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3324054-000 Rev A Service Manual

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Page 1: Service Manual - techweb.stryker.com...LUCAS™ SERVICE MANUAL ART.NO. 3324504-000 Rev A, VALID FROM CO J2372, (C) COPYRIGHT JOLIFE AB 5 1 Introduction. 1.1 BACKGROUND . LUCAS is a

LUCAS™ SERVICE MANUAL ART. NO. 100469-00 REV C, VALID FROM CO J2372, (C) COPYRIGHT JOLIFE AB 2009

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3324054-000 Rev A

Service Manual

Page 2: Service Manual - techweb.stryker.com...LUCAS™ SERVICE MANUAL ART.NO. 3324504-000 Rev A, VALID FROM CO J2372, (C) COPYRIGHT JOLIFE AB 5 1 Introduction. 1.1 BACKGROUND . LUCAS is a

LUCAS™ SERVICE MANUAL ART. NO. 3324504-000 Rev A, VALID FROM CO J2372, (C) COPYRIGHT JOLIFE AB

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Important user information All Service technicians must read this entire Service Manual before opening or disassembling LUCAS.

SCOPE

This service manual comprehends LUCAS 100249-XX and LUCAS 100250-00. For older versions of LUCAS use the LUCAS service manual 100166-00.

REQUIRED SKILLS

Jolife AB strongly recommends that LUCAS only shall be serviced by Service Technicians with docu- mented technical skills, who have: • undertaken a Service Education for LUCAS, AND • have knowledge in how to use LUCAS, AND • have knowledge in how to use LISA, AND • have knowledge in how to use and understand the result from SoftLISA

DISCLAIMER

Jolife AB does not accept liability for injury to personnel or damage to equipment that may result from mis- use of LUCAS or LISA. Under no circumstances shall Jolife AB be liable for incidental or consequential damage arising from the use of LUCAS or LISA.

PATIENT SAFETY RELATED FAULTS

All discovered failures that directly or indirectly have, or may had, affected patient or user safety shall, with no delay, be reported directly to the Quality Manager at Jolife AB. Examples of Patient Safety related Faults: • Too low force – Might cause poor circulation to the patient • Too high force – Might cause serious injury if in conjunction with too high compression depth • Too low compression depth – Might cause poor circulation to the patient • Too high compression depth – Might cause serious injury to patient especially in conjunction with too

high compression force • No Suction Cup on the piston – Might cause serious injury to patient The limits are explained in section 7.

TRADEMARKS

LUCAS™ is a trademark of Jolife AB. LISA™ is a trademark of Jolife AB.

OTHER RELATED INFORMATION

For more information regarding LISA and LUCAS please read: LUCAS™ Chest Compression System - Instruction for Use LISA™ Test Equipment – Instruction for Use

WARRANTY

The customer has 12 months warranty from the date of delivery. The warranty covers defects in the construction, material or manufacture. All warranty service must be approved by the Service Manager at Jolife AB before any action is taken.

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REPORTING

All performed service shall be reported to Jolife AB, Att: Service Manager, on a monthly basis. The information shall comprise: • S/N of device serviced • Detailed description of symptoms and problem description • Actions taken • Replaced parts, with S/N or batch no. when applicable (replaced parts shall be returned to Jolife AB) • Person performing service actions (service technician)

DEVICE TRACKING

All performed service where modules are replaced, the serial no./batch no. of each module shall be stated in the service report. This information is then sent to Jolife AB, Att: Service Manager, on a monthly basis. The modules that have traceability are: • Compression Module • Timing Module • Cylinder/Main Valve • High Flow Valve (HFV) • Back Plate • Main Body • Support Leg

RECYCLING INFORMATION

LUCAS contains of several materials as listed below: • Polyamide reinforced with 30% glass fibre • Polycarbonate/Polybutylene Terepthalate • PVC • POM • Silicone • Aluminium • Stainless steel • Brass For further recycling information please contact Jolife AB, Sweden.

RESPONSIBILITY FOR INFORMATION

The Technical Manager at Jolife AB is responsible for the information in this Service Manual.

© Copyright Jolife AB 2007. All rights reserved.

Manufacturer, main office

Jolife AB Scheelev. 17 SE-223 70 LUND Sweden

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Table of Contents

1 INTRODUCTION .................................................................................................5

1.1 BACKGROUND ...................................................................................................................................... 5

2 WARNINGS AND PRECAUTIONS ..............................................................................6

2.1 PROTECTIVE EQUIPMENT....................................................................................................................... 6

3 THE FUNCTION OF LUCAS ...................................................................................7

3.1 PNEUMATICS........................................................................................................................................ 7 3.2 MECHANICS ......................................................................................................................................... 8

4 TROUBLESHOOTING ............................................................................................9

4.1 INTRODUCTION TO TROUBLESHOOTING ................................................................................................... 9 4.2 EXPLANATION TO THE TROUBLESHOOTING FLOW CHART ........................................................................ 10

5 TOOLS LIST ....................................................................................................12

5.1 STANDARD TOOLS .............................................................................................................................. 12 5.2 CUSTOM TOOLS ................................................................................................................................. 12 5.3 SUBSTANCES ..................................................................................................................................... 13 5.4 GAS SUPPLY ...................................................................................................................................... 13 5.5 LISA SYSTEM .................................................................................................................................... 13

