autoLog Service Manual Rev 00

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Inside Front Cover

Blood Management

autoLog™ Autotransfusion System

Service Manual

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autoLog™ AUTOTRANSFUSION SYSTEM SERVICE MANUAL SCOPE This manual is intended for use by qualified Biomedical Technicians involved with the operation and maintenance of the Medtronic autoLog™ Autotransfusion System. For further information, please contact Medtronic Blood Management, Parker, Colorado, 1-800-525-7055, or your local Medtronic Blood Management representative. The Operator’s Manual must be reviewed and understood prior to any attempts to service the autoLog™ Autotransfusion System.

PROPRIETARY INFORMATION The entire contents of this manual are copyrighted and are the property of Medtronic, Inc. No part of this manual may be used or reproduced in any form or by any means, or stored in a database or retrieval system, without the prior written authorization of Medtronic, Inc.

SPECIFICATIONS Technical data, features and options referenced in this manual are based on the information available at the time of printing. Medtronic, Inc. reserves the right to change specifications without notice.

© Medtronic, Inc. 1998 All Rights Reserved.

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WARNINGS, CAUTIONS AND NOTES In the preparation of this manual we have grouped certain information within the following categories as related to accepted industry standards.1

WARNING Advises against certain procedures or actions that could result in severe injury or death to the patient or operator. Please give WARNINGS careful attention.

CAUTION Advises against certain procedures or actions that could cause damage to the equipment, and there are minimal possibilities of personal injury to the patient or operator.

NOTE Provides information that is useful in clarifying a procedure or technique related to the operation of the equipment.

1. Preuss, C.F. 1986. Warnings and Instructions: How Much Is Enough? HIMA Seminar on Medical Devices and Diagnostics and The Product Liability Dilemma, 17-18 Nov.

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Warnings and Precautions

WARNINGS AND PRECAUTIONS

TAB

w WARNINGS AND PRECAUTIONS General Warnings and Precautions: 1. The autoLog™ must not be used in the presence of flammable agents. 2. Do not use the autoLog™ at temperatures higher than 30°C. Operation of the autoLog™ at temperatures over 30°C may cause overheating of the centrifuge, which could cause hemolysis. 3. Plastic materials used in the autoLog™ and its disposable kits may be sensitive to chemicals (such as solvents and certain detergents). Under certain adverse conditions exposure to these chemicals (including vapors), may cause the plastics to fail or malfunction. 4. Treat all blood and fluids using Universal Precautions (Bloodborne Pathogen Precautions). 5. Inside the autoLog™ cabinet there are various electrical components and wiring. Physical contact with any of these components while the unit is plugged in could result in severe electrical shock. Always turn off and unplug the unit prior to working inside the cabinet or changing any fuses. For continued protection against risk of fire, replace fuses only with the same type and rating of fuse. Internal grounding is provided for safety. 6. Leakage current is a primary indicator of electrical shock hazard to personnel making contact with any exposed portion of the equipment. Each autoLog™ is checked during the final quality inspection to verify that leakage current is less than 300 µA for 110V systems, and less than 500 µA for 220V systems. The owner or operator should have leakage current checked at least twice a year or as required by the operating facility’s biomedical engineering department or other qualified service technician. In addition, particular attention should be given to checking the leakage current after an event such as a fluid spill or major voltage surge in the power source has occurred, or after any machine repair. 7. It is important that the autoLog™ be maintained in good working order and calibrated on a regular basis. Otherwise, a reduction in the accuracy of a measuring function (such as RPM) may occur. 8. The operator should be aware that even small, rapidly rotating parts have enough dynamic energy to cause severe injury if clothing, jewelry, etc., is caught in the rotating parts. Do not attempt to defeat, remove, or override any of the safety mechanisms on the autoLog™.

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Notes:

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9800948EN/Tabs/CCS 10/2/98 4:05 PM Page 3

Technical Information

TECHNICAL INFORMATION

TAB

TECHNICAL INFORMATION Technical Data • Operating Features Centrifuge

- 0 - 10,000 RPM (± 5%)

Fluid Pump

- 0 - 600 ml/min (± 5%)

Clamps

- electromechanical, cam actuated

Vacuum

- 150 - 210 mmHg (200 - 280 mBar)

Operating Safety Features

- centrifuge cover sensor, air detector, tubing placement verification, watchdog timer

Clamp Valve Head

- FILL - WASH - EMPTY

• Working Dimensions

- width: 33 cm (13") - depth: 22 cm (9") - height: 75 cm (30")

• Transported Dimensions

- width: 77.47 cm (30.50") - depth: 55.87 cm (22.00") - height: 53.33 cm (21.00")

• Weight

- 35.6 Kg (78 lb.)

