Thopaz+ Cardiothoracic Drainage Service Manual Aug 2015

Table of Contents 1

Safety Instructions ... 4 1.1 1.2

Preparation

2

Overview ... 6 2.1 2.2

3

Repair Completion

Disassembly ... 20 Defective Vacuum/Motor assy. ... 22 Defective Mainboard PCB ... 22 Defective Level Sensor or Ambient Sensor ... 22 Defective Vent Valve ... 23 Defective Li-Ion Battery ... 24 Defective Keypad ... 24 Defective LCD Display ... 25 Assembly ... 26

Minor Repairs ... 28 Final Test and Documentation ... 31 8.1 8.2

Final Test with Testing System ... 31 Failure Description Codes ... 32

9 Packing ... 33 10 Spare Parts and Packing Material ... 34 11 Schematics ... 36 11.1 11.2

2

First Inspection ... 14 Information Readout ... 14 Troubleshooting (Issues without Error Code) ... 15 Warning, Alarm and Error Matrix ... 15 Module Tests ... 19

Main Repairs ... 20 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9

7 8

Equipment ...9 Cleaning and Disinfection Procedure ... 10 Clean up ... 13

Diagnostic Analysis ... 14 5.1 5.2 5.3 5.4 5.5

6

Required Facility ...8 Required Test Equipment ...8 General Equipment ...8

Decontamination ... 9 4.1 4.2 4.3

5

Device Overview ...6 Functional Overview ...7

Working Area ... 8 3.1 3.2 3.3

4

Structure ...4 Safety Instructions for this Device ...5

Electronic Cabling ... 36 Tube Connection ... 37

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©Medela AG

About this Manual Refer to Instructions of Use NOTE

This Service Manual Thopaz+ in no way replaces the Instructions of Use.

Purpose

Safety Check

This document is strictly for use by Medela certified service centers! It provides the information needed by an authorized technician to perform all service tasks with Thopaz+. The safe and efficient handling of Thopaz+ is defined within this document.

There are no prescribed or recommended safety checks to be carried out. For further information refer to the Instructions for Use (IFU).

Personnel Requirements The maintenance and service tasks on the device, its modules or options may only be performed by authorized maintenance personnel who fulfill the following requirements. For minor repairs which do not require the device to be opened, the technician must be trained by Medela accordingly. For main repairs the technician is required to pass Thopaz training comprising: •

Function of the device

•

Handling and decontamination of contaminated devices

•

Disassembly and reassembly of the device including replacement of the modules

•

Troubleshooting / failure analysis

•

How to operate the testing system

•

Documentation of the service action

•

ESD problems and prevention

Warranty The device comes with a 2-year warranty from the date of delivery. The manufacturer cannot be held liable for any damages / consequential damages caused by incorrect operation, inappropriate use, use by unauthorized persons or unauthorized repairs. See also International Warranty (200.2767).

Service Work Flow •

Decontamination (see chapter 4)

•

Diagnostic Analysis (see chapter 5)

•

Check upgrade information (Extranet/International Service Support/HC/Cardio Thoracic Systems/Service Notes)

•

Repair and upgrade if needed (see chapter 6 and 7)

•

Final Test and Documentation (see chapter 8)

•

Packing (see chapter 9)

Model Views In general, all views are illustrated with the standard device model. Available options are shown in dashed frames.

Available Documents •

Instruction for use Thopaz+

200.6841

•

Cleaning/Disinfection/Sterilization Guidelines for Healthcare Products

200.2391

•

WI_ISS_007_OSH_Procedure30

•

Manual & Technical Handbook (MTH)

•

WI_ISS_0035_Modul_test_equipment

•

DeviceUpdater_EN_IFU

•

WI_ISS_0032_Device_History

•

IFU_ThopEasy+_EN

•

A-MP05-SP03-FO0012_EN_Checklist_Repair_Thopaz, Invia, Avance

MTH_Testing_System_ThAvIa

Additional Required Documents •

Local regulations for biohazard waste disposal

©Medela AG

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3

Preparation

1

Safety Instructions

1.1

Structure

The safety instructions in this document are structured as follows:

CAUTION

1 2

ESD - Electrostatic Discharge

3

Contact with the product may cause electrostatic discharge leading to damage or destruction. Always observe ESD control requirements and handling instructions while working on the open device and handling components!

