Custo Med custo cardio 200 User manual

Operating Manual
ABPM
with custo screen 200 and custo diagnostic
Operating Features:
> custo diagnostic version 3.7.x
> Windows version (2000, XP, Vista)
GEB 0123 – DK 0907
Version 002 – 09/04/2009

Operating Manual
ABPM
with custo screen 200 and custo diagnostic
©2009 custo med GmbH
We point to the fact that this manual must not be partly or com-
pletely copied, reproduced in any form or translated into another
language, without the previous written permission of custo med
GmbH.
The manufacturer reserves the right to modify the indications
in this manual without prior notice. The current version can be
downloaded from our Internet site: www.customed.de, under
Support, Downloads, Manuals.
Contact data of the manufacturer:
custo med GmbH
Leibnizstr. 7
85521 Ottobrunn
Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Internet: www.customed.de

4ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
Contents
01
02
03
04
05
06
Introduction
01.1 Symbols on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
01.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
01.3 Symbols in the Operating Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Instructions
02.1 General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
02.2 Operator Instructions and User Qualications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
02.3 Safety Installations and Safe Working. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
02.4 Information on EMC (Electromagnetic Compatibility). . . . . . . . . . . . . . . . . . . . . . . . . . . 12
02.5 Maintenance (Regular Safety Checks) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
02.6 Exclusion of Liability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
02.7 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Description of Device, Basic Instructions for Initial Operation
03.1 Scope of Delivery and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
03.2 Operating the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
03.3 custo diagnostic – Basic Program Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
03.4 Connection and Selection of Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Hygiene
04.1 Cleaning and Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
04.2 Approved Cleaning Agents and Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Carrying out an Examination
05.1 Preparing the Patient for the Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
05.2 Preparing the Recorder for Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
05.3 Attaching the Recorder to the Patient’s Body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
05.4 Start Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
05.5 Download Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
05.6 Control and Close the Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Working with the Evaluation
06.1 Display Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
06.2 The Workspace at a Glance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
06.3 Navigation and Structure in the Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
06.4 Viewing Modes in the Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
06.5 Conrm Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
06.6 Auxiliary Tools for Writing Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
06.7 Close Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
06.8 Archive Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
07 Product Information
07.1 Presentation of Measured Values and Status in the Display. . . . . . . . . . . . . . . . . 34
07.2 Error Codes and their Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
07.3 Limit Values for Blood Pressure Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
07.4 Abbreviations in the Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
07.5 Technical Data and System Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
07.6 Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
07.7 Manufacturer’s Declaration on EMC (Electromagnetic Compatibility) . . . . . 40
07.8 EC Declarations of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
07.9 Shutdown, Storage and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
07.10 Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

6ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
Introduction01
01.1 Symbols on the Device
CE mark
Safety class designation of a medical electrical device according to
DIN EN 60601-1 (type BF)
Suitable for application with XXL blood pressure cu
Take note of the accompanying documents
Follow the operating manual
Recyclable material
Separate collection of electric and electronic equipment,
do not dispose with domestic waste
01.2 Intended Use
custo screen 200 is an ABPM recorder and serves for recording, analysing and
evaluating the blood pressure behaviour of a patient. The recording period is
24 hours. custo screen 200 can be applied with pacemaker patients without
any risk.
The device is not suited for small children or newborns as well as for the
unsupervised use with unconscious patients.

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
01.3 Symbols in the Operating Manual
In this operating manual the following symbols are used for marking important
information, comments and hints:
INTERDICTIONS
and undue behaviour, what you must not do in any case!
BEWARE
of situations which could result in personal or property damage
NOTE
important information and comments which you must absolutely observe
HINT
practical tips for facilitating work for you
Highlighted words in colour mark buttons or click paths to the described
program part, e. g. Examination, ABPM
Highlighted items

8ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
02 Safety Instructions
02.1 General Notes
The observation of the safety instructions prevents from personal and property
damages while using the device. This operating manual is an integral part of
the product and must be kept close to the device. As operator/user of this de-
vice you should have read and understood this operating manual, particularly
the safety instructions.
Product Relevant Laws and Regulations
This system is designed according to MDD 93/42/EWG (Medical Device Direc-
tive) class II a, and complies with safety class I or II (depending on the power
supply unit), type BF, according to DIN EN 60601-1
Further devices which are part of the system must comply with the Standard
for Safety of Information Technology Equipment (DIN EN 60950) and the
Standard for Electro-Medical Devices (DIN EN 60601-1).
The electrical installation of the rooms in which the system is operated must
comply with the requirements of current safety norms.
02.2 Operator Instructions and User Qualications
As operator you are responsible for:
Making sure that the operating sta get a technical brieng on the device and
take note of the operating manual
The intended application through trained, qualied sta
The compliance with safety regulations, safety instructions,
precautions for occupational medicine and accident prevention
The observation of maintenance instructions
The users must:
Be briefed on the correct operation of the device,
master required processes for handling,
know the valid safety regulations for the operation of such devices
and be informed about potential dangers.
Only medically qualied sta are permitted to operate the device, e.g. medical
secretaries, nurses, assistant medical technicians, physicians, etc.
For users outside the Federal Republic of Germany, those measures for
accident prevention, regulations and requirements apply which are valid in
the respective country.

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
02.3 Safety Installations and Safe Working
custo screen 200 is allowed to be operated in technically awless condition
only. Carry out a visual inspection of the device regularly. Only use accessories
approved by custo med.
Assembly of the System
Power bars must not be put on the oor.
Power bars delivered with the system, only serve for supplying devices which
are part of the system.
Additional power bars, wires and resources which are not parts of the system,
must not be connected to the system.
When using a power bar, the maximum permissible load is 3200 VA.
Slots within the supplied system which are not used (power bars) must be
closed with device cover plates.
Environmental Conditions, Handling
custo screen 200 is not suited for the operation in explosive rooms and/or
areas.
Strong electromagnetic sources in the near vicinity of custo screen 200 may
lead to faulty measurements (e. g. HF electrosurgical instruments, mobile
phones, inductions cookers).
The device must be protected against the intrusion of humidity, dust or dirt
and against mechanical impacts such as fall or transport damages.

10 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
02 Safety Instructions
Patient Safety
Without medical safety devices, e.g. medical protector, the PC and all non-
medical connected instruments (e.g. monitor and printer) of the system must
be installed and operated in a distance of at least 1.5 m to the patient seat
(see orange area in the illustration) because leakage current might occur.
During routine maintenance works on non-medical devices of the system,
the patient must not be touched (danger of electric shock).
All reports of the system must be considered as suggestions only. For diag-
nosis and therapy the control and evaluation of the results through a qualied
physician is indispensable.
Important hints regarding the handling of custo screen 200
See to it that the patient is not permanently impaired due to the short
interruption of blood circulation caused by the measuring method.
Any compression or reduction in cross-sectional area of the air tube must be
avoided.
The device does not have any protection against potential impacts by high
frequency (HF) surgical devices.
Risks arising from debrillator discharge according to the Standard EN
60601-2-30 are not known.
In no case use damaged batteries or accumulators. If custo screen 200 stands
idle for a longer time, remove the batteries from the device.
If liquid is spilled on the device, the batteries or accumulators must be remo-
ved immediately and the device must be sent to your authorised custo med
dealer or to custo med for inspection.
Safety distances between the patient
and the devices
1.5 m
1.5 m 1.5 m
1.5 m 1.5 m
2.5 m 2.5 m
1.5 m

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
Hygiene
When cleaning and disinfecting, the legal prescriptions and the current state of
the art of technology must be considered.
Use only cleaning and disinfecting agents approved by custo med. Clean
and disinfect your device according to the instructions in chapter 04 Hygiene.
System and Data Security
The device must only be operated with the supplied custo med software (custo
diagnostic).
As operator of the system you are responsible for data backups (e.g. patient
databases, evaluations, etc.) and system backups. We recommend carrying
out a data and system backup before eecting new installations, updates and
fundamental system congurations at the latest.
custo diagnostic new installations, updates and system congurations must
only be eected through your authorised custo med dealer.
Modify data generated in custo diagnostic only in custo diagnostic and not
in your EPR system (Electronic Patient Record) or your HIS (Hospital Informa-
tion System).
custo med does not assume any responsibility for potential changes to the
data which are made after the export from custo diagnostic in your EPR system
or HIS.
In order to assure a safe operation of custo diagnostic, disable the screen saver
and the energy management in your Windows operating system.
Install your Windows operating system in a way that neither accidental nor auto-
matic switching o of the PC or notebook during the examination is possible.
(Standby mode / sleep mode).

