990 82gicsten103

BTL SERVICE
General Instructions And

Common Service Tasks
About Document
Document Revisions and History
Date: Date: Previous

Version: Change description:
Created by: Approved by: version:
Changes in sections 1.8, 1.9, 2.6 2016-12-29 2016-12-29

103 102
Added section 2.5 Tomáš Jindra Viktor Pokorný
Changes in sections 1.9, 2.1

2016-01-11 2016-01-11
102 Added subsections 1.5.2, 2.4.2, 2.4.3, Tomáš Jindra 101
Viktor Pokorný
2.5.2
Changed reporting in section 1.9 2013-01-02 2013-01-02

101 100
Added section 1.11 Viktor Pokorný Viktor Pokorný
2012-11-20 2012-11-20
100 Initial version N/A
Viktor Pokorný Viktor Pokorný
i
Symbols and Comments
General warning, caution, risk or danger
IMPORTANT Please pay close attention to the information given
NOTE Additional recommending information
IMPORTANT: This service documentation has been designed to provide

information required for performing safe service repairs and maintenance tasks
on the Device.
All service and maintenance tasks stated in the service documentation can be
performed only by properly trained service technician.
Do not service any parts, components and Accessories of the Device for which
there is no repair description stated in the service documentation.
For Device specific service tasks please refer to the Device “Service Manual”.
For detail or specific information from user point of view please refer to the
“Operator’s manual”.
Failing to follow the instructions given in the service documentation can result in
loss of warranty.
NOTE: Following terms are used in the document:
Device = Unit + Accessories (Applicator, Handpiece etc.)
ii 990-82GICSTEN103
About Document
Document Structure
General Instructions and Common Service Tasks is document which contains general
information and tasks common to all Devices and is issued as an external file that belongs
to the Green Part of each Device “Service Manual“.
The Green part represents the essential know-how every service technician should be
familiar with. More information about the color parts is given in the Device “Service
Manual”.
This document is not a subject of frequent revisions. It is recommended that the printed
version of the document should be put into a binder.
IMPORTANT: This document is intended for service facilities at BTL distributors.

The document is also applicable internally in BTL but only if there is no relevant
internal document (SOP, PP) covering required field. If such internal document
with relevant instructions exists, it must be prioritized.
iii
iv 990-82GICSTEN103
BTL SERVICE
Table of Contents
Document Revisions and History .................................................................................................... i
Symbols and Comments................................................................................................................... ii
Document Structure ......................................................................................................................... iii
v
1 General Instructions ................................................................................................................... 1-1
1.1 Safety .................................................................................................................................... 1-3
1.2 Service Standard IEC 62353 .......................................................................................... 1-4
1.3 Technical Support.............................................................................................................. 1-7
1.4 Technical Trainings ........................................................................................................ 1-10
1.5 Service Documentation................................................................................................. 1-13
1.6 Service Tools .................................................................................................................... 1-18
1.7 Service Case Workflow ................................................................................................. 1-19
1.8 Complaints........................................................................................................................ 1-25
1.9 Service Reporting ........................................................................................................... 1-27
1.10 Recommended Practices ......................................................................................... 1-33
1.11 Examples of Service Cases ...................................................................................... 1-40
2 Common Service Tasks ............................................................................................................ 2-1
2.1 Operation Modes ............................................................................................................... 2-3
2.2 Event Logging ..................................................................................................................... 2-6
2.3 Error Codes System........................................................................................................... 2-9
2.4 Common Device System Features ............................................................................. 2-11
2.5 BTL License Server ......................................................................................................... 2-16
2.6 Common Tasks................................................................................................................ 2-17
2.7 Periodical Inspection...................................................................................................... 2-35
2.8 Electrical Safety Measurement ................................................................................... 2-36
2.9 Advanced Repairs ........................................................................................................... 2-42
2.10 Troubleshooting Basics............................................................................................. 2-43
vi 990-82GICSTEN103
BTL SERVICE
1 GENERAL INSTRUCTIONS
1.1 Safety ........................................................................................................................................ 1-3
1.1.1 Service Technician Safety ........................................................................................... 1-3
1.1.2 Operator and Patient Safety ....................................................................................... 1-3
1.1.3 Device Safety Checking ............................................................................................... 1-4
1.1.4 Adverse Events .............................................................................................................. 1-4
1.2 Service Standard IEC 62353 .............................................................................................. 1-4
1.3 Technical Support .................................................................................................................. 1-7
1.3.1 Technical Support Structure ...................................................................................... 1-7
1.3.2 Support Request............................................................................................................ 1-8
1.3.3 RMA Number ................................................................................................................. 1-9
1.4 Technical Trainings ............................................................................................................ 1-10
1.4.1 Certificates ................................................................................................................... 1-12
1.5 Service Documentation ..................................................................................................... 1-13
1.5.1 Service Documents.................................................................................................... 1-13
1.5.2 BTL Service Server ..................................................................................................... 1-15
1.5.3 BTL Service Info .......................................................................................................... 1-18
1.6 Service Tools ........................................................................................................................ 1-18
1-1
1.7 Service Case Workflow ..................................................................................................... 1-19
1.7.1 Service Cases Management .................................................................................... 1-23
1.8 Complaints ............................................................................................................................ 1-25
1.9 Service Reporting ................................................................................................................ 1-27
1.9.1 Report Number ........................................................................................................... 1-27
1.9.2 Service Record ............................................................................................................ 1-28
1.9.3 Final Inspection ........................................................................................................... 1-31
1.10 Recommended Practices .............................................................................................. 1-33
1.10.1 Transportation ............................................................................................................. 1-33
1.10.2 Installation of a Device .............................................................................................. 1-33
1.10.3 Cleaning ........................................................................................................................ 1-34
1.10.4 Decontamination ........................................................................................................ 1-34
1.10.5 Loaner Device.............................................................................................................. 1-37
1.10.6 Reference Device ....................................................................................................... 1-38
1.10.7 Spare Parts Stock ....................................................................................................... 1-38
1.10.8 Ordering of Spare Parts ............................................................................................ 1-39
1.10.9 Non-conforming Parts ............................................................................................... 1-39
1.10.10 Warranty................................................................................................................... 1-40
1.11 Examples of Service Cases........................................................................................... 1-40
1.11.1 Simple............................................................................................................................ 1-41
1.11.2 Complex ........................................................................................................................ 1-42
1.11.3 Difficult .......................................................................................................................... 1-45
1-2 990-82GICSTEN103
General Instructions
1.1 Safety
1.1.1 Service Technician Safety

Servicing of Devices must be carried out only by a technician who successfully
accomplished official BTL Technical training and is holder of actually valid Certificate
issued by BTL.
Every service technician is required to follow safety instructions given in the Device
“Service Manual“ or/and all other valid service documentation and become familiar with
them. For Device related safety features please refer to the Device “Service Manual“,
section “Service features”.
Only tools specified in the Device “Service Manual“ must be used to carry out the service
action.
To avoid electric shock or Device malfunction any liquids must not be allowed to come in
contact with unprotected electronic parts of the Device.
Never test or operate the Device in environments with imminent danger of explosion or
fire.
Any possible damages or injuries caused by breach of the safety instruction given in this
and other valid service documentation are the sole responsibility of the service technician
or service facility carrying out such repair.
1.1.2 Operator and Patient Safety

For Device specific safety instructions for operator and patient refer to Device “Operator’s
Manual”.
Safety of each Device shall be periodically checked to protect operator and patient from
any danger.
In case occurrence of any Adverse event connected with Device is being suspected it is
mandatory to immediately contact manufacturer of the Device and report all details related
to the event.
For more details about recognition and reporting of Adverse event refer to section
1.8 Complaints.
1-3
1.1.3 Device Safety Checking
Safety of each Device shall be checked regularly to verify that the Device is in working
order and does not present any danger for patient or operator. Such checks are performed
after each repair or modification, after receiving a loaner Device from customer to service
facility (see subsection 1.10.5 Loaner Device) or during Periodical inspection. The Device
safety checking is part of procedures described in documents “Final Inspection Report” and
“Maintenance and Safety Report”.
For more details about Device safety check and related documentation refer to sections
1.2 Service Standard IEC 62353, 1.9.3 Final Inspection and 2.7 Periodical Inspection.
1.1.4 Adverse Events

When a Device is being used, a situation, which is suspected to be endangering for safety
of patient or operator, can occur. Such situation called Adverse event shall be reported to
manufacturer of the Device as a Safety related complaint. BTL has implemented system
for logging and recognizing the Safety related complaints to be able to take corrective
action.
For more details about Complaints and their reporting refer to section 1.8 Complaints.
1.2 Service Standard IEC 62353

Service standard IEC 62353 defines procedures for performing of inspection of medical
electrical equipments (in BTL documentation referred as Device or Unit). The standard is
applicable on Devices built in compliance with IEC 60601-1.
There are defined three types of Inspections of a Device:
Inspection After repair - the inspection shall be performed if any repair or modification of
Device has been carried out. As official record about performing of the test after repair of
BTL Device, “Final Inspection Report” shall be used. For more information please refer to
subsection 1.9.3 Final Inspection.
Recurrent test is intended for periodical verification of safe and correct function of Device.
Period for performing of the test is primarily defined in specific Device “Operator’s manual”.
In case no period is defined, the standard requires performing the test in range 6 and 36
months after previous recurrent test. For BTL Devices it is recommended to perform first
recurrent test 24 months after installation and then each 12 months. If possible, the test
should be performed in customer’s place. As official record about performing of the
recurrent test of BTL Device, “Maintenance and Safety Report” shall be used. For more
information please refer to section 2.7 Periodical Inspection.
1-4 990-82GICSTEN103
Test before putting into service can be performed on request of customer during
installation of Device at customer’s place. The test is optional for BTL Devices as BTL
declares that its final production testing fully replaces on-site testing before putting into
service. On the other hand the test shall be performed if requested by customer or if service
technician suspects the Device could be damaged by rough handling during transportation
in original packing or was transported in unoriginal packing. As official record about
performing the test, “Maintenance and Safety Report” shall be used.
All types of Inspections mentioned above include procedures for performing visual
inspection of the Device (condition of its covers, cables, accessories etc.), electrical safety
measurement, verification of functionality of safety and essential performance elements
and other features of the Device.
Electrical safety measurement described in the standard is derived from standard

IEC 60601-1 for production and simplified to be feasible in common service practice.
Compared with IEC 60601-1, none of these tests is destructive and does not present any
danger for tested Device.
Electrical safety measurement according to IEC 62353 includes checking of:
 protective earth resistance
 equipment leakage current
 applied part leakage current
 insulation resistances
IMPORTANT TERMS
Applied part necessarily comes into direct physical contact with the patient. The standard
divides applied parts into classes B (Body), BF (Body floating) and CF (Cardio floating) with
increasing degree of insulation against other parts of Device. Applied part of class B is
usually connected directly to protective earth. F-type applied parts (BF, CF) feature
insulation barrier in circuit of patient output to limit leakage currents through the patient
and increase his protection. In BTL service documentation the applied part is referred as
Applicator or Handpiece.
Accessible conductive parts are metal parts of Device, which can be touched by operator
or patient. The standard distinguishes between earthed (connected to protective earth)
and non-earthed accessible conductive parts (insulated from protective earth).
Protection class of Device defines degree of protection against electrical shock. Devices
are designed in two Protection classes:
1-5
 Protection class I contains only basic insulation in mains part, accessible metal
parts of the Device are connected to protective earth to ensure sufficient protection
of operator and patient.
 Protection class II contains basic and double or reinforced insulation in mains part
to ensure sufficient level of protection for operator and patient. Devices in this class
can be equipped by a functional earth terminal, which is not intended to be used
as any kind of protection.
Protective earth resistance presents resistance between all protectively earthed parts of
the Device (usually all metal covers) and protective earth terminal of mains plug. Total
resistance of the path shall be lower than 300 mΩ. Mains cable should be mechanically
stressed during the measurement to verify its conductivity under all conditions. The test is
applicable only for Devices in Protection class I. Current in measuring circuit during the
test shall be at least 200 mA. Hence, it’s not possible to perform the measurement with
common multimeter. Measuring equipment, which measures in accordance with standard
IEC 62353, should be used.
Equipment leakage current can flow from all applied and metal accessible parts to
ground in normal or single fault condition. It presents current which can flow through
operator or patient when touching any conductive part of a Device. There are three
methods for measuring the leakage current; we prefer using of direct method over the
others. Leakage current shall be measured in both polarities of mains and higher value
shall be documented. Limits for the Equipment leakage current for direct method are
500 µA for Protection class I and 100 µA for Protection class II.
Applied part leakage current flows between F-type applied part and metal parts of
a Device (accessible conductive parts + protective earth) when external voltage (typically
mains voltage) is applied. The measuring simulates presence of mains voltage on applied
part e.g. patient is connected with the Unit by Applicator and also touches Line pin in mains
plug or live wire. Measured value represents current flowing through patient’s body under
this condition. There are three methods for measuring of the leakage current; we prefer
using of direct method over the others. Leakage current shall be measured in both
polarities of mains and at least higher value shall be documented. Limits for Applied part
leakage current measured by direct method are 5000 µA for BF type and 50 µA for CF
type.
Insulation resistance measurement is intended to check condition of insulation barriers

between following parts of a Device: mains parts - protective earth, mains parts - non-
earthed accessible parts, mains parts - applied parts, applied parts – protective earth,
applied parts - non-earthed accessible parts. Test voltage is 500 VDC, lower value
250 VDC may be used if overvoltage protection is included in the Device or the higher
voltage would endanger functionality or safety of the Device. Limits for Insulation
1-6 990-82GICSTEN103
Resistance are between 2 – 70 MΩ in dependence on type of performed measurement.

