SECTION

C HAPT ER

Performance verification 5 5
Conduct the performance verification to check the performance of the 840 Ventilator
System. Field performance verification testing includes electrical safety tests, the extended
self test (EST), plus specific performance verification tests, using the Puritan Bennett PTS 2000
Performance Test System with 840 VTS software. A manual ventilator check can be performed
to check general ventilator performance.

NOTE:
Performance verification procedures do not apply to ventilator accessories. Refer
to the specific accessory operator’s or service manual for performance verification
information. Malfunctioning accessories may affect some ventilator functions and
may result in false test results.

5.1 Tools, test equipment, and service materials

In addition to the standard set of tools listed in Chapter 1 of this manual, the test
equipment and materials listed in Table 5-1 are required for performance verification
procedures. Specific parts required for conducting the performance verification,
using the PTS 2000 Performance Test System with BreathLab® 840 Ventilator Test
Software (VTS), are indicated with “X” in the third column.

5.2 When to run

Run the entire performance verification after servicing or repairing the ventilator. The left-
hand column of Table 5-2 lists the types of service activity that require performance
verification. In addition, run the electrical safety tests, which are part of the performance
verification, in accordance with your hospital’s requirements.

Table 5-1: Tools, equipment, and service materials required for

performance verification

Manufacturer/model or Required for

Description Puritan Bennett PTS 2000
part number use?

840 VTS (Ventilator Test Software) 4-075359-00 and X

current revision Software
Download CD-ROM

Adapter, patient pressure (“T” connector) *4-011521-00 X

Cable, trigger *4-075360-00 X

Cable, null modem *4-075361-00 X

* These parts may be purchased individually or by ordering an 840 VTS Accessories Kit, P/N 4-076599-00.

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5 Performance verification

Table 5-1: Tools, equipment, and service materials required for

performance verification (continued)

Manufacturer/model or Required for

Description Puritan Bennett PTS 2000
part number use?

Collector vial 4-074647-00 X

Connector, barbed *4-000845-00 X

Coupling, barbed connector (qty. 2) *4-003443-00 X

Digital multimeter (DMM) accurate to 3 decimal places, with test Fluke Model 87 or equivalent
leads

Digital multimeter patch cords (optional) G-061567-00

Disinfectant/cleaner See Table 1-10 for acceptable

products.

Double banana jack for ground isolation test Pomona Electronics,

P/N 1330-2

Electrical safety analyzer capable of measuring ground resistance and Dale Model 600, Dale
leakage current Technology Inc., P.O. Box 196,
401 Claremont Ave.,
Thornwood, NY 10594 USA,
800.544.3253
http://www.daletech.com/
or equivalent

Exhalation port test hose assembly *4-076704-00 X

(use directly on ventilators with Metabolic Monitor port on exhalation
housing, otherwise use no. 5.5 stopper with adapter in exhaust port)

Filter, expiratory bacteria filter DAR 351P19005

Filter, expiratory bacteria filter, reusable (Re/X800) 4-070305-00 X

Filter, inspiratory, Re/Flex (for use on PTS 2000 tester port) 4-074600-00 X

Finger cots or gloves Local supplier

Fitting, Luer, bulkhead *4-012470-00

Flex tube (Gold standard tube), 21.0 in. (53.4 cm) (quantity = 2) *4-018506-00 X

Hose, regulator calibration (refer to Section 5.8 for regulator *4-079050-00 (quick X
calibration hose repair instructions) disconnect) (4-079050-00
4-079051-00 (female) only)

Luer fitting, female Local supplier X

Mounting plate, NeoMode 4-076405-00

Patient circuit, adult (reusable, without water traps or heated wire) *N-4401008 X
(quantity = 2)

Patient circuit, pediatric (reusable, without traps or heated wire) G-061223-00

Patient circuit, neonatal (disposable) Allegiance Healthcare

PN 7441-452

* These parts may be purchased individually or by ordering an 840 VTS Accessories Kit, P/N 4-076599-00.

