Gold Standard Model 2150 and Gold Standard Plus Model 2160 Service Manual Issue 8

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected]

www.vitalograph.com

 Copyright Vitalograph 1997, 2008 Current Edition (Issue 8) Cat. No. 081030

Vitalograph is a registered trademark

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Table Of Contents GOLD STANDARD ...5 INTRODUCTION...6 SYSTEM CONFIGURATION ...7 Principle Of Operation...7 ACCURACY CHECK/CALIBRATION ADJUSTMENT ...8 Recommended 1-L Syringe Procedure...8 FUNCTIONAL CHECK ...10 INSTRUMENT ACCESSIBILITY ...11 Disassembling the Vitalograph Gold Standard ...11 REPLACING PARTS ...12 Carrier-Start Micro Switch (31005SPR) ...12 Carrier - Limit switches (31005SPR)...12 Chart carrier (78860SPR) ...13 Power switch (311235SPR) ...13 Carrier control switch (311234SPR) ...13 Chart carrier motor (78098SPR) ...14 PCB removal/replacement (78002SPR) ...14 Fuse ...15 Bellows removal/replacement (20647SPR) ...15 GOLD STANDARD PLUS...17 INTRODUCTION...18 Principle Of Operation...18 ACCURACY CHECK/CALIBRATION ADJUSTMENT ...19 Recommended Procedure...19 FUNCTIONAL CHECK ...21 INSTRUMENT ACCESSIBILITY ...22 REPLACING PARTS ...23 Main PCB (81002SPR) ...23 BIOS Prom...23 Software...23 Installation: ...23 Run Sequence:...24 Programming Units With Their Serial Numbers:...24 Resetting Unit...24 LCD Board (2160011)...24 Membrane Keypad (2120008) ...25 Potentiometer (311206SPR)...25 GOLD STANDARD/GOLD STANDARD PLUS ...27 CLEANING AND DISINFECTING...28 General Recommendation...28 Routine Practice...28 Breathing Tubes...28 Table of Materials used & cleaning/disinfection methods...28 ROUTINE ANNUAL SERVICE...29 Training & Qualifications Required To Perform Service Procedure...29 Copyright Vitalograph 1997, 2008

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Service Tools ...29 PPM Service Kit ...29 Service Procedure ...29 ACCURACY CHECK & MAINTENANCE LOG. ...32 Your Unit's Accuracy Check History Log...32 When to check accuracy? ...32 Maintenance log: ...34 CONSUMABLES, ACCESSORIES & SPARES ...35 Spare parts ...35 Consumables/Accessories ...35 Service Kit ...35 PowerSAFE...36 TECHNICAL SPECIFICATIONS...37 APPENDIX A: CIRCUIT DIAGRAMS...38 APPENDIX B: FUNCTIONAL BLOCK DIAGRAM ...41 APPENDIX C: FAULT FINDING GUIDE...42 Wiring loom ...45

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GOLD STANDARD

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INTRODUCTION The Vitalograph Gold Standard is a simple dry wedge bellows type spirometer for the diagnosis and assessment of pulmonary function, certified to meet IEC601-1 safety standards and ATS 1994 Spirometry Standards in all respects: accuracy, performance, back pressure, minimum detectable flow rate and test duration. The Vitalograph Gold Standard also complies with all other major spirometry standards: ERS93; BTS and OSHA. This Service Manual should be used in conjunction with the Vitalograph gold Standard User Manual (081003), and is intended for use by suitably trained/qualified technicians only. ESD and Health and Safety precautions are to be observed when working on this equipment. For further assistance, or to find the address of your approved Vitalograph Service Centre, please contact Vitalograph at one of the addresses given in CUSTOMER SERVICE at the rear of this manual.

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SYSTEM CONFIGURATION Principle Of Operation The measurement of gas volume is accurately performed by means of a calibrated wedge-shaped bellows that opens as air enters it. Air is expired into the bellows (2) via a breathing tube (1). As the bellows expands to accommodate this air it moves the stylus arm (3) relative to a Vitalogram chart positioned on the chart carrier (4). This arm describes an arc proportional to the volume of air in the bellows which is translated via an attached stylus to a tracing on the Vitalogram chart. During dynamic tests (FVC) the chart carrier moves across the stylus thus giving a tracing of volume against time.

