ICP EXPRESS 82-663x Biomed Manual Rev A

WI-10204 Rev A

Table of Contents 1.0

PURPOSE OF DOCUMENT ...3

2.0

TEST EQUIPMENT REQUIRED ...3

3.0

REQUIRED TOOLS ...3

4.0

RELATED DOCUMENTS ...3

5.0

PRODUCT DESCRIPTION ...3

6.0

GENERAL SAFETY SUMMARY...3

7.0

TABLE OF SYMBOLS ...4

8.0

TECHNICAL SPECIFICATIONS ...10

9.0

CLASSIFICATION/SAFETY ...11

10.0

SERVICE SAFETY SUMMARY ...11

11.0

ELECTROSTATIC DAMAGE PREVENTION ...11

12.0

REPLACEABLE PARTS ...12

13.0

TEST PROCEDURE (82-6634 & 82-6637 ONLY) ...14

14.0

TEST PROCEDURE (82-6635 ONLY) ...24

15.0

SPARE PARTS...34

16.0

DHF (82-6634 & 82-6637 ONLY) ...35

17.0

DHF (82-6635 ONLY) ...38

ICP EXPRESS™ SERVICE MANUAL

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WI-10204 Rev A 1.0

2.0

Purpose of document •

This document describes the process, test equipment, tools and spare parts needed to repair and test the ICP Express.

•

This service manual is intended to be used for the service and repair tasks by trained and authorized personnel at approved service centers.

Test Equipment Required Equipment Description Digital Multimeter (DMM)

Part #

Calibration Schedule

Fluke 8808A (or equivalent)

Pressure Simulator Fogg BP-600 DWG-166646002 (or equivalent)

Leakage Tester Adapter Cable

3.0

Codman 198433

calibrate per manufacturers requirement calibrate per manufacturers requirement N/A Visual Inspection

Required Tools Tool Description

Part #

Philips Head Screwdriver #2 70% isopropyl alcohol solution

Standard Tool Standard Tool

Clean soft cloth

4.0

5.0

Standard Tool

Related Documents (Verify for correct model) Document Agile #

Description

LCN 182446-001

82-6634 Instructions for use (IFU)

LCN 195440-001

82-6637 Instructions for use (IFU)

LCN 182937-001

82-6635 Instructions for use (IFU)

Product Description The ICP EXPRESS Monitor 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 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.

6.0

General Safety Summary Review the safety precautions outlined in section 10.0 in order to prevent injury to the patient and operator, and to avoid damage to this product or any products connected to it. Only trained and authorized personnel should perform service procedures.

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WI-10204 Rev A

7.0

Table of Symbols 7.1

82-6634 (110v /120v)

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WI-10204 Rev A

ICP EXPRESS™ SERVICE MANUAL

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WI-10204 Rev A 7.2

82-6637 (Japan Version)

ICP EXPRESS™ SERVICE MANUAL

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WI-10204 Rev A

ICP EXPRESS™ SERVICE MANUAL

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WI-10204 Rev A

7.3

82-6635 (220v /240v)

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WI-10204 Rev A

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WI-10204 Rev A 8.0

Technical Specifications

Pressure Channel Operating Range: Transducer Excitation Voltage: Transducer Sensitivity (Gain): Input Impedance: Frequency Response: Zero Range: Drift: Pressure Display Accuracy: Pressure Display Resolution: Isolation: Leakage Current: Alarms Alarm Parameter: Low (LO) Limit, Default: High (HI) Limit, Default: Low (LO) Limit Range: High (HI) Limit Range: External Patient Monitor Interface Output Signal Sensitivity: Output Signal Accuracy: Reference Signals: Input Impedance: Source Impedance: Frequency Response: Recommended External Patient Monitor Specifications Excitation Voltage Range: Excitation Voltage Frequency: Transducer Sensitivity (Gain): Drift: Zero Range: Frequency Response: Leakage: Isolation: Display Type: Active Viewing Area: Matrix Size: Backlight: Viewing Angle: Environmental Operating Temperature Range: Non-Operating Temperature Range (Storage and Transportation):

–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 Isolated from ground related circuits by >4000 Vrms. <10 μA at 117 VAC, 50–60 Hz (826634) <10 μA at 100 VAC, 50–60 Hz (826637) <10 μA at 230 VAC, 50–60 Hz (826635) Mean ICP 0 mmHg (user adjustable) 20 mmHg (user adjustable) –50 to +249 mmHg; 1 mmHg steps –49 to +250 mmHg; 1 mmHg steps