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Performance verification 5
Table 5-1: Tools, equipment, and service materials required for
performance verification (continued)

Manufacturer/model or Required for

Description Puritan Bennett PTS 2000
part number use?

Pentium 166 Mhz computer, equipped, at a minimum, with the Local supplier X
following:
• 32 MB RAM (64 MB for NT systems)
• 800x600 screen display resolution with 256 colors
• Two available serial ports or USB/serial adapters
• Windows® 95, 98, 2000, XP or NT 4.0 operating system
• Mouse or equivalent pointer device
• 2x or higher CD-ROM drive
• 1 Gigabyte available hard disk space
• One available TCP/IP network port with BNC connector (if software
download desired)

Pneumatic calibration analyzer or equivalent devices capable of Puritan Bennett PTS 2000 X
measuring oxygen percent, flow, BTPS volume, pressure, and Performance Test System (also requires
barometric pressure. Oxygen analyzer connector tee. Required (4-074686-00) (includes 840 VTS
accuracies: accessory kit with serial cable) software)
• Flow: 2.75% of reading ± 0.05 slpm for performance verification; or
• Volume: 2% of reading or ± 1 digit equivalent device for manual
• Low pressure (-150 to +150 cmH2O): ventilator check
0.75% of reading ± 0.04 cmH2O
• High pressure (0 to 150 psig): 1.0% of reading ±0.1 psi
• Oxygen percentage: ± 2% oxygen
• Barometric pressure: Range: 10 to 16 psia; resolution: 0.0 to 1 psia;
operating temperature: 10 to 40 °C; measurement accuracy:
± 0.75 of reading; response: ≤ 100 ms

Resistor for ground isolation test, 1K ± 1% Allied Electronics,

P/N 697-3356 or equivalent

Serial Card, Socket I/O Ruggedized or equivalent (Provides second Socket Communications Corp.
serial port) Newark, CA
http://www.socketcom.com/

Static-dissipative field service kit (includes wrist strap, static dissipative 4-018149-00
mat, and earth (ground) cord)

Stoppers, no. 1, 5, and 5.5 Local supplier X

(with center bore and luer fitting: 4-071856-00)

Stopper, no. 1 (quantity = 1) *4-009523-00

Stopper, no. 5 *4-076828-00 X

Stopper, no. 5.5 with center bore and 4-076467-00

Fitting, luer, bulkhead 4-012470-00

Test lung, 0.5 L 4-000612-00 X

Test lung, 3 L N-3800006 X

Test lung, 4 L 4-075578-00 X

Tubing, silicone, 3/16 in. ID x 5/16 in. OD, 36 in. (91.4 cm) 4-008577-00 X

Tubing, silicone, 1/8 in. ID x 1/4 in. OD, 4.75 in. (12.1 cm) *4-008578-00 X

* These parts may be purchased individually or by ordering an 840 VTS Accessories Kit, P/N 4-076599-00.

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5 Performance verification

Table 5-1: Tools, equipment, and service materials required for

performance verification (continued)

Manufacturer/model or Required for

Description Puritan Bennett PTS 2000
part number use?

Vacuum cleaner, ESD-safe, with 0.2 µm filter (rated for photocopiers Local supplier
and laser printers)

Wye, patient circuit *4-000338-00 X

* These parts may be purchased individually or by ordering an 840 VTS Accessories Kit, P/N 4-076599-00.

5.3 Preliminary ventilator cleaning and inspection

Clean and inspect the ventilator as follows:

Warning
To prevent disease transmission, use personal protective equipment when handling
contaminated bacterial filters or other patient accessories. Refer to the 840 Ventilator System
Operator’s and Technical Reference Manual for instructions on sterilizing patient system parts.

Caution
Do not soak any portion of the ventilator in solvent, alcohol, or any other cleaning agent.
Soaking ventilator components may damage the ventilator.