6 REPLACING PARTS/MODULES IN LUCAS ...............................................................14

6.1 HOW TO REPLACE THE HOOD............................................................................................................... 14 6.2 HOW TO REPLACE THE MODE SWITCH .................................................................................................. 16 6.3 HOW TO REPLACE THE SUPPORT LEG................................................................................................... 17 6.4 HOW TO REPLACE THE COMPRESSION MODULE..................................................................................... 21 6.5 HOW TO REPLACE THE HIGH FLOW VALVE (HFV) .................................................................................. 22 6.6 HOW TO REPLACE THE MAIN HOSE....................................................................................................... 24 6.7 HOW TO REPLACE THE TIMING MODULE ................................................................................................ 25 6.8 HOW TO REPLACE THE MAIN VALVE...................................................................................................... 29 6.9 HOW TO REPLACE THE SUCTION CUP ................................................................................................... 31 6.10 HOW TO REPLACE THE BELLOWS ......................................................................................................... 33 6.11 HOW TO REPLACE THE ADJUSTMENT HANDLE........................................................................................ 35 6.12 HOW TO REPLACE THE ADJUSTMENT BRACKET ...................................................................................... 36 6.13 HOW TO REPLACE THE CYLINDER ......................................................................................................... 37

7 MEASUREMENTS AND ADJUSTMENTS .....................................................................39

7.1 INTRODUCTION ................................................................................................................................... 39 7.2 FUNCTION CHECK .............................................................................................................................. 39 7.3 LEAKAGE TEST .................................................................................................................................. 41 7.4 MAXIMUM FORCE TEST ....................................................................................................................... 42 7.5 TIMING MODULE ADJUSTMENT ............................................................................................................. 43 7.6 HIGH FLOW VALVE (HFV) ADJUSTMENT ............................................................................................... 45

8 PREVENTIVE MAINTENANCE OF LUCAS .................................................................46

8.1 YEARLY MAINTENANCE (300 TREATMENTS OR 12 MONTHS, WHICHEVER COMES FIRST)............................. 46

9 MAINTENANCE OF LUCAS CONNECTOR ................................................................47

9.1 LUCAS CONNECTOR MAINTENANCE ................................................................................................... 47

10 MAINTENANCE OF LUCAS AIR REGULATOR ...........................................................48

10.1 VISUAL INSPECTION AND CLEANING...................................................................................................... 48 10.2 REPLACE O-RING ............................................................................................................................... 49 10.3 LEAKAGE TEST AND FUNCTIONAL CHECK .............................................................................................. 50

11 APPENDIX A ...................................................................................................51

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1 Introduction

1.1 BACKGROUND

LUCAS is a Chest Compression System used on adult patients suffering from acute cardiac arrest.

LISA is designed to measure and test the properties of LUCAS, such as compression depth, force, pressure and frequency.

This Manual is a part of the Service Education Program that, together with Technical Training, will provide the Service Technician with the knowledge to examine and repair LUCAS.

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2 Warnings and precautions

Except the warnings stated below, there are also warnings and precautions mentioned in the following documents that are of relevance during service and maintenance of LUCAS

LUCAS Chest Compression System - Instruction for Use

LISA Test Equipment – Instruction for Use

2.1 PROTECTIVE EQUIPMENT

It’s strongly recommended to use the following protective equipment when working with LUCAS and LISA:

Hearing protection

Eye protection

Protective Gloves

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3 The Function of LUCAS

3.1 PNEUMATICS

LUCAS is supplied with Compressed Air according to Instructions for use LUCAS.

In order to produce a compression force that is independent of pressure supplied, LUCAS contains a High Flow Valve (HFV) that regulates the pressure to approximately 2.8 bar.

The regulated pressure goes to the Mode Switch which have the function of a 3/3 valve (three inlets/outlets and three different states). When the Switch is in Adjust mode, no pressure is present at any of the outlets.

When the Switch is turned into Lock position, the pressure will go through one of the outlets of the Mode Switch to the Height Adjustment Lock and its cylinder, affecting the Piston to lock the Height Adjustment.

Turning the Switch into Active position will let the pressure through both outlets, affecting the Height Adjustment Lock, but also letting pressure into the regulator of the Timing Module.

In the Timing Module the pressure is regulated to 2.5 bar. The output from the Timing Module will supply 2.5 bar to the Main Valve in square formed pulses.

The Main Valve has a piston that will control the flow to the Main Cylinder with pressure from the HFV, either to the Compression Cylinder to move the Piston down, or to the Decompression Cylinder to move the Piston up.

Mode Switch

High Flow Valve

Hood MainValve

Timing Module

Main Body

Cylinder Brake Cylinder

LUCAS Main Hose

Suction Cup

Figure 1 Schematic picture of the mechanics and pneumatics of LUCAS.

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3.2 MECHANICS

LUCAS has two Support Legs that lock to the Back plate with Claw Locks. The Support Legs are foldable for convenient transportation. The Claw Locks automatically lock to the Back plate when LUCAS is pressed on to it. To unlock the Claw Locks, pull the Release Rings. The 3.3 m long Main Hose supply LUCAS with compressed air.

