monitor (Equipment and Systems that are NOT Life-Supporting) The Model 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the Model 82-6634 ICP EXPRESS Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Model 82-6634 ICP EXPRESS Monitor as recommended below, according to the maximum output power of the communications equipment. Recommended Separation Distances for the Model 82-6634 ICP EXPRESS Monitor Maximum Output Power (Watts)

80 MHz to 800 MHz

150 kHz to 80 MHz

d = 1.1667

d = 1.1667

800 MHz to 2.5 GHz d = 2.3333

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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Symbol

Title of Symbol

Meaning of Symbol

Standard

Reference Number

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

5.1.1

Authorized representative in the European Community

Indicates the authorized representative in the European Community

5.1.2

Date of manufacture (YYYY-MM-DD)

Indicates the date when the medical device was manufactured.

5.1.3

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

Catalogue Number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

5.1.6 ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied

Non-sterile

Indicates a medical device that has not been subjected to a sterilization process.

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

5.2.8

Consult instructions for use

Indicates the need for the user to consult the instructions for use.

5.4.3

Caution

Indicates the need for the User to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

5.4.4

Refer to instruction manual / booklet

To signify that the instruction manual/ booklet must be read.

ISO 7010 – Graphical symbols – Safety colors and safety signs – Registered safety signs

M002

Prescription Use Only

Caution: Federal (US) law restricts this device to sale by or on the order of a physician or licensed healthcare practitioner.

Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements, dated January 21, 2000

N/A

Magnetic Resonance (MR) conditional

An Item with demonstrated safety in the MR environment within defined conditions.

ASTM F2503 – Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

N/A

Waste Electrical and Electronic Equipment Symbol

Dispose of in accordance with WEEE regulations.

BS EN 50419:2006 – Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)

N/A

Quantity

To indicate the number of devices per package

Proprietary

N/A

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2797 0086

Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 USA

EC REP

Integra LifeSciences Services (France) Immeuble Séquoïa 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France

Codman, ICP EXPRESS, Codman Microsensor, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. CereLink is a trademark of Integra LifeSciences Corporation or its subsidiaries. ©2020 Integra LifeSciences Corporation. All rights reserved. LCN 182446-001 Rev R 02/20 1090038-3