Kinetec Spectra User Manual

Manuel d'utilisationManuel d'utilisation

Avant toute utilisation lire ce document. AbilityOne Kinetec se réserve le droit de toutes modifications techniques.

User manualUser manual

Before use, please read this document. AbilityOne Kinetec reserves the right to effect technical modifications.

BedienungsanleitungBedienungsanleitung

Vor Benutzung unbedingt dieses Dokument lesen. AbilityOne Kinetec behält sich das Recht vor, jegliche technische Änderung durchzuführen.

Istruzioni per l’usoIstruzioni per l’uso

Prima di mettere in funzione l’apparecchio leggere con attenzione il presente documento. La AbilityOne Kinetec si riserva il diritto di apportare modifiche tecniche.

Manual de empleoManual de empleo

Antes de cualquier utilización, lea este documento. AbilityOne Kinetec se reserva el derecho a cualquier modificación técnica.

Your contact:

SUMMARYSUMMARY

Page Page

• Definition__________________________2

• Description ________________________3

• Safety____________________________4

• Electrical connection __________________5

• Use of the hand control

- Select your language _______________________6

- Locking the hand control setting ________________7

- START/STOP/REVERSE function_________________7

- Quick Start _____________________________8

- Possible values for each parameter ______________8

- How to adjust the basic parameters of the movement ___9

- How to modify programs PROGRAM MODE __________10-12

- Using Programs __________________________13

- Reading the values of a program________________14

- How to use the WARM UP key _________________ 15

- How to use the MODULATION key _______________ 16

- How to use the BYPASS key __________________ 17

- Session Time____________________________ 18

• Patient Pad kit_______________________ 19

• Setting up the patient___________________ 20

• Options ___________________________ 21

• Product information

- Maintenance____________________________ 22

- Troubleshooting__________________________ 22

- Cleaning_______________________________ 23

- Technical specifications _____________________ 23

- Symbols used ___________________________ 24

- Warranty ______________________________ 24

- Maintenance sheet ________________________ 25

SAFETY RECOMMENDATIONSSAFETY RECOMMENDATIONS

• The physician defines the protocol and ensures that it is correctly implemented (adjustments, session time and frequency of use).

• We recommend that you lock the hand control when you give it to the patient.

• For optimum safety, always give the hand control to the patient before starting the system.

• Explosion hazard: KINETEC Spectra is not designed for use in the presence of flammable anaesthetics.

• Check that the electrical socket is in good condition and is suitable for the splint power supply cord. The latter complies with current standards and has a grounding socket. The plug may be connected to any standard socket. The socket must however have a grounded pin. To connect the power supply, only use the original cable supplied with the machine. Check that the cables remain free around the device so that they do not get damaged.

Manuel N°467896275 - Updated 21/02/03

DefinitionDefinition

The KINETEC Spectra is a Knee PASSIVE mobilization device enabling the extension and flexion movement from -10° to 120°.

• Indications• Indications

• Knee replacement surgery.

• Fractures (patellar, tibia plateau, femoral,...).

• Arthrolysis

• Hip surgery, including hip replacement, hip pinning, osteotomy,...).

• Ligament repairs.

• Arthroscopic surgery (menisectomies, patellectomies,...)

• Burns, joints sepsis,...

• Clinical Benefits• Clinical Benefits

• Breaks the cycle of trauma, inflammation and the loss of range of motion.

• Prevents joint stiffness.

• Speeds the recovery of post-operative range of motion.

• Maintains the quality of the joint surface.

• Reduces pain and edema.

• Promotes joint cartilage healing.

• Reduces hospitalization time

• Reduces the need for pain medication.

• Provides immediate post-operative continuous passive motion.

• Digital ROM readout on the patient hand control for positive reinforcement.

• Maintains desired positions for stretching and muscular rest.

• Contraindications• Contraindications

Bone Cancer, Warped joint surfaces, Spastic paralyses, Unstable fractures, Uncontrolled infection. The machine are not adapted for patients height more 2 m(6'7") or under 1,40m (4'7").