ON/OFF knob

Hood

Patient strap

Patient strap holders

Shaft Seal

Release ring

Adjustment handle

Suction cup

Support leg

Claw lock

Back plate LUCAS unique connector Connector Air Main Hose

Figure 2. Components of LUCAS Chest Compression System.

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or Oxygen or Oxygen?

No

4 Troubleshooting

IN THIS SECTION WE WILL EXPLAIN THE WAY OF TROUBLESHOOTING LUCAS

4.1 INTRODUCTION TO TROUBLESHOOTING

In the flowchart below you will be able to find the solutions to the most common failures related to operation, at least you will be able to locate which module to replace.

Troubleshooting concerning cracked or missing parts is considered self-explanatory and will not be instructed in this section.

For more details se section 4.2

LUCAS starts with irregular

ratio

LUCAS doesn't start

too little compression- depth / Td too

long

with irregular frequency

No

Connected to Air

Yes

Connect to Air

No LUCAS

starts?

Yes

HFV OK?

#4.2.4

No

Replace HFV

according to 6.5

Yes

Replace gas bottle or check

wall outlet

LUCAS No starts?

Yes

Problem solved!

No Gas

supply OK?

Yes

Mode No

Switch OK? #4.2.1

Yes

Timing

Module OK? #4.2.2

Yes

Main No

Valve OK? #4.2.3

Yes

Replace

Compression Module

Problem solved! Replace Mode

Switch according to 6.2 Replace Timing

Module according to 6.7

Replace Main Valve according

to 6.8

LUCAS starts?

No Contact Service

Department at according to 6.4

Yes

Jolife AB

Problem solved!

Figure 3 Schematic flow chart diagram for trouble shooting on LUCAS.

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4.2 EXPLANATION TO THE TROUBLESHOOTING FLOW CHART

This section is an explanation to the Troubleshooting Flow Chart 4.2.1 MODE SWITCH

The Mode Switch is supplied with approximately 2.8 Bar on the inlet (1) from the High Flow Valve (HFV).

With the Mode Switch in position “Adjust” there should be no pressure at any of the outlets (2 and 3)

With the Mode Switch in position “Locked” there should be 2.8 Bar on outlet 2 that supplies the Locking Mechanism.

With the Mode Switch in position “Active” there should be 2.8 Bar on both outlet 2 and 3, supplying both the Locking Mechanism and the Timing Module.

Figure 4 Mode switch shown from connecting side.

Nipple number

Mode

1

2

3

Adjust

2.8 Bar

0

0

Locked

2.8 Bar

2.8 Bar

0

Active

2.8 Bar

2.8 Bar

2.8 Bar

Table 1 Pressure outputs on Mode switch. 4.2.2 TIMING MODULE

The Timing Module is supplied with 2.8 Bar from the Mode Switch.

The Timing Regulator regulates the pressure to 2.5 Bar.

The outlet from the Timing Module should be a square formed pulse, 0 – 2.5 Bar with a frequency of about 100 pulses/minute.

The Timing Module can be adjusted according to 7.5

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4.2.3 MAIN VALVE

The Main Valve is supplied with a square formed pulse 0 – 2.5 Bar from the Timing Module.

The piston in Main Valve should move back and forth, forcing the main pressure (2.8 Bar) to alternate between the Compression Cylinder and the Decompression Cylinder.

4.2.4 HFV

The HFV (High Flow Valve) regulates the input pressure to about 2.8 Bar.

If the maximum force is too low, too high or if Td (Time down) is too long an adjustment of HFV can be done according to 7.6.

Before adjusting HFV make sure that the Main Cylinder works ok and is lubricated properly, if the resistance is too high in the Cylinder this has to be dealt with first.

An increased friction inside the HFV may cause a too long Td (Time down), if this is the case a replacement has to be done.

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5 Tools list

IN THIS SECTION IT IS LISTED THE TOOLS NEEDED FOR PERFORMING SERVICE AND MAINTENANCE OF LUCAS

5.1 STANDARD TOOLS

Torx Driver T9, T10, T20, T25 (or set of Torx Keys)

Philips Driver PH1

Flat Screw Driver 0.4x2.5 mm

Long Socket 17 mm

Set of Allen Keys mm

Micrometer Adjustable Torque Screwdriver 0.5-4.5 Nm

Bits Philips 1 (PH1)

Bits Torx 10 (T10)

Bits Torx 20 (T20)

Bits Torx 25 (T25)

Bits Allen Key 2,5 and 3 mm

7, 12, 17, 19, 20 mm Wrench

Hammer Mandrel

Adjustable Pliers

5.2 CUSTOM TOOLS

Art.no:

15 mm Wrench (Special) 100138-04

HFV Adjustment Tool 100417-00

Suction Cup Washer Tool 100324-00

Suction Cup Torque Wrench 100400-00

Spanner Insert 20 mm for Torque Wrench

100534-00

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5.3 SUBSTANCES

Art.no:

Pipe Sealant 675 (Oxygen compatible)