Detailed description of the limits is in standard IEC 62353, chapter 5.3.3.2, Table 2.
1.3 Technical Support

Technical support is responsible for installations, maintenance and repairs of Devices. The
structure involves all service technicians, helpdesk and management of the support.
Detailed organization of Technical support is described below.
1.3.1 Technical Support Structure

Structure of BTL Technical support is divided into three levels:
Service technicians carry out installation of Devices, their repairs (including Final
inspection after repair) and Periodical inspection. Data about service cases are reported to
BTL (find details in section 1.9 Service Reporting). Technicians also answer technical
questions of customers and assist them with common tasks during operation of the
Device. All service technicians shall be properly trained and receive Technical training
certificate entitling them to perform servicing of Devices.
International Service Center (further

referred as BTL ISC) is responsible for:
 technical support of service

technicians during solving of
technical issues;
 performing of common and advanced

repairs;
 providing of spare parts and service

tools;
 providing of HW and Time limitation keys;
 collecting of faulty components from service cases for further analysis.
Service Operations Support (further referred as SOS) is responsible for strategy and
management of Technical support, collecting and evaluation of service reports, releasing
and controlling of service documentation, definition of spare parts and service tools,
administration of BTL service server, BTL license server and organization of technical
trainings. SOS takes over know-how about Devices from R&D and cooperates with BTL
ISC during solving exceptional service cases.
1-7
1.3.2 Support Request
During communication with BTL ISC the technician should keep a few basic principles to
simplify understanding of problems and speed up process of solving the requests.
You can contact BTL ISC if you need:
 help with technical problems;
 to send a Device to be repaired by BTL ISC;
 spare part;
 specific service tool;
 unlock code for a Device (HW key, Time limitation key);
 to send trash-box with failing components to BTL ISC;
 anything other and don’t know whom to ask.
The recommended procedure before contacting BTL ISC is:
 Collect as much information about the Device and failure as possible – serial
number, type, model and firmware version of the Unit and all connected
Accessories. Assign Report number to the service case (see 1.9.1 Report Number).
 Check Dialog history for recent Error codes (see subsection 2.2.2 Dialog History).
Export Unit log data as described in 2.2.3 Unit Log Data Export.
 Read Service documentation of the Device. Be sure you have the latest version of
all related documents.
 Ask some experienced colleague from your or another service facility.
 If previous steps were unsuccessful, try out to find the problem by exchanging of
whole blocks. For troubleshooting reasons you can use parts from Reference
device. See more details about Reference device in subsection 1.10.6 Reference
Device.
IMPORTANT: Never use parts from Reference device as spare parts for
customer’s Devices. Otherwise, traceability of serial numbers of Device’s
components will be lost. Only brand new spare parts can be used for repairing
of faulty Device to maintain standardized quality of repairs.
1-8 990-82GICSTEN103
After checking all above-mentioned steps, you can contact BTL ISC. This workflow
prevents BTL ISC from overloading by plenty of simple questions which solution can be
found in service documentation and solved individually by service technician.
Prepare all necessary information about the Device (Unit + Accessories), Report number
assigned to the service case, thorough and well-structured description of the problem,
found Error codes and undertaken actions. Unit log data, other documents, pictures or
videos describing the problem are appreciated. Brief information of kind “My Unit is not
working at all.” is not sufficient description of the problem from certified service technician.
If you are requesting spare parts for warranty case or based on instructions in service
bulletin, BTL ISC can be also contacted. Send them the same information about service
case as mentioned above. Based on these data BTL ISC decide if it is warranty case and
you should get the parts for free or not.
1.3.3 RMA Number

RMA number (Return Merchandize Authorization) is created by BTL ISC and is intended
for unique identification of service cases solved in cooperation with field service
technicians. The number has format
AF000000
where 00000 is a sequence number of the service case.
When contacting BTL ISC, the Service technician shall (next to other information) always
provide Report number of the service case assigned by his local service facility. BTL ISC
receives the requirement, assign own RMA number and pair it in internal system with
Report number. After that, BTL ISC uses only RMA number for further communication with
the technician, sending of spare parts and receiving of faulty parts.
BTL ISC does not use Report numbers to prevent mistakes in numbering of service cases.
NOTE: Sequence of RMA numbers is independent on sequence of Report numbers.
Example: Service facility in Poland received request from customer for repair of a Device.
 Technician assigns Report number PLA10024 to the service issue, fill in 1st page of
“Service record“ including Report number and send XML file from the Service record
to BTL.
1-9
 Analysis reveals faulty generator PCB under warranty.
 The technician sends request for spare generator PCB by email to BTL ISC. He
encloses Report number and details about the faulty Device (serial number, type
and model of the Device, connected Accessories etc.).
 BTL ISC generates RMA number, e.g. AF012764 and confirms receiving of the
request by email where the RMA number is stated.
 When the spare part is ready and packed, BTL ISC marks it by RMA number
AF012764 and sends it to service facility.
 After receiving and installing of the brand new spare part in service facility, the faulty
part is marked by Report number PLA10024 and stored in a box with non-
conforming parts. When the box is full, it is sent to BTL ISC for further analysis.
 Technician repairs the Device, perform Final Inspection and fill 2nd page of “Service
record“ where Report number PLA10024 has been used. XML file from “Service
record“ have to be sent to BTL together with scanned “Final Inspection Record”.
After that the service technician closes the service case.
For more information about Report number refer to subsection 1.9.1 Report Number.
1.4 Technical Trainings

During Technical training, service technician get thorough information about features of
Devices, methods of servicing, common service operations and service documentation.
Technical trainings are provided in a few qualification levels with different range of trained
skills and authorizations for performing service procedures.
Technical training Certificate issued after the training declares, that the holder of the
Certificate has been properly trained and meets requirements for BTL service technician.
The technician also receives access to BTL service server where complete service
documentation is available.
Calendar of planned Technical trainings is released at the beginning of each year and is
sent by email to all BTL distributors and service technicians. During the year, the calendar
can be updated.
1-10 990-82GICSTEN103
NOTE: For registration to Technical training or for details about planned trainings
contact SOS department (sos@btlnet.com). Deadline for registration to Technical
training is 1 month before the first day of the training.
1-11
1.4.1 Certificates
Technical training certificate authorizes its holder to perform service actions on Devices in
extent defined in the Certificate. Certificates are related to name of technician and to
company and are not transferable.
Technical training certificates are issued in four qualification levels:
Inspector
Inspector certificate holder can only perform maintenance, electrical safety and functional
inspections on Devices in compliance with the Service documentation. Additionally he can
carry out other service operations on Devices specified in IEC 62353 standard.
Standard
Standard certificate holder is allowed to:
 replace parts of the Devices, specified in the commercial price list or the service
price list in compliance with the respective Service documentation;
 carry out other service in accordance with the Technical training or additional
instructions from BTL ISC;
 upload software and firmware and insert memory modules in the Devices;
 perform maintenance, electrical safety and functional inspections on Devices in

compliance with the Service documentation and also carry out any other service
actions on Devices specified in IEC 62353 standard;
 provide information and technical support to customers within the scope of this
qualification level.
Advanced
Advanced certificate holder is allowed to carry out service operations allowed to holder of
Standard certificate and additionally to carry out repairs which are not described in Service
documentation. After such repair the Device must be in compliance with production
documentation and tested according to production final inspection procedure.
Professional
Professional certificate holder is authorized to train Service technicians for all above
mentioned certificate levels and to carry out service operations allowed to Advanced
certificate holder.
Technical training certificates are issued with validity up to 2 years. When the certificate
has been expired, it is necessary to renew it.
1-12 990-82GICSTEN103
1.5 Service Documentation

Service documentation contains detailed information about Devices important for solving
of technical issues and performing of Inspections. Documents have fixed internal structure
to keep it uniform and to facilitate their use for service technician.
1.5.1 Service Documents

Service manual is a document describing Device from service point of view. It contains
technical information about the Device, description of basic and advanced repairs,
troubleshooting and error codes, procedure for disassembly and list of spare parts and
consumables.
Service Manual is divided into four color parts - Green, Blue, Red and Yellow where each
part is represented by a color strip placed in the header of the document:
Green Part contains information about safety, maintenance and basic service tasks. This
part is further divided into two subparts:
 The first subpart is an external document called “General Instructions and Common
Service Tasks” which contains general information and tasks common to all
Devices.
 The second subpart contains complementary information specific for a particular
Device and is part of this Manual.
Green part describes procedures, which require basic servicing skills, and knowledge every
service technician should be familiar with.
Blue Part describes repairs done by replacement of whole component blocks. This chapter
should represent standard servicing skills and knowledge of a service technician. The Blue
part can also be complemented by description of the Device operation.
Based on the type of the document (“Service Manual” / “Service Quick Guide”) and the
technical complexity of the concerned Device the Blue part can describe all possible
component exchanges on the Device, or can be omitted in cases when such information
is not necessary (e.g. due to simplicity of some Devices).
NOTE: The preferred way of servicing Devices is replacement of either individual

components or larger functional blocks of the Device. All potential hardware problems
can be resolved by this manner.
1-13
Red Part contains guide for repairs that are alternative to the repairs specified in the Blue
part. Repairs mentioned in the Red part are generally more complex and skill demanding
(e.g.: exchange of components by soldering on a PCB or difficult component replacements)
and therefore considered as a non-standard way. There are however cases, when
mentioning of alternative ways of repair is beneficial.
Procedures described in the Red part must be carried out by experienced and appropriately
qualified service technician.
Yellow Part represents the core of the document, a minimum that should be present in
both types of the document (Service Manual / Service Quick Guide) for Device. Yellow part
contains mainly Device troubleshooting and spare part list.
The “Service Manual” is a document that is not a subject of frequent revisions. It is

recommended that the printed version of the document should be put into a binder where
each part is divided by colored tabulators. This will greatly enhance speed of finding the
requested information.
Service Manual Appendix contains the latest known service information and know-how
that is available to service technicians. The information is put into this section in its original
layout (e.g. “Service Bulletin”).
The Appendix is kept as an external document as it can be a subject of frequent changes.