• Transported Weight

- 40.2 Kg (88 lb.)

• Cabinet Material

- all stainless steel, opens up completely

• Rated Voltage (switchable)

- 110 VAC - 220 VAC

• Rated Frequency

- 50-60 Hz single phase

• Rated Current

- 1.6 Amp @ 110/120 VAC - 0.8 Amp @ 220/240 VAC

• Plug and Power Cord

- power cord - 2 wire + earth conductor - power cord - 10' (3.1 m) - 3 prong hospital grade (USA models only)

• Temperature Limits

- operational: - storage:

10°C - 30°C (50°F to 86°F) 5°C - 50°C (41°F - 122°F)

• Humidity Limits

- operational: - storage:

10 to 95% non-condensing 10 to 95% non-condensing

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• Leakage Current

- <300 µA, under single fault condition (per UL2601 Standard) - <500 µA, under normal condition; <100 µA under fault condition (per IEC601-1 Standard)

• Electromagnetic Compatibility

- Meets requirements of CISPR 11 (EN 55011), Class B, for Industrial, Scientific, and Medical Equipment. - EN 60601-1-2 - Medical electrical equipment Part 1: General Requirements for Safety Section 1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests, 1993.

• Product Safety

- Underwriters Laboratories (UL), UL 2601-1, Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety. - IEC 601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety.

• Classification

- Class I, Type B, Ordinary, Continuous Operation

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Notes:

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System Block Diagram

SYSTEM BLOCK DIAGRAM

TAB

SYSTEM BLOCK DIAGRAM BLOCK DIAGRAM

AC POWER

VACUUM MOTOR

MAIN POWER SUPPLY

CENTRIFUGE LAMP

COOLING FAN

I/O BOARD

MICROPROCESSOR BOARD

CENTRIFUGE MOTOR

HALL SENSORS

PUMP MOTOR

PUMP MOTOR ENCODER

VALVE MOTOR

LEVEL SENSOR

CENTRIFUGE BOWL COVER SENSOR

AIR BUBBLE DETECTOR

KEYPAD/DISPLAY

VALVE POSITION SENSOR

SELFSTART

VALVE CARD

Figure 3-1. Functional block diagram of the autoLog™

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SYSTEM BLOCK ANALYSIS I. Power Supply AC power is applied to the machine through the power entry module. This module contains two input fuses and the voltage selector. The output of the voltage selector is applied to the primary of the transformer. The secondary of the transformer operates at a constant 220VAC level regardless of input voltage selection. The secondary is applied to a line filter. The output of the line filter is applied to the +24Vdc power supply and to the vacuum pump switch. The output of the vacuum pump switch is applied to the vacuum pump. See Figure 3-2. TRANSFORMER

POWER ENTRY MODULE

MAIN POWER SUPPLY (+24 VDC)

LINE FILTER MAIN POWER SWITCH VACUUM PUMP SWITCH

VACUUM MOTOR

Figure 3-2. Power supply block diagram

II. Display The display is capable of giving output information only. The display is directly controlled by the I/O Board. See Figure 3-3.

III. Keypad The I/O Board monitors the keypad activity. If a switch on the keypad is depressed, the I/O Board recognizes this and sends information to the display via the Command Card Board. See Figure 3-3. DISPLAY

I/O BOARD KEYPAD COMMAND CARD BOARD

Figure 3-3. Keypad and display block diagram

IV. Centrifuge Activation Centrifuge activation is controlled by the I/O Board. Before the I/O Board activates the centrifuge motor, it first checks to see that a kit is in place. The centrifuge cover sensor must be activated before centrifuge activation can begin; otherwise a message will be displayed “Kit not Installed ” and the I/O Board will cancel the centrifuge activation. See Figure 3-4.

I/O BOARD

VALVE CARD

CENTRIFUGE COVER SENSOR

Figure 3-4. Centrifuge cover sensor block diagram

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Once the I/O board verifies that the centrifuge cover is closed, it now checks for a kit in the Valve (see Figure 3-5). The Valve sensor located on the Valve Card also must be activated before centrifuge activation can begin; otherwise a message will be displayed “Insert Kit in Valve ” and the I/O Board will cancel the centrifuge activation.

I/O BOARD

VALVE CARD

VALVE SENSOR

Figure 3-5. Valve sensor block diagram

Once the I/O Board verifies that a kit is in place, it now sends power to operate the centrifuge motor. See Figure 3-6.

