®

Operation, Calibration,
Maintenance

Version ML3B 2.1

Publication No. 931-00-243

CORTEX. Pioneers in Metabolic Testing.

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Dear User

Welcome to CORTEX Biophysik.

Thank you for purchasing the

“CORTEX Biophysik MetaLyzer® 3B stationary CPX system”

“CORTEX Biophysik MetaSoft® CPX testing software”.

We hope you will enjoy using your MetaLyzer® 3B as much as we enjoyed

developing it for you!

To help us provide the product and service excellence you expect now and in the
future, CORTEX Biophysik welcomes your comments and suggestions.

We look forward to sharing your experience using MetaLyzer® 3B.

Sincerely

Nonnenstrasse 39
04229 Leipzig
Germany
Phone +49 (0)341 48 74 9-0
Fax +49 (0)341 48 74 9-50
email: [email protected]
http://www.cortex-medical.de

2 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Table of Contents
Chapter Page
I. Before you start 5-7
§ Introduction 5
§ Intended use 5
§ Safety regulations 6
§ Interference with other devices 7

II. Technical Data 8-10

III. Figure: MetaLyzer ® 3B Base S ystem 11-12

§ Base System Front View 11
§ Base System Rear View 12

IV. Installation 13-17

§ Connect device to PC/Notebook 13
§ Connect volume transducer 14
§ Connect sample line 14
®
§ Connect Polar receiver cable 15
®
§ Fix Polar receiver cable to bike/treadmill 15
§ Connect bicycle ergometer/treadmill 16
§ Power System 17
§ Create device profile using MS Device Configuration 17

V. Key Operations prior to each test 18-22

P re p a r e s yst em
§ Power system for warm-up 18
§ Check physical connections 18

P re p a r e p at ie n t /t e st sub je ct f o r t he t e st
®
§ Fix Polar heart rate transmitter belt 19
§ Select mask and fix head cap 20
§ Connect volume transducer/sample line to mask 20
§ Fix and adjust mask 21
§ Ready for the test 22

VI. Calibration 23-49

§ General 23
§ Calibration Procedures & Practices Overview 23
§ CORTEX Calibration Kit Parts List 25
§ Steps prior to calibration 28
§ Volume Calibration 29
§ Two-Point Gas Calibration with Calibration Gas Saver 35
§ Two-Point Gas Calibration with automatic Gas Calibrator 41
§ Pressure Calibration 45
§ Print Calibration Reports 47
§ Check Analyzer Function 48
§ Edit Calibration Values 49

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 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Table of Contents
Chapter Page
VII. Maintenance & Cleaning 50-64
§ Cleaning & Maintenance Routines Overview 50
§ Cleaning & Maintenance Instructions 52
- Replace O2 Analyzer 52
- Clean & disinfect face mask 57
- Clean head cap assembly 58
- Clean housing 58
- Clean & disinfect DVT volume transducer 59
®
- Clean & disinfect Triple V volume transducer 61
- Replace sample line 63
- Visual inspection of system & parts prior to next use 63
§ Maintenance of Calibration Equipment 64
- Replace reference gas bottles 64
- Clean & replace tube set 64
- Clean gas saver 64

VIII. Annexes 65-71

§ Troubleshooting Tips 66
§ Certificates of Quality Assurance 69
§ Manufacturer’s Declaration of Conformity 71

IX. Contact CORTEX Biophysik 72

X. Trademarks 73
XI. Disclaimer 73
XII. Personal Notes 74

4 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

I. Before you start

Introduction
This Operator’s Manual refers to
®
MetaLyzer 3B, Firmware Version 2.0
®
MetaSoft , from version 2
®
It is designed to help you getting started performing CPX tests with your new MetaLyzer 3B,
answering basic questions about how to install the system, assemble the parts, prepare your
®
patient / test subject for a test and maintain your MetaLyzer 3B system to obtain maximum
® ®
performance. Your MetaLyzer 3B comes complete with MetaSoft software which is required to
®
measure and evaluate the data recorded. Please refer to your MetaSoft Operator’s Manual for
software instructions. Please contact your local CORTEX sales partner for hotline support and / or
preventive maintenance and service agreements.

Please read the following instructions and safety regulations carefully before first use to obtain the
®
best performance from your MetaLyzer 3B. Keep these instructions in a safe place for future
reference.

Intended use
®
The MetaLyzer 3B is a stationary metabolic stress test system (or CPX system) for pulmonary gas
exchange measurements during ergometer or treadmill exercise. Direct measures of gas exchange
include O2 and CO2 concentration of the expired / inspired air, heart rate, ventilation, ambient
temperature and pressure. In addition, other valuable physiological variables can be obtained (e.g.
AT, VO2max), allowing the physician to completely assess a patient’s or an athlete’s
cardiopulmonary status. This device may be used with adults and children over the age of 14
years.
®
During a CPX test with MetaLyzer 3B, the patient / test subject is wearing a small face mask,
breathing out through a volume transducer fixed to the face mask. The gas samples are collected
while the patient / test subject exercises on an ergometer or treadmill. The optional 3-channel, 5-
lead ECG enables the physician to record the ECG of his/her patient / test subject and to monitor
his / her heart function throughout the test. Selected ECG sequences can be saved for online
display and / or a detailed analysis after the test (Note: The 3-channel ECG option is supported by
MS 2 version from 2.4). In addition, other external diagnostic devices (e.g. ergometers) can be
®
connected and directly controlled via the MetaSoft software.
®
As a breath-by-breath system the MetaLyzer 3B measures volume continuously and
simultaneously determines expired CO2 and O2 concentration. The CO2 output and O2 uptake
during each breath are calculated, and data sampled is transferred breath-by-breath to a PC for
immediate display. Breath-by-Breath systems allow very accurate measurements under non-
steady-state and changing ambient air conditions. They are considered appropriate for extended
CPX testing requirements aimed to accurately follow up the physiological responses during
exercise tests in which work rates change more frequently.
®
The MetaLyzer 3B is operated via the mains supply. It is directly connected to a PC for real-time
®
display of the data recorded during measurement, using MetaSoft software. The data recorded is
®
saved in the internal database of MetaSoft for a precise performance analysis after the test.

CORTEX. Pioneers in Metabolic Testing. 5

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1
®
The MetaLyzer 3B has to be operated by appropriately trained physicians, properly trained
nurses, exercise physiologists, or medical technicians working directly under the supervision of a
physician who should be in the immediate vicinity and available for emergencies.
®
The MetaLyzer 3B must not be used in intensive care environments or for monitoring vital body
functions. The ultimate judgement as to which patients / test subjects should undergo a metabolic
stress test and as to which protocols are selected and / or adapted must be made by the
physician based on the limitations of the individual and in light of his medical history and of all of
the circumstances presented by that patient / test subject.

Neither CORTEX Biophysik nor its sales partners assume any responsibility for the final use of its
equipment.

For further information on metabolic stress testing please contact your local CORTEX sales
partner.

Note: Federal law restricts this device to sale by or on the order of a physician.

Safety regulations
®
For safety reasons, the MetaLyzer 3B must not be operated or used with accessories,
disposables, optional modules or analyzers other than offered and / or authorized by the
®
manufacturer. Ergometers and / or treadmills which are to be controlled via MetaSoft must meet
the legal requirements for medical equipment and may only be used with the appropriate
® ®
MetaLyzer 3B option. Computers which are connected to the MetaLyzer 3B, but were not
supplied by CORTEX Biophysik, must comply with the technical standards for electronic
equipment. They must meet the minimum requirements recommended by CORTEX Biophysik for
® ®
use with MetaSoft CPX testing software to ensure a proper function of the MetaLyzer 3B.
®
The operation of the MetaLyzer 3B in combination with other devices (PC, ergometer) must
comply with the requirements of DIN EN 60601-1-1 / DIN EN 60601-1-1/A1.

CORTEX SmartCart trolleys are designed for exclusive use with CORTEX systems. They can only
be equipped with the appropriate CORTEX devices. Do not add trays or equipment other than
offered and / or authorized by CORTEX for the respective SmartCart model. Please note that
®
Cortex devices (CardioLyzer, MetaLyzer ) are connected to a patient / test subject. For patient
safety, PCs, printers and other devices which do not comply with EN 60601-1, must be connected
to an isolating transformer if they are operated within a patient environment, i.e. at a distance of
less than 150 cm from a patient / test subject.