After printing, the Sevice Manual Appendix becomes the latest chapter of the “Service
Manual”.
NOTE: Before starting using the document it is strongly recommended to make sure,
that you are using the latest available revision of the “Service Manual Appendix”.
When looking for any advice regarding to service repair please check the “Appendix”
chapter first as it can contain the most up-to-date information for the required repair.
Then continue with searching in the chapter “Troubleshooting Guide” of the “Service
Manual”.
In case any of the respective documents (“Service Manual”, “General Instructions and
Common Service Tasks”, “Service Manual Appendix”) do not contain the required
1-14 990-82GICSTEN103
information, or when further assistance is needed, refer to chapter 3 Technical Support

Contact.
Service bulletin contains specific procedure, which solves known problem of the Device
(e.g. systemic error) and is not described in “Service manual” yet.
It is recommended to print Service bulletin and insert it to chapter Appendix of “Service

Manual”. Information stated in Service bulletin is usually included into Device’s “Service
Manual” during next revision.
Final Inspection Report is intended for performing of Final inspection after each repair or
modification of a Device. The report includes visual inspection of the Device, electrical
safety measurement and check of correct setting and functionality of all parts. Completed
report should be printed and kept in a binder for evidence about performed Final
inspections. Organization of the procedure is in accordance with recommendation of IEC
62353. For more details refer to subsection 1.9.3 Final Inspection.
Maintenance and Safety Report is intended for performing of Periodical inspection of

a Device or for performing of Test before putting the Device into service (after installation).
The report includes visual inspection of the Device, maintenance, electrical safety
measurement, verification of functionality of all parts and cleaning. Procedures are
designed in accordance with recommendation of IEC 62353. Cleaning of the Device is not
defined by the standard. We consider it as a good practice and service for customer to
return the Device after maintenance in a better condition than during receiving into BTL
service. For more details refer to subsection 2.7 Periodical Inspection.
1.5.2 BTL Service Server

BTL service server is a web based portal for storage of service documentation, firmware
and other documents important for service technician as well as tutorials for server
operations. All documents on BTL service server are regularly updated. The server is
available on service.btlnet.com.
ACCOUNT
BTL service server is intended for service technicians with valid Technical training
certificate. A new account will be created upon issue of the Certificate. At the same time
the login details will be sent to the service technician by e-mail.
In case of expiry of the Certificate the account is suspended until the technician receives a
valid Certificate. For more information about Technical trainings and Certificates see
section 1.4 Technical Training.
1-15
BTL SERVICE SERVER DESCRIPTION
After receiving BTL service server account details find login screen on address
service.btlnet.com. It is highly recommended to change login password immediately after
first login. Find tutorial for this procedure in corresponding folder on the server.
Structure of the server
Double-clicking on the icon “File Station” will open the tree of accessible folders. There are
document directories named CardioPoint, DeviceDocs and GeneralDocs.
CardioPoint directory
CardioPoint directory contains documents, software and drivers related to BTL CardioPoint
software.
1-16 990-82GICSTEN103
DeviceDocs directory
Folder DeviceDocs contains documents, firmware, drivers and other necessary software
tools for Devices. Structure of each folder as shown below is the same for every device.
GeneralDocs directory
Directory GeneralDocs contains general documents and materials for service technicians.
For example in “01- Documents” folder the actual version of “General Instructions and
Common Service Tasks” document can be found together with “Decontamination
certificate”.
In “06-Service server” there are tutorials for the BTL service server available and in “08-
Others” a PC drivers and simulators of Devices are stored.
1-17
1.5.3 BTL Service Info
All service technicians with valid Technical training certificate will receive e-mail
notification called “BTL Service Info” every time a new service document, firmware or
information of their particular scope is released. BTL Service info contains overview of
published document, name of Device to which the content is related to and date of release.
The new content is released in an appropriate folder at BTL service server.
1.6 Service Tools

Service tools are recommended tools for performing of repairs and Inspections on Devices.
Tools are divided into three groups:
TOOLS FROM TOOL SET
Tool set for service technicians is set of basic tools as screwdrivers (Flat, Phillips, Torx, Nut),
spanners and pliers, special wrenches for Devices, cables for Firmware upload and other
tools for servicing of all Devices. Complete list of items in Tool set is in “GICST Appendix”.
The Tool set can be ordered from the BTL ISC.
SPECIFIC TOOLS
Specific tools are used for functionality verification of Devices (e.g. Dummy loads, Pressure
meter, Fluke cables set) or for performing of special procedures (e.g. Coolant extractor).
Using of these tools is described in document “Instructions for use” and in specific service
documentation. Complete list of available specific tools is in “GICST Appendix”. Specific
tools are not contained in Tool set, they can be ordered separately from the BTL ISC.
OTHER TOOLS
Other tools are necessary for common service actions and for some specific repairs. The
other tools have to be purchased separately by each service facility on local market. They
are not supplied by BTL ISC. List of other tools is always present in description of each
procedure. Among these tools belong mainly:
 Electrical safety analyzer Fluke ESA612 for measuring of leakage currents,

grounding and other safety parameters of Device
1-18 990-82GICSTEN103
 Multimeter Fluke 289 (alternatively Fluke 117 or 179) which is capable to be

calibrated and can be used as a reference measuring instrument
1.7 Service Case Workflow

Recommended workflow for processing of service cases for Devices is described below. It
should help to service facility manager and service technician to optimize processes during
solving of service cases.
1. REGISTRATION OF SERVICE CASE
After receiving a request for service action, try to obtain as much details about the issue
as possible.
The most important are:
 customer’s description of the problem;
 type, model, serial number and firmware of the Device;
 type, model, serial number and firmware connected Accessories.
Ask customer for supplementary pictures or videos related to the issue (e.g. photo of
damaged parts, videos of strange behavior of the Unit).
Assign Report number to the service case. Record all these data to your system and also
to the Part 1 of “Service record“. Save the record to folder dedicated for data from service
cases for future use and send it to BTL by pressing button “Send Report”.
IMPORTANT: Part 1 of the “Service Record“ must be sent to BTL in the date of
receiving a request for service action form customer.
For more details about document “Service record“ refer to subsection 1.9.2 Service Record.
NOTE: This step can be performed by logging person who is acquainted with the
procedure. Such distribution of work saves time to service technician.
2. INFORMING OF CUSTOMER ABOUT FURTHER STEPS OF SERVICE CASE
At least following day after receiving request for service action the customer must be
informed about further steps.
1-19
If possible, estimate probable cause of the error based of customer’s description. Check
availability of required spare part on service facility stock or check with BTL ISC its price
and delivery time in case it is not available locally. Calculate supposed price of the repair.
Inform customer about supposed cause of the error, estimated price and time of repair for
the Device. Agree with the customer mode of transportation of the faulty Device to and
from service facility (by courier, picked up personally by technician).
Service facility may also agree to loan a Device during the service action, calibration or
maintenance of the customer’s Device (usually if the service action would take significant
time).
For details about Loaner device refer to subsection 1.10.5 Loaner Device.
3. RECEIVING AND DECONTAMINATION OF FAULTY DEVICE
When the faulty Device is received in service facility, it has to be placed in HOT
decontamination zone including its original packing to prevent spreading of possible
infections. If “Equipment Decontamination Certificate” is enclosed the Device can be
moved directly to CLEAN zone. If there is no document about decontamination, a trained
service technician has to perform it.
After decontamination service technician has to pack the Device in new plastic bag, fill in
“Equipment Decontamination Certificate” and enclose it to the Device. Now the
decontamination is finished and the Device can be moved to CLEAN zone for further
processing.
Detailed description of decontamination procedure is in subsection

1.10.4 Decontamination.
4. ANALYSIS OF THE FAULTY DEVICE
Perform inspection of functionality of the Device and Accessories. Try to simulate the error
described by customer to locate failing components. Check Dialog history of the Device
for occurrence of any error message and check results of selftests of generators. Follow
procedures described in Troubleshooting of specific Device “Service Manual” or other
service documentation. For testing purposes it is possible to use also some steps from
“Final Inspection Report” or “Maintenance and Safety Report”.
During the analysis BTL ISC can be asked for an advice. Prepare all necessary information
about the analyzed Device and analyzed error as described in subsection 1.3.2 Support
Request.
1-20 990-82GICSTEN103
NOTE: Using comparative method you can check functionality of the Device with
parts which functionality have been verified (e.g. from Reference device). If the error
disappears when fully functional part has been used, problem is highly probably in
replaced part (e.g. the Device is functional with brand new Power adaptor and cannot
be turned ON with the original one).
If additional faulty parts were revealed during analysis, customer has to agree with their
exchange and confirm change of estimated price.
After the analysis, mark parts to be exchanged. Do not use parts from Reference device as
spare parts. Always assemble the Reference device back to its original state and use spare
parts from service facility stock or order it from BTL ISC.
5. REPAIR OF THE FAULTY DEVICE
Based on previous analysis the faulty parts should be replaced. Each facility should keep
spare parts for sold Devices on stock to be able to repair them in the shortest possible term
(for recommended management of spare parts stock refer to subsection 1.10.7 Spare
Parts Stock). Write down serial numbers of all spare parts which were exchanged in
repaired Device (for filling it into Part 2 of “Service record“).
During each repair exchange of complete functional blocks is preferred (e.g. whole PCBs,
display together with Touch panel, cables) ahead of their repair. It ensures high quality of
repairs and prevents recurrent repairs caused e.g. by other wear parts which can became
faulty a short time after the repair.
Soldering and non-standard repairs in Devices are allowed only for repairs described in
chapter “Advanced repairs” of specific Device “Service Manual” or “Service Bulletin”.
Additionally, such repairs can be carried out if it is allowed by BTL ISC.
In case the service facility is not able to perform the repair due to lack of service tools,
knowledge, qualification or from other reason it is possible to send the Device for repair to
BTL ISC. Inform BTL ISC about this situation. Pack the faulty Device into original packing,
enclose “Equipment Decontamination Certificate” and mark the consignment by RMA
number received from BTL ISC. For more information about RMA number refer to
subsection 1.3.3 RMA Number.
BTL ISC will repair the Device, perform Final inspection and send the Device back with
description about the repair and serial numbers of faulty and new parts to be included into
the “Service record“.
1-21
6. FINAL INSPECTION
After each repair, performing of Final inspection is mandatory to verify that the Device is
in working order and safe for operation. Final inspection also includes cleaning of the
Device. For performing of Final inspection follow instructions given in subsection
1.9.3 Final Inspection.
Unit Log Data Export
During the Final inspection Unit log data export must be performed. Save the data to a
compressed file (e.g. ZIP file) and archive it in a structured folder dedicated for data from
service cases. The Unit log data must be also sent to BTL. For more details refer to
subsection 2.2.3 Unit Log Data Export.
Filled form “Final Inspection Report” has to be signed and archived together with “Service
record“ in each service facility. In addition, the signed form should be scanned and sent to
BTL together with the “Service record“ in next step. Name of the scanned file should
contain original name of service document combined with Report number,
e.g. “300-82FinalInspectionReportEN100_PLA10024”.
If the Final inspection was performed during repair in BTL ISC, it is not necessary to repeat
it in service facility.
7. CLOSING OF THE SERVICE CASE
Continue with filling of Part 2 of “Service record“ which has been saved in step 1. For filling
the record follow instructions in subsection 1.9.2 Service Record.
If the Final inspection was not performed in local service facility (e.g. Final inspection was
performed during repair in BTL ISC), mark it in the “Service record“ by checkboxes “Final
inspection”.
NOTE: Part 2 of “Service record“ may be filled only by certified service technician.
Save the record to folder dedicated for data from service cases and send the Report to
manufacturer by pressing button “Send Report”. Archive the filled “Service record“
together with “Final Inspection Report” if available.
1-22 990-82GICSTEN103
By pressing button “Print page 3” in Part 3 of the “Service record” the custom sheet can be
printed. The custom sheet should be delivered to the Customer together with repaired
Device.
Pack the Device into its original packing including all customer’s Accessories and
necessary documents and prepare it to be sent to the customer.
8. RECEIVING OF LOANER DEVICE BACK TO SERVICE FACILITY
If a Loaner device has been sent to the customer, organize its sending back to service
facility when the repaired Device has been delivered to the customer. After receiving of
the Loaner device perform decontamination, tests in range of Periodical inspection and fill
in “Maintenance and Safety Report”. Archive the report for evidence. Record necessary
information about the Loaner device to dedicated table, and prepare the device for next
use. For details about processing of Loaner devices see subsection 1.10.5 Loaner Device.
9. GETTING FEEDBACK FROM CUSTOMER
About a week after the repaired Device has been returned to the customer a person from
local service facility (not necessarily service technician) should contact the customer and
verify that the repaired Device is fully working and customer is satisfied with the repair.
The feedback should be reported to service technician.
1.7.1 Service Cases Management

Service facility should keep standardized quality for all service cases and minimize their
length and costs. Manager of local service facility is responsible for management of service
cases. Instructions stated below are recommended to maintain fluent processes in service
facility.
Time of repairs should be observed to minimize duration of service cases and prevent
forgotten ones. Priority should be assigned to all service cases to distinguish between
them. There are two points of view on this issue (ordered with decreasing priority).
Prioritization according to type of customer’s Device:
1. Repairs of demo Devices
2. Warranty cases
3. V.I.P.
4. Non-warranty cases
1-23
Prioritization according to time to finishing and closing of the service case:
1. Quickly solvable cases – no spare parts needed
2. Fast solvable cases – consumable parts available on stock
3. Standard cases – spare parts available on stock, analysis of problem and repair
needed
4. Long term cases – spare parts not available or technical support from BTL ISC
needed
Both points of view should be taken into account for assigning of priority to each service
case and its maintaining is responsibility of service facility manager.
Spare parts stock should be regularly checked to prevent its depletion. Minimal stock level
of items should be revised from time to time and be set according to actual consumption
trends and number of Devices sold on the market.
Only brand new spare parts ordered from BTL ISC can be used for repairs except common
parts, which can be bought in local shop. Any unapproved repairs of parts of Devices or
PCBs are forbidden to keep standardized quality of repairs.
Maintain prioritization of lending of Loaner devices as described in subsection