DescriptionDescription

KINETEC Spectra consists of the following components: 1 • Lower limb support.

2 • Thigh support. 3 • Foot support and hand control location for transport. 4 • Hand control. 5 • Thigh support setting lock. 6 • Lower limb support setting lock . 7 • Foot support positioning setting lock. 8 • Transport handle. 9 • ON/OFF switch and fuses.

10 • Liquid-crystal display (2 lines of 16 characters). 11 • SESSION TIME display key. 12 • BYPASS mode key. 13 • MODULATION key. 14 • WARM UP key. 15 • EXTENSION setting key. 16 • FLEXION setting key. 17 • Increase / decrease keys. 18 • START key. 19 • STOP key. 20 • FORCE key. 21 • SPEED key. 22 • PAUSE key. 23 • TIMER key. 24 • PROGRAM access key.

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SafetySafety

The physician defines the protocol and ensures that it is correctly implemented (adjustments, session duration and frequency of use). The patient must know the start/stop/reverse function on the control handle. Hand control must be accessible to patient at all times. (See page 7). KINETEC Spectra complies with Directive 93/42/CEE.

EXPLOSION HAZARD:EXPLOSION HAZARD:

KINETEC Spectra is not designed for use in the presence of flammable anesthetics.KINETEC Spectra is not designed for use in the presence of flammable anesthetics.

In case of electromagnetic interference with other devices move the device. KINETEC Spectra is in compliance with standards in force (IEC 601.1.2), electromagnetic compatibility standard for medical devices.

Kinetec

30 STOP 15 90

Please wait

KINETEC

Spectra V01.0

Electrical connectionElectrical connection

KINETEC Spectra is a type B class I device. Before connecting the device to the power supply, check that the mains voltage matches that shown on the identification plate (100-240 V~ 50-60Hz). Connect the hand control (4) Connect the power supply cable (25).

IMPORTANTIMPORTANT Check that the electrical socket is in good condition and is suitable for the splint power supply cord. The latter complies with current standards and has a grounding socket. The plug may be connected to any standard socket. The socket must however have a grounded pin. To connect the power supply, only use the original cable supplied with the machine. Check that the cables remain free around the device so that they do not get damaged.

Starting the unitStarting the unit

Switch on (9). While the unit begins an auto diagnostic, the display shows the following :

Your KINETEC Spectra is ready to be used.

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Use of the hand controlUse of the hand control

Select your languageSelect your language

Beginning Keys to press Display Remarks

Switch the unit ON Check if the hand control is not blocked

(See page 7).

Press the 2 keys in the same time The display indicate the language selected.

To change the language or

The English language is selected. English

French German Italian Spanish

To validate the new language.

To exit and confirm the new language, switch OFF and Switch ON the unit.

Kinetec

30 STOP 15 90

Please wait

KINETEC

Spectra V01.0

Language:

english

Language:

English

Switch on/off

Use of the hand controlUse of the hand control

Locking the hand control settingLocking the hand control setting

The hand control allows the patient to control the machine as appropriate. Simultaneously press the and keys to lock the hand control, The display reads "LOCK", you can not change the parameters, if you try the display reads "LOCK". To unlock the hand control, simultaneously press the and keys, The display reads "UNLOCK".

We recommend that you lock the hand control when you give it to the patient.We recommend that you lock the hand control when you give it to the patient.

Comment: The hand control is unlocked when you switch the unit ON/OFF.

START/STOP/REVERSE functionSTART/STOP/REVERSE function

As with all KINETEC systems, KINETEC Spectra is equipped with a START/STOP/REVERSE function.

When the unit is running, the display reads RUN Press the key of the hand control. The movement stops. The display reads STOP. Press the key of the hand control. The movement starts in the opposite direction and the display reads RUN.

Caution:Caution:

For optimum safety, always give the hand control to the patient before starting the system.For optimum safety, always give the hand control to the patient before starting the system.

Use of the hand controlUse of the hand control

Quick StartQuick Start

Set up the patient and proceed as below:

Beginning Keys to press Display Remarks

Switch the unit ON

Check if the hand control is not blocked (See page 7).