1 Clean ventilator exterior using an approved cleaner/disinfectant.

2 Remove any water from humidifier jar and collector vial; dry. Reattach collector vial.
3 Inspect air and external water trap assemblies. Clean or replace as required.
4 Visually inspect ventilator exterior for obvious problems such as missing or broken parts;
loose assemblies; or disconnected wires, connectors, or tubing. Repair as needed.

5.4 Preliminary ventilator setup

NOTE:
A humidification device is not necessary for performance verification, but is
required for completion of SST.

Set up the ventilator for performance verification as follows:

1 Install expiratory filter and collector vial.
2 Connect ventilator to air and oxygen sources (35 to 100 psi).
3 Connect ventilator power cord to AC power source.
4 Make sure BPS is securely attached and connected.
5 If ventilator is equipped with optional compressor, verify all electrical and pneumatic
connections with BDU.

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Performance verification 5
5.5 Preliminary calibrations and tests
Before running the performance verification tests, perform the applicable calibrations and
tests in Table 5-2. The numbers in the columns indicate the sequence in which the
calibrations/tests must be performed.

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5 Performance verification

Table 5-2: Pre-performance verification testing and calibration requirements

verification testing (PVT)

Extended self test (EST)
transducer calibration
Atmospheric pressure

Oxygen sensor (OS)

Short self test (SST)
Ventilator warm-up
Test or calibration

Compact flash test

Expiratory valve

Vent inop test

Performance
Flow sensor
calibration

calibration

calibration
Download
Software
cycle1
Type of service

Ventilator installation 1 -- 2 3 4 5 6 7 8 -- 92

Software update 1 2 3 4 5 6 7 8 9 -- --3

Data key update/option -- -- -- -- -- -- -- 24 -- 15 --

installation without software
download

10,000-hour preventive 1 -- 2 3 4 5 6 7 8 -- 9
maintenance (ventilator or
compressor)

Oxygen sensor 1 -- -- -- -- 3 -- 4 2 -- --

PSOL1, PSOL2, flow sensors, 1 -- 2 3 4 5 6 7 8 -- 9

expiratory valve, safety valve,
SOL1, SOL2, AI PCB, inspiratory
electronics PCB, exhalation
transducer PCB, regulators,
power supply, alarms,
motherboard, all blindmate
cables, BDU and GUI LED PCBs,
touchframe PCB, LCD panels

Compressor 15,000 hour -- -- -- -- -- 1 -- -- -- -- 26

preventative maintenance

Compressor, compressor PCB, -- -- -- -- -- 1 -- -- -- 25 --

keyboard assembly, VGA LCD
controller PCB, backlight inverter
PCB, BPS PCB, battery pack, GUI
cable, compact flash

BD CPU PCB or GUI CPU PCB 1 2 3 4 5 6 7 8 9 -- 10

replacement

6 month ventilator check 1 -- -- -- -- 2 -- -- -- -- --

Yearly ventilator check 1 -- 2 3 4 5 6 7 8 -- --

1. Warm-up must be done in the service mode.

2. Perform the electrical safety test only.
3. Performance verification testing (PVT) is not required for simple software updates, provided all of the following conditions exist:
The ventilator passes the Extended Self Test before the software is updated.
The reason for service is software update or software option installation only.
There are no events or entries in the ventilator’s diagnostic logs that indicate a need for hardware repair.
No functional hardware repairs are conducted or required during the software update service call.
Unless the ventilator meets all of these requirements, PVT must be performed following the repair.
4. NeoMode only.
5. Perform Compact Flash Test only if Trending software option is installed or if compact flash component replaced.
6. Perform EST and electrical safety testing only.

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Performance verification 5
5.6 Performance verification guidelines

NOTE:
To ensure that the ventilator performs within specifications, Puritan Bennett
recommends that you use the Puritan Bennett PTS 2000 Performance Test System
in conjunction with the BreathLab 840 Verification Test Software. If this
equipment is not available, you can use an alternative test that checks some
parameters but does not guarantee the integrity of the entire system. Refer to
Table 5-3 to determine the approximate test limits if you use equipment other
than the PTS 2000 Performance Test System.