100167-00

BLR Bloc’Lube 100169-00

PTFE Spray Lubricant 100539-00

Shaft Seal Glue Kit 100741-00

5.4 GAS SUPPLY

Pressure 3.2 to 6 Bar (4.5 Bar is preferred)

Flow more than 55 liters/minute in average

Dried Air and free from Oil (Dew point below 10ºC)

Reservoir tank to avoid pressure drops

5.5 LISA SYSTEM

LISA

Laptop with installed software: SoftLISA

PCMCIA Sample card

Data cable

Power supply

Calibrated Pressure gauge

LISA Test tool

Calibrated weight 10 kg

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6 Replacing Parts/Modules in LUCAS

IN THIS SECTION IT IS EXPLAINED HOW TO REPLACE SOME OF THE MOST COMMON PARTS/MODULES.

6.1 HOW TO REPLACE THE HOOD 6.1.1 DISASSEMBLING

Remove all four screws for the hood. PH1.

Remove the On/Off-knob. Small flat screwdriver.

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Unscrew Mode Switch from the hood. Long socket 17.

6.1.2 REASSEMBLING

Replace the Hood and follow the instructions above in opposite order, make sure that all screws are locked and tightened according to instructions below.

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in).

Apply thread lock to the nut holding the Mode Switch and tighten.

If the nut is not locked properly, the Mode Switch may come loose, and fall into LUCAS

making it impossible to turn off LUCAS.

When putting back the Hood make sure that no hoses get jammed or squeezed as this may affect the function of LUCAS.

6.1.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Function Check according to 7.2.

If no access to LISA perform the routine check according to 4.2 in Instructions for use LUCAS.

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6.2 HOW TO REPLACE THE MODE SWITCH 6.2.1 DISASSEMBLING

Remove all four screws for the hood. PH1.

Pull off the three hoses from the Mode Switch. Note the placement.

Remove the On/Off-knob. Small flat screwdriver.

Unscrew the Mode Switch from the hood. Long socket 17. 6.2.2 REASSEMBLING

Replace the Mode Switch and follow the instructions above in opposite order, make sure that all screws are locked and tightened according to instructions below.

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in)

Apply thread lock to the nut holding the Mode Switch and tighten.

If the nut is not locked properly, the Mode Switch may come loose, and fall into LUCAS

making it impossible to turn off LUCAS. 6.2.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Function Check according to 7.2.

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6.3 HOW TO REPLACE THE SUPPORT LEG 6.3.1 DISASSEMBLING

Remove the patient strap.

Remove the Shaft seals by bending with a small flat screwdriver.

Remove the Patient Strap Holders.

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Lay LUCAS on the side. The side where the Torsion spring ends with a 180° round should be placed upwards.

Knock the spring out with a hammer and a mandrel. Knock it sideways and downwards.

When the spring is removed, the Angle shafts can be removed with a pair of Adjustable pliers. Observe the orientation of the Angle shafts. (It might be necessary to knock out the opposite Angle shafts, that are press fitted, with a hammer and a mandrel or similar.)

Remove the support leg.

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6.3.2 REASSEMBLING

With LUCAS still on the side, place the new support leg pointing straight out from LUCAS. Observe the angle of the leg in the picture below:

Insert the Angle shafts. Start with the one that is press fitted into the profile, then turn around LUCAS on the other side and insert the other Angle shaft. The Angle shafts should be oriented so that the grooves in them are aligned and pointing towards the profile.

Insert the Torsion spring with the rounded end first.

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With the spring in place, turn the support leg to its right position, knock down the Angle Shaft carefully with a hammer.

Put the Patient Strap Holder in place (two sides).

Apply Plastic Primer (from the Glue Kit 100741-00) to the groove all around the Shaft Seal and the corresponding surface on the Support Leg, let it dry for a couple of minutes.

Apply Glue in the groove all around the Shaft Seal.

Apply glue all around in groove

Snap on the Shaft Seal (two sides).

Wipe off any residues.

Mount back the Patient Strap.

If the replaced Support Leg had a Type Label, if possible try to move the existing label to the new Support Leg, if that doesn’t work contact Jolife to get a new one.

6.3.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Check the locking function by locking and unlocking against the backplate.

Check the function of the torsion spring by folding and unfolding the Support legs.

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6.4 HOW TO REPLACE THE COMPRESSION MODULE 6.4.1 DISASSEMBLING

Remove all four screws for the Hood. PH1.

Pull off the three hoses from the Mode Switch. Note the placement.

Remove the four screws holding the Compression Module from underneath. Torx T25.

Lift out the Compression Module carefully, make sure not to harm any of the hoses. 6.4.2 REASSEMBLING

Replace the Compression Module and follow the instructions above in opposite order, make sure that all screws are locked and tightened according to instructions below.

Apply thread lock to the four screws holding the Compression Module, tighten to 4.0 Nm (35 lbf/in)

Attach the three hoses to the Mode Switch, make sure to place them right.

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in).

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!

6.4.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

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6.5 HOW TO REPLACE THE HIGH FLOW VALVE (HFV) 6.5.1 DISASSEMBLING

Remove all four screws for the Hood. PH1.