4 5

1 2 3

Safety signal word with safety symbol Source of danger Impact of danger

4 5

Specialized safety symbol Prevention of danger

The following types of safety warnings are used in the present manual: Symbol Safety signal word

WARNING CAUTION NOTICE

Meaning The safety warning with the signal word “Warning” is used to indicate a hazardous situation which, if not avoided, could result in death or serious injury. The safety warning with the signal word “Caution” - in combination with the safety alert symbol - is used to indicate a hazardous situation which, if not avoided, could result in minor or moderate injury. The safety warning with the signal word “Notice” is used to address practices that could lead to property damage but not to injury.

Hints The hint is used to address practices that help the reader using the equipment. Example: Cleaning Detergent NOTE

4

If the device does not come clean using only sterile, cold water, Mikrozid can be used in addition.

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©Medela AG

Preparation 1.2

Safety Instructions for this Device

WARNING Biohazard Cross-contamination can occurr and must be prevented by correct cleaning and disinfection. But be aware that the interior of the pump cannot fully be disinfected. • If alcohol is used for cleaning, all residues or proteins must be wiped off within the first 15 min. • Water temperatures higher than 45 °C (113 °F) can reduce the cleaning efficiency. • The entire surface must be covered with the disinfectant. • The alcohol based disinfectant must come into contact with the microorganisms. After this first contact, the disinfectant needs the contact time to inactivate or destroy microorganisms. It is not necessary to keep the surface wet! • If the surface is wiped dry after disinfection, this must not be done until the specified contact time for microbial effectiveness has elapsed.

CAUTION ESD - Electrostatic Discharge Contact with the product may cause electrostatic discharge leading to damage or destruction. Always observe ESD control requirements and handling instructions while working on the open device and handling components!

NOTICE Fluid Damage Fluids can destroy the electronics. • Do not spray or pour liquid directly onto the device. • Do not place the device in a dishwasher. • Immersion disinfection, thermal disinfection and ultrasound cleaning are not permitted. • The pump, docking station and charger cannot be sterilized.

NOTICE Damage by Inappropriate Detergent Inappropriate detergent can destroy the surface of the device. • Do not used phenol-based cleaning agent / detergent. • Do not use steel brushes or steel wool for cleaning. Vacuum Levels and Atmospheric Pressure In the area of application of medical pump devices, the level of the vacuum is normally expressed as the difference (as an absolute value) between the absolute pressure and the atmospheric pressure, or as a negative value in kilo pascals (kPa). NOTE Therefore, a value of e.g. -10 kPa in this document always means a pressure level below the ambient atmospheric pressure in kPa.

©Medela AG

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Preparation

2

Overview

2.1

Device Overview

2

1

3

8

7

6

5

4

9 17 16 15 10

14 13 12

11

1 2 3 4 5 6 7 8 9 6

Carrying handle Release button Vacuum port with seal Standard rail holder Bed holder USB port Mains adapter port Display Keypad

10 11 12 13 14 15 16 17 200.8636-A

Vacuum/Motor assembly Mainboard PCB Li-Ion battery Ambient sensor Vent valve Check Valve Level sensor LCD display ©Medela AG

Preparation

2.2

Functional Overview Functional Explanation

Explanation of the function can be found in the Extranet/Healthcare/Cardio Thoracic Systems/ NOTE Trainings/Thopaz/01 Thopaz Training 2012/BIN/START.

16

1

2

3

15

4

14 13

5 6 7

1 2 3 4 5 6 7 8

Pressure sensors LCD display Keypad Check valve Vacuum/Motor assembly USB port Mains adapter port Mainboard PCB

©Medela AG

12

11

9 10 11 12 13 14 15 16

Li-Ion battery Buzzer Exhaust Ambient sensor Vent valve Level sensor Canister Double lumen tubing

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9

8

7

Preparation

3

Working Area

3.1

Required Facility

Cleaning and Disinfection Agents

•

Self contained decontamination area

•

ESD protection equipment (ESD protective bracelet, etc.)

•

Workbench for repair

•

Storage space for spare parts

•

Sterile cold water (< 40 °C / 104 °F)

•

Lint-free non-woven wipes

•

Mikrozid AF wipes (Schülke&Mayr)

•

or CaviWipes (Metrex Research)

•

or Mikrozid AF liquid (Schülke&Mayr)

Required Tools

Dishwasher

•

Phillips screwdriver

A dishwasher can be used to clean the front and back. This dishwasher is only to be used for medical devices. Consider the runtime of the programs to optimize the workflow.

•

Screwdriver

•

Short torx TX 06

•

Hammer

•

2 torx TX 06

•

Extractor tool

•

Holder tool Thopaz

•

Spring hook

To disinfect with a regular dishwasher an A0 value of at minimum 600 must be reached.