To ensure systematic performance verification and logical fault diagnosis, perform tests in the
order given. Follow these general guidelines when running the performance verification:

Warning
Follow accepted safety procedures for electrical equipment when making connections,
adjustments, or repairs.

• If a problem is encountered during the performance verification, verify that procedures

have been correctly followed before attempting to repair the ventilator.
• Do not change the control settings during performance verification procedures, unless
specifically instructed.
• Malfunctions detected during performance verification must be corrected before the unit
is returned to service. Refer to Chapter 8 for required repairs. When repairs are completed,
repeat the performance verification tests.

5.7 Performance verification tests

Run the following performance verification tests in the sequence given. Before performing these
tests, be sure you have cleaned and inspected the ventilator (Section 5.3).

Warning
Do not enter the service mode while a patient or other person is connected to the ventilator.
To do so may cause patient injury or death. While in the service mode, normal ventilator
operation is not accessible.

NOTE:
The procedures that follow do not verify the performance of accessories. Verify the
performance of accessories using the appropriate procedures in the applicable
operator’s or service manual.

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5 Performance verification

5.7.1 Electrical safety test

The electrical safety test verifies ground continuity and verifies that forward leakage current
are within safe limits. Perform this test whenever the ventilator is serviced and in accordance
with hospital requirements.

Warning
If the ventilator fails an electrical safety test, do not proceed to the next electrical safety test
until the problem is corrected and the ventilator is retested.

Caution
To prevent possible equipment damage, do not attempt to perform HI-POT testing on the
ventilator. The ventilator design incorporates high-voltage protective devices that may be
damaged if HI-POT testing is performed on the entire system. The ventilator is HI-POT-
tested during manufacturing, using processes that do not damage the protective devices.

NOTE:
• After servicing the ventilator, perform an electrical safety test before putting the
unit back into operation.
• Before performing the electrical safety test, make sure the compressor unit (if
installed) and all accessories are connected and operational.

1 Verify that ventilator power switch is off.

2 Verify that ground resistance is < 0.1 Ω. If performing full performance verification
testing, record this value for later entry when prompted by the Breathlab 840 VTS
software program (Section 5.7.6).
3 Turn on ventilator.
4 If ventilator has a compressor unit installed, disconnect external air supply from
ventilator and verify that pressure from hose has been relieved.
5 Verify that compressor unit (if applicable) is running. Failure to do so will produce an
inaccurate total leakage current reading.
6 Verify that forward-current and reverse-current leakage to earth ground is ≤ 300 µA
(100 – 120 V AC) or ≤ 500 µA (220 – 240 V AC). If performing full performance
verification testing, record these values for later entry when prompted by the Breathlab
840 VTS software program (Section 5.7.6).
7 Turn off ventilator.
8 Reattach external air supply, if applicable.

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Performance verification 5
5.7.2 Ground isolation check
This check verifies that the digital ground has not been disrupted. It requires a DMM, test
leads, and a 1K resistor placed in parallel between the leads.
1 With the ventilator power cord disconnected from AC and the ventilator turned off:
Set the DMM to the appropriate resistance range (or to autorange if available) and verify
that the resistance between pin 3 of the PTS 2000 tester port on the side of the ventilator
(Figure 5-1) and the ventilator chassis (at the power supply cooling fins) is > 975Ω.
PTS 2000

pin 3

Figure 5-1. 840 ventilator side view — PTS 2000 port

2 Disconnect DMM test leads and resistor.

5.7.3 Extended self test (EST)

NOTE:
• A test (gold standard) patient circuit and a no. 1 stopper are required to perform EST.
• The nurse’s call circuit is tested during EST and may be bypassed by selecting the CLEAR
button.
• If the ventilator has not reached operating temperature from recent usage, allow it to
warm up for at least 10 minutes in service mode before running EST, to ensure accurate
testing.