Fig. 1: Side view of the Gold Standard

The Vitalograph Gold Standard MUST be used with the purpose built low voltage PowerSAFE unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the PowerSAFE is 10 volts DC. There is no high voltage inside the Vitalograph Gold Standard. The jackplug from the PowerSAFE connects into the socket on the rear of the Vitalograph Gold Standard. The IEC connector on the mains lead plugs into the socket on the PowerSAFE. Plug the mains plug into a suitable socket. The unit is switched on by the rocker-type illuminated switch which is located on the front left hand side of the unit. This switch must be pressed to I to switch the unit on. Pressing it to O turns the unit off.

Fig. 2: System configuration of Vitalograph Gold Standard. Dynamic tests cannot be performed unless the unit is connected to a power supply. if the power supply is not connected to the unit then the chart carrier will not move horizontally across as the bellows inflates and a volumetime curve cannot be traced. For a description on how to operate the spirometer, the User Manual(s) should be consulted.

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ACCURACY CHECK/CALIBRATION ADJUSTMENT An accuracy check should be performed as required by your own quality control procedures and the calibration should be certified (traceable to international standards) annually. Most spirometry standards recommend checking accuracy ‘at least daily’. Accuracy should also be verified after Cleaning/Disinfecting or any other Disassembly/Re-assembly of the Vitalograph Gold Standard. The accuracy check routine allows the user to simply check and validate the accuracy of the spirometer. In the unlikely event that the spirometer is reading outside it’s precision tolerance, first re-check the procedure, spirometer and syringe before considering adjusting the calibration setting. The Gold Standard is calibrated when it leaves the factory and it has a unique facility which enables accuracy checks and calibration adjustments to be carried out quite simply, without recourse to complex apparatus or equipment. To perform the accuracy check/ adjust calibration, a precision 1 L syringe (Cat No. 20.408, as illustrated in the diagram in No.3) is required. Alternatively a 3-L syringe (Cat No 36020) may be used but this is not recommended as the linearity will only then be checked at 3L and 6L instead of every L position.

Recommended 1-L Syringe Procedure 1.

Ensure the precision syringe and the Gold Standard are at the same temperature (±2°C).

2.

Connect the 1 L precision syringe to the spirometer via the breathing tube, making sure all connections are airtight (Fig. 3).

3.

Insert a Vitalogram and set the stylus onto the “STYLUS START” line, (not the zero line). Also manually line up the chart carrier so that the stylus is positioned on the ATPS scale in the centre of the Vitalogram.

4.

Ensure that the RECORD switch is in the centre (cal) position.

5.

Fill the syringe by withdrawing the piston to its limit (Fig. 4).

6.

Discharge the syringe into the spirometer, pushing the piston steadily to maintain a steady flow of air (typically 1 L/s). Ensure that the piston travels fully to the end stop, but do not use excessive force (Fig. 5).

7.

Mark the stylus position on the ATPS scale by gently tapping the side of the stylus head. Repeat steps 4, 5 and 6, litre by litre until full scale deflection is achieved. Repeat the test procedure to verify readings, especially after making calibration adjustments.

8.

On the ATPS scale there is a shaded area on either side of the litre graduation. This area corresponds to the allowed errors. If the stylus has marked the ATPS scale within this shaded area for all litre increments then the accuracy check is complete and no adjustment is necessary. If however it has moved outside the shaded area for one or more of the 1 L increments then the calibration has to be adjusted.

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Fig.4

Fig. 5

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This is achieved as follows: Remove the top cover. Primary Adjustment Adjustment can be set and controlled by the graduated scale and pointer provided. If, when the litre by litre test is carried out, the readings all show positive errors increasing with each litre, i.e. over-reading, then the bellows should be moved back. When the most favorable position has been established, the two clamping screws should be tightened.

Fig. 6

Secondary Adjustment The SECONDARY or fine adjustment is effected by means of a series of Hexagon Key (Allen) set screws. An Allen Key is supplied with every spirometer for this purpose and is stored internally (see diagram). Each screw controls the setting at each successive litre position, starting at No. 1. DO NOT alter the setting of the No. 0 screw. Turning the screws clockwise will increase the reading, anticlockwise will reduce it. The screws are self locking. It is preferable to make an adjustment and then repeat the litre by litre procedure, as previously described, to check the new setting before proceeding to the next position. It is important to ensure that the contour formed by the ends of the adjusting screws do not depart markedly from a continuous, smooth curve. If the calibration cannot be brought within the specified limits without producing excessive discontinuities (a ‘notchy’ tracing may result), then it may be necessary to adjust the PRIMARY setting as described above.