Always ensure the power outlet is secured. Devices connected must meet the legal requirements
according to DIN EN 60601-1-1 / DIN EN 60601-1-1/A1.

Do not use or connect any defective, broken or non-genuine parts and / or accessories.
Defective parts and / or accessories must be replaced prior to use. If in doubt, always
contact an authorized CORTEX sales partner or CORTEX Biophysik to check the system
before use.

The system may only be opened to exchange the O2 analyzer. Prior to opening the system,
®
make sure your MetaLyzer 3B is switched off and disconnected from the mains supply.
For repairs return the system to your local CORTEX sales partner or to CORTEX Biophysik. The
®
MetaLyzer 3B and / or its parts may only be repaired by an authorized CORTEX sales partner or
by CORTEX technical support staff. Repairs undertaken by non-authorized personnel may
cause severe risk for the user and patient / test subject. The CORTEX warranty expires in
case of non-authorized repair.
® ®
Do not use a MetaLyzer 3B with an open or defective housing. The MetaLyzer 3B must not
be used with anaesthesia gas in combination with oxygen or nitrous oxide (it is not a device of
class AP or APG). Always keep the device in a dry and protected position. Never operate the
devices in or close to water (DIN VDE 0100, Part 702).

6 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Neither CORTEX Biophysik nor its sales partners assume any liability for defects, damages or
®
any injuries caused due to improper use of the MetaLyzer 3B or due to a violence of its safety
regulations and maintenance instructions.
Gas under pressure involves certain risks for user and equipment. The calibration procedures
and routines described in this manual should therefore be performed by properly trained or
experienced staff only.
®
During intended use of the MetaLyzer 3B, no waste is produced or compounds are generated
which need to be disposed. At the end of its life cycle, the device and its accessories should be
disposed at a service center specialized in electronic scrap disposal.

For cleaning and maintenance instructions please see chapter “Maintenance & Cleaning” to
®
ensure a proper and long-time performance of your MetaLyzer 3B.

Important
§ Always use original parts offered or sold by the manufacturer or
specified as equivalent by the manufacturer.

§ Never use defective or broken parts. Visually check each part of the
equipment prior to use. Replace defective parts, accessories and/or
power supplies immediately. If in doubt, always contact an authorized
CORTEX Biophysik sales partner or CORTEX Biophysik.

§ Do not open device housings.

§ Repairs should be undertaken by authorized personnel only. Repairs

undertaken by non-authorized personnel may cause severe damage
to the equipment and / or system and may result in severe safety
risks for the user.

§ Replace tubes at regular intervals to maintain a high performance of

your calibration equipment and thus ensure a proper function of your
®
MetaLyzer 3B system.

Interference with other devices

®
The MetaLyzer 3B has been tested for electromagnetic tolerance and meets the required
®
standards. There may be minimum risks, however, of the MetaLyzer 3B to interfere with other
®
electronic devices. Since heart rate signals are transferred wirelessly (if Polar HR monitor is
used), the heart rate measurement may be interfered with very strong electromagnetic transmitters
(e.g. devices not built to required standards) which are used in the vicinity. Should this occur,
please contact your local CORTEX sales partner or CORTEX technical support for assistance.
®
For further information on the operation of the MetaLyzer 3B, technical details and optional
modules, please contact your local CORTEX sales partner or the technical support of CORTEX
Biophysik. Please also see chapter “Technical Data” and back page for contact details of CORTEX
Biophysik.

CORTEX. Pioneers in Metabolic Testing. 7

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

II. Technical Data

Measurement Device
®
The MetaLyzer 3B is a stationary cardiopulmonary exercise system for pulmonary gas exchange
measurements during treadmill or bike exercise, using breath-by-breath technology.

Parameters MetaSoft®
The following parameters are measured and / or calculated during a measurement with
® ®
MetaLyzer 3B using MetaSoft CPX Testing software:

S = Standard
Parameter O = Option

Circulation
- HR (Heart Rate) S
- HRmax (Maximum Heart Rate) S
- Blood Pressure (systolic, diastolic, mmHg) O
- Workload:
Level (rest, load, recovery), work rate (watts), grade (watts/ min., S
grade/min.), speed (m/sec., km/h, m/h), elevation
- 3-channel ECG (5, 10,20 mm/mV, 15, 25, 75 mm/sec., Einthoven I-
III, Wilson V, Nehb, Goldberger aVR, aVF, aVL, ST segment O
elevation)
- 12-channel ECG (Einthoven, Wilson, Goldberger) O

Gas Exchange
- FIO2, FEO2 (O2 Concentration in inspired / expired gas, Vol. %) S
- FICO2, FECO2 (CO2 Concentration in inspired / expired gas, Vol. %) S
- VO2 BTPS (Oxygen Uptake BTPS, l/min) S
- VCO2 BTPS (Carbon Dioxide Output BTPS, l/min) S
- VO2 STPD (Absolute O2 Uptake STPD, l/min) S
- VCO2 STPD (Absolute CO2 Output STPD, l/min) S
- VO2/kg (Relative O2 Uptake, l/min/kg) S
- VCO2/kg (Relative CO2 Output, l/min/kg) S
- VO2max (Maximum O2 Uptake, l/min/kg) S
- METS (Metabolic Equivalent) S
- RQ (Respiratory Exchange Ratio VCO2/VO2) S
- AT (Anaerobic Threshold) S
- VO2/HR (Oxygen Pulse) S
- VO2/HRmax (Maximum Oxygen Pulse) S
- VO2 / WR (Aerobic Capacity, l/min./W) S
- O2 kinetics (Oxygen Deficit/redemption, l/min.) S

Ventilation
- RR (Respiratory Frequency or Rate, Breath/min.) S
- VT (Tidal Volume, l/Breath) S
- VE ATPS (Minute Ventilation, l/min.) S
- VE / VO2 (Ventilatory Equivalent for O2) S
- VE / VCO2 (Ventilatory Equivalent for CO2) S
- PETO2 (End-tidal O2 Partial Pressure, mmHg) S
- PETCO2 (End-tidal CO2 Partial Pressure, mmHg) S
- PACO2 (Arterial CO2 Partial Pressure, mmHg) S

8 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Technical Specifications

MetaLyzer® 3B Base System

Size (L/W/H) 235x165x85 (mm)
Weight 1,100g

Analyzers
Volume transducer Type: DVT turbine, digital
Range: 0.1 – 12 l/s
Resolution: 7ml
Accuracy: 2%
®
Type: Triple V turbine, digital
Range: 0.05 – 20 l/s
Resolution: 7 ml
Accuracy: 2%
Resistance: ≤ 0.1 kPA/l/s at 16 l/s

O2 analyzer Type: electro-chemical cell

Range: 0 – 35 % O2
t90: 100 ms
Accuracy: 0.1 Vol.%

CO2 analyzer Type: ND infrared

Range: 0 – 13 % CO2
t90: 100 ms
Accuracy: 0.1 Vol.%

Temperature sensor Type: NTC Thermistor

Range: -55°C - +155°C
Accuracy: 1° C

Pressure sensor Type: Silicon

Range: 200 – 1050 mbar
Accuracy: 1.8%
®
Heart rate POLAR heart rate monitor

CORTEX. Pioneers in Metabolic Testing. 9

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Electrical / environmental specifications

During intended use:

Temperature +10°C - +35° C
Humidity 0 - 99%
Pressure 500 - 1050 mbar
Power supply 100 - 240 V AC, 50 - 60 Hz,
During transport:
Temperature -50°C - +70°C
Humidity 0 - 99%
Pressure 500 - 1200 mbar
During storage:
Temperature +2°C - +25°C
Humidity 0 - 60%
Pressure 500 - 1200 mbar

Safety
Safety Standards EN 60601-1 (1996)
EN 60601-1-1 (1994)
EN 60601-1-1/A1 (1996)
Class Class II, Type BF
Protection Class IP 30
EMC EN 60601-1-2 (1994)
Conformity Class II a
(according to 93/42/EWG; Appendix IX)

Disinfection instructions see chapter “Maintenance & Cleaning” of this manual.

No device of class AP/APG.
Suitable for continuous use.

Certified Quality

CORTEX Biophysik has successfully implemented a Quality Management

System satisfying Quality System Standards ISO 9001 and EN 46001.