12 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
02 Safety Instructions
02.4 Information on EMC (Electromagnetic Compatibility)
The use of other accessories, other converters and wires than the ones indi-
cated, except for the converters and wires sold by custo med as spare parts
for inner components, can lead to increased electromagnetic emissions or to a
reduced electromagnetic immunity of the system. For connecting the device
to other equipment, only specially screened cables supplied by custo med
must be used.
You will nd further information on this subject under 07.7 Manufacturer’s
Declaration on EMC (Electromagnetic Compatibility).
02.5 Maintenance (Regular Safety Checks)
The operator is responsible for maintenance. The operator has to make sure
that the device is checked for proper condition every two years at the latest.
The functionality and the condition of the accessories must be controlled at re-
gular intervals. In the event of damages and/or coarse pollution the complete
system is no longer allowed to be operated.
All interventions into the existing system, changes to system components,
extensions as well as interior cleaning and repairs must only be carried out by
your authorised custo med dealer or by custo med.
Technical Safety Controls
After each repair, modication or conversion of the system or device a technical
safety control through your authorised custo med dealer must be carried out.
Metrological Controls
For the ABPM recorder custo screen 200 metrological controls are prescribed
every two years. Please contact your authorised custo med dealer.
02.6 Exclusion of Liability
The manufacturer is not liable for improper use, failure to observe the safety
instructions and negligent disregard of guidelines. custo med will only assume
responsibility for the safety and reliability of the custo screen 200 if all changes,
extensions, repairs and other works on the device and/or system are eected
by authorised custo med dealers or by custo med and if the operating manual
is being followed.

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
02.7 Warranty
It is our product philosophy to supply faultless products only, matching your
expectations. However, if you have legitimate complaints, we will be anxious
to remove the defects immediately or to provide a compensation delivery.
Excluded are damages due to usual wear and tear, usage for purposes other
than intended, unauthorised modication of parts and severe force eects.
Even after the guarantee expires, use original spare parts and accessories by
custo med exclusively. Solely in this case a safe and faultless operation of your
device will be assured.
Warranty periods
12 months custo screen 200
custo com USB
6 months Blood presssure cu
without warranty Carrying bag and belt

14 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
03 Description of Device, Basic Instructions for Initial Operation
03.1 Scope of Delivery and Accessories
custo screen 200 ABPM recorder
Blood pressure cu (standard)
Carrying belt
Carrying bag
Batteries (3 pieces)
Mignon 1.5 Volt, Type AA
custo com USB
Infrared interface for connection
of custo screen 200 to the PC
(included in delivery
when purchasing a system)
USB cable for connection to the PC

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
03.2 Operating the Device
Insert batteries or accumulators
Open the battery case as illustrated on the left
and insert three customary batteries or accumula-
tors. The direction of insertion is shown on the illus-
trations in the battery case.
Functional elements on the device
Turn-on-o button:
for turning on and o the recorder
Infrared interface:
for transferring data between
custo screen 200 and PC
Port for blood pressure cu
Functional key
for starting and stopping measurements
Display
for showing results and error messages
(Errors see chapter 07.2 Error Codes and
their Causes)
Port for blood pressure cu

16 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
03 Description of Device, Basic Instructions for Initial Operation
03.3 custo diagnostic – Basic Program Structure
The program is divided into three areas – User, Patient and Examination. This
structure always allows to recognise who (which user) with whom (which pati-
ent) is carrying out which kind of examination.
The main menus of the corresponding areas can be accessed by clicking on
User, Patient or Examination.
In the main menu of the screen area User, the users of the system can be crea-
ted and administrated. The user administration allows to grant user rights and
to control user-specic settings, e. g. the implementation of a proper patient
database for each user.
In the main menu of the area Patient, the patient administration takes place.
Among the most important functions are Search Patient, New Patient and
Search Evaluation.
In the main menu of the area Examination, all types of examinations which are
possible with custo diagnostic are listed. All modules which you do not possess
are inactive – this can be distinguished due to the light grey font. In this menu
you can also access the area Settings. There program-wide, examination-rela-
ted and user-specic settings can be established.