Remove the inlet flow angle mounting to the HFV. PH1.

Pull off the 3 mm hose on the side of the HFV.

Remove the two screws holding the HFV and remove it. Torx T10.

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6.5.2 REASSEMBLING

Replace the HFV, make sure that the O-ring is in place..

Apply thread lock to the two screws and tighten to 1.0 Nm (9 lbf/in).

Apply thread sealing also to the screws holding the angle mounting and tighten to 1.0 Nm (9 lbf/in), make sure that the O-ring is in place.

Put the hose in place on the side of the HFV.

Make a Maximum Force Test with LISA. If the value is right continue to the next step. If not, the HFV must be adjusted according to 7.6.

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in).

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!.

6.5.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2

Leakage test according to 7.3

Maximum Force Test according to 7.4

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6.6 HOW TO REPLACE THE MAIN HOSE 6.6.1 DISASSEMBLING

Make sure that the main hose is not pressurized by disconnecting the hose.

Remove the Hose Fitting using a 12 mm wrench.

6.6.2 REASSEMBLING

Replace the Hose

Apply thread lock to the Hose Fitting and tighten, make sure the gasket is in place.

6.6.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Leakage test according to 7.3.

Functional check according to 7.2

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6.7 HOW TO REPLACE THE TIMING MODULE

THERE ARE TWO VERSIONS OF THE TIMING MODULE: 100409-00 HERE CALLED VERSION 1,

AND THE NEW IMPROVED TIMING MODULE 100655-00 HERE CALLED VERSION 2.

THE VERSION 2 HAS REPLACED THE VERSION 1 AS SPARE PART.

6.7.1 DISASSEMBLING (VERSION 1)

Remove all four screws for the Hood. PH1.

Remove the main body lid, 4 screws. Torx T20

Remove the two screws holding the Timing Module. Torx T25

Disconnect the two hoses from the Timing Module and remove the timing module from its place. 6.7.2 REASSEMBLING (VERSION 1)

Replace the Timing Module.

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Apply thread lock to the two screws holding the Timing Module and tighten to 4,0 Nm (35 lbf/in).

Connect the two hoses.

Put the Main Body Lid in place and tighten the screws to 1,5 Nm (13 lbf/in)

Make a functional check at LISA according to 7.2 and if necessary adjust the Compression- /Decompression-Time (Frequency and Ratio) according to instructions in chapter 7.5.1

When the Frequency and Ratio is set, apply BLR Bloc’Lube to the adjustment screws according to 7.5.1

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in).

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!.

6.7.3 TEST (VERSION 1)

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

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6.7.4 DISASSEMBLING (VERSION 2)

Remove all four screws for the Hood. PH1.

Remove the main body lid, 4 screws. Torx T20

Remove the two screws holding the Timing Module. Torx T25

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Disconnect the two hoses from the Timing Module and remove the timing module from its place, it might be necessary to bend the mounting plate with a flat screwdriver to get it off.

6.7.5 REASSEMBLING (VERSION 2)

Replace the Timing Module.

Apply thread lock to the two screws holding the Timing Module and tighten to 4,0 Nm (35 lbf/in).

Connect the two hoses.

Put the Main Body Lid in place and tighten the screws to 1,5 Nm (13 lbf/in)

Make a functional check at LISA according to 7.2 and if necessary adjust the Compression- /Decompression-Time (Frequency and Ratio) according to instructions in chapter 7.5.2

When the Frequency and Ratio is set, apply BLR Bloc’Lube to the adjustment screws according to 7.5.2

Apply thread lock to the four screws holding the Hood, tighten to 1,5 Nm (13 lbf/in).

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!.

6.7.6 TEST (VERSION 2)

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

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6.8 HOW TO REPLACE THE MAIN VALVE 6.8.1 DISASSEMBLING

Follow the instructions in 6.5.1 to remove the HFV.

Remove the hose attached to the Main Valve.

Remove the two screws holding the Main Valve. PH1

6.8.2 REASSEMBLING

Replace the Main Valve, make sure that the O-rings are in place.

Apply thread lock to the two screws and tighten to 0.7 Nm (6 lbf/in)

Connect the hose to the Main Valve.

Follow the instructions in 6.5.2 to mount the HFV.

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!

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6.8.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

Leakage test according to 7.3.

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6.9 HOW TO REPLACE THE SUCTION CUP 6.9.1 DISASSEMBLING

Make sure that the device is not pressurized and that the piston is in its outer position.

Unscrew the suction cup sleeve from the Suction Cup Mounting. Suction Cup Torque Wrench and Suction Cup Washer Tool

When the Suction Cup Sleeve is off the locking screw on the Suction Cup Mounting is visible, unscrew the locking screw. Allen key 2 mm

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Remove the Suction Cup Mounting from the Piston. 15 mm wrench (Special) and 20 mm wrench

6.9.2 REASSEMBLING

Replace the Suction Cup.

Tighten the new suction Cup against the Piston with 8 Nm (71 lbf/in). 15 mm wrench (Special) and Torque Wrench 20 mm.

Lock the Locking screw in the Suction Cup Mounting.