1.10.5 Loaner Device.
When travelling connected to servicing is necessary, service cases should be grouped

together (periodical inspections, delivering of repaired Devices or Loaner devices, picking
up of faulty Devices etc.) according to region to minimize costs for travelling and save time
of service technician.
Communication with the customer should be active to capture his needs and prevent
delays and misunderstandings.
Records about all service cases should be kept at least in well-arranged electronic table
(e.g. in Excel) to have overview and evidence about running and finished service cases. The
file should be regularly backed up.
The table should contain following items:
 Report number
 Date of receiving of request for repair
 Type of service case (repair, periodical inspection, calibration)
 Priority
 Customer’s invoicing details
1-24 990-82GICSTEN103
 Place of installation of the Device
 Serial number of the Device
 List of used spare parts (Part numbers, serial numbers, prices)
 Serial number of Loaner device (if applicable)
 Date of receiving of Loaner device back to service facility
 Status (Request received, Device received, Decontaminated, Under repair, Pending

(for spare parts), Inspection performed, Waiting for loaner, Closed)
 Transportation costs (to/from customer, to/from BTL ISC, Loaner device)
 Hours worked (man/hours)
 Price for customer
 Date of closing of the service case
 Automatic calculation of duration of service case
Items mentioned above are recommended as basis for management of service cases.
Other items can be added in accordance to needs of local service facility.
1.8 Complaints
Complaint means any written, electronic or oral communication that alleges deficiencies
related to the identity, quality, durability, reliability, safety, effectiveness, or performance of
a Device after it is released for distribution.
If a Complaint occurs, BTL can be contacted on email cs@btlnet.com or

service@btlnet.com or in any other way – find contacts in chapter 3 Technical Support
Contact.
SAFETY RELATED COMPLAINT
Safety related complaint (also called Adverse event) is any undesirable experience
associated with the use of a medical product in a patient. Such event is serious and should
be reported when the patient outcome is:
 Death
 Life-threatening
 Hospitalization (initial or prolonged)
1-25
 Disability or Permanent Damage
 Congenital Anomaly/Birth Defect
 Required Intervention to Prevent Permanent Impairment or Damage (Devices)
 Other Serious (Important Medical Events)
Safety related complaint can be reported by the means mentioned above.
1-26 990-82GICSTEN103
1.9 Service Reporting

Reporting of service actions is necessary for registration of service cases, collecting of data
about reasons of failures and undertaken corrective actions and for improving of quality
and reliability of Devices. Reporting is mandatory for every service facility.
1.9.1 Report Number

Report number is intended for unique identification of service case. It is created by service
facility in format
XXY00000
where
 XX are letters identifying reporting country
 Y is letter identifying reporting company from the country
 00000 is a sequence number of the service case
Example: Service facility in Poland obtained code A for reporting. When the 24th service
case is reported, Report number is PLA10024.
NOTE: If any service cases have never been reported by the service facility, it is
necessary to contact BTL ISC to get Report number prefix “XXY” for the service facility.
Numbering of service cases starts usually from “10001”.
Check with your colleagues from the service facility that Report number assigned to your
service case was not assigned also to another service case started in the same time.
For reporting of service cases using “Service record“ use only Report number. During
communication with BTL ISC regarding to specific service case use preferably RMA
number. For details about RMA number refer to subsection 1.3.3 RMA Number.
NOTE: Sequence of RMA numbers is independent on sequence of Report numbers.
1-27
1.9.2 Service Record
“Service record“ is a document, which facilitates reporting of information about service
cases. This information is sent to BTL and serves for observation of service issues of
Devices during their lifetime. Based on “Service record“, reported errors are analyzed and
corrective actions are considered. The “Service record“ form is available on service server
and is regularly updated. Always use the latest released version.
The document contains three parts, which are filled in different phases of processing the
service case.
PART 1
Part 1 is intended for logging of basic information about service case immediately after
receiving a request for servicing. This part contains:
 Report number – number assigned by local service facility
 Reported on – date of opening the service case (receiving the request from
customer)
 Customer details
 Customer’s description
IMPORTANT: Text filled in field “Customer’s description” shall be enough detailed

so BTL can assess severity of the issue and evaluate possible Safety related
complaint.
 Device details – name, serial number and FW version
 Device subpart details – which part of the Device is suspected to be faulty (Unit,
Accessories etc.)
 Information about Loaner device – only if the Loaner has been sent
 Activity status – should be marked as “Open” to indicate running service case. The
checkbox is automatically changed to “Close” when value “End of activity” is set in
Part 2.
 Identification of the logging person
NOTE: This step can be performed by logging person who is acquainted with the
procedure. Such distribution of work saves time to service technician.
1-28 990-82GICSTEN103
Save the “Service record“ file to PC using option “Save as...” in Adobe Reader. As file name
use combination of original name of the file and Report number of the service case. The
file name will be in format
990-82ServiceRecordENvvvvvv_XXY00000.pdf
where
 “990-82ServiceRecordENvvvvvv” is original file name of the “Service record“

including version of the document (“vvvvvv”)
 “XXY00000” is Report number of the service case.
Example: Service technician is reporting “Service record“ using template

990-82ServiceRecordEN201601. Report number is PLA10024. The “Service record“
should be saved in PDF file with file name
990-82ServiceRecordEN201601_PLA10024.pdf.
When the “Service record“ file is saved, it has to be reported to BTL. In Part 2 press button
“Send Report”. The document will automatically create email using default email client in
PC, fills email address, text of message and encloses XML file with reported data. Send the
prepared email to finish reporting of Part 1.
IMPORTANT: Part 1 of the “Service record“ must be sent to BTL in the date of
receiving a request for service action.
NOTE: In case Gmail web interface is used, it is necessary to install Adobe Reader XI
or higher. Lower versions of Adobe Reader are not compatible with the web interface.
PART 2
When the service action and Final inspection of the Device has been finished and the
Device is ready to be dispatched back to the customer, the Part 2 of “Service record“ needs
to be filled and reported. Open appropriate file saved when the service case was opened.
Part 2 of “Service record“ contains details about problem found, its reason and final
solution. Fill in the field “Device received on” with date when the faulty Device has been
received to the service facility. The problem / activity is determined in section
1-29
After selection of “Device” and “Device subpart” a list of the most common failures is
available in “Root cause of problem / activity” field. Check the list and choose an option
describing the problem. Select “Other”, if no option is suitable – in that case
“Supplementary information from service technician” is required.
By completing the selection of “Device”, “Device subpart” and “Root cause of problem /
activity” an “Activity code” will be automatically generated. The field also allows to fill in
Activity code directly, related fields are filled automatically.
IMPORTANT: The serial number of the item selected as “Device subpart” must be
written in “S/N of device subpart”.
If the Device is not in warranty (post warranty repair, improper use etc.), mark it in
corresponding field and add description of reason for warranty loss in the field below.
When any parts with serial number are replaced, fill in description and the serial numbers
of faulty and replaced parts.
Item “Final inspection” should be marked “YES” in case the Final inspection has been
performed by the service facility. Enclose the “Final Inspection Report” to the “Service
record“. In other cases (e.g. the Final inspection has been performed during repair in BTL
ISC etc.) mark it by “NO”.
1-30 990-82GICSTEN103
If the FW has been updated during the service action, write the version of used MBIN file
to the field “FW updated to mbin”.
When closing the service case, select name of technician who is responsible for the service
case and mark date of end of the activity.
IMPORTANT: Part 2 of the “Service record“ can be filled and reported only by
certified service technician. List of technicians is updated regularly. If name of
service technician is missing there, ask BTL ISC for adding the name to the list of
technicians.
Save the “Service record“ under the same file name and overwrite the original file (e.g. 990-
82ServiceRecordEN201601_PLA10024.pdf).
When the “Service record“ file is saved, report it to manufacturer in the same way as
described for Part 1. Press button “Send Report” and send the email created in your mailing
client.
Archive all “Service records“ together with related “Final inspection” documents in service
facility.
PART 3
Using of the third part “Job sheet” is optional for facilities for which the form is useful and
beneficial. It is generated automatically from information given in previous parts of the
document. Responsible service technician must add description of the service action to
the field “Response to customer”. Job sheet is intended for the customer as a record of the
service action. It is recommended to keep a customer signed copy of the “Job sheet” as an
evidence of customer’s acceptance of repaired device.
1.9.3 Final Inspection

Final Inspection is procedure for verification of safety and functionality of Device after
repair or modification during which the Device was at least partially disassembled and any
internal part was disconnected. Performing of Final inspection is allowed only to service
technicians certified on level Standard or higher. For details about certification levels see
section 1.4 Technical Training.
1-31
Final inspection has to be performed according to document “Final Inspection Report”,
which should be enclosed to the “Service record“.
The inspection contains performing of visual inspection of the Device (condition of its
covers, cables, Accessories etc.), electrical safety measurement, verification of
functionality of safety and essential performance elements and other features of the
Device. The last steps of Final inspection are Unit log data export and cleaning. Cleaning
of the Device must be performed according to recommendations given in the document
“Final Inspection Report”, in Device specific “Operator’s Manual” and in subsection
1.10.3 Cleaning.
IMPORTANT: Unit log data must be downloaded during each Final inspection. The
data are saved to a compressed file (e.g. ZIP file) and archived in a structured
folder dedicated for data from service cases. The Unit log must be also sent to
BTL. For more details refer to subsection 2.2.3 Unit Log Data Export.
“Final Inspection Report“ describes steps for performing the inspection with respecting
requirements of standard IEC 62353. The document is divided into two parts. First part
(first two pages) of the document is form which contains all necessary data about tested
Device and steps of the inspection. In header of the form, besides of details about checked
Device and used equipments, is field for filling of Report number what uniquely bind the
Report with certain service case. Rest of first part contains individual steps of the
inspection. Result of each step of the inspection has to be marked in check boxes in the
end of each row. The first part is intended to be printed, filled, scanned and archived.
Second part “Appendix” contains detailed description of all steps listed in the first part.
Following of these steps in given order is recommended to prevent security risk for service
technician and tested Device. The Appendix should be printed and added to a binder for
daily use of the document.
“Final Inspection Report” is specific for each Device. Performing of Final inspection and
filling of the “Service record” after each service action is mandatory for all BTL service
facilities.
1-32 990-82GICSTEN103
1.10 Recommended Practices
1.10.1 Transportation
The Devices should be transported only in original packing. Foam inserts in the original box
are designed to protect the Device from damage.
When a faulty Device for repair is transported to BTL ISC, always mark it by assigned RMA
number. In case of other consignments (e.g. box with non-conforming parts) inform BTL
ISC in advance.
If Devices using water-based coolant are transported pay attention to instructions given in
specific Device “Service Manual”. Usually, the coolant should be drained from the Device
to prevent its leakage to internal parts of the Device or to prevent its freezing. Otherwise,
keep the Device in upright position or in position recommended for transportation.
For detailed instructions for other Devices, which transportation needs specific conditions
refer to part “Service features” of specific Device “Service Manual”.
1.10.2 Installation of a Device