1 Enter service mode. (Refer to Section 3.2 for instructions.)

2 On lower screen, select EST, and follow prompts to being testing.
The test currently running is highlighted, and any measurement data is displayed on the
upper screen. (This information may also be viewed later by pressing the individual test
button to repopulate the upper screen with the data parameters.) All lower and upper
screen select buttons and the EST subscreen TEST SELECT buttons are hidden. The date/
time and outcome are shown only for tests that have already run.

NOTE:
During testing, it is sometimes necessary for the user to perform test-related tasks,
such as disconnecting a gas supply or blocking the To Patient port. For each such
step, messages are displayed in the prompt area.

3 Verify that EST completes all tests with a PASS result. Performance verification is not
complete if any EST test results in an ALERT, OVERRIDE, or FAILURE. If a test fails, refer
to Chapter 8 for repair information. You will enter the results of EST when prompted by
the Breathlab 840 VTS software (Section 5.7.6)

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5 Performance verification

5.7.4 Regulator setting verification

Caution
To prevent damage to ESD-sensitive components, always follow ESD guidelines when
performing this procedure.

NOTE:
Regulator performance must be verified each time performance verification or a
manual ventilator check is performed. Use the appropriate type of regulator
calibration hose (see Table 5-1).

1 Remove inspiratory cover from BDU.

2 Attach appropriate regulator calibration hose to pneumatic analyzer, and verify that
analyzer does not register pressure.
3 Remove air side test port cover and set aside. Attach hose to test port. Verify that
analyzer reads 10.5 ± 1.5 psi. If performing full performance verification testing, record
your measurement for later entry when prompted by the Breathlab 840 VTS software
program (Section 5.7.6).
4 Remove hose from test port, and verify that analyzer does not register pressure. Replace
test port cover.
5 Repeat steps 3 and 4 for oxygen side.

NOTE:
If regulators are out of specification, refer to Chapter 8 for service and repair of the
inspiratory module.

5.7.5 Serial loopback test (10.4-inch GUI only)

A serial loop back test can be accessed through the service mode other screen function. This
test is only required when performing PVT on a 10.4-inch GUI.
1 Connect a null modem cable between the two top serial ports.
2 Follow the on-screen test prompts. If performing full performance verification testing,
you will enter the result of the serial loopback test when prompted by the Breathlab 840
VTS software (Section 5.7.6).

5.7.6 Performance verification using PTS 2000 Performance Test System and
BreathLab 840 VTS software

NOTE:
If performing full performance verification testing, use the results recorded from the
previous performance verification tests to complete this step of Performance Verification
Testing.

1 Assemble test equipment indicated in Table 5-1. Refer to Figure 5-4 and Figure 5-5 for
equipment setup information. (Software installation instructions are provided with
BreathLab 840 VTS Software.)
2 Turn on computer, and bring up the VTS program.
3 Turn ventilator on, and bring up in service mode.

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Performance verification 5
4 Using ventilator test program, press START TEST to begin test application.
5 Follow prompts displayed on computer screen to complete performance verification
Access the 840 VTS Software Help Screen for additional information.

5.7.6.1 How to view the test results log

After you have finished the performance verification tests, you can view and print the test
logs.
1 In the VTS software test screen, click the reports icon (Figure 5-2).

Reports icon

Figure 5-2. How to access the test logs

The report selection menu appears (Figure 5-3).

Figure 5-3. Report selection menu

2 Click the desired report button and then click to view a test results log or to
cancel. The test results log appears in a text document to save and print as desired.

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5 Performance verification

To Patient Port Bacteria filter to high

flow port with tube
connection to
+ low pressure port
Gold
840 BDU standard
tubing PTS
2000

From Patient Port

INITIAL PVT TEST SETUP

Use for most tests 0.5-L lung

Use for 600 mL and 2500 mL only 3-L lung

Use for PCV tests only 4-L lung

SWITCH TO THIS SETUP AT THE PVT
VOLUME TEST WHEN PROMPTED TO RUN SST

To Patient
To Patient Port
Port
PTS2000
PTS
840 840
BDUBDU
Adult
Patient
2000

Circuit
Insert cork into high flow exhaust
From Patient port during SST. After SST, attach

Port
From Patient Port lungs here.