5 μV/Vex/mmHg or 40 μV/Vex/mmHg (user selected; referenced to excitation voltage of patient monitor) ±1 mmHg or 1%, whichever is greater (exclusive of transducer) 0, 20 and 100 mmHg 350–500 Ω 350 Ω 0 to 200 Hz (–3 dB)

0.5 to 10.0 VDC or VAC rms DC to 5000 Hz 5 μV/Vex/mmHg or 40 μV/Vex/ mmHg <0.1 mmHg/°C at least ±100 mmHg at least 10 Hz <10 μA at 117 VAC, 60 Hz (826634) <10 μA at 100 VAC, 60 Hz (826637) <10 μA at 230 VAC, 60 Hz (826635) Isolated from ground related circuits by 4000 Vrms. Liquid Crystal Display (LCD) 2.215 in. x 1.51 in. (5.6 x 3.8 cm) 128 x 64 pixels Blue-Green Electroluminescent (EL) ±30° 41°F to 113°F (5°C to 45°C) –40°F to 140°F (–40°C to 60°C)

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WI-10204 Rev A Operating/Non-Operating Humidity Range: Mechanical Size: Weight: Power Requirements

Supply Frequency: Supply Voltage: Battery Operation Type: Battery Operating Time: Charge Time: Low Battery Alert:

• •

11.0

Lead Acid, rechargeable 3 hours, nominal (fully charged, new battery) 12 hours maximum (for fully discharged battery) <15 minutes life remaining

Classification/Safety • •

10.0

6.1 in. H x 3.5 in. W x 6.2 in. D (15.5 cm H x 8.9 cm W x 15.7 cm D) 4.75 lbs (2.15 kg) 100 - 120 VAC 0.2A (826634 & 826637) 200–260 VAC 0.1A (826635) 50/60 Hz 100 - 120 VAC (826634 & 826637) 200–260 VAC (826637)

Rated Input:

9.0

5% to 90% (non-condensing)

The ICP EXPRESS Monitor is a Class I, CF Type Medical Equipment. The input of ICP EXPRESS is protected against defibrillator discharge with no interruption to normal functionality. 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

Service Safety Summary •

Only trained and authorized personnel should perform service procedures. Read the Service Safety Summary and the General Safety Summary before performing any service procedures.

•

All repairs requiring opening of the case should only be performed by a trained and qualified repair center. Please direct all repairs to a trained and qualified repair center. (800-343-5969 within the United States).

•

Do not service alone. Do not perform internal service or adjustments on this instrument unless another person capable of rendering first aid and resuscitation is present.

•

Use care when servicing with the Power on. Dangerous voltages or currents may be present in this product. To avoid electric shock, do not touch exposed connections. Do not remove the top cover or any protective cover while the instrument is powered or connected to AC mains.

•

Full Safety Verification Tests must be performed after a service procedure. Any service procedure that involves removing the board assemblies must be followed by complete safety verification procedures.

Electrostatic Damage Prevention The ICP Express contains electronic components that are susceptible to damage from electrostatic discharge. Static voltages of I kV to 30kV are common in unprotected environments. Observe the following precautions to avoid static damage: •

Minimize handling of static-sensitive components.

•

Transport and store static-sensitive components or assemblies in their original containers, or a metal rail, or on conductive foam. Label any package that contains static-sensitive assemblies or components.

•

Discharge the static voltage from your body by wearing a wrist strap while handling these components. Servicing static-sensitive assemblies or components should only be performed at a static-free workstation by qualified personnel.

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WI-10204 Rev A

12.0

•

Nothing capable of generating or storing a static charge should be allowed on the workstation surface.

•

Pick up components by the body, never by the leads.

•

Do not slide the components over any surface.

•

Avoid handling components or assemblies in areas that have a floor or work surface covering capable of generating a static charge.

Replaceable parts Pole clamp and handle (Part# 182756-001 Handle, Part# 182774-001 Clamp) •

Using a #2 Phillips screwdriver, remove the 2 screws connecting the pole clamp to the rear panel, as outlined in Figure 1.

Figure 1

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WI-10204 Rev A •

Using a small flat headscrewdriver, release the fuse holder by pressing on the latch on each side of the fuse holder as outlined in Figure 2

Figure 2

.