Installation of Device can be performed only by properly trained service technician with
Certificate at least of Standard level. During installation, the service technician should
check if the environment where the Device is installed complies with operating conditions
stated in “Operator’s manual”. The Device must be placed out of direct sunlight and strong
electromagnetic fields of nearby devices (diathermy, X-rays, mobile phones and other
radio-frequency equipment) to prevent unwanted interference.
When the Device is transferred from a cold environment to a warmer one, wait with further
steps of installation until temperatures are equalized (at least 2 hours). Humidity, which
can condense on internal parts, can cause serious damage of the Device.
Devices usually heat up during operation and therefore must not be located near to other
sources of heat. Devices are cooled by forced air circulation. Make sure that no cooling
vents are covered and there is at least 10cm of free space around the vents.
For other recommendations toward installation refer to specific „Operator’s manual“.
Device can be optionally tested during installation on request of customer or in case the
service technician suspects the Device could be damaged or not fully working. As official
record about performing the test, “Maintenance and Safety Report” shall be used. For
further information about testing of the Device refer to section 1.2 Service Standard IEC
62353.
1-33
1.10.3 Cleaning
Generally, for the cleaning of the Device use a soft cloth slightly moistened with water or
a 2% detergent solution. Never use agents containing alcohol, chlorine, ammonia, acetone,
benzine or thinners.
The display shall be cleaned very gently using a dry soft cloth. The cloth may be slightly
moistened with a commercially available screen cleaner. Never apply the agent cleaner
directly on the screen!
Never use abrasive materials for the cleaning otherwise the surface of the Device could
get damaged.
The Accessories that come into direct contact with the patient’s body shall be cleaned
after each use with disinfectants approved for the use in health service. Do not use agents
containing chlorine or those with a high alcohol content (more than 20 %). After the
disinfection, it is necessary to rinse the Accessories with clean water to prevent
undesirable allergic reaction.
The Accessories are designed usually for non-invasive use therefore they do not need to
be sterile.
Before cleaning of the Device always check specific “Operator’s Manual” for recommended
procedures and cleaning agents.
Cleaning of the device must be performed during each repair or periodical inspection.
Follow instructions given in documents “Final Inspection Report” and “Maintenance and
Safety Report”.
1.10.4 Decontamination
Medical devices commonly come into physical contact with plenty of patients. Even if the
Devices are routinely cleaned and disinfected, spreading of infections cannot be
eliminated. During servicing, the technician is in direct touch with such Devices and is
potentially threatened by contagious infections. Therefore, decontamination after
receiving of each Device to repair has to be carried out to prevent infecting. All staff
performing decontamination has to be properly trained and instructed into the principles
of safety and health at work.
1-34 990-82GICSTEN103
See below description of the procedure and requirements for decontamination.
DECONTAMINATION ZONE
Service facility has to allocate special space (room or place) where decontamination can
be carried out with reflecting of nature, frequency and type of the decontaminated
equipment. The space has to be visibly marked with a sign “Decontamination zone” and
has to be dedicated from production, manufacturing, finished goods storage or servicing
or commercial areas.
Decontamination zone can be divided into three parts:
 HOT/DIRTY zone – space for storage of the Devices before decontamination. This
may include shelves, storage area, rack etc. The zone should be marked by red
color.
 WARM/WORKING zone – space in which the decontamination of the Devices is

carried out. The zone has to be on washable surface, no carpets or tablecloths are
allowed. The zone should be marked by orange color.
 COLD/CLEAN zone – space for storage of decontaminated Devices. The zone
should be marked by yellow color.
Within the decontamination zone has to be located following stuff:
 All tools and agents necessary for decontamination
 Decontamination cloth or disposable paper towels
 Protective equipment – disposable gloves, protective eyewear, masks, lab coats,

apron etc.
 Container for the used clothes and gloves
 Instructions for decontamination process
In case of performing decontamination it is necessary to sanitize/decontaminate the

working surface in the WARM/WORKING decontamination zone by means of the
decontaminant every week. Use the same decontamination agents as those used for the
Devices. The decontamination/sanitation of WARM/WORKING zone has to be indicated
in a Sanitation schedule, which is to be put up visibly in the Decontamination Zone. The
Sanitation schedule should contain date of decontamination of the zone and name and
signature of person who has carried it out.
DECONTAMINATION AGENTS
1-35
Medical equipment should be decontaminated using agents defined by US Environmental
Protection Agency EPA, European Medical Device Directive (93/42/EEC) or by agents
which are in compliance with local regulation. The agent should not contain chlorine.
See below properties of one of recommended agents Incidin® Foam:
 High disinfection efficacy on all surfaces and medical Devices
 For use with medical equipment in accordance with European Medical Device
Directive (93/42/EEC)
 For use on: metal, plastics, varnished surfaces, polycarbonate, polysulphone,

acrylic glass, etc.
 Agent specification: 100g contains 20g 2-propanol, 10g ethanol, 0.2g

benzalkonium chloride, 0.01g glucoprotamine
 Microbiological Properties : Broad spectrum of efficacy against bacteria (incl.

tuberculosis), fungi, hepatitis B virus (HBV), AIDS agents (HIV), rotaviruses, vaccinia
viruses, adenoviruses and papovaviruses.
Before decontamination, check specific “Operator’s manual” for recommended and

forbidden agents. If you are not sure about reaction between agent and cleaned material,
check its behavior on small hidden area of the Device.
EQUIPMENT DECONTAMINATION CERTIFICATE
Equipment Decontamination Certificate (further referred as EDC) filled after

decontamination procedure declares that the Device was decontaminated of chemical,
biological and radioactive contaminants and is safe for unprotected human contact. The
certificate has to be enclosed to the decontaminated Device and archived after finishing
the service case for evidence. Find the form on BTL service server.
DECONTAMINATION WORKFLOW
After receive the Device has to be stored in HOT/DIRTY zone in its original package. In
case EDC is enclosed, the Device can be moved to “Clean zone”. If there is no EDC the
Device have to be decontaminated. Move the Device to WARM/WORKING, unpack it and
begin with decontamination. Put a sufficient amount of disinfectant on the Device or the
cloth and apply it on all surfaces of the Device and Accessories, which can be expected to
have come into contact with the patient or an operator. Sensitive parts of the Device, such
as the display, vents etc., must be handled with care to prevent the disinfectant from
penetrating into these parts. Observe the exposure time depending on the disinfectant
used and the manufacturer’s recommendation. Fill in the EDC and put it together with the
Device into new plastic bag. Move the packed Device to COLD/CLEAN zone. In case of
use of disposable cloths or protective equipment throw it into a container and handle this
waste as hazardous according to the local regulations.
1-36 990-82GICSTEN103
1.10.5 Loaner Device

Loaner device is intended to be lent to a customer as a temporary replacement of his
Device during service action. Service facility should be equipped by at least one piece of
Loaner device for each type of sold Devices.
When Loaner device is requested for customer, service technician should record number
of appropriate service action, convey the Loaner device to the customer and record date
of its dispatching. During the service action, the customer uses Loaner device and his
workflow is not adversely affected. Meanwhile, faulty Device is transferred to service
facility and repaired.
Loaner device should be lent according to following priority (ordered with decreasing
priority):
1. Warranty cases
2. V.I.P.
3. Expensive repairs
4. Other repairs
When service case has been solved and repaired Device is returned to the customer, loaner
is conveyed back to service facility. After receiving the Loaner Device has to be considered
as potentially infectious and has to be decontaminated before next procedures. Refer to
subsection 1.10.4 Decontamination for details about decontamination procedure.
In next step performing of tests in range of Periodical inspection is mandatory to verify

safety and functionality of the Loaner device. The “Equipment Decontamination Certificate”
and “Maintenance and Safety Report” should be printed and archived for evidence about
usage of the Loaner device. After performing all these steps the Device is ready to be used
for other service case.
Records about usage of Loaner devices have to be kept in a table in electronic or in paper
form. Each record should contain:
 Serial number of the Loaner device
 Status (in operation, received from customer, ready for use)
 Report number of service case for which the Loaner device is used
 Date of dispatching of Loaner device to the customer
 Date of receiving of Loaner device from customer
 Date of decontamination
 Date of performing of “Maintenance and Safety Report”
1-37
Loaner device is in property of service facility and can be used as Reference device (see
subsection 1.10.6 Reference Device). Before sending Reference device as Loaner device
perform “Final Inspection Report” to be sure that the Reference device is in working order
and safe for patient and operator.
1.10.6 Reference Device

One of possible approaches to troubleshooting of repaired Devices is to replace potentially
faulty parts by parts whose functionality is verified and service technician can check that
the issue was solved by the exchanged part. In case there is no spare part available on
stock, it is possible to use Reference device as source of spare parts for purpose of
troubleshooting.
After finding real cause of the problem replace the failing part in repaired Device by brand
new spare part and return all parts taken from Reference device back.
IMPORTANT: Never use parts from Reference device as spare parts for
customer’s Devices. Otherwise, traceability of serial numbers of Device’s
components will be lost. Only brand new spare parts may be installed to the
customer’s Device to maintain standardized quality of repairs.
Reference device may be the same as Loaner device to reduce costs for service equipment.
1.10.7 Spare Parts Stock

Service facility should keep spare parts for Devices sold in local market to speed-up service
actions where exchange of Device’s part is necessary.
Generally, the stock level should be set according to the most frequent errors and number
of sold Devices on local market. Minimal stock level equals to average monthly
consumption of each spare part. If there is no history of service cases for local service
facility, BTL ISC can recommend number of spare parts which should be on stock.
For service facilities with monthly number of service cases higher than 5 is recommended
to keep minimal stock level on average monthly consumption of each spare part and
1-38 990-82GICSTEN103
additionally keep 2 pieces of each spare part listed in Spare Part List of specific “Service
Manual”.
Keep the spare parts stock organized. Always place newly received spare parts at the end
of row of certain part. In case spare parts have limited lifetime (e.g. batteries) keep this
information also in table to have overview about their expiration dates. It ensures that older
parts will be primarily utilized and inventory will be continuously renewed (FIFO system).
IMPORTANT: Preferential consumption of older spare parts (FIFO) is important

especially for batteries and consumables with expiration date. In case such
handling of stock material is not followed, expired goods must be discarded.
Some spare parts need to be maintained on stock to avoid their degradation,

e.g. rechargeable accumulators. Keep them always fully charged and check periodically
their condition. Recharge the accumulators each 3 months at least.
1.10.8 Ordering of Spare Parts

Spare parts can be ordered only by certified service technician with Certificate of level
Standard or higher. Pricelist of spare parts for Devices is available on request from BTL ISC.
To order spare parts for Devices send to BTL ISC:
 Part number – find it in specific Device “Service Manual”
 Quantity
 Serial number of the Unit of Accessory for which the spare part is intended (if
applicable)
Price of spare parts announced by BTL ISC is recommended end user price. Service
facilities get discount from this price.
1.10.9 Non-conforming Parts

Non-conforming parts are those which functionality or integrity has been corrupted. Such
parts are collected by BTL ISC for further analysis. Results of the analysis are implemented
during development of new Devices and during improvement of current Devices.
1-39
Service facilities have to collect all non-conforming parts from all warranty service cases
and also from non-warranty cases if possible. Only exceptions are large or heavy parts
whose transportation would be too expensive. These parts should be collected on request
from BTL ISC.
When the service case is finished, put non-conforming parts into plastic bag, mark it by
Report number and store it in a box. Handle with the parts as with functional ones and
pack them into the box carefully to prevent further damage during transportation (follow
instructions given in subsection 2.6.3 Manipulation with Repaired Device). Parts corrupted
by improper handling or packing are useless.
When the box is full, it should be sent to BTL ISC. Inform BTL ISC about it in advance and
agree with them which parts should be sent.
1.10.10 Warranty
All Units are covered by standard 24 months, Accessories are covered by 6 months
manufacturer’s warranty unless agreed otherwise in written. Standard warranty is
3 months for all repairs and 6 months for spare parts. The warranty applies from the date
of dispatching to BTL distributor. This warranty does not cover batteries or any other
consumable items. The warranty will not apply if the factory-applied serial number has
been altered or removed from the product. The warranty will not apply in case of damage,
malfunction or failure resulting from alterations, accident, misuse, abuse, fire, liquid
spillage, misadjustment of customer controls, use on an incorrect voltage, power surges
and dips, voltage supply problems, thunderstorm activity, acts of God, tampering or
unauthorized repairs by any persons, use of defective or incompatible Accessories,
exposure to abnormally corrosive conditions or entry by any insect, vermin or foreign
object in the Device.
The warranty does not cover normal wear and tear of the Device.
1.11 Examples of Service Cases