®
The MetaLyzer 3B complies with the Medical Device Directives, MDD
0124 93/42/EEC, and has been approved to carry the CE Mark as shown.

CORTEX Biophysik is a member of the Quality Circle of Medical Software.

10 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

III. Figure: MetaLyzer® 3B Base System

Base System Front View

Cable/Tube Connectors:

Socket Function
gas Socket to connect sample line
volume Socket to connect volume transducer cable
ecg Socket to connect ECG patient cable
®
hr Socket to connect Polar heart rate receiver cable
digital Digital input/output to connect external devices
(e.g. CBP 2000 Blood Pressure Module)
on / off On/off switch

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 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Base System Back View

Sockets

Socket Function
12-15V / 1.5A DC To connect external medical power supply.

PC To connect PC connection cable.

Download key for sales partner or CORTEX support staff to

program
download updated firmware.

12 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

IV. Installation
Connect device to
PC/Notebook
®
The MetaLyzer 3B is operated using
®
MetaSoft software.
®
To connect the MetaLyzer 3B base system
to your PC/notebook, use the PC connection
cable supplied.

1. Plug the black connector into the PC

®
socket at the back of the MetaLyzer 3B
base system and turn its shaft to the right
to fasten it.

2. Plug the serial plug-in of the cable into

the serial port of your PC/notebook.

Serial plug-in to be
inserted into PC/notebook

PC connection cable
Black cable connector to be inserted
®
into MetaLyzer 3B base system

CORTEX. Pioneers in Metabolic Testing. 13

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Connect volume transducer

DVT
volume transducer with
cable

®
Triple V
volume transducer with
cable

1. Plug the black connector of the volume

transducer cable into the volume socket at
®
the front of the MetaLyzer 3B base
system.
2. Turn the shaft of the connector to the right
to fasten it.

Fig: The left photo shows connection of the

DVT volume transducer to base system.

Connect sample line

Sample line

Plug the plastic plug-in of the sample line into

®
the gas socket at the front of the MetaLyzer
3B base system.

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Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Connect Polar® receiver

cable
By default, the heart rate is measured using
®
a Polar belt and receiver which are
included in your standard extent of supply.
®
POLAR receiver with cable

1. Plug the black connector of the

®
POLAR receiver cable into the hr
®
socket at the front of the MetaLyzer 3B
base system to measure the heart rate
during the CPX test.

2. Turn its shaft to the right to fasten it.

Fix Polar® receiver cable

to bicycle ergometer/
treadmill

®
Fix the POLAR receiver to the
ergometer/treadmill.

The receiver should be fixed on the bike or

treadmill with its front pointing towards the
transmitter belt worn by the patient to
optimize data transfer between the belt and
the receiver.

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 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Connect bicycle
ergometer or treadmill
®
The MetaSoft exercise device control
allows an automatic and/or manual control of
a broad range of bicycle ergometers/
treadmills.

§ If you use a digital ergometer /

treadmill, connect the ergometer to
the serial port of your PC via an
interface cable which is included in
your basic supply package.

For a list of bicycle ergometers /

®
treadmills supported by MetaSoft ,
®
Connection of please refer to your MetaSoft
digital ergometer Operator’s Manual.

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Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Power system

®
1. The MetaLyzer 3B is operated
exclusively through the medical power
supply.

Plug the power cable into your

®
MetaLyzer 3B base system, then
connect the power supply unit to a
mains supply.

®
2. Switch on your MetaLyzer 3B by
pressing the on / off button on the front
panel of the base system.

Create device profile

using MetaSoft® Device
Configuration
®
Start MetaSoft Device Configuration to
design a device configuration profile and
check connections, following the instructions
®
in your MetaSoft Operator’s Manual
included in your basic supply package.

CORTEX. Pioneers in Metabolic Testing. 17

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

V. Key operations prior to each test

Prepare System
Power system for warm-up
®
Switch on your MetaLyzer 3B by pressing the on / off
button on the front panel of the base system.

Your MetaLyzer® 3B needs at least 30 minutes to

warm up prior to test start.

Check physical connections

Make sure the
· volume transducer cable
· sample line
®
· Polar receiver cable
are plugged in firmly prior to test start.

We recommend not to disconnect these parts unless

they need to be replaced and/or cleaned.

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Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Prepare patient/test
subject for the test
Fix Polar® HR Transmitter
Belt

The heart rate can be measured via

®
POLAR or the optional 3-channel ECG
module.
®
Fix the elastic strap to the POLAR
transmitter belt.

®
Fix the POLAR transmitter belt to the
thorax of your patient/test subject, using the
elastic strap included in your basic supply
package.

Put some gel or water on the back side of

the transmitter belt to provide for
optimum skin contact.

®
Fig: Polar transmitter belt fixed to patient’s
thorax.

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 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Head cap
Select mask
and fix head cap

Select an appropriate face mask or mouthpiece

and fix it to the head cap as shown on the left.

Only the top clips of the head cap are fixed to

the head cap assembly.

Mask

Connect volume transducer and

sample line to mask

Plug the sample line into the sample line outlet of

the volume transducer, then insert the volume
transducer into the face mask.

When inserting the volume transducer, the

sample line should be plugged in from the top.

Fig. DVT volume transducer and sample line

connected to face mask.

®
Fig. Triple V volume transducer and sample line
connected to face mask.

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Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Fix and adjust mask

1. Pull the head cap with the face mask

over your patient’s/test subject’s head.

2. Then fix the bottom clips.

3. Use the Velcro straps of the head cap

to fit the face mask to your patient’s
face. Take care that no air escapes.

Important

To make sure that no air is escaping

from under the face mask, keep a
flat hand to the volume transducer,
asking your patient/test subject to
breathe through the volume
transducer. If no air escapes at the
sides, the mask fits correctly.
Otherwise try a different face mask
size or adjust the straps of the head
cap.

CORTEX. Pioneers in Metabolic Testing. 21

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Ready for the test

Your patient/test subject is now ready to start
his/her test. Ask him/her to mount the bicycle
ergometer or treadmill.

®
Perform your test using MetaSoft .
For further instructions refer to your
®
MetaSoft Operator’s Manual.

Important!

Remember to disconnect the sample line

from your volume transducer prior to
starting an ambient air measurement,
then plug it in again once the ambient air
measurement has been performed.

22 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

VI. Calibration
General
®
To maintain the highest possible accuracy, periodic calibration of the MetaLyzer 3B analyzers
with certified calibration equipment and in accordance with the instructions described in this
manual is strongly recommended.

Please read the calibration instructions thoroughly prior to performing a calibration

measurement. Calibration procedures should be performed by trained personnel only to ensure
®
utmost operator safety and to maintain a proper function of your MetaLyzer 3B system.
®
Each analyzer of the MetaLyzer 3B is individually pre-calibrated on delivery of the system,
®
enabling users to operate their MetaLyzer 3B immediately upon installation. A calibration report
is included in the extent of supply, specifying the calibration factors and the barometric pressure
at the time of calibration.

Depending on the prevailing altitude level of your area or the operating conditions in which you
®
intend to use your MetaLyzer 3B upon installation, it may be necessary to recalibrate its gas
®
analyzers prior to first use. It should be noted that the MetaLyzer 3B is calibrated based on a
barometric pressure level of approximately 1000 mbar when delivered. Should the mean level of
barometric pressure in your area be lower than 900 mbar, a gas and volume calibration should
®
be performed prior to first use of the MetaLyzer 3B system.

Calibration Procedures
The following calibration procedures are available:

· Gas calibration of the O2 and CO2 analyzer (2-point calibration),

· Calibration of the volume transducer,
· Calibration of the pressure analyzer.

A proper calibration compensates for differences due to

· specimen differences between analyzers,

· ageing of analyzers,
· changing operating conditions.

Important
®
To ensure the highest possible accuracy, the MetaLyzer 3B analyzers
should be calibrated under conditions (temperature, pressure, humidity)
similar to the environmental conditions in which the system is operated.

Example:
®
If the MetaLyzer 3B is usually operated at normal barometric pressure, it
is strongly recommended to recalibrate its analyzers under the new
conditions if a test is to be performed at high altitude.