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH
03.4 Connection and Selection of Device
For the following steps custo diagnostic must be installed on your PC. Data
transfer between recorder and PC is made via the infrared interfaces on custo
screen 200 und custo com USB.
Installing custo com USB (infrared interface)
For data exchange between the recorder and your PC the driver for custo com
USB must be installed on your PC (the driver is installed automatically during a
custo diagnostic standard installation) and custo com USB must be connected
to the PC.
Check in the Device Manager which COM connection is assigned to custo com
USB so that you can enter the COM connection in custo diagnostic afterwards.
Make a right click on the icon My Computer in your Windows surface, on Admi-
nister in the context menu, there on Device Manager (left window half), open
the item Connections (COM and LTP) in the right window half and make a note
of the custo com USB connection, e. g. (COM5).
Open the page Examination, Settings, Interface, Device in custo diagnostic.
Select custo com USB under Device and the corresponding COM connection
from the Device Manager under Interface. Your inputs will be taken over with
Save.
Installing custo screen 200
Open the page Examination, ABPM, Settings, Device, Device Connection.
Activate custo screen 100/200. In the eld Connection, custo com USB must
be specied. Your inputs will be taken over with Save. Your device is ready for
operation.

18 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
Hygiene04
04.1 Cleaning and Disinfection
Important specications
Use only cleaning and disinfecting agents approved by custo med. The use of
unsuitable agents may damage the device. Consider the manufacturer’s inst-
ructions (e. g. regarding dosage and residence times)
Under no circumstances must the device or the cu be immersed in liquids or
be washed with too much water.
custo screen 200
Cleaning: custo screen 200 should always be clean and aesthetic from out-
side. If there is dirt, rub o the surfaces slightly with a damp cloth and an acid-
free cleaning agent.
Disinfection: The authorised disinfectants area allowed to be sprayed on
slightly.
Carrying bag and belt
Cleaning: Bag and belt can be washed in the washing machine at 30°C with a
mild detergent, however must not be put into a dryer.
Blood pressure cu
Cleaning: After use, the blood pressure cu should be cleaned from dirt and
sweat. Rub o the surfaces slightly with a damp cloth and an acid-free cleaning
agent.
Disinfection: The authorised disinfectants can be sprayed on slightly.
04.2 Approved Cleaning Agents and Disinfectants
Cleaning Agents
for custo screen 200 and blood pressure cu
mild soap, neutral cleaning agent
usual dishwashing agents
Disinfectants
for custo screen 200 and blood pressure cu
Fugaten Spray (Lysoform)
Esemx (Schülke & Mayr)
Discuss the application of other cleaning agents and disinfectants with your
authorised custo med dealer.

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ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK -0907 | Version 002 – 09/04/2009 | custo med GmbH

20 ABPM with custo screen 200 and custo diagnostic | GEB 0123 – DK 0907 | Version 002 – 09/04/2009 | custo med GmbH
Carrying out an Examination05
05.1 Preparing the Patient for the Examination
Applying the blood pressure cu
In order to attach cu and tube optimally, the
patient should undress to the waist.
Tip for applying the blood pressure cu:
Slip the patient a tube bandage over the left upper
arm – take a suciently sized piece so that you can
put the bandage bottom-up over the cu later. Thus
you increase the level of hygiene and the wearing
comfort.
Attach the cu to the left upper arm, two to three
centimetres above the crook of the arm. Apply the
cu in a way that the marking is situated on the
arteria brachialis. The cu must not be attached
too rmly. It should still be possible to put approxi-
mately two ngers between arm and cu.
Lay the tube from the left shoulder over the right
shoulder to the right hip. There, the recorder will be
placed later.
Fix the cu and the tube at the patient’s body. Thus
faulty measurements due to incorrect cu or tube
position are excluded.
Attaching the carrying belt
Attach the carrying bag to the carrying belt. Apply
the carrying belt with the patient. The bag should
be positioned on the patient’s right hip.