(no. 0 and no. 1) (no. 1-2)

077.0143 +

200.8057 (Baco 5419/6T)

NOTE T: Temperature in °C t: time in seconds Example: The dishwasher runs for 10 min at 86 °C.

This is ok because the value is greater than 600.

3.2

Required Test Equipment

•

Testing system

200.6098

•

Module test equipment

200.5328

3.3

General Equipment

Biohazard Protection •

Disposable gloves

•

Personal Protective Equipment (PPE) (gown, goggles, face mask, etc.)

8

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Preparation

4

Decontamination

4.1

Equipment

Always wear suitable protective work clothing: •

disposable gloves (change the gloves at least every 2 hours)

•

Personal Protective Equipment (PPE) (gown, goggles, face mask,...)

Cleaning and disinfection agents: •

sterile cold water (<40 °C / 104 °F)

•

lint-free non-woven wipes

•

Mikrozid AF wipes (Schülke&Mayr)

•

or CaviWipes (Metrex Research)

•

or Mikrozid AF liquid (Schülke&Mayr)

Required tools: •

Phillips screwdriver (no. 1)

•

Screwdriver (no. 1-2)

•

Extractor tool

©Medela AG

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Preparation 4.2

Cleaning and Disinfection Procedure

WARNING Biohazard Cross-contamination can occur and must be prevented by correct cleaning and disinfection. Always wear suitable protective work clothing: •

Disposable gloves (change the gloves at least every 2 hours)

•

Personal Protective Equipment (PPE)

►►Carefully unpack the device. ►►Note all accessories on the checklist.

WARNING Disposal of Packing Material Contaminated material can cause infection and be harmful to health. Dispose of contaminated packing material as biohazard waste. Clean material can be disposed as regular waste. ►►Open the bed holder and cover ports. ►►Wet a wipe with sterile water (<40 °C / 104 °F) ►►Clean the device including all edges, corners, bed holders and port covers. Cleaning Detergent If the device does not come clean using only sterile, cold water, Mikrozid can be NOTE used in addition.

►►Use the disinfection wipe to completely disinfect the device. Pay particular attention to edges, narrow corners and the bottom side. ►►Ensure all surfaces are thoroughly moisturized with disinfectant.

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Preparation

►►Consider the contact time before reuse according manufacturer’s IFU. The microbiological effectiveness has to be bactericidal, fungicidal and fully virucidal. ►►If Mikrozid AF or CaviWipes are used, allow the device to dry for at least 5 minutes.

►►Remove the four cover plugs. ►►Remove the safety plug with the extractor tool. ►►Remove the four screws.

►►Carefully remove the rear cover and seal.

►►Remove the front cover and seal.

©Medela AG

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Preparation

►►Impregnate a wipe with sterile, cold water and clean the middle frame housing, including all edges, corners and port covers.

►►Disinfect the middle frame housing thoroughly.

►►Clean and disinfect the front and back cover. Dishwasher NOTE

The front and back cover can be cleaned in a dishwasher, if available.

►►The device is now ready for repair.

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Preparation

Disinfecting the Mains Adapter ►►Wet a wipe with sterile, cold (< 40 °C / 104 °F) and clean the device

water

►►Completely disinfect the device. Pay particular attention to edges, corners and the bottom side. ►► Consider the contact time before reuse according to the manufacturer’s IFU. ►►Allow the device to dry.

Disinfecting the Docking Station ►►Wet a wipe with sterile, cold (< 40 °C / 104 °F) and clean the device

water

►►Completely disinfect the device. Pay particular attention to edges, corners and the bottom side. ►► Consider the contact time before reuse according to the manufacturer’s IFU. ►►Allow the device to dry.

Room Change If follow-up activities are performed in a different room, we recommend placing all parts, including the written report, in one NOTE box. This will prevent parts being lost or interchanged.

4.3

Clean up

►►Dispose of contaminated and dirty material (cardboard, polystyrene, pump parts and accessories, etc.) as biohazard waste. ►►Clean and disinfect the workbench at least once a day.

©Medela AG

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13

Repair

5

Diagnostic Analysis

5.1

First Inspection

►►Read the corresponding complaint information. ►►Inspect the pump for visual damages and switch it on to check if the pump passes the self-check during start-up.

5.2

Information Readout

Start the Testing System ►►Push the start button for > 5 seconds until an acoustic signal is audible. ►►Login. ►►Select the corresponding device type.