In this section, three examples of service cases are described together with all necessary
steps which must be done.
1-40 990-82GICSTEN103
1.11.1 Simple
Service facility received request from customer for repair of BTL-08 ECG MT Plus.
Customer’s description of the Device behavior was:
“There are dropouts in printout from the Unit.”
Receiving of service case
All available details about the customer, faulty Device (Unit + Accessories) and customer’s
description of the problem were recorded to “Service record“. The customer did not need
Loaner device.
Report number assigned to this case is MXA10793.
After filling the Part 1 of “Service record“ the data from the form were sent to BTL and the
case was handed over to responsible service technician from the service facility.
Informing the Customer about further steps of service case
Service technician checked service documentation for description and solution of the
problem. Cause of the problem can be dirt on printer’s head or defective printer. Spare
printer is available on stock of service facility.
Service technician called to the customer and informed him about probable cause of the
problem, estimated price and time of repair. Customer agreed with the service action and
sent the Unit by courier to service facility.
Receiving and decontamination of the faulty Device
After receiving the Unit in service facility decontamination was performed at first and
“Equipment Decontamination Certificate” was filled and enclosed to the Unit.
Analysis and repair of the faulty Device
The technician cleaned the printer’s head but the problem persisted. Therefore, whole
printer was exchanged.
Final inspection
To verify functionality of the Device the technician performed Final inspection according
to appropriate documentation. Unit log data export is not available in BTL-08 ECG MT Plus,
the procedure was skipped here. The Device was cleaned in the end of the service
operation according to instructions given in “Final Inspection Report” and in “Operator’s
Manual”. Filled “Final Inspection Report” was printed, signed and scanned to be archived.
1-41
Closing of the service case
The service technician packed the Unit and sent it back to the customer. The technician
filled Part 2 of “Service record“, sent the data from the form together with scan of filled and
signed “Final Inspection Report” to BTL and closed the service case.
Faulty printer was marked by Report number and putted into plastic bag and stored in box
with non-conforming parts.
After closing the service case the technician archived following documents in the service
facility:
 Service Record
 Final Inspection Report
 Unit log data – archived and also sent to BTL (not applicable in case of BTL-08 MT
Plus)
 Equipment Decontamination Certificate
Getting feedback from customer
About a week after the service case had been closed a person from service facility
contacted the customer and asked him if the Unit works properly.
1.11.2 Complex
Service facility received request for service action. Customer’s description of the Device
behavior is:
“Sometimes it’s not possible to run a therapy with large Exilis applicator. Therapy is
interrupted, the Unit is beeping and does not allow to continue. There is no error message
shown on the display.”
description of the problem were recorded to “Service record“.
Report number assigned to this case is PTA10198.
1-42 990-82GICSTEN103
According to customer’s description the service technician checked possible causes of

problem in Troubleshooting of Device “Service manual”. The problem is most probably
broken Cable for reference patch electrode or inside the Applicator.
According to “Service manual” there is a simple test to differ between both possibilities –
folding of one end of the reference patch electrode to establish connection between both
parts of the electrode. If the problem is in the cable for reference patch electrode,
grounding is still insufficient. Otherwise, the problem is in Applicator.
The technician called to the customer and asked him for cooperation during first
troubleshooting. The test confirmed that the problem should be in the Applicator.
Service action in customer’s facility was arranged. The technician prepared loaner
Applicator for case it is necessary to give replacement to the customer.
First analysis of the faulty Device
At customer’s place the service technician tried unsuccessfully to simulate the failure with
customer’s Applicator. He decided to continue with analysis in service facility. Loaner
Applicator has been temporarily installed to customer’s Unit.
Information about loaned Applicator was recorded to appropriate table in service facility
for evidence.
In service facility decontamination of the customer’s Applicator was performed at first and
“Equipment Decontamination Certificate” was filled and enclosed to the Applicator.
Analysis and repair of the faulty Device
In the service facility the customer’s applicator was thoroughly tested. When the
Applicator’s cable was bended near to holder of the Applicator, grounding was lost.
Internal cables were probably broken. The Applicator is not repairable in service facility so
the service technician contacted BTL ISC for advice with further steps.
BTL ISC confirmed result of technician’s analysis and asked him to send the Applicator for
repair to BTL ISC.
RMA number assigned by BTL ISC to the service case was AF008772 and was used during
further communication regarding this issue.
1-43
The technician packed the applicator to the box, marked it by RMA number, enclosed
“Equipment decontamination certificate” and sent it to BTL ISC.
BTL ISC repaired the Applicator and sent it back to the service facility together with
description of the service action and used spare parts.
Repaired Applicator was installed to customer’s Unit and FW of the Unit was updated.
Final Inspection
to appropriate documentation. The technician performed Unit log data export. The data
were saved to a compressed file (e.g. ZIP file), archived in a structured folder dedicated for
data from service cases and sent to BTL. The Device was cleaned in the end of the service
In service facility the technician filled Part 2 of “Service record“, sent the XML file together
with scan of filled and signed “Final Inspection Report” to BTL and closed the service case.
Following documents must be archived in service facility:
 Service Record
 Unit log data – archived and also sent to BTL
Loaned Applicator taken from the customer was decontaminated. Filled document
“Equipment Decontamination Certificate” was archived. The Applicator was connected to
the Reference Unit and the technician performed Periodical inspection. Filled
“Maintenance and Safety Report” was signed and archived. Information about performed
inspection of the Applicator was recorded to appropriate table and the Applicator was
marked as “Ready for use”.
contacted the customer and asked him if the Unit works properly.
1-44 990-82GICSTEN103
1.11.3 Difficult
Service facility received request for repair of BTL-6000 SWT Topline. Customer’s
description of the Device behavior is:
“The Unit shows error message ‘An internal exception has occurred. Restart the Unit. If
problem persists, call service.’. Shown error code is E-2464-000-157. After restarting the
Unit is working for a few minutes and fails again.”
description of the problem have to be recorded to “Service record“.
Report number assigned to the service case is CZA10943.
Service technician checked Troubleshooting in Device “Service manual” for possible

reasons of the failure. Unfortunately, there is no description of such error code. The
technician asked BTL ISC for advice.
RMA number assigned to the service case by BTL ISC was AF016489.
BTL ISC responded that such problem is usually related to problem with powering of the
generator PCB. Possible causes sorted by incidence are:
1) Faulty power adaptor
2) Air leakage through water separator or from other part of pneumatic system
3) Firmware issue
4) Faulty generator PCB
5) Faulty pump
Based on this information the service technician decided to take the faulty Unit from
customer and give him temporarily a Loaner device instead.
The customer was informed about the future steps and sent the faulty Unit to the service
facility by courier. The Loaner unit was sent to the customer.
Information about loaned Unit was recorded to appropriate table in service facility for
evidence.
1-45
After receiving the Unit in service facility decontamination was performed at first and
“Equipment Decontamination Certificate” was filled and enclosed to the Unit.
Analysis and repair
In the beginning of analysis the service technician tried to simulate error described by the
customer. Testing tool 190-PRESSUREMETER was connected to the Unit to act as
an Applicator. Common therapy was started and the technician changed properties of the
therapy during testing. The error message appeared after a few minutes of testing.
Output voltage of original power adaptor was 19VDC while nominal voltage is
24VDC±2VDC. According to recommendation from BTL ISC the technician exchanged the
power adaptor by brand new piece from spare parts stock.
Functionality was tested again and the same error occurred after 20 minutes of testing.
Output voltage of the power adaptor was 24VDC. Probably the power adaptor was not the
only failing part.
The service technician checked other mentioned steps (he exchanged all recommended
parts and uploaded the latest firmware), but the problem was still present. After
consultation with BTL ISC the technician downloaded Unit log data and sent it to BTL.
Based on analysis of the Unit log data and on further communication, BTL ISC
recommended exchange of release valve.
Spare release valve was not present on Spare parts stock of the service facility so BTL ISC
arranged its delivery to the facility. Box with the spare part sent from BTL ISC was marked
by RMA number.
After exchanging the release valve the Unit was tested more than 30 minutes in all therapy
modes. During testing the error message did not appear.
Final inspection
to appropriate documentation. The technician performed Unit log data export. The data
are saved to a compressed file (e.g. ZIP file), archived in a structured folder dedicated for
data from service cases and sent to BTL. The Device was cleaned in the end of the service
1-46 990-82GICSTEN103
The service technician packed the repaired Unit and sent it back to the customer. The
technician filled Part 2 of “Service record“, sent the data from the form together with scan
of filled and signed “Final Inspection Report” to BTL and closed the service case.
After closing the service case the technician archived in service facility:
 Service record
 Unit log data – archived and also sent to BTL
After receiving Loaner device back to the service facility, the technician performed
decontamination of the Device and prepared it for future use.
Faulty power adaptor and release valve were marked by Report number and putted into
box with non-conforming parts.
When the Loaner unit was received from the customer, its decontamination was
performed. Filled document “Equipment Decontamination Certificate” was archived. The
technician performed Periodical inspection of the Loaner device. Filled “Maintenance and
Safety Report” was signed and archived. Information about performed inspection of the
Loaner device was recorded to appropriate table and the Unit was marked as “Ready for
use”.
contacted the customer and asked him if the Applicator works properly.
1-47
1-48 990-82GICSTEN103
BTL SERVICE
2 COMMON SERVICE TASKS
2.1 Operation Modes ................................................................................................................... 2-3
2.1.1 Key Combinations ......................................................................................................... 2-4
2.2 Event Logging ......................................................................................................................... 2-6
2.2.1 Dialog Windows ............................................................................................................ 2-6
2.2.2 Dialog History ................................................................................................................. 2-7
2.2.3 Unit Log Data Export .................................................................................................... 2-7
2.3 Error Codes System ............................................................................................................... 2-9
2.3.1 Runtime Errors ............................................................................................................... 2-9
2.3.2 Selftest Errors .............................................................................................................. 2-10
2.4 Common Device System Features ................................................................................. 2-11
2.4.1 User Mode ................................................................................................................... 2-11
2.4.2 Distributor Mode ........................................................................................................ 2-14
2.4.3 Sales Mode .................................................................................................................. 2-14
2.4.4 Service Mode .............................................................................................................. 2-14
2.4.5 Safe Mode .................................................................................................................... 2-15
2.4.6 Firmware Restore Mode ........................................................................................... 2-15
2.5 BTL License Server ............................................................................................................. 2-16
2-1
2.6 Common Tasks .................................................................................................................... 2-17
2.6.1 Firmware Update ........................................................................................................ 2-17
2.6.2 Time Limitation ........................................................................................................... 2-26
2.6.3 Manipulation with Repaired Device ...................................................................... 2-28
2.6.4 Connectors Fastening ............................................................................................... 2-30
2.6.5 Applicator’s Labels ..................................................................................................... 2-32
2.6.6 Touch Panel Calibration ............................................................................................ 2-34
2.7 Periodical Inspection .......................................................................................................... 2-35
2.8 Electrical Safety Measurement........................................................................................ 2-36
2.8.1 Measuring with ESA612 .......................................................................................... 2-36
2.8.2 General recommendations for ESA612 ............................................................... 2-41
2.9 Advanced Repairs ............................................................................................................... 2-42
2.10 Troubleshooting Basics ................................................................................................. 2-43
2-2 990-82GICSTEN103
2.1 Operation Modes

Units can work in several operation modes with different features:
USER MODE
User mode is intended for end users. The mode allows performing of therapies, adjustment
of user settings, using of basic service functions, getting data about the Unit and connected
Accessories and launching Unit log data export. The Unit is run in User mode after turning
ON by „on/off“ button.
DISTRIBUTOR MODE
In Distributor mode displayed background image and on-screen information about the Unit
can be set. The background image can be selected from list of prepared files or loaded
from SD card if the Unit features it. These changes will take effect after restart of the Unit.
Function Firmware update is available in the mode. Other functions present in User mode
can be used except running a therapy. Displayed menus may vary with different unit types
and firmware versions. Distributor mode is intended to be used only by qualified service
technician or appropriate person. For entering the mode a specific password is required.
SALES MODE
In addition to functions available in Distributor mode, the Sales mode allows to

enable/set/disable function “Time limitation”. This function is intended for functionality
restriction of the Unit after defined time period, e.g. for Units rented on monthly base or
for demo Units. Find detailed description of the function “Time limitation” in subsection
2.6.2 Time Limitation. Function Firmware update is available in the mode. Other functions
present in User mode can be used except running a therapy. Displayed menus may vary
with different unit types and firmware versions. Sales mode is intended to be used only by
qualified service technician or appropriate person. For entering the mode a specific
password is required.
SERVICE MODE
In service mode the function Firmware update and device specific advanced service
functions are present. Other functions present in User and Distributor mode can be used
as well except running a therapy. Service mode is intended to be used only by qualified
service technician. For entering the mode a specific password is required.
SAFE MODE
Safe mode enables service technician to perform Touch panel calibration immediately after
launching the Unit, start basic service functions, Firmware update, Unit log data export and
to obtain data about the Unit and connected Accessories. Uploading of firmware in this
mode is preferred over the other modes. Safe mode is intended to be used only by qualified
service technician.
2-3
Calibration of Touch panel is automatically started on entering the mode. In case the
calibration of Touch panel cannot be carried out (e.g. because of defective Touch panel),
the Unit can be controlled by knobs and buttons.
FIRMWARE RESTORE MODE
Firmware restore mode enables to service technician restoring of Unit’s firmware in case
it is not possible even to enter Safe mode. In this mode only Master PCB firmware update
is possible. Firmware for generators or other PCBs has to be uploaded in next step in Safe
mode. The mode is used also for Firmware upload by Serial programming.
2.1.1 Key Combinations