CORTEX. Pioneers in Metabolic Testing. 23

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Calibration Practices
®
If the MetaLyzer 3B is operated in stable environmental conditions, i.e. if it is used in the same
environmental conditions or if environmental conditions in which it is used, do not change significantly
between the measurements, the following calibration practices are recommended to verify and maintain
accuracy of its analyzers:

Gas analyzers
A two-point gas calibration should be executed prior to a series of coherent tests, after oxygen
sensor exchange or at least every 30 days. Please note that an ambient air measurement must
be performed prior to each measurement/test. For instructions on how to perform this please refer
to the chapter „Perform ambient air measurement“ of this user manual.

Volume transducer
The volume transducer should be calibrated at least once a day before the first test.

Pressure analyzer
It is not necessary to recalibrate the pressure analyzer unless barometric pressure changes
significantly. It is recommended, however, to check the barometric pressure measured by
MetaLyzer from time to time (e.g. every six months) against a reference barometer. If the values
measured differ more than 10 mbar, the pressure analyzer should be recalibrated.

Important

Remember to execute a two-point gas calibration

after the pressure analyzer has been recalibrated.

24 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

CORTEX Calibration Kit

Parts List

The calibration procedures and routines described in this manual are based on CORTEX calibration
equipment which is optionally available and can be purchased from your CORTEX Biophysik sales partner
or CORTEX Biophysik. Always use original parts offered or sold by CORTEX Biophysik or parts specified
as equivalent by CORTEX Biophysik.

Equipment for Volume Calibration

1-3 Liter Calibration Syringe, adjustable

Equipment for Pressure Calibration

Digital Barometer

Common Equipment for Gas Calibration

Certified Calibration/Reference Gas,

with 15% O2, 5% CO2, bal. in N2,
in a handy 1.2 liter bottle,

Reduction Valve for 1.2 liter gas bottle

CORTEX. Pioneers in Metabolic Testing. 25

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

CORTEX Calibration Kit: Parts List (continued)

Equipment for Gas Calibration with CORTEX Calibration Gas Saver

Calibration Gas Saver

Tube Set, including:

Tube to connect sample line to gas saver and

Tube to connect gas bottle to gas saver.

Power Supply, type Multinorm, with plug adapter(s) to operate calibration

gas saver on mains supply and
9V Battery to operate calibration gas saver on battery.

Equipment for Gas Calibration with Automatic Gas Calibrator

CORTEX Automatic Gas Calibrator

Connection Set, including:

Data Cable for connecting PC and Automatic Gas Calibrator,

Tube to connect sample line to Gas Calibrator and

two tubes to connect gas bottle(s) to Gas Calibrator.

26 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

CORTEX Calibration Kit: Parts List (continued)

Equipment for Gas Calibration

Power Supply, type Multinorm, with country-specific power cord or plug

adapter(s) to operate Automatic Gas Calibrator on mains supply

Optional Equipment for Calibration Kit

Transport Case, here shown with CORTEX calibration gas saver

CORTEX. Pioneers in Metabolic Testing. 27

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Steps prior to calibration

Run system for a warm-up period

®
To execute a calibration, your MetaLyzer 3B base
system must be powered and connected to a
PC/notebook. A warm-up time of 45 minutes is
required for gas calibration. Volume and Pressure
calibration can already be done after 15-minute
warm-up.
®
Switch on your MetaLyzer 3B by pressing the on / off
button on the front panel of the base system.

Check connections
Make sure the
· volume transducer cable
· sample line
are plugged in firmly prior to test start.

We recommend not to disconnect these parts unless

they need to be replaced and/or cleaned.

28 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Volume Calibration

Equipment required:

§ Manual Calibration Syringe (included in CORTEX Calibration Kit or equivalent syringe) or certified
automatic syringe

Calibration Steps:

1. Follow the steps described in chapter

“Steps prior to calibration”.

2. Close the sample line outlet of the

®
volume transducer (DVT or Triple V)
with the black plug-in which is part of
your volume transducer accessory.

3. Adapt transducer to calibration syringe.

Fig. Equipment and volume calibration

®
setup prior to calibrating the Triple V
volume transducer.

CORTEX. Pioneers in Metabolic Testing. 29

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

®
4. Start MetaSoft .

5. To access the volume calibration

screen select Volume

from the Calibration Program Folder

®
of MetaSoft .

Note:
The volume (flow) sensor should be
calibrated at the beginning of each
day.

6. The Volume Sensor Calibration

window will appear.

7.
a. Select the appropriate calibration
syringe from Syringe selection
box.

3 liter is the default syringe /

syringe volume displayed. Last
selection will be saved until
changed.

Note:
The volume of the calibration
syringe used has to be within the
upper ventilation range expected
to be measured during tests with
®
MetaLyzer 3B.

30 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

b. To enter a new syringe / syringe

volume, first click in the

Edit Syringe button of the Volume

Sensor Calibration dialog.

The Syringe List window will

appear, displaying information on
the selectable syringes.

c. To enter a new syringe / syringe

volume, click in the

New Syringe button.

d. Type name, manufacturer of

syringe and syringe volume in the
appropriate boxes of the Syringe
Parameters window. Click

to save your new entry in the

database. Click in the Close button
to return to the Syringe List. Press
the Close button again to return to
the Volume Sensor Calibration
screen.

8.
a. Select the appropriate volume
(flow) sensor from Volume Sensor
selection box.

Standard is the default volume

(flow) sensor/ volume (flow) sensor
displayed.

Note:
This setting allows you to handle
several volume (flow) sensors. If
you have only one volume (flow)
sensor, select Standard from the
Volume Sensor drop-down
selection box.

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 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

b. To enter a new volume (flow)

sensor, first click in the

Edit Volume Sensor button.

The Volume Sensor List window

will appear, displaying information
on the selectable volume (flow)
sensors.

c. To enter a new volume (flow)

sensor, click in the

New Volume Sensor button.

d. Type name and description of

volume (flow) sensor in the
appropriate boxes of the Volume
Sensor Parameters window. Click

to save your new entry in the

database. Click in the Close button
to return to the Volume Sensor
List. Press the Close button again
to return to the Volume Sensor
Calibration screen.

9. Press the

button to start calibration.

Note:
Make sure that the sample line outlet
of your volume (flow) sensor is
closed with the black plug-in and the
volume (flow) sensor is connected
both to your syringe and device.

32 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Fig. Volume calibration

10. Start pumping by pulling the plunger

of the calibration syringe all the way
forward and backward.

Important!

Pump gently. Do not stop between

inspiratory and expiratory pump
strokes. The minimum and maximum
flow values should be within the two
shaded green ranges of the
“Calibration Measurement” graph.

Use the two rhythm bars at the

bottom as a guidance for performing
suitable pump strokes. The upper bar
is moving automatically, giving the
rhythm. The lower bar moves along
with your strokes. When pumping,
the two bars should move
synchronously.

11. Repeat this procedure until all pump

cycles have been completed. During
calibration measurement, the Start
button turns into a Stop button.

Volume calibration stops automatically

after 5 valid strokes.

The actual calibration factors are

displayed in the “Inspiration” and
“Expiration” boxes under “Results”.

CORTEX. Pioneers in Metabolic Testing. 33

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

12. If the calibration factors (values)

calculated are lower than 0.8 or exceed
1.2, an error message will be displayed.
Possible reasons may be:
- syringe volume of the calibration:
syringe volume selected from the
Syringe selection box may have
been different to the volume of the
calibration syringe used,
- - pumping procedure was not
correctly performed,
- volume (flow) sensor is damaged

The volume (flow) sensor must be

recalibrated.

13. Click in the Transfer button to transfer the

®
values to your MetaLyzer 3B
measurement device.
The calibration values are stored in your
CPX device until new calibration values
are transferred.

34 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Two-Point Gas Calibration using CORTEX Calibration Gas Saver

Equipment required:

§ Gas 1 (clean ambient air or span gas with 0% CO2, approx. 21% O2 , bal. in N2)
§ Calibration/Reference gas
(Reference/calibration gas from CORTEX Calibration Kit or equivalent span gas with
4-6% CO2, 14-16% O2, bal. in N2)
§ Gas Saver with power supply or 9V battery (from CORTEX Calibration Kit)
§ Set of various connection tubes to gas bottle and sample line
(CORTEX Calibration Kit or equivalent tubes with connections)

Calibration Steps:

1. Follow the steps described in chapter “Steps prior

to calibration”.

