PiCCO2 Service Manual Sw V3.x Feb 2010

Service Manual PiCCO2

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Service Manual PiCCO2

Contents 1 2 3

Introduction ...5 Test and Service Equipment ...7 System description ...9 3.1 Hardware ...10 3.2 Technical Data...15 3.3 Scope of delivery / Optional accessories ...17 4 Replacing the battery ...19 5 Service Screen...21 5.1 Basic Service Level ...23 5.1.1 Measurements ...24 5.1.2 Parameter Selection ...25 5.1.3 Normal Range...25 5.1.4 System...26 5.1.5 Calib Check...27 5.2 Advanced Service Level ...32 5.2.1 Advanced Service Screen...32 5.3 Demo Mode ...33 6 Calibration ...35 6.1 Input channel calibration...35 6.1.1 Coding resistor channel “CR”...35 6.1.2 Arterial blood pressure channel “AP” ...36 6.1.3 Central venous pressure channel “CVP”...36 6.1.4 Blood temperature channel “TB” ...36 6.1.5 Injectate temperature channel “TI” ...37 6.2 Output channel calibration ...38 6.2.1 AP out channel “AP out” ...38 6.2.2 CVP out channel “CVP out” ...38 7 Touch Calibration ...39 8 PiCCO2 Software Update V1.2 to V1.3...41 9 PiCCO2 Software Update V1.3 or V2.x to V3.x ...43 10 Safety Tests ...45 10.1 Protective Earth Impedance ...46 10.2 Earth Leakage Current (IEC 60601-1 Figure 16)...47 10.3 Enclosure Leakage Current (IEC 60601-1 Figure 18)...48 10.4 Patient Leakage Current (IEC 60601-1 Figure 20) ...49 10.4.1 Test 1...49 10.4.2 Test 2 (IEC 60601-1 Figure 21) ...50 10.4.3 Test 3 (IEC 60601-1 Figure 24) ...51 11 Mounting the PiCCO2 Monitor ...53 11.1 Universal adapter plate...53 11.2 VESA...54 12 Cleaning and disinfection of the device ...55 12.1 General remarks...55 12.2 Precautions...55 12.3 Cleaning ...56 12.4 Disinfection ...56 13 Appendix ...57 13.1 STK sheet...57 3

Service Manual PiCCO2 13.2 13.3

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Service Protocol... 57 Fax Reply Form ... 57

Service Manual PiCCO2

1 Introduction This Service Manual contains technical details for the PiCCO2. It describes how to perform function tests, provides instructions for repairing simple failures and describes miscellaneous maintenance procedures. Advisory: PULSION is liable for the safety of its equipment only if maintenance, repair and modification are performed by authorized personnel and if components affecting the equipment’s safety are replaced with original PULSION spare parts. Any modification or repair must be documented and added to the device documentation! Additionally a copy of the documentation shall be added to the „Fax Reply Form“ that can be found in the appendix and sent to PULSION. Thus it is assured that PULSION is informed about this modification or repair and hence statutory regulations are fulfilled. Such documentation must: - be signed and dated. - contain the name of the company performing the work. - describe the changes and repairs made. It is the responsibility of the user to contact PULSION to determine warranty status and/or liabilities if other persons than an authorized PULSION technician repair or make modifications to medical devices. Service Policy: The design of the PiCCO2 does not allow repair of internal electronic parts. If a device is defective, the device needs to be send back to the PULSION headquarters via your distribution partner. Recommended test frequency: It is recommended to perform the following tests: -

Calibration Check (chapter 5.1.5): once a year Safety Tests (chapter 10): once every two years CAUTION: These recommendations do not supersede local requirements.

NOTE Functionalities which are not available in V1.x are marked with a “*”. All figures are out of PiCCO2 V2.x. Some might be slightly different which does not have any influence on the functionality if not described otherwise.

Service Manual PiCCO2

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Service Manual PiCCO2

2 Test and Service Equipment 

1x PiCCOplus-CALBOX (PCCAL-01) + power supply unit o Interval for recalibration: every 12 months o Temperature simulation accuracy: ± 0.1 °C o Blood pressure simulation accuracy: ± 2 mmHg

  

2x Pressure connection cable (PMK-206) 2x PiCCO2 pressure out adapter (PC85200) Screwdriver

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Service Manual PiCCO2

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Service Manual PiCCO2

3 System description

PiCCO2 housing Sensors

Connectors

Data Acquisition

Processing

In- / Output

PC

Touchscreen

Optical Module ScvO2

Data Acquisition

SpO2 PDR

A/D conversion

Keys

Blood temperature

A/D conversion

Injectate temperature

Catheter detection

Arterial Blood Pressure

A/D conversion

Central Venous / Pulmonary artery* Blood Pressure

A/D conversion

Patient separation

Navigation dial AUX USB RS232 LAN

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Service Manual PiCCO2

3.1 Hardware Front

8

1 1 2 3 4 5 6 7 8

10

2

3

4

ON/OFF key Help key Print key Mute key Main key: Back to the last active screen display Back key: Back to previous interaction level Navigation dial Touch screen

5

6

7

Service Manual PiCCO2 Side

5

1 2 3 4

1 2 3 4 5

SO2 – Connector for central venous or partial arterial oxygenation CO – Temperature sensor connector of arterial line (PULSIOCATH) and injectate sensor (CVC) AP – Arterial pressure connector CVP / PAP* – Central venous / Pulmonary artery* pressure connector Connector label

Symbol Description: Caution, consult accompanying documents Defibrillation-proof type BF applied part Defibrillation-proof type CF applied part

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Service Manual PiCCO2 Rear side