Entering the modes described above is possible according to following list of buttons’
combination.
NOTE: Always hold all buttons except “on/off” button until the Unit enters selected
operation mode.
AESTHETICS / PHYSIO UNITS
Distributor /
Firmware restore Hardware
Unit type Safe mode Sales /
mode reset
Service mode
BTL-4000 start 1 + start 2 +

Optimal ----- enter + on/off on/off + enter + prog + menu
Professional mains switch to “I”*
start + stop +
BTL-4000
esc + on/off enter + on/off on/off + enter + man + enter
Topline
mains switch to “I”*
BTL-4000
esc + enter +
Smart esc + on/off enter + on/off hold on/off
on/off
Premium
enter + time + esc + enter +

BTL-5000
esc + on/off enter + on/off intensity + time +
Series
on/off intensity
BTL-6000 esc + enter + esc + enter +

esc + on/off enter + on/off
Series on/off start/stop
* See details in specific “Service Manual”
2-4 990-82GICSTEN103
CARDIO UNITS
Distributor /
Firmware restore Hardware
Unit type Safe mode Sales /
mode reset
Service mode
BTL-08 auto + monitor leads + button on the

----- -----
ECG SD on/off* rear panel
BTL-08 button on the

----- ----- auto + filter + on/off*
ECG MD rear panel
BTL-08 menu + button on the

+ on/off auto + filter + on/off*
ECG MT+ on/off rear panel
BTL-08 menu + button on the

+ on/off start + print + on/off*
Spiro on/off rear panel
BTL-08 menu +
+ on/off auto + filter + on/off* restart + esc
ECG Lx on/off
BTL-08 *
----- * -----
Holter (Service mode only)
* See details in specific “Service Manual”
Refer to specific Device “Service Manual” to find key combinations for Units, which are not
listed above.
NOTE: Password for Distributor / Sales / Service mode differs for each of them. To
get proper password contact BTL ISC.
2-5
2.2 Event Logging
Devices are equipped by system for logging of system events during operation of the
Device, e.g. parameters and lengths of carried out therapies, temperatures of internal and
external parts of the Device, history of displayed dialog windows, errors etc. The data are
stored in internal memory. The Unit log data must be downloaded during each service
action on the Device, archived and also sent to BTL.
2.2.1 Dialog Windows

Devices use Dialog windows, which inform operator about status of the Device. Each
Dialog window contains text message with description of reported status and Message
code, which uniquely identifies type of the message and details about the reported status.
Message code has following structure:
E-2094-031-150
Type Dialog ID Event ID Gener ID
where
 Type distinguishes type of message by letters
o “M” – Information message
o “E” – Error message = Runtime error
 Dialog ID represents identification of displayed message
 Event ID is extended specification of the message
 Gener ID contains ID of generator to which the message is related
NOTE: If a customer is reporting a displayed message, always ask him about text of
message and Message code. The code is important especially for identification of
origin of the Error messages and facilitates their solving.
For more details about Error messages see subsection 2.3.1 Runtime Errors.
2-6 990-82GICSTEN103
2.2.2 Dialog History

History of Dialog windows can be checked by function “Dialog history”. The list contains
date and time of displaying the message and Message code. If the function is available in
the Unit, check specific Device “Operator’s manual” for exact location of the function.
Detailed descriptions of all Error messages (Message codes with prefix “E”) together with
suggested procedures are present in specific Device “Service Manual”
Error message
Information
message
“Dialog history” has to be checked during each Inspection of the Device for occurrence of
any Error message. It helps to service technician to reveal failures, which did not appear
during previous steps of the inspection or were not reported by the customer.
2.2.3 Unit Log Data Export

Events logged by the Unit during its operation are stored in internal memory. Log with
recorded events can be downloaded to PC and serves for analysis of Device’s behavior.
Based on the data the Technical support is able to reveal failures, which are difficult to be
found by standard methods (e.g. FW errors, random failures, selftest errors etc.).
IMPORTANT: Unit log must be downloaded during each service action on the
Device (as part of Final inspection or Periodical inspection procedure). The data
are saved to a compressed file (e.g. ZIP file) and archived in a structured folder
dedicated for data from service cases. The Unit log data must be also sent to BTL.
2-7
The function is located in menu “Service functions” and is available in all operation modes
except Firmware restore mode. Data can be exported to two type of storage (USB, SD card)
in dependence on type of the Unit. If available, set option “Export settings” to “Export all”.
EXPORT TO USB DISC
Connect the Unit by USB cable to PC in the same way as for uploading of firmware.
Location of the USB connector on the Unit and type of interconnecting cable are described
in specific Device “Service Manual“.
Press button “Export data to USB disc”. After a while USB disc named “BTL_LOG_DAT” will
appear in the PC. Download all folders from the USB disc.
EXPORT TO SD CARD
Press button “Export data to SD card“ to run the function. Wait until the Unit finishes the
export and displays message that data are available on SD card. Remove the SD card from
the Unit and download folder “EXP_LOG” to your PC.
NOTE: SD card is secured by hot glue in the socket. Release the hot glue before
removing the SD card by applying alcohol.
When the SD card is back in the socket, fasten it again by hot glue.
2-8 990-82GICSTEN103
2.3 Error Codes System

Error codes system inform operator about non-standard behavior of the Device. Error codes
are divided into two groups based on their cause and appearance.
2.3.1 Runtime Errors

Runtime error appears immediately when a problem is detected by the Unit. The Unit
displays dialog window with Message code (in this case called Runtime error code) and
description of the problem.
In specific Device “Service Manual” check list of Runtime error codes to find information
and instructions regarding the displayed Error message and undertake corrective actions.
In case the Dialog window disappears before customer or service technician note down
number of the Runtime error code, history of displayed Dialog windows can be checked to
find the code. For details about Dialog windows history refer to subsection 2.2.2 Dialog
History.
NOTE: When Runtime error related to any generator occurs (Gener ID is different from
000), running therapy on the generator is stopped. In such case checking of selftest
results is recommended beside other service actions.
2-9
2.3.2 Selftest Errors
At start-up, each generator performs set of selftest routines to check its functionality and
safety. Selftest results can be checked in menu (“Menu > Unit settings > Unit information >
Geners info“) under item „Selftest“.
The selftest error code is reported in format:
DDD (0xHHHH)
where
 DDD is decimal representation of the selftest Error code
 0x is a prefix denoting number in hexadecimal numeric system
 HHHH is hexadecimal representation of the selftest Error code
Results of selftest stated in “Service Manuals” are usually represented in hexadecimal

format.
Selftest error codes are specific for each generator type. Find list of selftest error codes in
specific Device “Service Manual” together with their description and recommended
corrective action.
When a selftest error occurs, starting of therapy on particular generator is blocked.

Troubleshoot the error according to description in “Service Manual” and restart the Device.
If the error has been removed, therapies on affected generator are available again.
NOTE: Until the sequence of selftests is not finished, the generator is not available for
therapies. If tab or button of particular generator stays inactive (grey) after start-up of
the Device, a selftest error probably occurred.
2-10 990-82GICSTEN103
2.4 Common Device System Features

Devices are equipped by operation system, which organization and principles are similar
for most of Devices. See below description of common features and functions used in the
system.
2.4.1 User Mode

SETTING OF HW KEY
This function facilitates change of Device configuration mode by entering HW key,

e.g. adding of special therapy types. The HW key can be generated using BTL license
server. Find details about the server in section 2.5 BTL License Server. Alternatively the
code can be obtained from BTL ISC.
For generating of the HW key is necessary to prepare required configuration mode and
serial number of Device which configuration should be changed. The code will be provided
by email in text file.
The HW key contains 64 characters, which must be entered in Unit’s menu “Setting of HW
key”. Refer to specific “Operator’s manual” to find location of the function in Unit’s menu.
Enter the received code to corresponding fields and press button “enter”. Change of HW
key will be confirmed by message on the display. Restart the Unit to load new
configuration.
NOTE: In Units where Master PCB has been replaced by a spare one the serial number
is different from the original. Do not forget to change also HW key of the Unit to return
it to the customer in original configuration.
2-11
UNIT INFORMATION
The menu „Unit information“ provides basic

information about the Unit - serial number,
type of the Device, firmware version, mode of
HW key and other system details. The menu is
accessible in menu (“Menu > Unit settings >
Unit information”).
If the serial number of the Unit is ascertained

for service purposes, always compare
displayed serial number with the one stated
on Unit’s label. Record both of them if the numbers are different.
GENERS INFORMATION
Menu „Geners Info“ provides information

about each installed generator – ID, result of
selftest, version of firmware, temperature and
other features. The menu is accessible from
(“Menu > Unit settings > Unit information >
Geners info”).
Values “ID” and “Selftest” in the menu are the

most important for troubleshooting. ID clearly
identifies each generator. The number is also
mentioned in error codes of the Unit. Each generator installed in the Unit has own ID based
on its type, position (Master / Slave) and power mode (A / B). List of IDs and corresponding
generators is stated in specific “Service Manual”.
Selftest value refers to result of selftest performed during starting of each generator.
Generator performs set of tests to verify functionality of all components and operation
modes. If the selftest is performed without an error result is 000. In other case number of
selftest error is displayed and the generator stays inactive (tab of the generator is grey, it
not possible to run therapy on the generator). Refer to specific “Service Manual” for details
about selftest errors and recommended solutions.
ACCESSORIES
Menu „Accessories“ contains information about type of connected Accessory and its serial
number and version of firmware if applicable.
2-12 990-82GICSTEN103
SERVICE FUNCTIONS
Service functions enables performing of basic system functions of the Unit. Find the
functions in menu (“Menu > Unit settings”) or in location defined in specific Device
“Operator’s manual”.
 Repair of files – the function verifies consistency of data, searches for corrupted
files and repairs them. The function can solve problems connected with user data
(freezing or restarting of the Unit).
 File system formatting – erases all user data from the Unit (user sequences, clients,
user settings) and set the Unit to default setting. Problems connected with user
data (freezing or restarting of the Unit in particular menus) can be solved by this
function.
 Delete accessories – deletes data about Accessories connected to the Unit in past.
The function can solve problems with detecting of Accessories.
 Default settings without loss of user data – restores default settings of the Unit
(touch panel calibration, language, color and sound schemes setting etc.). All user
data will be preserved (clients, user sequences, therapeutic protocols, I/t curves
etc.). The function can solve problems connected with user setting of the Unit.
 Unit log data export – the function exports Unit log data. The data can be
downloaded to PC by USB cable or from SD card. For more details refer to
subsection 2.2.3 Unit Log Data Export.
For resolving of problems connected to user data and settings of the Device is
recommended to use service functions in following order:
 Repair of files
 Default setting without loss of user data
 File system formatting
DIALOG HISTORY
The menu contains list of Information and Error messages displayed by the Unit. For
detailed description of the function refer to subsection 2.2.2 Dialog History.
2-13
SPECIFIC SETTINGS
The menu “Specific settings” contains functions and options related to each type of
generator. There are located functions for calibration of Accessories, settings of Unit’s
behavior for each type of therapy, signalization of lost contact etc.
2.4.2 Distributor Mode

DISTRIBUTOR LOCALIZATION
The menu contains several options for setting of Unit’s display background appearance:
 OEM picture on first screen – allows selection of background image from list of
prepared files. If the Unit uses SD card, it is possible to load an image there to
folder FSCREEN and use it for background.
 Initial logo of device, prefix of device name, initial address – are applied only when
background image is not set
 System language – preset of language which will be used after user file system
formatting
For entering the mode a specific password is required.
2.4.3 Sales Mode

In addition to functions available in Distributor mode, the Sales mode allows to
enable/set/disable function “Time limitation”. This function is intended for functionality
restriction of the Unit after defined time period, e.g. for Units rented on monthly base or
for demo Units. Find detailed description of the function “Time limitation” in subsection
2.6.2 Time Limitation. For entering the mode a specific password is required.
2.4.4 Service Mode

SERVICE FUNCTIONS - SPECIAL
This group of functions in menu (“Menu > Service functions – special”) is specific for each
type of Device (e.g. test of pneumatic system, starting of service therapy). For detailed
description of the functions see Device specific service documentation. The functions are
intended to be used only by certified service technician. For entering the mode a specific
password is required.
2-14 990-82GICSTEN103
2.4.5 Safe Mode