Logfile ►►Push “Test - Start”. ►►Follow the display messages. ►►Read out the pump data. ►►Check the recent error codes in the logfile and refer to the alarm matrix to localize the faulty module. ►►Cancel the test sequence.

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Repair

5.4

3

Check mains adapter, charge battery

Seal (vacuum port)

Tubing

Vent Valve

Ribbon Cable

LCD Display

4 2 3 3 1

Keypad

Keypad does not react (not switching ON/OFF) Pump does not charge Nothing displayed on the display Pump does not react at all Pump does not charge, only on docking station

Level Sensor

Issue

Mainboard PCB

Faulty module(s)

Li-Ion Battery

Troubleshooting (Issues without Error Code) Vacuum/Motor assy.

5.3

2

1 1

3 2 2

1 1

Warning, Alarm and Error Matrix

The device distinguishes between warnings, alarms and errors. Warnings and alarms indicate a handling problem. Internal errors point to a faulty module. If more than one module can cause the error, replace the modules according the given priorities. First troubleshooting with an error is always a restart of the device, if the error remains, the module should be replaced. Module Replacement

Seal (vacuum port)

Tubing

Vent Valve

Ribbon Cable

LCD Display

Keypad

Li-Ion Battery

Errors, alarms, warnings

Level Sensor

Mainboard PCB

Faulty module(s)

Vacuum/Motor assy.

If the error 112 is more than once listed in the logfile, first check the ribbon cables. If no problem can be found with the cables, replace the Vacuum/Motor Assembly. If the error still appears, replace NOTE the Mainboard PCB.

100 Internal Errors During Startup 101 RTC returned invalid data 102 Flash ROM CRC is invalid 103 MCU clock mismatch 104 Supply Voltage Vdd ( 5 V ) < 4.75 V 105 Supply Voltage Vdd ( 5 V ) > 5.25 V 106 Charger in error state 107 Battery voltage < 5.5 V 108 Battery voltage > 9.2 V 109 Main switch failed 110 Intermediate voltage < 5.2 V 111 Intermediate voltage > 6.2 V ©Medela AG

1 1 1 1 1 3 2 2 1 1 1 200.8636-A

2 1 1

1

15

16

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3 1 1 3 3 1 3 1 1 1 1 1 1 2 1 1 1 1 1 1 3

2 2

1

2

1 1

2

Seal (vacuum port)

Tubing

Vent Valve

Ribbon Cable

LCD Display

Keypad

Li-Ion Battery

Level Sensor

Errors, alarms, warnings 112 Motor / valve supply voltage low 113 Motor / valve supply voltage high 114 RTC indicated low voltage 115 Motor connection / PWM transistor 116 Valve connection / PWM transistor 117 Temperature > 50 °C 118 Level sensor failed 119 Reset by watchdog / software failure 120 Hardware watchdog test failed 121 Hardware revision not supported 122 Alarm supply voltage < 3.0 V 123 Alarm supply voltage > 5.25 V 124 Temperature sensor failed < - 71 °C or > 49 °C 125 Hardware alarm failed on reset 126 FFS root block invalid 127 Safety MCU failure 128 Patient sensor (P2) offset out of range 129 Patient sensor (P2) stored offset out of range 130 V alarm regulator switch failed 131 V alarm storage capacitor failed 132 TFT display not supported 140 Level sensor error: E_VOLTREF 141 Level sensor error: VOLT25 142 Level sensor error: E_VOLT5 143 Level sensor error: E_ACCEL 144 Level sensor error: E_CANIST 145 Level sensor error: OFFSET 146 Level sensor error: E_LOOP 147 Level sensor error: E_CONSIST 148 Level sensor error: _I2C 149 Level sensor error: E_DEVCRC 150 Level sensor error: E_WDOG 151 Level sensor error: E_ROMCRC 152 Level sensor error: E_HWCOMP 153 Level sensor error: E_STACK 154 Level sensor error: E_PINRESET 155 Level sensor error: E_HARDFAULT 156 Level sensor error: E_IRQ

Mainboard PCB

Faulty module(s)

Vacuum/Motor assy.

Repair

2

1

1

2

1

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 ©Medela AG

Tubing

2

1

Seal (vacuum port)

Vent Valve

Ribbon Cable

LCD Display

Keypad

Li-Ion Battery

Errors, alarms, warnings 157 Level sensor error: E_OS_STACK

Level Sensor

Mainboard PCB

Faulty module(s)

Vacuum/Motor assy.