If the Warm Up mode is selected, switch OFF this mode by pressing on the key

Start the session with the original parameters of the movement (default setting).

The value change at the speed of the movement.

Possible values for each parameter:Possible values for each parameter:

Possible values Default setting

• Treatement Mode

Normal

• Extension limit -10 to 115° 30°

• Flexion limit -5° to 120° 90°

• Speed

1 to 5 (from 30° to 160° per minute)

• Force 1 to 6 6

• Extension pause 0 to 900 seconds (15minutes) 0

• Flexion pause 0 to 900 seconds (15minutes) 0

• Timer No timer(00H00) to 24H00 0

Kinetec

30 STOP 15 90

Please wait

KINETEC

Spectra V01.0

WARMUP

30 STOP 15 90

KINETEC

30 run 45 90

Use of the hand controlUse of the hand control

How to adjust the basic parameters of the movementHow to adjust the basic parameters of the movement

Beginning Keys to press Display Remarks

To stop the unit

Check if the hand control is not blocked (See page 7).

To display the extension or flexion limit of the movement

or The value blinks.

To change the limit if necessary Or The new value blinks.

To validate the new value, press another key or wait more than 3 seconds.

While the value blinks press the or key to change if necessary.

Or Or to display pause in extension or flexion limit

Successive presses on this key selects the pause at the extension or flexion limit.

To change the pause if necessary Or The new pause value blinks. To validate the new value press another key

or wait more than 3 seconds. The display shows the selected mode.

The unit is ready to start with the new parameters.

KINETEC

30 STOP 15 90

KINETEC

40 Flex 15 110

KINETEC

30 Ext 15 90

KINETEC

40 Flex 15 90

KINETEC

SPEED 2

No timer

KINETEC

PAUSE HIGH 0

Pause low 0

FORCE _ _ _ _ _ _

KINETEC

PAUSE low 15

KINETEC

40 STOP 15 110

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Use of the hand controlUse of the hand control

How to modify programs PROGRAM MODEHow to modify programs PROGRAM MODE

Beginning Keys to press Display Remarks

To switch off the unitTo switch off the unit

Check if the hand control is not blocked (See page 7).

Press the two keys at the same time and switch the unit ON

Welcome text during 3 seconds.

Then The program number blinks.

To change the program if necessary or The new program number blinks.

To choose the treatment mode

The display indicates the selected treatment mode, the program number blinks again.

To display the extension or flexion limit of the movement

or The value blinks.

KINETEC

Spectra V01.0

Program 2

EMPTY

Program 10

25 kinetec 110

Program 10

25 warmup 110

Program 10

25 kinetec 110

Program 10

30 warmup 100

Program 10

30 warmup 110

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Use of the hand controlUse of the hand control

How to modify programs PROGRAM MODE (continued)How to modify programs PROGRAM MODE (continued)

Beginning Keys to press Display Remarks

To change the limit of movement if necessary or The new value blinks.

To validate the new value, press another key or wait more than 3 seconds While the value blinks press

the or key to change if necessary.

To record the program 10

Then

The program 10 has been recorded and the display indicates the next program so you can change another program.

OR To cancel the program

The program 10 has been cancelled and the display indicates the next program so you can change another program.

To exit program mode, switch OFF and switch ON the unit. To use the modified program see page 10.

Program 10

30 warmup 120

Program 10

SPEEd: 2

No timer

Pause low 0

FORCE _ _ _ _ _ _

Program 10

Save:+ clear:-

Program 10

Save

Program 11

EMPTY

Program 10

clearing

Program 11

EMPTY

KINETEC

Spectra V01.0

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Use of the hand controlUse of the hand control

Comments Comments:

• When a program has been deleted, the display shows

Program table:Program table:

• Program number

Treatment Mode Flexion limit Extension limit Speed Force Flexion Pause Extension Pause Timer

11 22 33 44 55 66 77 88

99 1010 1111 1212 1313 1414 1515 1616

Program 11

EMPTY

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Use of the hand controlUse of the hand control

Using ProgramsUsing Programs

The KINETEC Spectra allows you to store up to 16 programs, including the type of treatment, ROM, speed, load, pauses and timer. The original parameter values of the program are empty.