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FUNCTIONAL CHECK It is recommended that the following functional check be carried out on the Vitalograph Gold Standard on a regular basis: • • • • • • • • •

Check Breathing tube for damage. Check inlet connector for damage, and sit of breathing tube. Check the Chart carrier for smooth travel and surface damage Check Switch operation and Carrier Return Check Stylus writes evenly and clearly, without excessive pressure Check Start of carrier travel – in Record mode, carrier should only trigger after exhalation has begun, and with 40 ml Check for Leaks in Breathing Tube and Bellows Perform an Accuracy Check procedure. Perform an FVC test and check values

Refer to Appendix C, Fault Finding Guide, if difficulties are experienced with any of the above checks

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INSTRUMENT ACCESSIBILITY The Vitalograph Gold Standard is dismantled and re-assembled as shown in the diagrams below.

Disassembling the Vitalograph Gold Standard To remove the top cover (Fig. 8) of the Vitalograph Gold Standard unit:

1.

Slacken the three plastic screws at the rear.

2.

Tilt the cover towards the front of the unit and lift clear of the two locating screws that are positioned at the front of the top cover.

Fig. 8

3.

The removal of the top cover gives sufficient access for most servicing operations. However for work on the potentiometer and the chart carrier motor, either or both side panels can be removed by undoing the two external screws and one internal nut from each panel, as shown in Fig. 9.

Fig. 9

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REPLACING PARTS Carrier-Start Micro Switch (31005SPR) The carrier-start micro switch is adjusted when the sensitivity thumbscrew located under the base is adjusted. By turning the unit on its side and referring to the label it can be seen that rotating the thumbscrew in a clockwise direction raises the micro switch while rotating it anti-clockwise will lower the micro switch. The micro switch is mounted onto a phosphor bronze spring clip. It is located by means of two screws at its base. A moulded plastic cover (20110SPR) is fitted to the switch. To remove and/or replace the micro switch the following steps should be undertaken: 1.

Remove both screws attaching the spring clip to the base.

2.

Lift the spring clip with the attached micro switch slightly from the base.

3.

Remove both fixing screws from the micro switch.

4.

Remove the micro switch complete with the moulded plastic cover from the spring clip.

5.

Slide the plastic cover down the wires to expose the wire ends.

6.

Disconnect both wires from the micro switch using a soldering iron.

7.

To install a new micro switch reverse the above procedure remembering that the orange wire goes to the back of the micro switch and the black wire goes to the front. Care must also be taken not to over-tighten the fixing screws as they may damage the switch.

Fig. 10

Carrier - Limit switches (31005SPR) The limit switch is very similar to the micro switch except the upper fixing screw of each switch operates in a slot that permits rotation (and therefore adjustment) of the switch. The two limit switches are located at either side of the central pivot and are actuated when the stylus tip reaches the extents of travel of the Vitalogram chart. Care should be taken to ensure that the actuating lever on the micro switch does not ‘bottom’ on the switch body. Both switches are identical and removal and/or replacement is achieved in the same fashion as steps 3, 4, 5, 6 and 7 of the section on the micro switch, reconnect as in Fig. 11.

Fig. 11 - The limit switches which are located at the top of the unit as you look in from the back

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Chart carrier (78860SPR) To remove the chart carrier, take out the screws in the carrier rod, then ease the rod from between the end brackets, pulling the carrier towards you; this will disengage the carrier rack from the motor drive pinion. The carrier and rod can then be lifted clear. Withdraw the rod from the carrier.

Fig. 12 - Removal of the chart carrier

Power switch (311235SPR) The power switch is a rocker-type illuminated switch that is connected to the power supply by means of ‘spade connectors’. Before removing and/or replacing the switch it is important that the power supply is disconnected from the back of the unit. Once the power supply is disconnected removal of the switch is made possible by removing the top cover and the left side panel (viewed from the front). The switch has integral spring catches on the underside. These must be depressed whilst pushing out the switch from the panel. To replace, simply push the new switch into place. The underside of the power switch is shown in Fig. 13.

Fig. 13 When replacing a power switch it is important to connect it using the following connections. Terminal 1A

connected to red loom wire

Terminal 2A

connected to red/black loom wire

Terminal 4B

connected to blue loom wire

Terminal 5B

connected to grey/blue loom wire

Carrier control switch (311234SPR) The auto-return/recording switch is also a rocker-type switch. It is removed in a similar way to the aforementioned power switch except that the right side panel (viewed from the front) is removed. The underside of the carrier control switch is shown in Fig. 14.