Repair

1

200 Internal Errors During Runtime 201 Level sensor failed 202 Software failure 203 Supply Voltage Vdd (5 V) failed < 4.75 V or > 5.25 V 204 Intermediate voltage (5.5 V) failed > 6.2 V 205 Temperature equal or > 50 °C 206 Charger failed 207 Battery voltage < 6.2 V 208 Valve failed to open 209 CRC check on vital data failed 210 Pressure sensor(s) failed 211 RPM sensor failed 212 Watchdog state failed 213 Stack check failed 214 Battery over voltage > 9.2 V 215 Battery over current (charge > 1000 mA / discharge > 2500 mA) 216 Pump motor uncontrolled/pump vacuum high 217 Pump vacuum sensor dead 218 Patient vacuum sensor dead 219 MCU or RAM failed 220 Input voltage high 221 Pressure too high 222 Pressure high 223 Clog Factor Measurement failed 224 TFT display is blocked

3 1 1 1 1 3

2

1

2 1

3 1 2 3 1 1 1 3

1

1 2

1

1

2

1 2 1 1 1

1

2

1 Perform an FPT-test

3 3

2

1 2

1

300 Alarm (handling problem, see IFU) 301 Leak in system 302 System clogged 303 Canister is missing 304 Water detected in tubing 305 Battery empty 306 Canister full 307 Pump run time expired 308 System clogged 309 RTC date / time invalid 310 RTC indicated low voltage ©Medela AG

5 2

4

3

(Try with different vacuum level)

2 1

1

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1 1 1

17

2 2 2 2 1

Seal (vacuum port)

Tubing

Vent Valve

Ribbon Cable

LCD Display

Keypad

Li-Ion Battery

Level Sensor

Errors, alarms, warnings 311 Vacuum sensor P1 out of range 312 Air leak detected 313 Reservoir filter clogged / Pump vacuum too high 314 P2 offset out of range 315 Thopaz overheated

Mainboard PCB

Faulty module(s)

Vacuum/Motor assy.

Repair

1 1 1 1

400 Warning (handling problem, see IFU) 401 Battery Low 402 USB connection not permitted 403 Pump run time low 404 Leakage (turned off by default) 405 Pump in standby mode too long (> 5 min) 406 Temperature too high 407 High fluid flow 408 Canister change detected 409 Fluid level sensor out of order

Charge battery - connect device to mains Unplug USB cable Check system for leaks and patient status Switch Thopaz on or off Don’t expose to head source, prepare backup Check patient status Press to confirm, canister has been changed Fluid meas. unavailable / faulty level sensor

500 Events (no action required) 501 Screen copy recorded 502 Positive pressure seen on patient sensor 503 Entered protected mode 504 Exited protected mode 505 Automatic turn off 508 FPT test passed 509 FPT test failed 510 Valve did not open (Invia Liberty only) 510 HW reset at TFT display initiated (Thopaz+ only) 511 Canister change confirmed 512 Canister change not confirmed 513 MMI state set to default 514 Fluid Counter: started 515 Fluid Counter: restarted 516 Fluid Counter: stopped

2 3

1 2

1

900 Text Messages (no action required) 901 Unspecified message 902 Firmware update detected 903 Reports values on error 904 Debug messages

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©Medela AG

Repair 5.5

Module Tests

The module test equipment can be used to check the individual modules during the troubleshooting. Further Information NOTE

For further information about the handling and use of the module test equipment, refer to WI_ISS_0035_Module_test_equipment.

Connection ►►Connect the module test equipment to the mains adapter.

Navigation

1

►►The device can be operated with the following buttons: 1 ESC button 2 OK button 3 DOWN button 4 UP button

2 4

3

Test Procedure ►►To start a test, connect the corresponding cable to the module test equipment. ►►Select the test with the UP and DOWN button. ►►Start the test with the OK button. ►►If the test is passed, the program automatically returns to the menu. ►►To exit a test, press the ESC button.

©Medela AG

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Repair

6

Main Repairs WARNING Biohazard Crosscontamination can appear and must be prevented by correct cleaning and disinfection. The interior of the pump can not fully be disinfected. Always wear suitable PPE.

6.1

Disassembly

Required Tools: •

ESD protective bracelet

•

Spring hook

•

Phillips screwdriver (no. 1)

•

Screwdriver (no. 1-2)

•

Extractor tool

►►Check that the device is disassembled, decontaminated and ready for repair.

►►Disconnect the battery cable. ►►Disconnect the valve cable. 1 2

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