Tighten the Suction Cup Sleeve against the Suction Cup Mounting with 8 Nm (71 lbf/in). Suction Cup Torque Wrench and Suction Cup Washer Tool

6.9.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

If no access to LISA perform the routine check according to 4.2 in Instructions for use LUCAS.

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6.10 HOW TO REPLACE THE BELLOWS 6.10.1 DISASSEMBLING

Follow the instructions in 6.6.1 to remove the Main Hose.

Follow the instructions in 6.9.1 to remove the Suction Cup.

Push the Piston fully into the Cylinder to protect its surface against mechanical damage.

Remove the four screws holding the Adjustment Bracket and the Pinch Protection. Allen Key 3 mm

Remove the six screws holding the Bellows. Torx T10 and T20

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Remove the Bellows and the lower Bellows Plate.

6.10.2 REASSEMBLING

Place the new Bellows in the lower Bellows Plate.

Mount the Bellows Plate with the six screws, apply thread lock and tighten.

Mount the Pinch Protection and the Adjustment Bracket, lock the screws with thread lock and tighten to 2,0 Nm (18 lbf/in).

Follow the instructions in 6.9.2 to reassemble the Suction Cup.

Follow the instructions in 6.6.2 to reassemble the Main Hose

6.10.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Check that it’s possible to adjust from smallest to largest patient size.

Functional check according to 7.2.

Leakage test according to 7.3.

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6.11 HOW TO REPLACE THE ADJUSTMENT HANDLE 6.11.1 DISASSEMBLING

Remove the two screws holding the handle. Torx T20

Remove the handle. 6.11.2 REASSEMBLING

Replace the handle and use the enclosed screws to fasten it.

The screws should be tightened to 1.5 Nm (13 lbf/in).

6.11.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Make sure that the handle is firmly attached to the Adjustment Bracket.

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6.12 HOW TO REPLACE THE ADJUSTMENT BRACKET 6.12.1 DISASSEMBLING

Follow the instructions in 6.9.1 to remove the Suction Cup.

Push the Piston fully into the Cylinder to protect its surface against mechanical damage.

Remove the four screws holding the Adjustment Bracket. Allen Key 3 mm

Remove the Adjustment Bracket. 6.12.2 REASSEMBLING

Mount the Adjustment Bracket, lock the screws with thread lock and tighten to 2.0 Nm (18 lbf/in).

Follow the instructions in 6.9.2 to reassemble the Suction Cup.

6.12.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Check that it’s possible to adjust from smallest to largest patient size.

Functional check according to 7.2.

If no access to LISA perform the routine check according to 4.2 in Instructions for use LUCAS.

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6.13 HOW TO REPLACE THE CYLINDER 6.13.1 DISASSEMBLING

Follow the instructions in 6.5.1 to remove the HFV.

Remove the hose connected to the Main Valve.

Follow the instructions in 6.10.1 to remove the Suction Cup and the Bellows.

Now the Cylinder can be removed by unscrewing 2 screws on the lower Cylinder Bracket, Allen Key 2.5 mm

and 2 screws on the upper Cylinder Bracket. Torx T20

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6.13.2 REASSEMBLING

Replace the Cylinder and lock the screws with thread lock, tighten to 2,0 Nm (18 lbf/in).

Follow the instructions in 6.10.2 to reassemble the Bellows and the Suction Cup.

Follow the instructions in 6.5.2 to reassemble the HFV.

NB! Make sure you note the serial number of both the old and the new Module in the Service Report!

6.13.3 TEST

Do the following tests to verify that the repair/replacement has been performed correctly:

Functional check according to 7.2.

Leakage test according to 7.3.

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7 Measurements and Adjustments

7.1 INTRODUCTION

The following points shall be carried out before any tests are made with LUCAS on LISA,

Check that the LISA system is connected and working according to Instructions for use LISA.

Check that the daily check for LISA has been done without any remark.

7.2 FUNCTION CHECK

To make a Function Check of LUCAS, use the following steps:

Setup LISA (if not previously done).

Start SoftLISA software (if not already running).

Press start and follow the instructions in the dialog box to perform the calibration. (if previous tests has been performed with the same device this and the next step can be skipped)

Continue with filling in the user information in the Start dialog box.

Lock the Interface plate.

Attach LUCAS to LISA and connect the hose.

Use the Adjustment handle to press the Suction Cup tight onto the LISA Interface plate. Set the On/Off knob to Locked position.

Unlock the Interface plate and start LUCAS. Let it run for 20-30 seconds.

Press Freeze Plot on SoftLISA. Turn off LUCAS.

Now the curves can be analyzed and measured using the cursors. For more information read SoftLISA Help

NB! Time down is measured to 50 mm Compression Depth for the European (outside US) device (100249-0X) and 44 mm for the US device (100250-00 and 100249-0X after Serial#: 1409 XXXX, or on devices with replaced Cylinders (100441-00)), See Appendix A

Check that the following values are within the approved limits:

Measurement Min Max

Time down (tdn) NA 0,120 s

Time up (tup) NA 0,100 s

Table 2 Limits on time down and time up

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Please observe that there are different limits on different devices. Check the type label on the LUCAS device to determine which limits apply.