Fig . 14 The wiring arrangement for the switch is given below. Terminal 1A

connected to Red/blue loom wire

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Terminal 2A

connected to violet loom wire

Terminal 3A

connected to black loom wire

Terminal 4B

connected to yellow loom wire

Terminal 5B

connected to black & red/blue loom wires

Terminal 6B

no connection

Chart carrier motor (78098SPR) The chart carrier motor used in the Gold Standard is a reversible synchronous motor, and it's four wires (one pair for each winding) are connected to the main PCB. The motor is screwed onto the motor mounting plate, which in turn is attached to the motor bracket with nuts tightening onto clinch-studs located in the vertical slots on the motor mounting plate. To remove the motor the following procedure should be adhered to; 1.

Disconnect the motor connector from the PCB.

2.

Remove the two nuts and washers from the studs in the motor slots. (Note: these are the upper pair that attaches the motor mounting plate to the motor bracket. The second pair that are located in the recess of the motor body which the motor to the mounting plate.)

3.

Withdraw the motor/bracket assembly, tilting it slightly downwards as it clears the studs.

4.

The motor is then removed from the motor mounting bracket by removing the brass pinion from the front of the motor.

5.

Replacement of the motor is achieved by reversing the above procedure with the associated wires plugging into the PCB.

In addition to being able to remove and/or replace the motor, it is also possible to adjust the motor height and thereby control the volume-axis geometry of the spirometer. To check for correct motor height the following procedure is recommended; Position a Vitalogram in the chart carrier Adjust the stylus contact to give a tracing over the full travel on the volume-axis by pulling out the stylus arm manually. Observe the space between the cap on the top of the moving pin of the stylus and the threaded, adjustable holder. If, over its operating arc of travel, this gap varies by more than 2mm, motor height adjustment is required. This is achieved by slackening the two nuts (the same nuts as are undone for motor removal) and sliding the complete assembly up or down in the slots (Fig. 15) . If the gap increases as the volume position increases, the motor must be lowered. The converse also applies.

Fig. 15

PCB removal/replacement (78002SPR) Access to the main PCB is achieved by removing the top cover. Once this is done the PCB is removed by first unplugging all of the connectors going into it and then removing the nuts, one at either corner. The PCB will then slip straight out. To Insert a new PCB the reverse applies. Copyright Vitalograph 1997, 2008

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On the bottom right hand corner of the PCB as you look at it there is a 10 way dip switch. This switch controls the frequency supplied to the chart carrier motor which in turn controls the speed at which the chart carrier moves. The Crouzet motor used in the Gold Standard operates at a frequency of 224 Hz and switches' numbers. 1, 4, 6 and 8 should be set to ‘OFF’ while all the others should remain ‘ON’ for this motor to function properly.

Fuse A one amp fuse is used to protect the internal circuits and equipment of the Gold Standard. The fuse is located at the back of the unit under the power input and can be accessed using a coin to open the holder.

Bellows removal/replacement (20647SPR) The bellows used in the Gold Standard can be easily replaced. It is recommended that after twelve months of continuous use the bellows be replaced following the procedure outlined below.

Fig 16 Bellows and Graduated Scale To remove the bellows/support plate assembly, the following procedure is suggested:Pull out the stylus arm to its fullest extent and trap in this position by looping a strong elastic band around the carrying handle and the stylus head. Remove the 2 adjustment screws from the rear edge of the Bellows Support Plate. Slide rearwards the complete assembly, lifting gradually the rear edge of the support plate whilst withdrawing the bellows neck from under the edge of the platform, lift the assembly clear of the machine.

Fig 17 Bellow/Bellows Support Plate Removal.

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Remove the existing part from the Bellows Support Plate by removing the 2 nuts at the neck, and the 2 clips from the rear edge. When refitting, position the Bellows Neck first, over the 2 protruding studs in the Support Plate. Fit and tighten the nuts and then replace the clips at the rear edge. Do not over tighten the nuts on the bellows neck. CAUTION: When fittings the clips do not trap moving segments, clamp only on the thicker base section of the Bellows. To replace the bellows/bellows support plate apply a small amount of silicone grease to the inside of the bellows neck tube. The bellows can then be returned to the instrument by reversing the removal procedure described, taking care to clamp the bellows squarely and in exactly the same position.

Fig 18 Applying Vacuum Grease to the Bellows Neck Check the accuracy and adjust, if required, the calibration as described under Accuracy Check/Calibration Adjustment section. Replace the Top Cover.

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GOLD STANDARD PLUS

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INTRODUCTION The Vitalograph Gold Standard Plus consists of the Vitalograph Gold Standard plus demographic/test storage facilities, a display screen and its associated electronics. The Gold Standard Plus provides all of the features offered by the Gold Standard plus additional features: • • • • • • • •

Database of subject information. Calculates the pre-post percentage change for FVC and VC tests. Compares measured results against predicted values. Test results are time and date stamped. Stores the results of at least 100 tests. Audible incentive. Facility to connect to a printer to obtain a permanent hard copy of all subject data. Facility to connect to a PC to download data to a subject database for trending and other analysis, or to obtain real time FV graphs, or to upload subject demographic data from PC to Gold Standard Plus.