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WI-10204 Rev A 13.0

Test Procedure (82-6634 & 82-6637 Only) Note: DUT = Device (ICP Express) Under Test Note: If the DUT fails any of the following tests please return the unit for service to a trained and qualified repair center. (800-343-5969 within the United States)

13.1

Visual Inspection 13.1.1 Record DUT serial number.

13.2

Fuses Equipment: Small slotted head screwdriver Remove the external fuse holder from the rear panel AC entry module and verify the proper installation of the two 5x20 mm fuses. Verify and record the proper fuse rating: 250 mA (0.25 A), 250 V, time delay (type SB or T). Re-install the fuses and the external fuse holder into the AC entry module. Press firmly on both sides of the fuse holder to ensure correct installation in the AC entry module.

13.3

Electrical Safety Inspection 13.3.1 Leakage Current Note:

Leakage current tests are to be performed in accordance with IEC60601-1, 2nd, ed..

Equipment:

Digital multimeter, RC input circuit per IEC60601-1, 2nd ed., front panel receptacle shorting connector, leads, 60 Hz specified power source.

13.3.1.1

Chassis Leakage (refer to Figure 3) Measure and record the chassis leakage current for each condition listed in Figure 3. Set the DMM to read in the "AC" mode in the 1000 mV range. All DMM readings must measure less than 1000 mV (equivalent to 1000 FA). This test must be performed with the DUT in the ON condition.

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WI-10204 Rev A

TEST CONDITIONS: CHASSIS LEAKAGE CURRENT TEST

S3 (LINE)

S4 (POLARITY)

S5 (GROUND)

DMM LIMIT

1

CLOSED

NORMAL

OPEN

1000 mV

2

CLOSED

REVERSED

OPEN

1000 mV

3

CLOSED

NORMAL

CLOSED

500 mV

4

CLOSED

REVERSED

CLOSED

1000 mV

Figure 3 13.3.1.2

Patient Leakage (refer to Figure 4) Measure and record the patient leakage current for each condition listed in Figure 4. Set the DMM to read in the "AC" mode in the 100 mV range. All DMM readings must measure less than 50 mV (equivalent to 50 uA).

TEST CONDITIONS: PATIENT LEAKAGE CURRENT TEST

S3 (LINE)

S4 (POLARITY)

S5 (GROUND)

DUT ON/OFF

LIMIT

1

CLOSED

NORMAL

OPEN

OFF

50 mV

3

CLOSED

REVERSED

OPEN

OFF

50 mV

5

CLOSED

NORMAL

CLOSED

OFF

50 mV

7

CLOSED

REVERSED

CLOSED

OFF

50 mV

Figure 4

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WI-10204 Rev A

13.3.2 Ground Continuity (refer to Figure 5) A. Disconnect the test cable from the meter and press the test button on the meter to force it to failure as resistance is higher than 0.15 Ohm. Record the result in the attachment table (PASS/FAIL) B. Test resistance between the earth terminal of the AC power cord and AC entry inlet metal screw head using high current meter ROD-L, Model–M30 as shown in Figure 5. Resistance threshold of this meter is set to 0.15 ohm. Record the result in the attachment table (PASS/FAIL)

Ground Continuity Tester ROD-L Model-M30

ICP Back Panel

Power Cord

Test Test Cable Cabl e

13.4

Figure 5

Functional Inspection 13.4.1 Power-Up Sequence 13.4.1.1 Plug the DUT into a standard 120 VAC, 60 Hz (82-6634) or 100VAC, 60HZ (82-6637) AC mains supply. At this point, do not attach any cables other than the AC power cord. 13.4.1.2 Verify that the green AC and Battery Charging indicators illuminate. Verify that the yellow BATTERY indicator does not illuminate. 13.4.1.3 Switch the rear panel BACKLIGHT switch to the OFF position. Verify that the front panel LCD backlight is not illuminated. 13.4.1.4 Switch the rear panel BACKLIGHT switch to the ON position. Verify that the front panel LCD backlight illuminates. 13.4.1.5

Press the front panel ON/OFF key. Verify the following power-up conditions. A. Audio alarm sounds for approximately 2 seconds (at which time the LCD screen is in a random state) followed by, B. All pixels on LCD display turn black for approximately 3 seconds, followed by,

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WI-10204 Rev A C. Introductory Screen, per Figure 6, displayed for approximately 10 seconds.

Figure 6 NOTE:

82-6637 screen may be in Japanese.

13.4.1.6

Record the software revision as displayed in the Introductory Screen.