2. Plug power cable into DC IN socket of gas saver and

connect power supply to mains supply using the
power adapter included in your CORTEX Calibration
Kit.

Note: The gas saver can also be operated on 9 V

batteries. One battery is included in your CORTEX
Calibration Kit.

Connect appropriate tube from the Cortex Calibration

Kit to P OUT socket of gas saver.

Note:
The sample line is not yet connected to gas saver.

Fig. Calibration equipment and test setup for a Gas 1 /

ambient air calibration measurement.

3. Switch on gas saver.

CORTEX. Pioneers in Metabolic Testing. 35

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

®
4. Start MetaSoft and select Manual
Gas Sensor Calibration Method.

To access this option please select

first General in the Configuration
Folder, then General Settings.

The General Settings window will

appear.

Note: You can skip this step if the

manual setting has not been changed
since last calibration.

5. To access the gas analyzer calibration

screen, select Gas

from the Calibration Program Folder

®
of MetaSoft .

Note:
A two-point reference gas calibration
should be executed prior to a test
series or at least every 30 days. It
must be executed if the oxygen
analyzer has been exchanged.

Prior to starting calibration, connect

and check the equipment required and
ensure that your device is sufficiently
warmed up (45 minutes). Make sure
that the room is sufficiently ventilated
for an accurate Gas 1 measurement.

If you use a span gas instead of

ambient air for Gas 1 measurement,
please proceed as described for
Gas 2 measurement.

36 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

6. The Gas Sensor Calibration window

will appear.

7.
a. Select the appropriate gas
concentrations for Gas 1
(ambient air or span gas) and
Gas 2 (calibration/reference
gas from CORTEX Calibration
Kit or see manufacturer label
of calibration gas bottle) from
the “Gas 1” and “Gas 2”
selection boxes in the gas
sensor calibration screen.

b. To enter a new reference /

calibration gas, first click in the

Edit gas button. The Gas List

window will appear, displaying
information on the selectable
calibration gases.

c. To enter a new gas, click in the

New gas button.

CORTEX. Pioneers in Metabolic Testing. 37

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

d. Type gas name, gas

concentrations and description
of the gas to be added in the
appropriate boxes of the Gas
Parameters window. Click

to save new gas entry in the

database. Click in the Close
button to return to the gas list.
Press the Close button again to
return to the Gas Sensor
Calibration screen.

8. Press the

button to start calibration with

Gas 1 (ambient air or span gas).

If ambient air is used as Gas 1, the

sample line must be exposed to fresh
air.

If a span gas is used as Gas 1, the

sample line has to be connected to the
span gas bottle for Gas 1 (refer to
sections 10-14).

During Gas 1/ambient air calibration,

the Gas 1 button turns into a Stop
button.

9. Gas 1 calibration stops automatically

once stable values have been reached.

The Gas 2 button is now enabled, the

Gas 1 button is disabled.

38 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

10. Proceed with calibration of Gas 2

(reference/calibration gas).

Check the bottle valve (black knob) on

the pressure reduction valve and close it
if still open. Counterclockwise turn out
the pressure knob completely (on top of
the reduction valve).

Remove the protective cap from the gas

bottle and screw the reduction valve in.

Connect gas saver to calibration gas

bottle using the appropriate connection
tube. Plug connection tube into P IN
socket of gas saver and connect it to
gas bottle.

Note:
The sample line still remains
unconnected to gas saver.

11. Now open the bottle valve and slowly

screw in the pressure knob on top of the
reduction valve.

Visually check the correct pressure of

gas flow via the LED displays of the gas
saver.

Open the reduction valve of the

calibration/reference gas bottle until the
LED switches from green to yellow.

12. Press the

button to start calibration with

Gas 2 (reference/calibration gas from
CORTEX Calibration Kit or equivalent).

During reference gas calibration,

the Gas 2 button turns into a Stop
button (see left illustration). The
Gas 1 button is disabled.

CORTEX. Pioneers in Metabolic Testing. 39

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

13. Connect sample line to the short tube

connector on P OUT socket of gas saver

Adjust gas pressure until green LED is

flashing.

P< = pressure too low, LED is red.

P> = pressure too high, LED is yellow.
OK = Pressure OK, LED is green.

14. Gas 2 (or reference gas) calibration stops

automatically once stable values have
been reached.

The Gas 2 button

is disabled, the Gas 1 button is now

enabled.

The calculated new offset / factors are

displayed in the “O2” and “CO2” boxes
under Results.

Note:
Please close the reduction valve of the
calibration/reference gas bottle and
disconnect the sample line from gas
saver.

15. Click in the Transfer button to transfer the

O2 and CO2 values to your CPX device.
The calibration values are stored in your
CPX device until new calibration values
are transferred.

40 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Two-Point Gas Calibration using Automatic Gas Calibrator

Equipment required:

§ Gas 1 (clean ambient air or span gas with 0% CO2, approx. 21% O2 , bal. in N2)
§ Calibration/Reference gas
(Reference/calibration gas from CORTEX Calibration Kit or equivalent span gas with
4-6% CO2, 14-16% O2, bal. in N2)
§ CORTEX Automatic Gas Calibrator with power supply (from CORTEX Calibration Kit)
§ Set of various connection tubes to gas bottle(s) and sample line (CORTEX Calibration Kit)
§ Connection Cable PC - Automatic Gas Calibrator (CORTEX Calibration Kit)

Calibration Steps:

1. Follow the steps described in chapter “Steps prior to calibration”.

2. Connect the power supply from your calibration kit with the calibrator's socket labeled DC in and a
mains supply.

Note: The gas calibrator can also be operated on either regular or rechargeable batteries. Use of
alkaline batteries (AA / LR6 size) or rechargeable batteries (AA size) with a capacity of at least
1,500 mAh is recommended. The batteries compartment is located on the bottom side of the unit.

Nearly exhausted batteries are indicated by a flashing On / LowBat LED. In this case you will be
able to complete the calibration process before exchanging the batteries.

3. Plug the connection cable (from CORTEX Calibration

Kit) into the PC COM port which is in use by
®
MetaSoft and into the PC socket on the calibrator.
®
Connect the MetaLyzer 3B PC socket and the unit's
CPX socket using the appropriate cable.

Now connect the short tube, included in your

Calibration Kit, to the Sample Line socket of the
automatic calibrator.

Notes:

The Automatic Gas Calibrator allows you to perform the calibration procedure without needing to
disconnect or unplug any connections even when using two gas bottles with different calibration
gases.

If you are calibrating using ambient air and one calibration gas (e.g. from CORTEX calibration kit),
the calibration gas bottle has to be connected to the GAS 2 inlet. The GAS 1 inlet is unused in that
case.

If you are using a second calibration gas instead of ambient air, please connect this bottle to the
GAS 1 inlet.

The following steps refer to a calibration process using ambient air and one calibration gas (from
CORTEX calibration kit).

CORTEX. Pioneers in Metabolic Testing. 41

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

4. Check if the bottle valve (black knob) on the pressure reduction valve is closed.
To set the proper output pressure turn the pressure knob towards higher pressure (clockwise in '+'
direction) until you reach the mechanical stop. Now screw it back out again ('-' direction) by 2.5 turns.
Remove the protective cap from the gas bottle and screw the reduction valve in.

Note: If your reduction valve is equipped with a manometer please adjust the pressure to a value of
14 - 29 PSI (1 - 2 Bar). Avoid pressure settings higher than 29 PSI (2 Bar).

5. Connect the GAS 2 inlet at the automatic gas calibrator and the gas bottle using the appropriate tube
from your calibration kit.
Plug the end of the sample line into the short tube which is already connected to the calibrator
(Sample Line socket).

6. Open the bottle valve by about one

turn.

7. Switch on the automatic gas

calibrator by pressing the Off / On
switch.
The green LED On / LowBat lights
up.

Fig.
Calibration equipment and test setup
for performing an automatic gas
calibration.
®
8. Start MetaSoft and select General
from the Configuration Folder, then
click on the General Settings icon.

The General Settings window will

appear. Click on the Calibration tab
sheet and select the automatic gas
sensor calibration method.

Note: You can skip this step if the

automatic setting has not been
changed since last calibration.

42 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

9. To access the gas analyzer calibration

screen, select Gas

from the Calibration Program Folder

®
of MetaSoft .