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8

1 1 2 3 4 5 6 7 8 9

12

AP out CVP / PAP* out Serial Interface RS232 LAN USB ports (2x) Potential equalization Mains supply connector Mains switch VESA mounting possibility

2

3

4

5

6

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Service Manual PiCCO2 Top

1

2

1 2

Handhold Type label

Symbol Description: AP

Arterial pressure: analogue signal output

CVP / PAP*

Central venous / Pulmonary artery* pressure: analogue signal output

RS232

Serial interface

LAN

Network connection

USB1/USB2

USB ports

Potential equalization connector Manufacturer REF

Reference Certification according to Annex II of Directive No. 93/42/EEC for medical devices. ETL certification for electrical safety Separate disposal of electrical and electronic equipment

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Service Manual PiCCO2 Bottom

1 2

1 2

Universal mounting bar Device label with serial number and date of manufacture

Symbol Description: Date of manufacture SN

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Serial Number

Service Manual PiCCO2

3.2 Technical Data General Equipment

PiCCO2

Article Number

PC8500

Equipment Class

IIb

Equipment Type

Type BF: ScvO2; Type CF: CO, AP, CVP;

all defibrillation-proof Protection Class:

I

Screen Type

13.3" (=338 mm) TFT LCD colour display, touch screen, active matrix

Size (W x H)

299 x 195 mm

Viewing Area (W x H)

286 x 178 mm

Resolution

1280 x 800 Pixel

Electrical Specifications Mains Voltage

100 to 240 VAC

Mains Frequency

50 to 60 Hz

Power Consumption

85 VA

Internal Battery

14.4 V 36 Wh

Cell Type

Lithium-Ions

Charging Time

3–5h

Battery Operating Time

> 30min

Operating Conditions Temperature Range

10 to 40 °C

Relative Humidity

75 % (non-condensing)

Altitude Range

-300 to 3000 m

Transport and Storage Conditions Temperature Range

-20 to 60 °C, (with rechargeable battery -20 to 50 °C)

Relative Humidity

90% (non-condensing)

Altitude Range (Transport)

-300 to 10000 m

Altitude Range (Storage)

-300 to 3000 m

Physical Attributes Size (W x H x D)

328 mm x 248 mm x 180 mm (with navigation dial)

Weight

< 5 kg

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Service Manual PiCCO2

Standards EN 60601-1:1990 + A1:1993 + A2:1995 EN 60601-1-1:2002, EN 60601-1-2:2002, EN 60601-1-4:2001, EN 60601-1-6:2005, EN 60601-2-34:2001 PiCCO2 complies with directive 93/42/EEC (medical products) and bears the CE mark User Interface User Controls

Touch screen Navigation dial Function keys

Data Transmission Capabilities Interfaces

RS232 LAN 2x USB

Printer

USB

Device Specification

The instrument specifications have been validated using synthetic waves and database waves (laboratory testing). The following table shows the parameters measured by the PiCCO2 device and their specifications: Label

Unit

Lower limit

Upper limit

Accuracy)

Remark

CO

l/min

0.25

25.0

Coefficient of variation  2 %

Valid over full range

GEDV

ml

40

4800

Coefficient of variation  3 %

Valid over full range

ITBV

ml

50

6000

Coefficient of variation  3 %

Valid over full range

EVLW

ml

10

5000

Coefficient of variation  6 %

Valid over full range

PCCO

l/min

0.25

25.0

Coefficient of variation  2 %

Valid over full range

SV

ml

1

250

Coefficient of variation  2 %

Valid over full range

ScvO2

%

1

99

±3%

Within 50 – 80 %

SpO2

%

45

100

≤2%

70% < SpO2 < 100%

PDR

%/min 0.0

50.0

± 3 %/min (absolute) ± 15 %/min (relative)

Valid over full range

) Statistical evaluation based on random examination of actual production output

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Service Manual PiCCO2

3.3 Scope of delivery / Optional accessories Scope of delivery Arterial connection cable and injectate temperature interface cable

Art. No.: PC80150

Injectate temperature sensor cable

Art. No.: PC80109

Pressure cable (2x)

Art. No.: PMK-206

PiCCO2 pressure out adapter (2x)

Art. No.: PC85200

Mains power cable (dependent on country)

Art. No.: 401090-x

Grounding cable (dependent on country)

Art. No.: 401080

CeVOX module

Art. No.: PC3010/PC3015

LiMON module

Art. No.: PC5100

Operators manual (dependent on country)

Art. No.: PC856xx

Optional accessories PiCCO2 cart

Art. No.: PC85230

Basket for cart

Art. No.: PC85231

Anchoring clip

Art. No.: PC85232

PiCCO2 variable wall mounting arm for horizontal standard bar

Art. No.: PC85233

PiCCO2 Thermotransfer printer

Art. No.: PC85300

Printer labels (565 labels per roll)

Art. No.: PC85350

Thermo-transfer ink ribbon

Art. No.: PC85355

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Service Manual PiCCO2

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Service Manual PiCCO2

4 Replacing the battery The battery should be changed, if the operating time of the fully charged battery drops below 30 minutes. In order to change the battery of the device, the device must be opened on the bottom side. Therefore, the four marked screws must be removed with a hex key (2.5 mm), then the bottom plate can be demounted. 1. Demount the bottom plate of the device by removing the four screws (marked below).



2. Press the battery

to the right side. The battery disengages.



3. Rotate the battery at an angle of 90°. The battery can be removed.

 4. Insert the battery the other way around. 5. Mount the bottom plate by using the four screws. In order to check if the battery works properly, connect the device to mains power, switch on mains power switch on the back of the device and start the device. If the device shows a loading battery in the information bar, the battery works properly. If the battery does not work the symbol of a crossed battery is shown.

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Service Manual PiCCO2

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