13.4.1.7 Verify display changes to "NO TRANSDUCER DETECTED (CHECK CONNECTIONS)" per Figure 7.

Figure 7 NOTE:

If the screen is in Japanese, press the menu key and change to English.

13.4.2 Pressure Signal Display and Monitor Output Accuracy Test. Equipment:

Fogg BP-600 Pressure Simulator, Fogg Adapter Cable

13.4.2.1

Adjust the Fogg BP-600 simulator to a setting of 0 mmHg.

13.4.2.2

Connect the Fogg BP-600 simulator to the DUT using the Fogg adaptor cable.

13.4.2.3 Verify that the DUT displays the message "'TRANSDUCER DETECTED PLEASE WAIT..." per Figure 8, for approximately 5-10 seconds.

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WI-10204 Rev A

Figure 8

13.4.2.4 Verify that the display changes to "PRESS ZERO TO ZERO TRANSDUCER" per Figure 9.

Figure 9 NOTE:

“ZERO” = P →O” on 82-6637

13.4.2.5 Press the front panel ZERO key and verify that the display changes to "TRANSDUCER ZEROING IN PROCESS PLEASE WAIT..." per Figure 10, for approximately 5 seconds.

Figure 10

13.4.2.6 Verify that the display message changes to ZEROING COMPLETE ZERO REFERENCE = NNN / RECORD ZERO REFERENCE THEN PRESS MENU/ENTER" per Figure 11. Verify that NNN = 497 to 503. Record NNN, then press the MENU/ENTER key. Record values.

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WI-10204 Rev A

Figure 11 NOTE:

MENU/ENTER” = “MENU” on 826637

13.4.2.7 Verify that the display changes to the standard run mode per Figure 12 with the mean, systolic and diastolic pressures reading zero +/- 1 mmHg. Verify that the ALARM is in the OFF condition and that no ALARM LIMITS are displayed on the screen. Record values.

Figure 12 NOTE:

13.5

On 82-6637, “ALARM OFF” = Bell with slash marks, “MEAN” is absent

LED Indicator Test 13.5.1 With the DUT still plugged into the AC mains supply and in the standard run mode, verify that the green AC and Battery Charging indicators are illuminated. Verify that the yellow BATTERY indicator is not illuminated. 13.5.2 Press the DUT ON/OFF key to turn the DUT OFF. Verify that the AC and Battery Charging indicators remain illuminated. Verify that the BATTERY indicator does not illuminate. 13.5.3 Press the DUT ON/OFF key to turn the unit back ON. Unplug the AC power cord from the AC mains supply and verify that the green AC and Battery Charging indicators turn off and the yellow BATTERY indicator illuminates. 13.5.4 Press the DUT ON/OFF key to turn the unit OFF. Verify that none of the indicators are illuminated.

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WI-10204 Rev A 13.6

Pressure Display and Audio Alarm Functionality Test Equipment:

Fogg BP-600 Pressure Simulator, Fogg Adapter Cable

13.6.1 Plug the DUT back into the AC supply and press the front panel ON/OFF key to turn the unit ON. 13.6.2 Verify that the Fogg simulator is still connected to the DUT (reconnect if necessary). After the power-up sequence is complete, verify that the DUT displays "PROCEED TO ZERO PATIENT MONITOR / PRESS MENU/ENTER WHEN MONITOR DISPLAYS 0”. 13.6.3 Adjust the Fogg Simulator to the 0 mmHg setting and press the ZERO key on the DUT front panel. Press MENU/ENTER when prompted by the DUT. 13.6.4 From the standard run mode screen, press the MENU/ENTER key to access the main menu. Verify that the display appears as shown in Figure 13.

MEAN = 0 mmHg * Figure 13 NOTE:

“Mean” = 0 mmHg is for 82-3364 only.

13.6.5 With the cursor on the "TURN ALARM ON" item, press the MENU/ENTER key. Verify screen returns to RUN mode with "ALARM ON" at top of screen. Press MENU/ENTER and verify top menu item is "TURN ALARM OFF". (NOTE: Audible alarm may start at any time.) 13.6.6 Use the DUT front panel arrow keys to move the menu cursor to the "SET ALARM LIMITS" item. Press the MENU/ENTER key and verify that the "SET HI ALARM" screen appears as shown in Figure 22 with the displayed limit = 14.

Figure 14 NOTE:

“SET HIGH ALARM = “↑” on 82-6637 “MEAN” is absent.

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