These values can be modified and recorded at any time (see ‘How to enter a program’ page 10).

Beginning Keys to press Display Remarks

To stop the unit

Check if the hand control is not blocked (See page 7).

To access the program mode The program number blinks.

To change the program if necessary or The new program number blinks.

To exit and validate the selected program

The current parameters have been recorded in program 3.

To exit without validation of selected program Back to the starting parameters.

Start the unit

The value change at the speed of the movement.

Comments:Comments:

• The values shown in the ‘Display’ column are examples. They actually depend on the stored programs.

• The current movement parameters can be changed while using that program but no data will be stored in the original program. See the programming mode (p 10) to modify programs.

KINETEC

40 STOP 15 110

PROGRAM 1

70 WARMUP 110

PROGRAM 3

25 warmup 90

KINETEC

Please wait

warmup

25 run 20 90

KINETEC

40 STOP 15 110

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Use of the hand controlUse of the hand control

Reading the values of a program: example SPEEDReading the values of a program: example SPEED

Beginning Keys to press Display Remarks

To stop the unit

Check if the hand control is not blocked (See page 7).

To access the program mode The program number blinks.

To change the program if necessary or To change the program if necessary.

To read the speed value Displays the speed value.

After 15 seconds or after pressing on another key

To exit and validate the selected program

The current parameters have been recorded in program 3.

Start the unit

The value change at the speed of the movement.

Comments:Comments:

• The values shown in the ‘Display’ column are examples. They actually depend on the stored programs.

• The current movement parameters can be changed while using that program but no data will be stored in the original program. See the programming mode (p 10) to modify programs.

KINETEC

40 STOP 15 110

Program 1

70 WARMUP 110

PROGRAM 3

25 warmup 90

PROGRAM 3

Speed 5

PROGRAM 3

70 WARMUP 110

KINETEC

40 STOP 15 110

KINETEC

40 run 15 110

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Use of the hand control Use of the hand control

How to use the WARM UP keyHow to use the WARM UP key

Beginning Keys to press Display Remarks

To stop the unit

Check if the hand control is not blocked (See page 7).

To select the Warm Up mode

The display shows the default settings (see page 8). To change the movement value if necessary see page 9.

Start the movement

The value change at the speed of the movement.

Warm Up rules: The Kinetec Spectra starts at 70% of the full ROM, increasing 5% of the range

every other cycle until the pre-set ROM is reached.

CommentsComments: The calculation mode used enables reaching the pre-set ROM in approximately seven full cycles.

ExampleExample: For a Warm Up treatment with a pre-set ROM from 0° to 100°. The first cycle starts from 15° to 85° to 15° and increase 5% each cycle.

KINETEC

40 STOP 15 110

WARM UP

30 STOP 15 90

PLEASE WAIT

WARM UP

15 RUN 15 110

100°

0°

50°

Cycle 1 (70%)

Cycle 2 (75%)

Cycle 3 (80%)

Cycle 4 (85%)

Cycle 5 (90%)

Cycle 6 (95%)

Cycle 7 (100%)

Pre-Set ROM

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Use of the hand control Use of the hand control

How to define the patient tolerance • At the start of a sessionHow to define the patient tolerance • At the start of a session

This function, MODULATION Mode is a way to set within the tolerance of a patient at the beginning of a session. Set up the patient and proceed as below:

Beginning Keys to press Display Remarks

Switch the unit ON

Check if the hand control is not blocked (See page 7).

If the Warm Up mode is selected, switch OFF this mode by pressing on the key

To select the MODULATION Mode

The display indicates the keys to be used to drive the machine, this message is displayed 3 seconds.

To select the pain level ( for flexion, for extension)

The unit is moving to the selected way. It is waiting for you to select new limits.

To set the pain level when reached, immediately press or The new limit of the movement is recorded

To start the session with the new movement limits

The angle display changes with current movement.