Note:
A two-point reference gas calibration
should be executed prior to a test
series or at least every 30 days. It
must be executed if the oxygen
analyzer has been exchanged.

Prior to starting calibration, connect

and check the equipment required and
ensure that your device is sufficiently
warmed up (45 minutes). Make sure
that the room is sufficiently ventilated
for an accurate Gas 1 measurement.

10. The Automatic Gas Sensor Calibration

window will appear.

11. Select the appropriate gas

concentrations for Gas 1 (ambient air or
span gas) and Gas 2
(calibration/reference gas from CORTEX
Calibration Kit or see manufacturer label
of calibration gas bottle) from the “Gas
1” and “Gas 2” selection boxes in the
gas sensor calibration screen.

In case your calibration gas is not yet

®
listed you can edit the MetaSoft
database. Please refer to section 'Two-
point Gas Calibration using CORTEX
Calibration Gas Saver'.

CORTEX. Pioneers in Metabolic Testing. 43

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

12. Press the

button to start the automatic calibration.

If you are using ambient air as GAS 1
the automatic calibrator must be
exposed to fresh air. Please avoid
breathing close to the unit and do not
cover the little side hole of the unit's
case.

13. The unit is now performing both

calibration steps successively (ambient
air > GAS 2 or GAS 1 > GAS 2) and will
stop automatically after completion.

The calculated new offset factors are

displayed in the “O2” and “CO2” boxes
under Results.

In case of low gas pressure (bottle

closed or empty) an error message
window will pop up.

14. Click the

button to transfer the O2 and CO2

values to your CPX device.

The calibration values are stored in your

CPX device until new calibration values
are transferred.

Notes:

Please close the gas bottle(s) after finishing the calibration process since a complete pressure
tightness of the calibrator's internal pneumatic system cannot be guaranteed.

If you won't be using the automatic gas calibrator for a long time, please remove the batteries.

44 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Pressure Calibration

Equipment required:

§ Reference barometer

Calibration Steps:

1. Follow the steps described in chapter

“Steps prior to calibration”.

2. To access the pressure sensor

calibration screen select Pressure

from the Calibration Program Folder of

®
MetaSoft .

3. The Pressure Sensor Calibration

window will appear.

CORTEX. Pioneers in Metabolic Testing. 45

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

4. Type the actual barometric pressure in

the Actual pressure (mbar) box of the
pressure sensor calibration screen.

To measure the actual barometric

pressure you may use a reference
barometer.

Attention:
The barometric pressure must be
entered in mbar. Change the
barometric pressure measured in
mmHg to mbar using the following
formula:
P[mbar] = 1.33322 * P[mmHg]

5. Press the

button from the Pressure Sensor

Calibration window to start the
calibration of the pressure analyzer.

The calculated new offset is displayed in

the Offset box under Results.

Click in the Transfer button to transfer

the new offset value to your CPX device.

Important

Always perform a two-point

reference gas calibration
after a pressure analyzer
calibration measurement.

46 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Print Calibration Reports

To view the calibration results, select

Print from the Calibration Program Folder
®
of MetaSoft .

The calibration report with the actual

calibration values will be displayed on the
screen. Click the Print icon to print the
report displayed.

CORTEX. Pioneers in Metabolic Testing. 47

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Check Analyzer Function

To check if your analyzers need to be
recalibrated without having to execute a
calibration measurement, start Check from
the Calibration Program Folder of
®
MetaSoft .

The Check window will appear. Select the

analyzer to be tested by clicking on the
respective tab sheet, then click on the Test
Measurement button in the tab dialog to
perform the test measurement.

48 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Edit Calibration Values

To manually enter calibration values in
case you want to use the calibration values
of a previous calibration measurement
select Edit from the Calibration Program
®
Folder of MetaSoft .

The Edit window will appear.

Enter the new values into the respective

selection fields, then click on the

button to transfer the new values to your

device.

To read out the values currently saved in

your device, click on the

button.

CORTEX. Pioneers in Metabolic Testing. 49

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

VII. Maintenance & Cleaning

The maintenance and cleaning instructions described in this manual are intended to provide
®
guidance on routine maintenance of the MetaLyzer 3B and its accessories to satisfy your
internal quality assurance and as a matter of good hygienic practice.
®
To maintain your MetaLyzer 3B at peak performance it is strongly recommended to observe
these maintenance and cleaning instructions. Non-observance of these instructions may result in
®
a failure to properly operate your MetaLyzer 3B system and/or in a severe safety risk for the
user. The warranty expires in case of non-observance of the maintenance and cleaning
instructions.

Please contact your local CORTEX Biophysik sales partner or CORTEX Biophysik for a
preventive maintenance agreement.

Cleaning & Maintenance Routines Overview

Cleaning & maintenance procedures to be performed

by the user:
Cleaning and disinfection after each test and/or after each patient

· Cleaning and disinfection of the face mask(s);

· Cleaning of the head cap;
®
· Cleaning of MetaLyzer 3B housing;
· Cleaning and disinfection of the volume transducer;
· Visual inspection of system and parts prior to next use;

Maintenance after six months of use

· Replacement of the sample line

50 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Maintenance to be undertaken by local

CORTEX sales partner or properly trained staff:

Replacement of O2 Analyzer

The oxygen analyzer (sensor) is an electro-chemical cell (fuel cell) which is used up after 18
®
months of use. It should therefore be replaced after 18 months. The MetaLyzer 3B base system
®
integrates an audio/visual self-test routine. A message will appear on your MetaSoft screen prior
to measurement in case the oxygen analyzer is used up and needs to be replaced.

The O2 analyzer should be replaced by your local CORTEX sales partner or properly trained or
experienced technical support staff only. To replace the analyzer, refer to the instructions
included in the next chapter of this manual.

Replacement parts and consumables can be purchased from your local CORTEX sales partner
or CORTEX Biophysik GmbH.

Preventive Maintenance
®
To maintain a long-time performance of your MetaLyzer 3B, the system should be thoroughly
checked for wear or damage of critical parts (e.g. filter, pneumatic components) every twelve
months.

Return the system to your local CORTEX sales partner or CORTEX Biophysik for a preventive
maintenance inspection, or contact your CORTEX sales partner or CORTEX Biophysik for a
maintenance agreement.

CORTEX. Pioneers in Metabolic Testing. 51

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Cleaning & Maintenance Instructions

Replace O2 Analyzer
®
This section describes how to replace the O2 analyzer of your MetaLyzer 3B stationary cardiopulmonary
exercise system. Remember to replace the analyzer after 18 months of use. The below step-by-step
instructions make it easy for you to remove and replace the O2 analyzer as often as necessary. To ensure
®
utmost operator safety and to maintain a long-time performance of your MetaLyzer 3B system, however,
service procedures should be performed by properly trained personnel only.
For further assistance please contact your local CORTEX sales partner or technical support of CORTEX
Biophysik.

Equipment required:
®
§ MetaLyzer 3B O2 analyzer, gas-tight sealed (CORTEX Part No. 000-45-020)
§ Screw driver

Steps:
Turn off and unplug your device.

To open device, press the internal snap

fasteners on the right- and left-hand side
of the housing, using a screw driver.

(Fig. 1)

Remove cover.

(Fig. 2)

52 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

O2 analyzer

Fig. 3: Cover removed.

Carefully pull O2 analyzer out of gray

plastic clamp.

(Fig.4)

Unscrew tube with white screw connector

from O2 analyzer.

(Fig.5)

CORTEX. Pioneers in Metabolic Testing. 53

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Then slide second tube (without screw

connector) off its shaft.

(Fig.6)

To unplug cable connection (black

connector) from O2 analyzer, press its
two snap fasteners to the right and left.

Unplug black connector. Then lift O2

analyzer out of housing half.

(Fig.7)

Cable connection

Tube connections

(Fig.8)

54 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

To attach cable of circuit board to

analyzer, first plug its black connector
into cable connection socket of O2
analyzer. Then close the right and left
snap fastener to secure cable.

(Fig.9)

Connect both tubes to their respective

sockets of O2 analyzer.

First slide tube without screw connector

onto respective shaft of O2 analyzer.
Remember to check that it sits firmly on
its shaft.

(Fig.10)

Then screw tube with white screw

connector onto respective socket of O2
analyzer.

(Fig.11)

CORTEX. Pioneers in Metabolic Testing. 55

 Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

After connecting tubes and cable, push

O2 analyzer back into grey plastic clamp.

(Fig.12)

Put cover back on device. Press it down

until you hear it snapping.

(Fig.13)

Calibration after O 2 replacement:

® ®
After replacing the MetaLyzer 3B O2 analyzer, take care to recalibrate your MetaLyzer 3B system
®
following the calibration instructions of your MetaLyzer 3B user manual.

56 CORTEX. Pioneers in Metabolic Testing.

Operator’s Manual MetaLyzer® 3B
Version ML3B 2.1

Clean & disinfect face mask(s)

The face mask must be removed, soak-cleaned and disinfected after each patient. The cleaning of
reusable devices usually begins soon after use.

Note: Protective attire is required of personnel handling contaminated devices. Manual cleaning must be
done in a manner that protects personnel handling the devices from aerosolization and splashing of
infectious material.

Cleaning
§ After the test, remove the volume transducer and the head cap from the face mask. Soil is wiped
from the device surface with a moist sponge or cloth.
§ Inspect the mask and its components for damages at all stages of handling. If damage is detected
on any of the components, it should be identified and replaced.
§ Soak or rinse the device in water of 20° – 45°C. Use a pH neutral mild detergent. If an enzyme
product is required, soak for two minutes. Remove, examine and extend the soak time for
components with dried-on matter for up to five minutes. Soaking of components over five minutes
may be detrimental, causing damage to the component’s surface.
§ After soaking, the mask must be thoroughly rinsed with clean water to remove the detergent
residuals and debris from the components.
§ Dry mask thoroughly using a soft clean cloth or disposable paper towels.

Disinfection with liquid solutions

The following disinfectants have been tested and approved:

§ Cidex, (Surgicos Inc., Johnson & Johnson Corp.),

§ Metricide, (Metrex Research Corp.),
§ Glutarex, (3M Company)
§ Lysetol med, (Schülke & Mayr GmbH)
§ Take care to observe the recommendations of the manufacturer when using specific disinfectants.
Use any of these disinfectants as recommended by the manufacturer.
§ Determine the required soak temperature and time of the disinfectant and assure that these
requirements are met. Activate the solution by mixing the components per manufacturer’s
instruction. Pour the activated solution into an appropriately-sized basin. Completely immerse the
mask in the basin The disinfectant agent must contact all surfaces to ensure disinfection. Cover the
basin.
§ Adequate rinsing must follow disinfection to remove all traces of the disinfectant. Rinse for at least
one minute with water (sterile water is preferred).
§ To prevent the growth of waterborne organism, the mask should be dried thoroughly using a soft
cloth or disposable paper towels.
§ In case skin irritations occur after use of a specific disinfectant, stop disinfecting with this solution
and use any other of the approved solutions. If none of the disinfectant solutions will stop the skin
irritation effect, use steam disinfection.

Disinfection with steam

The disinfection of the mask can be achieved with steam disinfection. The maximum temperature of cycle
must not exceed 135°C. The cycle time must not exceed 15 minutes.

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Clean head cap assembly

The head cap assembly should be removed and cleaned after each patient. The cleaning of reusable
devices usually begins soon after use.

§ The head cap assembly, including the clips, can be hand-washed in water of 20° – 45°C, using a non-
oily, mild detergent.

§ Rinse thoroughly in water. Machine or line dry. Do not iron the head cap.

§ Inspect the head cap for damages at all stages of handling. If damage is detected on any of its
components (e.g. the clips), it should be identified and replaced.

Clean housing
®
Before cleaning the MetaLyzer 3B base system disconnect any tubes and/or cables from the system.

Use a moist cloth to wipe the instrument clean. Liquids must not be allowed to enter the device. Any
hospital-grade cleaning agent and disinfectant may be used.

Danger

If liquids have entered the device it must be checked

by a service technician before it can be used again.

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Clean & disinfect DVT volume transducer

The DVT volume transducer must be cleaned and disinfected after each patient. This means one test can
be performed while the contaminated parts are being cleaned. The standard package includes one
volume transducer; exchange units are available on order from your local CORTEX sales partner or the
manufacturer.

§ Remove the volume transducer from the face mask.

§ Disconnect all tubes from the volume transducer.

§ Disassemble the volume transducer.

Turbine

The DVT volume transducer consists of two

parts:

- turbine with mask adapter

- electronic assembly with cable.

Electronic assembly

To disassemble the volume transducer,

carefully push turbine out of electronic
assembly.

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§ After disassembly of the volume transducer check its parts for mechanical damages (turbine,
sieve, housing of electronic assembly, cable connectors).

§ Rinse turbine in warm water (< 50°C). Do not hold the turbine under running water. This
may damage the turbine.

§ Put turbine into a disinfecting solution (see disinfectants recommended for face mask).

§ After disinfecting, first rinse the turbine in pure water, then in distilled water to avoid
calcification after air drying. Air dry the turbine. Do not use mechanical dryers, paper or
textile for drying to keep the turbine free from dust and fibre deposits.

§ The housing of the electronic assembly may be surface-cleaned, using a fluff-free, weakly
moistened cloth. Moisture must not get into the housing.

§ To reassemble the volume transducer, follow the opposite instructions by pushing turbine back
into electronic assembly. The parts must be thoroughly dried before assembling.

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Clean & disinfect Triple V® volume transducer

®
The Triple volume transducer must be cleaned and disinfected after each patient. This means one test
can be performed while the contaminated parts are being cleaned. The standard package includes one
volume transducer; exchange units are available on order from your local CORTEX sales partner or the
manufacturer.

1. Remove the volume transducer from the face mask.

2. Disconnect any tubes from the volume transducer.

3. Disassemble the volume transducer:

®
The Triple V volume transducer consists
of the following parts:
Housing
- housing
- turbine
- electronic assembly with cable

Turbine

Electronic assembly

®
Disassembly of Triple V volume
transducer:

1. Turn housing a half turn to the left to

unfasten electronic assembly.

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2. Remove electronic assembly from

housing.

3. Slide turbine out of housing.

4. After disassembly visually check the

parts for mechanical damages (turbine,
sieve, housing of electronic assembly,
cable connectors).

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Cleaning
1. Turbine:

§ Rinse the turbine/transducer in warm water (< 50°C). Do not hold the turbine/transducer under
running water. This may damage the turbine/transducer.

§ Put the turbine/transducer into a disinfection solution (see disinfectants recommended for face
mask).

§ After disinfection first rinse the turbine/transducer in pure water, then in distilled water to avoid
calcification after air drying. Air-dry the turbine/transducer. Do not use mechanical dryers,
paper or textile for drying to keep the turbine free from dust and fibre deposits.

2. Electronic Assembly:

The housing must be surface-cleaned, using a fluff-free, weakly moistened cloth only. Moisture must
not get into the housing.

3. Housing:

The housing can be easily cleaned using a non-oily, mild soap. Rinse thoroughly in running water.

Re-Assembly of Triple® V volume transducer

To assemble the parts, follow the opposite instructions. First slide turbine back into housing. Press
electronic assembly back into housing and turn housing a half-turn to the right to fasten electronic
assembly. The parts must be thoroughly dried before assembling. Take care that the sieve of the turbine
shows towards the mask adapter.

Replacement of the sample line

The entire sample line must be replaced in case of breakage. It is recommended to replace it after six
months of use. Defective or worn sample lines may result in inaccurate measurements. They allow
water condensate inside the sensor where it could damage the electronic components within the
measurement device, causing a severe system failure. Sample lines can be purchased via your local
CORTEX sales partner or CORTEX Biophysik GmbH.

Visual inspection of system and parts prior to next use

Visually check each part of the system and its cables for signs of mechanical damage (e.g. broken
connectors, crooked pin connections etc.) prior to each use. Should you detect damages or impaired
device functions which present a hazard to the user, replace the part immediately or return it for a
preventive maintenance inspection to your local CORTEX Biophysik sales partner or CORTEX Biophysik
before using it again.

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Maintenance of the calibration equipment

Replace reference gas bottles
Calibration gas bottles are optionally available. The 3 liter calibration gas bottle offered by the manufacturer
and included in the calibration kit allows you to perform approx. 15 gas calibration measurements when
using the gas saver. Replacement bottles can be purchased from your local CORTEX Biophysik sales
partner or CORTEX Biophysik.

Clean & replace tube set

The tubes included in the CORTEX Calibration Kit are not likely to become dirty if used properly. If
necessary, however, they can be cleaned by rinsing them in distilled water. After rinsing, air-dry the tubes.

Inspect the tube set at all stages of handling. Should you detect damages or breakages, replace the
defective tube immediately. It is recommended to replace the entire set after 12 months’ of use.
Replacement tube sets can be purchased from your local CORTEX Biophysik sales partner or CORTEX
Biophysik.

Clean gas saver / automatic gas calibrator

Before cleaning the unit, disconnect all tubes, unplug the power supply and remove the battery from its
compartment. Use a moist cloth to wipe the device clean. Liquids must not be allowed to enter the device.
Any hospital-grade cleaning agent may be used.

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VIII. Annexes

1. MetaLyzer® 3B: Technical tips & troubleshooting

2. Certificates for Quality Assurance

3. Manufacturer’s Declaration of Conformity

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Annex 1: Troubleshooting Tips

If any of the below faults occurs or any of the below diagnostic messages is
displayed via MetaSoft®, first check this troubleshooting guide. Should you be
unable to remedy the problem, please contact your local CORTEX sales partner or
the technical support of CORTEX Biophysik for assistance.

Warning: Do not try to repair defective parts yourself or to open the system as this would
invalidate your warranty!

Problem Possible Cause Remedy / Action

Operation
No power. - Power supply is not - Connect power supply
connected
Visual error messages
The sample line is blocked. - Sample line obstructed. - Remove obstruction (e.g. kink).
- Filter obstructed. - Replace sample line.
- Internal tubes obstructed. - Contact your local sales partner.
Please check calibration of - Calibration values got lost. - Recalibrate CO2 sensor.
CO2 sensor.
- If the error message still appears
after recalibrating the sensor, a
memory error may have occurred.
Contact your local sales partner or
CORTEX Biophysik to arrange for
a return of the system.
Please check calibration of O2 - Calibration values got lost. - Recalibrate O2 sensor.
sensor.
- If the error message still appears
after recalibrating the sensor, a
memory error may have occurred.
Contact your local sales partner or
CORTEX Biophysik to arrange for
a return.
Please check calibration of - Calibration values got lost. - Recalibrate volume transducer.
volume transducer.
- If the error message still appears
after recalibrating the sensor, a
memory error may have occurred.
Contact your local sales partner or
CORTEX Biophysik to arrange for
a return.
Please check calibration of - Calibration values got lost. - Recalibrate pressure sensor.
pressure sensor.
- If the error message still appears
after recalibrating the sensor, a
memory error may have occurred.
Contact your local sales partner or
CORTEX Biophysik to arrange for
a return of the system.

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Problem Possible Cause Remedy / Action

Visual error messages

Volume transducer defective - Volume transducer not - Check connection of volume
or not connected. securely connected to transducer cable.
MetaLyzer or not working.
- Visually check cable and cable
pins for signs of mechanical
damages. Should you detect a
damage, contact your local sales
partner or CORTEX Biophysik.
- Integrated temperature - Contact your local sales partner
sensor not working. or CORTEX Biophysik.
Error occurred during CO2 - CO2 sensor defective or - Contact your local sales partner
measurement. electronics failure. or CORTEX Biophysik to
arrange for a return of the
system.
Error occurred during O2 - O2 sensor defective or - Replace O2 sensor.
measurement. electronics failure.
- If the error message still appears
after replacing the O2 sensor,
contact your local sales partner
or CORTEX Biophysik to
arrange for a return of the
system.
O2 sensor used up. - O2 sensor older than six - Replace O2 sensor.
months.
Pump defective. - Mechanical damage of - Contact your local sales partner
pump or electronics failure. or CORTEX Biophysik to
arrange for a return of the
system.
Error occurred during - Pressure sensor defective - Contact your local sales partner
pressure measurement. or electronics failure. or CORTEX Biophysik to
arrange for a return of the
system.
Error occurred during - Differential pressure sensor - Contact your local sales partner
differential pressure defective or electronics or CORTEX Biophysik to
measurement. failure. arrange for a return of the
system.
Error occurred during - Humidity sensor defective - Contact your local sales partner
humidity measurement. or electronics failure. or CORTEX Biophysik to
arrange for a return of the
system.
Error occurred during - Internal temperature - Contact your local sales partner
temperature measurement. sensor defective or or CORTEX Biophysik to
electronics failure. arrange for a return of the
system.

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Problem Possible Cause Remedy / Action

Visual error messages

Water collected inside - Sample line too old. - Stop measurement immediately
sample line. and turn off device to avoid total
system failure.
- Replace sample line.
- Switch on device and run it for
approx. 5 hours under normal
conditions (approx. 20-25°C and
less than 60% humidity).
- Perform a two-point gas
calibration measurement prior to
next use.
- If you are unable to remedy the
problem, contact your local sales
partner or CORTEX Biophysik to
arrange for a return of the
system.
Measurement values - Sample line was exposed - Be careful to expose the free
unstable during one-point to breathing air. end of the sample line to
calibration (measurement ambient air during one-point
does not stop) calibration measurement.
Values measured are stable, - Room badly ventilated - Ensure an adequate ventilation
but differ significantly from (“used” air). and room temperature for
normal values (i.e. 20.93% maximum performance.
O2, 0.03% CO2)
- The last 2-point gas - Perform a 2-point gas calibration
calibration was performed measurement.
too long ago.
Ventilation values plausible, - Sample line not connected - Connect sample line.
but V’O2 or V’CO2 are the to volume transducer.
same or close to zero.
Ventilation values measured - Volume transducer not - Recalibrate volume transducer.
differ significantly from properly calibrated.
predicted values.
- Mechanical damage of the - Contact your local sales partner
turbine of volume or CORTEX Biophysik.
transducer.
- Turbine of volume - Clean turbine in accordance with
transducer may be dirty. maintenance and cleaning
instructions.
Gas values (V’O2, V‘CO2, - 1-point calibration not - Perform 1-point calibration
RQ) measured differ performed or not performed correctly.
significantly from predicted properly.
values.
- Gas analyzers not properly - Perform 2-point gas calibration
calibrated. measurement.
- Sample line leaking. - Replace sample line.

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Annex 2: Certificates for Quality Assurance

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Annex 2: Certificates for Quality Assurance (cont’d)

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Annex 3: Manufacturer’s Declaration of Conformity

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 Operator’s Manual MetaLyzer® 3B
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IX. Contact CORTEX Biophysik

Via email

Technical support: [email protected]

Product information: [email protected]

Via Internet http://www.cortex-medical.de

Via fax or phone

Technical support: Phone +49 341 4 87 49-0

Fax +49 341 4 87 49-50

Product information: Phone +49 341 4 87 49-0

Fax +49 341 4 87 49-50

Via mail CORTEX Biophysik GmbH

Nonnenstrasse 39
04229 Leipzig
Germany

We look forward to your feedback.

Enjoy using your MetaLyzer® 3B.

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X. Trademarks

Microsoft and Windows are registered trademarks of Microsoft Corp.

MetaLyzer and MetaSoft are registered trademarks of CORTEX Biophysik.

Triple V is a registered trademark of Erich Jaeger.

Nafion is a registered trademark of DuPont.

Polar is a registered trademark of Polar.

Cidex is a registered trademark of Surgicos.

Metricide is a registered trademark of Metrex Research.

Glutorex and 3M is a registered trademark of 3M Company.

Lysetol med is a registered trademark of Schülke & Mayr.

XI. Disclaimer

THE INFORMATION IN THIS GUIDE IS SUBJECT TO CHANGE AT ANY TIME AND WITHOUT
NOTICE.

CORTEX Biophysik GmbH reserves the right to make changes in its designs and specifications at
any time and without prior notice. The information provided by this document is believed to be
accurate and reliable. However, no responsibility is assumed by CORTEX Biophysik GmbH for its
use; nor for any infringements of patents or other rights of third parties resulting from its use.
Photos and images for representation purposes only.

©
CORTEX Biophysik GmbH 1993 – 2004. All rights reserved.

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XII. Personal Notes

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74 CORTEX. Pioneers in Metabolic Testing.