NB! The surrounding temperature should be 15-35 ºC (60-95 ºF). 7.2.1 LIMITS FOR LUCAS 100249-0X

Measurement Min Max

Frequency (f)* 100 comp./min 107 comp./min

Ratio (Rc)* 47% 53%

Compression depth (dc) 50 mm 57 mm

Table 3 Limits on Frequency, Ratio and Compression depth 7.2.2 LIMITS FOR LUCAS 100250-00 (US) AND 100249-0X AFTER SERIAL#: 1409 XXXX

OR ON DEVICES WITH REPLACED CYLINDERS (100441-00).

Measurement Min Max

Frequency (f)* 100 comp./min 107 comp./min

Ratio (Rc)* 47% 53%

Compression depth (dc) 44 mm 51 mm

Table 4 Limits on Frequency, Ratio and Compression depth

* If the frequency is outside 90-115 or the Ratio outside 40-60% an adjustment is not enough, further investigations are necessary and a replacement of either timing module or any other defective part must be done.

To adjust Frequency/Ratio follow the instructions according to 7.5

Make a printout and, if desirable, save also to file.

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7.3 LEAKAGE TEST

To make a Leakage Test of LUCAS, use the following steps:

Connect LUCAS to LISA Test outlet.

Set LUCAS On/Off knob to Locked position.

Start SoftLISA (if not already running) and select Leakage Test in the lower right corner

Set the Test outlet switch to On and adjust the pressure to 1.9-2.1 bar with the Module pressure regulator.

Set the Test outlet switch to Off.

Click Measure and fill in the user information, click Start in the dialog box.

The measurement is performed automatically during 30 seconds. The leakage reading is presented on the screen. Maximum allowed value is 120 ml/min.

If the value should be outside the limits, the reason therefore must be investigated and corrective action be taken.

Make a printout.

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7.4 MAXIMUM FORCE TEST

To make a Maximum Force Test of LUCAS, use the following steps:

Setup LISA (if not previously done).

Start SoftLISA (if not already running).

Press start and follow the instructions in the dialog box to perform the calibration (if previous tests has been performed with the same device this and the next step can be skipped).

Continue with filling in the user information in the Start dialog box. Press Start.

Using the LISA Control Tool, press down the Interface plate (according to Daily check in LISA Instructions for use) and lock it.

Attach LUCAS to LISA and connect the hose.

Use the Adjustment handle to press the Suction Cup tight onto the LISA Interface plate. Set the On/Off knob to Locked position.

Unlock the Interface plate and start LUCAS. Let it run for 2 minutes.

Press Freeze Plot on SoftLISA. Turn off LUCAS.

Now the force curve can be measured using the cursors. For more information read SoftLISA Help

Measurement Min Max

Maximum Force* 530N 570N

The force should be between 530 to 570 N. If the value should be outside the limits, an adjustment can be made according to 7.6

* If the force is outside 500-600N an adjustment is not enough, further investigations are necessary and a replacement of High Flow Valve might be necessary, it’s also possible that there is something wrong with the Compression Module.

Make a printout.

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7.5 TIMING MODULE ADJUSTMENT

There are two versions of the Timing Module: 100409-00 here called Version 1, and the new improved Timing Module 100655-00 here called Version 2.

When the Frequency and/or Ratio is out of limit an adjustment has to be made, this is done by turning the two adjustment screws at the Timing Module. NB! The surrounding temperature should be 15-35 ºC (60-95 ºF).

7.5.1 ADJUSTING TIMING MODULE (VERSION 1)

Timing Module Regulator (2.4-2.6 Bar)

Upper Adjustment Screw

Lower Adjustment Screw

Use a flat screwdriver 0.5x2.5 mm for the Lower Adjustment Screw and a 7 mm wrench to loosen the counter nut for the Upper Adjustment Screw. The upper screw can then be adjusted by hand. Run LUCAS at LISA while performing the adjustments.

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Tip! Set the markers in SoftLISA to the desirable values, then adjust the screws while running LUCAS until you reach the preset markers.

When the right value is achieved lock the adjustment screws with BLR Bloc’Lube (as picture).

Perform a Functional check according to 7.2.

7.5.2 ADJUSTING TIMING MODULE (VERSION 2)

Timing Module Regulator (2.4-2.6 Bar)

Adjustment Screw Compression Time

Adjustment Screw Decompression Time

Use a 7 mm wrench to loosen the counter nut for the Adjustment Screws. The screws can then be adjusted by hand.

Run LUCAS at LISA while performing the adjustments.

The left Adjustment screw affects the Compression time and the right screw affects the Decompression time.

Tip! Set the markers in SoftLISA to the desirable values, then adjust the screws while running LUCAS until you reach the preset markers.

When the right value is achieved tighten the lock nuts and apply BLR Bloc’Lube (as picture).

Perform a Functional check according to 7.2.

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7.6 HIGH FLOW VALVE (HFV) ADJUSTMENT

When the Maximum Force is too high or too low an adjustment of the HFV has to be made, this is done by turning the adjustment screw on the side of the HFV.