Kinetec

30 STOP 15 90

Please wait

KINETEC

Spectra V01.0

WARMUP

30 STOP 15 90

MODUL.: use + or -

30 STOP 15 90

MODUL.: use + or -

30manual 50 90

MODUL.: use + or -

30manual 50 50

KINETEC

30 run 45 50

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Use of the hand controlUse of the hand control

How to define the patient tolerance • During the sessionHow to define the patient tolerance • During the session

This function, The BY-PASS MODE is a way to address the pain threshold of a patient during a session.

IMPORTANT: Can be used only when the machine RUN.IMPORTANT: Can be used only when the machine RUN.

Beginning Keys to press Display Remarks

The unit is running

Check if the hand control is not blocked (See page 7).

To select the BYPASS mode

The display indicates the keys used to run the machine. This message is displayed 3 seconds.

To select the NEW pain level or

The unit is moving to the selected way. It is waiting for you to select new limits.

To set the NEW pain level when reached, immediately press

or The new limit of the movement is recorded.

Continue the session with the new movement limits.

The angle display changes with current movement.

Kinetec

30 RUN 15 90

WARMUP

30 RUN 15 90

PYPASS: use + or -

30 RUN 15 90

BYPASS: use + or -

30bypass 100 90

bypass.: use + or -

30manual 50 50

WARMUP

30 run 45 50

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TIME 02h25

30 STOP 15 90

Use of the hand controlUse of the hand control

Session TimeSession Time

This function shows the running time (in minutes) of the session (motor functioning).

• It directly accessible by the key , the display shows

This counter is reset each time the unit is switched ON.

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Use of the Use of the Kinetec Patient Pad KitKinetec Patient Pad Kit

The KINETEC Patient Pad Kit is designed for rapid fitting, optimal hygiene and maximum patient comfort.

- For using and positioning the straps, please refer to here under. Make sure that the self-adhesive parts (26) are visible.

- Place the sponge side next to the skin.

FOR OPTIMAL HYGIENE, A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT.FOR OPTIMAL HYGIENE, A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT.

Each cover is provided with a label to record the patient’s nameEach cover is provided with a label to record the patient’s name

CLEANING:

- Sterilization of the pads ( if necessary): Sterilized at 134 °C during 18 minutes.

- Disinfecting of the pads: Washing at 30°C with use of a disinfecting solution during the rising cycle. Example of product that can be used: Solution " Baclinge" at 0.125 % or "Souplanios" at 0,125% from ANIOS Laboratory. A complete list of distributors in your country is available on request.

The KINETEC Spectra is delivered with a complete set. Components:

- 4 straps

- 1 foot support

- 1 cover

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Setting up the patientSetting up the patient

Place the KINETEC Spectra machine in a position that will be comfortable for the patient.

- Measure in cm or inches the length of the patient’s femur (L); adjust the thigh support to this measurement using knobs (5)

- To install the patient on the KINETEC Spectra machine.

- Push the foot plate (3) up to the patient and tighten the knobs (6).

- Adjust the plantar flexion (40°) or the dorsal flexion (30°) of the foot, with the knobs (7).

- Adjust the internal (30°) or external (30°) flexion of the foot, with the knob (27). IMPORTANTIMPORTANT

Adjust the axis of the patient’s hip (28) with the axis rotation (29) of the KINETEC Spectra machine,

and the axis of the patient’s knee (30) with the axis rotation (31) of the KINETEC Spectra machine.

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CartCart

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Product informationProduct information

MaintenanceMaintenance

After 2,000 hours of operation, KINETEC Spectra requires a few lubrication and maintenance operations (lubrication of the joints, pointer stops and ball screws). The need for maintenance is indicated by display of the message SERV. MOTOR when the system is switched on. Despite that warning, you can continue to use your KINETEC Spectra by pressing START, but you should contact your nearest KINETEC technician to have the maintenance operations conducted as soon as possible.

• A motor running time counter is available. Simultaneously press keys and , the displays shows

this counter can be resetting by pressing the key .