I/O BOARD

CENTRIFUGE MOTOR

Figure 3-6. Centrifuge motor block diagram

V. Fluid Pump Activation The Fluid Pump Motor is controlled by the I/O Board. The I/O Board determines the direction and speed of the Fluid Pump Motor. The speed of the fluid pump motor is monitored by an encoder mounted to the end of the motor. This allows the I/O Board to monitor the speed of the fluid pump and to also show the amount of volume being pumped by the fluid pump on the display. See Figure 3-7.

I/O BOARD

FLUID PUMP MOTOR

FLUID PUMP MOTOR ENCODER

Figure 3-7. Fluid pump motor block diagram

VI. Air Bubble Detector The air bubble detector is monitored by the I/O Board. The air bubble detector monitors the disposable tubing for presence of air. See Figure 3-8.

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I/O BOARD

AIR BUBBLE DETECTOR

Figure 3-8. Air bubble detector block diagram

VII.Level Sensor The level sensor monitors the blood level in the centrifuge bowl during the FILL cycle and the WASH cycle. This allows the I/O board to know when to switch the machine from FILL to WASH and when red blood cells are spilling into the waste bag during the WASH cycle. See Figure 3-9.

I/O BOARD

LEVEL SENSOR

Figure 3-9. Level sensor block diagram

VIII. Valve Activation The valve motor is controlled by the I/O Board. Before the I/O Board activates the valve motor, it first checks to see that a kit is in place. The valve sensor must be activated before centrifuge activation can begin; otherwise a message will be displayed “Kit Misinstalled In Valve” and the I/O Board will cancel the valve motor activation. See Figure 3-10.

I/O BOARD

VALVE CARD

VALVE SENSOR

Figure 3-10. Valve sensor block diagram

The clamp motor rotates until the Valve Sensor locates the WASH position on a slotted cylinder spinning on the valve motor. This slotted cylinder passes through three photo sensors enabling it to detect what position it is in. After the WASH position is found, the I/O Board then rotates the fluid pump motor counterclockwise (CCW) to prime the saline line with saline. Once a sufficient amount of blood is detected by the self start sensor, the valve motor rotates to a position which enables blood draw from reservoir. If another position is required, the I/O Board rotates the valve motor until the appropriate slot is detected on the slotted cylinder.

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autoLog™ System Block Diagram

Fluid Pump Motor

Display Self start

Valve Card

Air Sensor

Centrifuge Lid Sensor Tubing Clamp

Command Card

Encoder Centrifuge Lamp

J1

J4

J2

J5 J6

J11

J7 Centrifuge J12

J8

J3

J9 J17

MPU

AC Input

J10

J13

Main Power Switch

Fuses Transformer

Centrifuge Motor

J14

I/O Board

Power Entry Module

Level Sensor

Line Filter

Main Power Supply

Cooling Fan

Vacuum Motor Vacuum Pump Switch

Figure 3-11. autoLog™ system block diagram

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Notes:

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A

B

C

D

E

LTR

REVISIONS

SIGNATURE

DATE

U?

C? 10uF

+

2 3 4

C? 10uF

+

5 6 7 8 9 10

J6 J6.01

TxD B RTS B

J6.10 J6.12

C1+

GND

VCC

C2-

C1-

VSS

VDD

Rx1

DO1

Tx1

DI1

Rx2

D02

Tx2

DI2

Rx3

DO3

Tx3

DI3

20 19

4

+

C? 10uF

18 VCC

17 16

C? 10uF

15 14 13 12 11

J19

MC145407

I/O Board, Sheet 1 CTS B

C2+

+

1

4

To Display

3

VCC

J19.04 J19.05 J19.01 J19.19 J19.13

17 16 20 19 13

TxD Test (RTS) Busy (CTS) VCC GND

3

Fluorescent Display

Go_key/ J6.12 Stop_key/ J6.10 Plus_key/ J6.08 FCT_key/ J6.06 Go_led Stop_led Plus_led FCT_led

J6.11 J6.09 J6.07 J6.05

VCC GND

J6.10 J6.10

VCC

VCC

2

2

2

2

2

2

LED 1

D1

LED 1

D2

LED 1

D3

LED 1

D4

FUNCTION

PLUS

STOP

GO

S4

S3

S2

R? R

R? R

R? R

R? R

S1

1

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Medtronic, Inc. Blood Management 18501 East Plaza Drive Parker, CO 80134

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Schematic, Display Interface Size B Scale

13

A

B

C

D

Rev

DWG NO

AD5102

B Sheet

1 E

of

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