Principle Of Operation The Gold Standard Plus consists of the Gold Standard plus additional circuitry and its principle of operation is an extension of the Gold Standard. In the body of the Gold Standard Plus there is a sensor in the form of a potentiometer attached to the bellows frame. A shaft from the potentiometer links the two and as the bellows inflates and moves the A-frame, the shaft in the potentiometer rotates. This rotation of the shaft brings about a changing voltage output from the potentiometer. The voltage change is a function of the bellows inflation and therefore proportional to the volume of air exhaled by the subject. The rate of voltage change is used to determine the flow. The digital signals from the A/D are monitored and analysed by the software, which is controlled by a 80C652 microprocessor. Results are calculated and displayed on a 4 x 20 character LCD.

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ACCURACY CHECK/CALIBRATION ADJUSTMENT The accuracy check routine allows the user to check, and adjust if necessary, the calibration of the electronics of the instrument. The calibration setting is retained in the device memory until altered again, even when the spirometer is switched off. To perform the accuracy check a 1 L precision syringe is required (as in section 3). Before checking accuracy, the Gold Standard Plus and the syringe should be at the same ambient room temperature. Note: if the Gold Standard Plus has just been programmed with new software, an initial calibration setting will need to be made for accurate measurements. This also will ensure that the calibration log on Spirotrac IV will not contain a date of 00/00/00 for a Calibration Update date.

Recommended Procedure The procedure for checking accuracy of the bellows/chart is outlined in the Gold Standard section of the service manual. In addition to the aforementioned procedure the following steps should be taken to set the calibration of the electronics. Before beginning, the Gold Standard Plus should be switched on and the main menu displayed. This menu will look something like: >

PAT I ENT TEST PR I NT POS T

DELETE SETUP V I EW CAL I B

Note: Ensure that the correct printer type is selected in the Setup option. Using the up arrow press once to move down to CALIB. Press the ↵ button. The next screen will look like: Se t

Am b i e n t

T emp .

T emp : 2 3 º C< P r e s s ↵ t o Co n t i n u e Use the up and down arrow buttons to select the ambient temperature and press the ↵ button to enter it. L a s t Ca l I b r a t I o n . u p d a t e 1 2 / 1 0 / 9 6 ↵=Co n t i n u e

ESC=E x i t

This screen shows when the unit was last calibrated. Press the ↵ button to continue. Se t S t y l u s S t y l u s S t a r t P r e s s

↵

=

t o . l i n e

Co n t i n u e

Set the stylus to the start line on the ATPS scale and press the ↵ button. You will then be requested to inject 1 litre into the bellows. It is advisable to pump at a rate of approximately 1 L/sec.

I n j e c t 1 l i t r e I n t o Be l l ows

While pumping into the bellows the screen will show that it is busy by displaying:

Me a s u r i n g . . .

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After pumping the screen will display how many pumps have occurred, what the reference volume is and what the actual measured volume is. Cy c l e s Re f : 1 . 0 0 Re p e a t ESC t o

1 of 7 Me a s : 0 . 9 9 P ump i n g Re s t a r t

The user then has the choice to either pump more air into the bellows or to restart the process. It is advisable to continue testing up to the maximum of 7 litres to ensure linearity over the entire range of the instrument. If you are going to continue, fill the syringe again and discharge the air into the bellows. The screen will then be updated to show the new number of cycles along with the new reference and measured volumes. Once you have finished the procedure the Gold Standard Plus will calculate the calibration error by comparing the reference volume with the measured volume. After this has finished the next screen that you will see is: P r o c e s s C omp l e t e Do y o u w i s h t o Au t o c o r r e c t ? ESC=No ↵=Ye s Press the ↵ button if you wish to update calibration. This is only necessary if the error at any of the litre increments is greater than 3%. If the instrument is accurate (less than 3% deviation from the reference volumes) it is important NOT to adjust the calibration. You will then be offered the chance to print a calibration report to have a permanent hard copy. Ensure that the printer is attached and on line. P r i n t Ca l i b r a t i o n ↵=Ye s

Re p o r t

ESC=No

You will finally be asked if you wish to recheck the accuracy.

Re c h e c k ↵=Ye s

A c c u r a c y ? ESC=No

At this screen press the ESC button to exit from the calibration process or the ↵ button to start the process again.

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