TroubleshootingTroubleshooting

A spare parts list and technical catalog are available to you on request from your KINETEC distributor. If, after connecting the power supply cable to the power supply and switching on KINETEC Spectra:

• The display does not indicate any information:

- Check that the electrical socket is live using another device.

- Replace the fuse(s) (32) of the connector with fuses of the same type and calibre: 2 fuses T 750 mA 250V (6.3 x 32) (KINETEC order: 4610007434).

- If the display still does not indicate any information, contact your nearest KINETEC technician.

• Your KINETEC Spectra does not work and the display indicates 50 STOP 25 115, Press START again. Your KINETEC Spectra still does not function: Contact your nearest KINETEC technician.

• Your KINETEC Spectra does not function and the display indicates:

ANGULAR POSI.: angle measurement function failure, or NO MOVEMENT: no movement, or BAD WAY: motor rotation failure, or LOAD MAXI: abnormal consumption, or POWER SUPPLY: power failure;

Contact your nearest KINETEC technician if the same message is displayed after having switched the device off, then on, and started it by pressing START.

RESET TIME 924H

Reset: limit low

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Product informationProduct information

CleaningCleaning

Before conducting any cleaning operation, SWITCH the unit OFF and disconnect the power supply. Use a DISINFECTANT (PROPANOL/ISOPROPANOL or ALDEHYDE-based solution). Spray the disinfectant on the SURFACES (plastic shells and metal components). In order to ensure optimal hygiene, you are advised to clean the covers for each new patient. All the consumables enable hazard-free disposal.

Technical specificationsTechnical specifications

Product:Product:

Weight: 11Kg (24 pounds) Splint dimensions: 94cm (37 inches) x 33cm (13 inches) x 33cm (13 inches) Angular limits: -10° to 120° Speed: from 30 to 160° per minute for average femur length Patient height: full leg: 71 to 104 cm (28 to 41 inches)

Tibia: 38 to 58 cm (15 to 23 inches) Femur: 33 to 46 cm (13 to 18 inches)

Electricity:Electricity: Power supply: 100-240 V~ Frequency: 50-60 Hz Power consumption: 50 VA Device of type B class I IP 20. Fuse T 750mA 250V 6.3x32mm (KINETEC order: 4610007434)

EnvironmentEnvironment

- Storage/transport conditions: Temperature: -40 to 70°C / -40 to 160°F

Relative humidity: up to 90%

- Operating conditions: Room temperature: 10 to 40°C / 50 to 105°F

Relative humidity: up to 80%

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Product informationProduct information

Symbols usedSymbols used

TYPE B device

(protection against electric shocks)

Speed Flexion limit

Caution (consult the accompanying documents)

Timer Warm Up

STOP (power off) Force Modulation

ON (power on)

Pause Bypass

Start movement Increase Session time

Stop movement Decrease

Alternative current

Program access Extension limit

WarrantyWarranty

The KINETEC warranty is strictly limited to the replacement free of charge or repair in the plant of the component or components found to be defective. KINETEC guarantees its joint passive mobilization systems for 1 year against all defects of manufacture from the date of purchase by the consumer. KINETEC is the only organization able to assess the application of the warranty to its systems. The warranty will be considered null and void if the device has been used abnormally or under conditions of use other than those indicated in the user's manual. The warranty will also be considered null and void in the event of deterioration or an accident due to negligence, inappropriate surveillance or inappropriate maintenance, or due to transformation of the equipment or an attempt to repair the equipment.

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Product informationProduct information

Maintenance sheetMaintenance sheet

Serial number: _______________

Purchasing date: ____________________

Date: _________________________________________ Operations done: ___________________________________ Technician: _____________________________________ ______________________________________________ Running time (see page 22): __________________________ ______________________________________________ Exchange parts: __________________________________ ______________________________________________

_____________________________________________ ______________________________________________

Date: _________________________________________ Operations done: ___________________________________ Technician: _____________________________________ ______________________________________________ Running hours (see page 22): _________________________ ______________________________________________ Exchange parts: __________________________________ ______________________________________________

_____________________________________________ ______________________________________________

Kinetec Spectra User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual