Service Manual

Resting and Stress ECG

with custo cardio 100/110/130

GEB 0160 – DK 1161

Version 002 – 20.02.2012
Table of contents

01 Introduction
01.1 Symbols on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
01.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
01.3 Symbols used in this Operating Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

02 Safety instructions
02.1 General notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
02.2 Operator instructions and user requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
02.3 Safety installations and safe working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
02.4 Information on EMC (Electromagnetic Compatibility) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
02.5 Maintenance (regular safety checks) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
02.6 Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
02.7 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

03 Description of device, basic instructions for initial operation

03.1 Part names, components for ECG recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
03.2 Operation of custo cardio 100/110 BT (Bluetooth) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
03.3 custo diagnostic – basic program structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
03.4 Connecting ECG devices to the PC
03.4.1 ECG device with USB port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
03.4.2 ECG device with Bluetooth connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
03.4.3 Selecting ECG device for resting and stress ECG. . . . . . . . . . . . . . . . . . . . . . . . . . 23
03.5 Connecting ergometer/treadmill to the PC
03.5.1 Connecting and configuring devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
03.5.2 Selecting devices for stress ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

04 Hygiene
04.1 Cleaning and disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
04.2 Recommended cleaning agents and disinfectants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

05 Carrying out an examination

05.1 Preparing the patient and examination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
05.1.1 Electrode application for resting and stress ECG . . . . . . . . . . . . . . . . . . . . . . . . . 29
05.1.2 Instructions for stress ECG with treadmill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
05.2 First work steps in custo diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

05.3 Recording resting ECG

05.3.1 Monitoring and electrode control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
05.3.2 Starting and ending a resting ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
05.3.3 Editing options during the recording process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
05.3.4 Online ECG printing (printing ECG). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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 05.4 Recording stress ECG
05.4.1 Selection of load profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
05.4.2 Monitoring and electrode control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
05.4.3 Overview of the workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
05.4.4 Hint for manual blood pressure measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
05.4.5 Starting the recording, resting phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
05.4.6 Stress phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
05.4.7 Recovery phase, ending the recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
05.4.8 Editing options during the recording process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
05.4.9 Online ECG printing (printing ECG). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

06 Working with the evaluation

06.1 Opening the evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

06.2 Resting ECG evaluation

06.2.1 Screen pages within an evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
06.2.2 Comparing several evaluations from one patient. . . . . . . . . . . . . . . . . . . . . . . . . 43
06.2.3 Note on navigation in the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
06.2.4 Overview of evaluation pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
06.3 Stress ECG evaluation
06.3.1 Screen pages within an evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
06.3.2 Comparing several evaluations from one patient. . . . . . . . . . . . . . . . . . . . . . . . . 53
06.3.3 Note on navigation in the evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
06.3.4 Overview of evaluation pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

06.4 Writing the report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

06.5 Ending the evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
06.6 Archiving evaluations (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

07 Product Information
07.1 Technical data and system requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
07.2 Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
07.3 Manufacturer declaration on EMC (Electromagnetic Compatibility)
according to IEC 60601-1-2:2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
07.4 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
07.5 Shutdown, storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
07.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
07.7 Keyboard navigation and shortcuts in custo diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Appendix
Values and formulas in the ECG evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 5
01 Introduction

01.1 Symbols on the device

Manufacturer:
custo med GmbH, Leibnizstr. 7, 85521 Ottobrunn, Germany

CE mark

Observe the Operating Manual

Separate collection of electrical and electronic equipment,

do not dispose with domestic waste

Protection class classification of medical electrical equipment

according to IEC 60601-1 (type BF, defibrillation protected)

01.2 Intended use

custo cardio 100/110/130 is a 12-channel PC ECG device which is designed for

recording, analysing and evaluating ECG recordings in medical practices and
hospitals.

custo cardio 100/110/130 is perfectly safe for patients with a pacemaker. The ECG
recording is not affected by pacemaker pulses. custo cardio 100/110/130 is not
suitable for intracardiac use.

6 Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH
01.3 Symbols used in this Operating Manual

This Operating Manual uses the following symbols to indicate important informa-
tion, comments and tips:

ACTIONS THAT ARE PROHIBITED

or not allowed under any circumstances!

WARNING
used to indicate situations which, if not avoided, may result in personal injury
and property damage

NOTE
provides important information which must be observed

TIP
contains practical information to assist you with your work

Words highlighted in colour indicate buttons or click paths Words highlighted

for the corresponding program point, e.g. Examination, Resting ECG in colour..

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 7
02 Safety instructions

02.1 General notes

Strict compliance with the safety instructions protects against personal injury and
property damage during device operation. This Operating Manual is designed to
accompany the product and must be kept ready to hand close to the device.
As either the operator or user of this device you should have read and understood
this Operating Manual, in particular the safety instructions.

Laws and regulations applicable to the product

This system is designed in accordance with Medical Device Directive 93/42/EEC,

Class IIa, and meets the requirements of protection class I or II (depending on the
power supply unit used; cardio 100/110 BT meets the requirements of protection
class III – device with an internal power supply), type BF (defibrillation protected),
according to IEC 60601-1

Other devices which are part of the system must meet the requirements of the
Standard for Information Technology Equipment (IEC 60950) and the Standard for
Electrical Medical Devices (IEC 60601-1).

The electrical installations in the rooms in which the system is used must meet the
requirements of the applicable safety standards.

02.2 Operator instructions and user requirements

As the operator you are responsible for:

Ensuring that the operating personnel have been instructed in the
technical use of the device and they have read the Operating Manual
The device is used as intended by suitably trained specialist staff
Compliance with the safety regulations and safety instructions,
provisions for safety at work and accident prevention regulations
Compliance with the maintenance instructions

Users must meet the following requirements:

Knowledge of the correct use of the device
Command of the required device handling processes
Knowledge of the safety regulations applicable when using such devices
Understanding of the potential hazards

The device may only be used by medical specialist staff, e.g. physician’s assistants,
nurses, assistant medical technicians, physicians, etc.
For users outside the Federal Republic of Germany, the respective national accident
prevention measures, regulations and requirements apply..

8 Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH
02.3 Safety installations and safe working

custo cardio 100/110/130 must only be used in a technically perfect condition. Re-
gularly carry out a visual inspection of the device and the cables, in particular the
patient cable. Only use accessories approved by custo med.

The device is protected against defibrillation only in connection with the manu-
facturer’s patient cable. For custo cardio 130 only patient cables with a defibrilla-
tion protection resistance of 10 KΩ must be used.

In the event of defibrillation, take note of the manufacturers’ instructions regarding

the safe and proper use of the defibrillator. Defibrillation has an interfering effect
on the ECG recording. custo cardio 100/110/130 has a recovery time of less than
ten seconds.

Installation of the system

Portable socket outlets must not be laid on the ground.

Portable multiple socket outlets which are supplied with the system are to be used
only for supplying devices which are part of the system. Additional portable multip-
le socket outlets, lines and other equipment, which are not part of the system, must
not be connected to the system.

When using a multiple socket outlet, the maximum permitted load is 3200 VA.

Slots which are not used in the delivered system (portable multiple socket outlets)
must be provided with covers.

Ambient conditions, handling

custo cardio 100/110/130 is not suitable for use in rooms or areas with a risk of
explosion.

Strong electromagnetic sources in the immediate vicinity of the custo cardio

100/110/130 may result in recording errors (e.g. HF electrosurgical devices, mobile
phones, induction furnaces).

The device must not be operated simultaneously with HF surgical equipment.

The device must be protected against the ingress of moisture, dust or dirt and also
against mechanical impacts such as damage due to dropping or transit damage.

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 9
02 Safety instructions

Patient safety

Safety distances of devices to the patient

1.5 m

2.5 m 2.5 m
1.5 m 1.5 m

1.5 m 1.5 m 1.5 m

Without medical protective devices, for example medical protector, the PC and all
the non-medical devices connected to the system (e.g. the monitor and printer)
must be set up and used at a distance of at least 1.5 m to the patient unit (see the
orange area in the figure) as leakage currents can occur.

When coupled with other devices, make sure that there is no danger due to the
accumulation of leakage currents.

During routine maintenance work to non-medical devices connected to the system

the patient must not be touched (risk of electric shock).

Make sure that the electrode contacts do not come into contact with other con-
ductive parts.

All results of automatic analysis and the resulting unconfirmed reports produced
by the system must be considered as suggestions only. For diagnosis and therapy
purposes it is essential that the results are checked and assessed by a qualified
physician.

custo cardio 100/110 BT (Bluetooth), rechargeable lithium-ion battery

Remove the rechargeable battery if the device is not used for a long period.

Only use the supplied charger to charge the rechargeable battery.

Do not expose the rechargeable battery to extreme temperatures, fire and moisture.
Do not immerse the rechargeable battery in liquids. Observe the operating and sto-
rage conditions.

Do not subject the rechargeable battery to strong shocks or drop it. The recharge-
able battery must not be disassembled, modified or short circuited..

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Hygiene

For cleaning and disinfection observe the legal requirements and the current state
of technology.
Use only cleaning agents and disinfectants approved by custo med for cleaning and
disinfection. Clean and disinfect your device in accordance with the specifications
given in chapter 04 Hygiene.

Safe use of treadmills during stress ECG

Please inform your patient before you stop the treadmill in custo diagnostic using
the Stop button and before you restart the treadmill using the Continue button.
Otherwise, the patient may become injured due to an unexpected, abrupt stopping
or starting of the treadmill.

Always inform you patient before the speed is changed.

Always set the treadmill so that the patient can safely move on the device. Ensure
that the acceleration, speed and slope of the treadmill are adjusted to the patient‘s
physical constitution, stamina and skill.

Observe the manufacturer‘s safety instructions.

Display of the ECG signal in custo diagnostic

If electrodes become detached from the patient during an ECG recording or the
electrode contact is too weak, a red signal line will be displayed on the correspon-
ding ECG channel in custo diagnostic. Below the ECG recording a hint will appear
(in red letters) indicating which electrodes are concerned. Reattach them.

The appearance of red signal lines in custo diagnostic does not indicate that the
patient has an asystole.

custo diagnostic provides pacemaker detection. Here, the pacemaker pulse from the
ECG signal (in two channels at least) is detected and then projected into the ECG
recording as an (artificial) spike, precisely timed.
However, the pulse width of the pacemaker is not calculated with the pacemaker
detection in custo diagnostic.

The device is not suitable for binding pacemaker checks. In case of doubt, use the
device approved by the pacemaker manufacturer (see the patient’s pacemaker
record).

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 11
02 Safety instructions

System and data security

The device must only be used with the supplied custo med software
(custo diagnostic).

As the operator you are responsible for ensuring regular data backups (patient
databases, evaluations etc.) and system backups. We recommend that you backup
the data at the latest before new installations, updates and far-reaching system
configurations.

custo diagnostic new installations, updates and system configurations may only be
performed by your authorised custo med dealer.

Only change data generated in custo diagnostic within custo diagnostic itself and
not in your EPR system (Electronic Patient Record) or your hospital information
system (HIS).

custo med does not accept any responsibility for any changes to data in your EPR
system or your HIS which were made after the export from custo diagnostic.

To ensure the safe operation of custo diagnostic, deactivate the screensaver and
energy management options on your PC.

Set up your operating system in such a way to prevent the PC from being switched
off either accidentally or automatically during the examination (standby mode/
idle mode).

custo connect

When you use custo connect to integrate additional medical devices in the custo
med system, for automatic PDF printouts from the connected medical device, check
whether the PDF file belongs to the current patient. Do not trigger any PDF prin-
touts in other programs during the PDF printout in the connected medical device.

When you use custo connect to integrate additional medical devices in the custo
med system, on starting the connected medical device check whether the patient
name was taken over correctly.

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Data management in custo diagnostic: Assign evaluation (allocate evaluation)

If an examination was conducted with incorrect patient data, the evaluation can
be subsequently allocated to the correct patient. Make sure that the evaluation
is definitely allocated to the correct patient. An incorrect allocation can lead to a
misdiagnosis. Please note that data which has already been exported to an external
system (e.g. surgery IT system) cannot be changed.

custo diagnostic is preset with the Assign evaluation function deactivated; however
it can be reactivated via user rights if necessary. Only the Supervisor can configure
the user rights. If the Assign evaluation function is activated, it can be found in the
evaluation search or in open evaluations in the Options menu.

We recommend configuring user rights in custo diagnostic so that only authorised

persons can execute the Assign evaluation function.

02.4 Information on EMC (Electromagnetic Compatibility)

The use of other accessories, other converters and leads than those indicated, except
for the converters and leads sold by custo med as spare parts for inner components,
can lead to increased electromagnetic emissions or to a reduced electromagne-
tic immunity of the system. For connecting the device to other equipment, only
specially screened cables supplied by custo med must be used.

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 13
02 Safety instructions

02.5 Maintenance (regular safety checks)

The operator is responsible for maintenance. The operator must ensure that the de-
vice is checked for proper condition at the latest every two years. The functionality
and the state of accessories must be checked at regular intervals. If damaged and/
or heavily soiled, the complete system must no longer be used.

All interventions in the existing system, changes to system components, enhance-

ments as well as internal cleaning and repairs may only be performed by your
authorised custo med dealer or custo med.

Technical safety check

After each system or device repair, modification or conversion, a technical safety
check must be performed by your authorised custo med dealer.

02.6 Disclaimer

The manufacturer is not responsible for improper operation, failure to comply with
the safety instructions and non-observation of specifications due to negligence.

custo med will only assume responsibility for the safety and reliability of the custo
cardio 100/110/130 when all changes, enhancements, repairs and other work to the
device or system have been performed by an authorised custo med dealer or custo
med and the Operating Manual has been observed during device operation.

14 Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH
02.7 Warranty

Our product philosophy is committed to providing you with faultless products which
meet your expectations. Should you have reason to complain we aim to rectify any
defects immediately or provide a replacement delivery.

This does not include damage that can be attributed to usual wear and tear, impro-
per use, unauthorised modification of parts and the use of violent force.

After the expiration of the warranty period only use original spare parts and
accessories from custo med. This is the only way to ensure the safe and trouble-free
operation of your device.

Warranty periods
custo cardio 100/110/130 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 months
neoprene case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . without warranty
carrying belt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . without warranty
ECG electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . without warranty

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 15
03 Description of device, basic instructions for initial operation

03.1 Part names, components for ECG recording

custo cardio 100 (USB)

custo cardio 100 (USB) ERG
Neoprene case, Carrying belt
ECG electrodes

custo cardio 110 (USB)

Neoprene case, Carrying belt
ECG electrodes

custo cardio 100 BT ERG

custo cardio 110 BT
Neoprene case, Carrying belt
ECG electrodes
Rechargeable lithium-ion battery
Charger with power supply unit
Bluetooth USB stick

Note about the electrodes

For optimal results, we recommend using high-quality
ECG electrodes, e.g. custo sensive, and custo prep ECG
cream to prepare the electrode application points.

custo cardio 130

ECG PC module
with 15-pin ECG input connector
(D-Sub screw connection or Siemens plug)
for connection of suction system
or patient cable

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Notes about on custo cardio 100 ERG
The systems with the "ERG" addition have shortened patient cables. The cable
lengths of the patient leads are adjusted /customised to the electrode application
points. The excess cable lenghts are reduced, leading to improved ECG quality. We
recommend this version for stress ECG.

Length of patient cables for ERG systems

custo cardio 100 ERG, custo cardio 100 BT ERG

R, L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .approx. 700 mm
C4 – C6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 650 mm
N, F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 600 mm
C1 – C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 500 mm

Length of patient cables for standard systems

custo cardio 100, custo cardio 110, custo cardio 110 BT

R, L, F, N. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 1050 mm
C1 – C6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .approx. 700 mm

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 17
07 Product information

07.1 Technical data and system requirements

Technical data of custo cardio 100/110/130
Frequency response 0.05 – 500 Hz
Accuracy < 1.5%
Time constant 3.2 sec
Sampling rate 1.0ms / 1000 Hz for extremities and chest wall
0.25ms/ 4000 Hz for pacemaker
A/D converter 24 bit
Input impedance > 50 MΩ
Amplitude quantification 0.3 μV/bit
CMRR > 70 dB
Impedance measurement *) At all electrode leads (not N) with automatic quality indication
Defibrillation protection Electrical strength 5000 V
Recovery time after defibrillation < 10s
Voltage supply USB devices USB cable
BT devices Rechargeable lithium-ion battery
Energy consumption Max. 2.5 watt during recording
IT connection USB (cable length 2.50 m)
or Bluetooth (range up to 80 m, depending on ambient conditions)
Software, additional functions Power filter, muscle filter,
(custo diagnostic) AD filter (Anti-drift), pacemaker recognition
Operating conditions Temperature +10°C ... +40°C
Air humidity 25 ... 95% rH
Air pressure 700 ... 1060 hPa
Transport and storage Temperature -20°C ... +45°C
conditions Air humidity 25 ... 95% rH
Air pressure 700 ... 1060 hPa
Dimensions Size custo cardio 100/110 approx. 160 * 85 * 25 mm (L * W * H)
Size custo cardio 130 approx. 160 * 78 * 32 mm (L * W * H)
Weight custo cardio 100/110 approx. 300 g
Weight custo cardio 130 approx. 430 g
Patient leads custo cardio 100/110 approx. 1050 mm (extremities)
approx. 700 mm (chest)
custo cardio 100 ERG approx. 600 – 700 mm (extremities)
approx. 500 – 650 mm (chest)
custo cardio 130 15-pin ECG input connector
(D-Sub screw connection or Siemens plug)
Classification Safety class II (custo cardio 100/110/130 USB)
Safety class III (custo cardio 100/110 Bluetooth)
Class IIa
Type BF defibrillation protected (not intracardiac)
IEC 60601-1
IEC 60601-2-25
IEC 60601-2-51
*) Does not apply to Bluetooth devices

66 Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH
System requirements
Operating system Windows XP (x64)
Windows Vista (x64)
Windows 7 (x64)
Windows Server 2003 (x64)
Windows Server 2008 (x64)
Windows Server 2008 R2
older versions are not supported
PC The PC hardware must meet the minimum requirements
of the operating system used.
custo diagnostic requires additional RAM (256 MB).
Ensure that there is enough free hard disk space
for the custo diagnostic evaluations.
File size of the evaluations Holter ECG approx. 15 MB (max. 60 MB)
ABPM approx. 128 KB (max. 512 KB)
Resting ECG approx. 200 KB (approx. 10 sec ECG)
Stress ECG approx. 6 MB (approx. 20 min. ECG)
CPET see Stress ECG
Spirometry approx. 50 KB (max. 256 KB)
Rehab approx. 6 MB (approx. 45 min. training session)
Hardware & ports DVD or CD-ROM drive
USB port

07.2 Support

If you have any questions or problems which are not dealt with here, please do not
hesitate to contact your authorised custo med dealer. A list of the authorised custo
med dealers can be found in the Internet under [Link], in the category
Contact, Dealers.

You can also contact custo med GmbH directly at any time. We will be pleased to
provide you with information about your authorised custo med dealer or contact
your authorised custo med dealer and forward your queries.

Resting and Stress ECG with custo cardio 100/110/130 and custo diagnostic | GEB 0160 – DK 1161 | Version 002 – 20.02.2012 | custo med GmbH 67
Manufacturer’s contact details:
custo med GmbH
Leibnizstr. 7
85521 Ottobrunn
Germany

Phone: +49 (0) 89 710 98 - 00

Fax: +49 (0) 89 710 98 - 10
Email: info@[Link]
Internet: [Link]
Service Manual

custo cardio 100/110 USB

Required tools:
- Different screw drivers
- Forceps
- Soldering iron
- PC with custo diagnostic

Required spare parts:

41524 ECG-lead set
32628 screw cover even
32629 screw cover bent
Additional spare parts:
41523 USB connection cable
37618 housing upper part cardio 100/110
37596 housing lower part cardio 100/110

Procedural method:
1. Prepare the device

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custo cardio 100/110 USB

2. Remove the screw cover

3. Screw cover removed

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custo cardio 100/110 USB

4. Unplug the 6 screws with a screw driver

5. Remove the upper part of the cover

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custo cardio 100/110 USB

6. Remove the screws

7. Lift the board out

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custo cardio 100/110 USB

8. Removed board

9. Remove strain relief for ECG leads

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custo cardio 100/110 USB

10. Unsolder protection cover at both sides

11. Detach the protection cover

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custo cardio 100/110 USB

12. Unsolder the broken ECG lead and pull off rubber grommet

- Clean the soldered joint

- Reinstall and solder the new ECG lead
- Reinstall strain relief
- Solder the protection cover
- Put the board in bottom part and bolt down
- Screw the upper part of the cover with the bottom part
- Connect the cardio 100/110 to a PC and use custo diagnostic for functional test
- If the test was successful please fix the two screw covers.

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