Figure 5-4. 840 ventilator PVT setup with PTS 2000

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Performance verification 5

GUI

GUI cable
Null modem cable

Port 1

PTS 2000 port

840 BDU

Trigger
cable Serial cable
Serial port
COM 1
Trigger RS-232 port
input

Serial port card

LAPTOP COMPUTER COM 2, 3, 4
PTS 2000 must be configured

Figure 5-5. 840 ventilator PVT setup with PTS 2000 and laptop computer

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5 Performance verification

5.7.7 Manual ventilator check using equipment other than PTS 2000
Performance Test System

NOTE:
• To ensure proper ventilator performance, Puritan Bennett recommends that you use the
Puritan Bennett PTS 2000 Performance Test System along with the BreathLab 840 VTS
software.
• If you are using a pneumatic analyzer other than the PTS 2000 Performance Test System,
you must also have an oxygen analyzer available.
• The manual ventilator check (i.e., without PTS 2000 PTS and 840 VTS software) does not
satisfy the manufacturer’s performance testing requirements. The manual ventilator check
can be used as a general indicator of ventilator condition.

1 Before beginning your ventilator check, perform these alarm tests:

a. Verify that remote alarm (nurse’s call) relay is functional by invoking an alarm and
verifying that your nurse’s call system registers appropriate alarm.
b. Verify that the BDU annunciates the “loss of GUI” alarm when GUI is disconnected.
c. Verify that low-, medium-, and high-urgency alarms sound by creating an alarmed
event for each of these. Refer to Operator’s and Technical Reference Manual for
assistance.
2 Measure ventilator parameters, and verify that they meet specifications in Table 5-3.

NOTE:
To accurately measure the parameters listed in Table 5-3, add the tolerance of
your measurement device to the target value of the ventilator. The test results you
obtain are approximate and may not guarantee the accuracy of the ventilator.

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Table 5-3: Manual ventilator check target values

Ventilation parameter Range Accuracy

Volume1 25 to 2500 ml ±10 ml +10% of setting

5 to 315 ml2 ± 4 mL + 10% of setting for

neonatal circuits

Pressure control 5 to 90 cmH2O ±3 +4% of setting3

Pressure support 5 to 70 cmH2O ±3 +4% of setting2

Breath rate 1 to 100 breaths/min ±0.5 breaths/min

Oxygen concentration 21 to 100% O2 ±3%

PEEP 0 to 45 cmH2O ±2 +4% of setting4

Spirometry 0 to 6000 ml ±10 ml +10% of reading

Inspiratory/expiratory pressure -20 to 100 cmH2O ±2 + 4% of reading

BPS 10 to 30 min5 Verified during EST

1. Compliance- and BTPS-compensated where TE = time to exhale 90% of exhaled volume

2. When equipped with NeoMode software and accessories
3. End inspiratory pressure at patient wye after 1 second
4. PEEP measured at patient wye with return flow less than 5 L/min
5. These values are for a new fully charged battery. Actual duration depends on ventilation parameters, battery age, and
level of battery charge.

5.8 Regulator calibration hose repair instructions

This section describes how to repair the quick-disconnect style regulator calibration hose
(P/N 4-079050-00). Refer to Figure 5-6.
1 Grasp the valve depressor with needlenose pliers, and pull out from the end of the brass
regulator fitting together with the silicone seal.
2 Cut a 1/4” piece of silicone tubing (P/N 4-008577-00) and slide it over the new valve
depressor (P/N 4-026790-00) and push the assembly into end of the brass fitting,
ensuring that the seal is flush with the end of the brass fitting.

1/4” silicone tubing Valve depressor Brass regulator fitting

Figure 5-6. Regulator calibration hose repair

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