Adjustment Screw

Turn the screw clockwise to increase the force and counter-clockwise to decrease the force. HFV Adjustment Tool (100417-00)

Run a Maximum Force Test according to 7.4 at LISA while performing the adjustments.

Tip! Set the marker in SoftLISA to the desirable value, then adjust the screw while running LUCAS until you reach the preset marker.

When the right value is achieved lock the Adjustment Screw by applying BLR Bloc’Lube (as picture).

Perform a Maximum Force Test according to 7.4

Perform a Functional check according to 7.2.

If the force is not correctly set, compression force and displacement may be reduced causing poor circulation for the patient.

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8 Preventive Maintenance of LUCAS

8.1 YEARLY MAINTENANCE (300 TREATMENTS OR 12 MONTHS, WHICHEVER COMES FIRST)

Routine Ref. / Instruction Ref. / Part no: Cleaning 4.1.4 IFU* 4.1.3 IFU* Replacement Suction Cup 6.9 Suction Cup SP V2, 100481-00** Replacement Patient Straps 4.1.2 IFU* Patient Strap, 100335-00 x2** Leakage Test 7.3 Function Check:

• Frequency • Ratio • Time down (Td) • Time up (Tu) • Compression depth

7.2

Maximum Force 7.4 Adjustments: (if necessary)

• Frequency • Ratio • Force

7.5 7.5 7.6

Claw lock check Check for unordinary wear Claw lock lubrication 8.1.1 PTFE Spray Lubricant (100539-

00)

* Instructions For Use (100359-XX and 100057-00). ** Part of Maintenance Kit 100488-00.

8.1.1 CLAW LOCK LUBRICATION

Use PTFE Spray Lubricant (100539-00)

Spray a small quantity of lubricant on all movable parts (gliding surfaces of the claws, where the axle goes into the plastic and the locking pin), see picture below.

Open and lock the mechanism continuously to work in the lubricant.

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9 Maintenance of LUCAS Connector

In this section it will explained how to maintain the LUCAS Connector (Article: 201-XX).

9.1 LUCAS CONNECTOR MAINTENANCE

In case of a leakage in the connector or every five years, the connector should be maintained.

Open the Connector and replace the valve and O-rings inside (Connector Sealing Kit, 200-40). 17 and 19 mm Wrench

Close the Connector again and tighten, check that it works and doesn’t leak.

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10 Maintenance of LUCAS Air Regulator

In this section it will explained how to maintain the LUCAS Air Regulator (Article: 301-X).

10.1 VISUAL INSPECTION AND CLEANING

Check if there is visible external damage to the product (including product labels and marking). If it shows signs of external damages, remove it from service. Contact your supplier.

Visually check if the product is contaminated; if needed, remove grease and dirt from the regulator by wiping it off with a clean cloth.

Check if the service is due on the regulator, (refer to the GCE date coding system, see below). If the service date code has been exceeded (five years from manufacturing date), remove the product from service and contact Jolife for mandatory service.

Product serial number YY MM XXXXX Y: manufacturing year M: manufacturing month X: production number A: manufactured in CZ

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10.2 REPLACE O-RING

Check the presence & the integrity of o-ring at the inlet stem

Replace o-ring at the inlet stem, a pointed device could be used to remove the o-ring

NB! Only use genuine o-rings supplied by GCE or Jolife.

Jolife Art. No: GCE Art. No: Article: O-ring Art. No:

301-3 0725024 LUCAS Regulator European 336-1

301-4 0725025 LUCAS Regulator US 336-2

301-6 0725027 LUCAS Regulator SSAIR 336-1

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10.3 LEAKAGE TEST AND FUNCTIONAL CHECK

Mount the regulator on a compatible compressed air cylinder with sufficient air pressure

Connect LUCAS to the regulator.

NB! Ensure the LUCAS unique connector is well engaged.

Ensure pressure outlet is in working condition by connecting and disconnecting a LUCAS unique connector.

Slowly open the cylinder valve by turning the hand wheel in a counter-clockwise direction approx 1 to 1½ turns.

NB! Insufficiently opening the cylinder valve could reduce the actual flow delivered.

Check the regulator gauge indicates pressure. Visually check for possible air leakages:

- regulator inlet connection to cylinder valve,

- pressure gauge to main body,

- pressure relief valve vent hole(s),

- LUCAS connector

If any leakage is detected, replace o-ring on inlet stem. NB! Only use genuine o-rings, supplied by GCE or Jolife, See 10.2 above.

If still leakage contact your supplier

Start LUCAS to ensure air is delivered to the device.

Turn off LUCAS

Close the cylinder valve by turning the hand wheel in a clockwise direction to the stop position. Do not use excessive force.

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11Appendix A THE FOLLOWING PAGES ARE SCREEN DUMPS FROM SOFTLISA

1. FUNCTION CHECK PRINTOUT

2. MAXIMUM FORCE PRINTOUT

3. LEAKAGE TEST PRINTOUT

Figure 5 Screen dump from SoftLISA, the yellow framed area contains the values of interest for the Function Check.

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Figure 6 Screen dump from SoftLISA, the yellow framed value is the Maximum Force

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Figure 7 Screen dump from SoftLISA, the yellow framed area contains the values of interest when checking the leakage.

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