TOUCH PANEL CALIBRATION
After turning the Unit ON in Safe mode the Touch panel calibration function is
automatically launched. It is intended for situation when the Touch panel has irregular or
no response due to wrong calibration or loss of calibration data. Refer to subsection
2.6.6 Touch Panel Calibration for more information.
FIRMWARE UPDATE
The function allows Firmware update of Master PCB and other boards intended to be
uploaded. Firmware update function allows only USB programming mode. For Firmware
update in other modes (serial programming, generator programming) the Unit must be
turned ON in Firmware restore mode.
Firmware update in Safe mode is preferred over update in Service mode due to lower
system requirements and availability even in case the Device cannot start in Service mode.
For more information about Firmware update refer to subsection 2.6.1 Firmware Update.
2.4.6 Firmware Restore Mode

In case the Unit cannot be started even in Safe mode (e.g. due to firmware failure of Master
PCB), the Firmware restore mode enables Master PCB for Firmware update. Firmware for
other boards present in the Unit cannot be updated in this mode. After restoring the
Firmware in Master PCB repeat the Firmware update for other boards in Safe mode to
ensure Firmware in all electronic parts of the Device is compatible.
For some Devices (e.g. BTL-08 ECG SD/MD) the Firmware restore mode is the only mode
for Firmware update.
2-15
2.5 BTL License Server
BTL license server is intended for generating of several types of BTL product licenses to
enable or disable their functions. The server keeps evidence of generated licenses for each
BTL distributor to simplify license administration, renewal and accounting.
BTL license server replaces direct requests to Technical support; nevertheless this option
is still available. The BTL license server is available on license.btlnet.com.
REGISTRATION AND LOGIN
Each user has to be registered on the server with assigned role and license rights.
Registration form for new users is available at the bottom of main page. Access for service
technicians is granted by local BTL distributor manager based on the submitted
registration form.
Login to the BTL license server is enabled after confirmation of the account by responsible
manager.
LICENSE TYPES
There are three types of licenses which can be generated according to rights of particular
user.
 BTL CardioPoint software license

 Device license – Unlock codes for function Time limitation (find details in
subsection 2.6.2 Time Limitation)
 Device license – HW keys (find details in subsection 2.4.1 User Mode)
Each of the licenses has specific data to be filled. Follow instructions given on
license.btlnet.com.
LICENSE GENERATION
When in the menu for license generation, select customer from the list or create new one
at first. Fill in necessary data for the particular license (type of license, validity restrictions
etc.) and confirm. The license can be sent directly to the email stated in details about the
customer or can be downloaded to the PC.
List of generated licenses is available under each license group menu. In addition different
background color of license records is used according to current expiration period (active,
soon expired and expired).
2-16 990-82GICSTEN103
2.6 Common Tasks
2.6.1 Firmware Update

Firmware in Devices can be reloaded if necessary to update or restore their functions.
Actual firmware is available on BTL service server. Description of BTL service server is in
subsection 1.5.2 BTL Service Server.
Firmware for Devices is released in two forms:
BIN FILE
BIN file contains firmware intended for one Unit’s type only. Compatibility of the file with
hardware is usually limited to certain versions of Master PCBs. Versions of PCBs installed
in the Unit can be checked by Firmware Loader in tab “Unit info”. File name of the BIN file
contains designation of Device type, version of firmware and description of compatible
versions of PCBs.
Example: Firmware name contains string “PCBV_120_200”. It means that the firmware can
be uploaded only to Master PCB of version between v120 and v200.
MBIN FILE
MBIN file (also called Multi Firmware) combines firmware files for different Units and their
versions in one package. Appropriate file is automatically selected from the MBIN file by
Firmware loader. Usage of MBIN files facilitates loading of firmware to Units regardless
their versions.
The MBIN file is released together with text file, which contains information about versions
of Units, Master PCB and Generator PCB for which the MBIN is intended.
Using of MBIN files is preferred over BIN files.
NOTE: Update of firmware should be done in following cases:
 After replacement of any internal PCB or Accessory containing electronics.

(e.g. Master PCB, Generator PCB etc.)
 When required by service documentation.
 When the Unit behaves strange (freezing, restarting, unexpected behavior)
2-17
FIRMWARE LOADER
Firmware loader for Service (further referred as FW loader) is service software intended for
loading of firmware or relevant data to the Devices and for obtaining of basic information
about Unit’s firmware and hardware configuration.
FW loader can be downloaded from BTL service server, always use the latest version of
FW loader unless otherwise stated.
The FW loader contains following tabs:
Settings – this part contains options for basic setting of communication with the Unit.
In part “Communication port”, set communication port and communication speed for
establishing of connection with the Unit. Use button “Refresh” for reloading of list of
communication ports. By pressing of “Auto find” button the FW loader scans COM ports
for Devices connected by serial cable.
Unit info – displays details about configuration of connected Unit.
Establish connection with the Unit and press button “Reload” to read information from
Unit’s CPU. Acquired data can be printed or saved for future use. Information about version
of PCB can be used for identification of correct BIN file during uploading of firmware
(especially for older Devices).
Programming – enables uploading of firmware using Serial programming to the Device.

Find further details in part “Serial programming” below.
2-18 990-82GICSTEN103
Multiple programming – enables uploading of firmware using USB programming to the

Device. Find further details in part “USB programming” in following part.
NAND – enables loading of NAND memory content to the Unit. Details about process of
loading are described in specific Device service documentation.
HW key – enables to read HW configuration of the Unit. In some cases HW configuration

can be changed by this function (e.g. BTL-08 ECG SD, BTL-08 Holter).
NOTE: User data will be preserved during firmware upload.
USB PROGRAMMING
USB programming is intended for uploading of Firmware to Units, which are equipped by
USB communication port. Uploading of FW using USB programming is faster compared to
other ways for FW upload. If available, this method is preferred over the others.
 Download appropriate firmware for the Unit from BTL service server.
 Turn the Unit ON in Safe mode. In menu “Firmware upgrade” press button “Run
firmware upgrade”. If Touch panel is irresponsive, control the Unit by knobs and
buttons. Find instruction for entering the mode in subsection 2.1.1 Key
Combinations.
 Connect the Unit to PC using appropriate interconnecting cable.
 Start the FW loader and go to tab “Settings”. In field “Communication port” select
option “USB_DISK”. Use the latest version of FW loader unless otherwise stated.
 Press button “Check connection” to verify that communication with the Unit has
been established. Connection is confirmed by message “Unit present”.
2-19
1.
2.
 Switch to tab “Multiple Programming”, press button “Browse file...” and select
appropriate firmware. If compatible firmware has been selected, status icon at the
beginning of each line turns green. In case older or the same version of firmware
has to be loaded to the Unit, mark the checkbox “Update always”.
 Start uploading of FW by button . Wait until the firmware is completely loaded

into the Unit and follow instructions given on Unit’s display. Do not disconnect
interconnecting cable until FW update is finished.
2-20 990-82GICSTEN103
 Restart the Unit to finish FW upload.
NOTE: Status of loading of firmware into Unit’s parts is signalized by status icon at
the beginning of each line in tab “Multiple programming”. Meanings of the icons are
as follows:
No firmware was selected or the selected firmware is not compatible with

connected hardware.
The firmware is compatible with connected Unit’s part and the firmware
uploading is ready to be started.
Firmware was successfully uploaded to the Unit’s part.
The firmware in the Unit’s part is of the same version as the firmware you
are trying to upload. The process has been skipped.
SERIAL PROGRAMMING
Serial programming is intended for uploading of Firmware to Units which are equipped by
serial communication port. For uploading a Firmware use following instructions:
 Download appropriate firmware for the Unit from BTL service server. Make sure
that the firmware is compatible for the Unit you are working with (see part “BIN
file”)
 Turn the Unit ON in Firmware restore mode and set it for uploading via Serial link.
Find instructions for entering the mode in subsection 2.1.1 Key Combinations.
 Start the FW loader and go to tab “Settings”. In field “Communication port” select
correct COM port according to setting in your PC. Communication speed in FW
loader should be set to 115 200 bit/s.
2-21
1.
2.
 Switch to tab “Programming”, press button “Browse file...” (next to field “File name
to programm”) and select firmware which should be uploaded to the Unit.
 Press button “Programm file Auto” to run FW uploading and wait until the process
is finished.
1.
2.
 After the FW upload is finished press the button “Restart unit” to exit Firmware
restore mode and restart the Unit.
2-22 990-82GICSTEN103
GENERATOR PROGRAMMING
Generator programming is intended for uploading of firmware directly into generators in

Units, which are not equipped by display. For uploading of firmware use following
instructions:
 Download appropriate firmware for the generator from BTL service server. Make
sure that the firmware is suitable for the Unit you’re working with.
 Start the FW loader and in field “Communication port” select appropriate COM port
where the generator is connected and press button “Switch to boot...”.
 Select appropriate generator type from list of generators and press button “Start
search”. Now the FW loader is searching for connected hardware.
1. 1.
2.
2.
2-23
 Turn the Unit ON (by “on/off” button or by mains switch), it will be automatically
run in mode for generator firmware uploading. Wait until the window “Switch
generator to Boot Mode” disappears.
2-24 990-82GICSTEN103
 Switch to tab “Programming”, press button “Browse file...” (next to field “File name
to programm”) and select firmware which should be uploaded to the Unit.
 Press button “Programm file Auto” to run FW uploading and wait until the process
is finished.
1.
2.
2-25
 After the FW upload has been finished, press the button “Restart unit” to exit
Firmware restore mode and restart the Unit.
2.6.2 Time Limitation

The function is intended for functionality restriction of the Unit after defined time period,
e.g. for Units rented on monthly base or for demo units. Time limitation can be set manually
in Sales mode of the Unit or remotely using Unlock code generated by BTL license server.
Find details about the server in section 2.5 BTL License Server.
26-digits Unlock code facilitates prolongation or disabling of Time limitation function by

customer in User mode. When the Time limitation is expired, an information window for
entering the Unlock code appears.
2-26 990-82GICSTEN103
The Unlock code can be generated using BTL license server or by BTL ISC (see chapter
3 Technical Support Contact). To generate the code it is necessary to prepare information
about:
 Type of generated key (Unlimited, Limited to date)

 Date of expiry
 Master code – Unlock code from previous period displayed in the information
window or in menu (“Menu > Unit settings > Unlock code”)
 Serial number (in case the Master code is not available)
ACTIVATION
The Time limitation function can only be activated in Sales mode in menu (“Service
functions – special > Time limitation”). Change value in field “Time limits” to ON and set the
date of expiry.
CHANGE THE DATE OF EXPIRY, PROLONGATION
Changing of expiry date can be performed in two ways:
1) Direct change in function Time limitation in Sales mode in menu (“Menu > Service
function – special > Time limitation”)
2) Entering Time limitation code during Unit’s start-up or in User mode in menu (“Menu >
Unit settings > Unlock code”).
2-27
DEACTIVATION
Time limitation function can be deactivated in two ways:
1) Deactivation in Sales mode in menu (“Menu > Service function – special > Time
limitation”)
2) Entering Time limitation code during Unit’s start-up or in User mode in menu (“Menu >
Unit settings > Unlock code”).
2.6.3 Manipulation with Repaired Device

GENERAL
Always perform decontamination before any handling with Devices received from
customers. Surfaces of the Devices are potentially infectious!
For the cleaning of the Device and its Accessories use a soft cloth slightly moistened with
water or a 2% detergent solution. Never use agents containing alcohol, chlorine, ammonia,
acetone, benzine or thinners.
The display shall be cleaned very gently using a dry soft cloth. The cloth may be slightly
moistened with a commercially available screen cleaner. Never apply the agent cleaner
directly on the screen and keep edges of the display out of reach of the cleaner. The cleaner
can easily leak inside the display and damage it.
Never use abrasive materials for the cleaning, otherwise the surface of the Device or
Accessories could get damaged.
Inner parts of Devices should be regularly cleaned from dust by vacuum cleaner or
compressed air. Vacuum cleaner shall be used especially for cleaning of parts where
important vents or cooling surfaces would be stuck when compressed air is used (e.g.
cooling radiators, coolers with tiny ribs etc.).
2-28 990-82GICSTEN103
ESD PROTECTION
To protect electronics against damage caused by electrostatic discharge (further referred

as ESD), ESD precautions must be taken. Device parts and components sensitive to ESD
are usually marked by yellow symbol below. Electronic components must be packed in
antistatic packing (bubble wrap bags or other packing materials) during transportation and
any other handling. Such packing materials are of pink color.
During disassembling / assembling a Device, electric potentials of the Device and Service
technician must be equalized at first to protect the Device from ESD and be kept on the
same level during whole service procedure. Before touching any internal part of the Device
the Service technicians must touch any accessible conductive part of the Device (chassis,
protective earth connection of the Unit, other conductive parts). During the repair electric
potentials must be kept on the same level by
 connecting conductive part of the Device or components directly to ESD wristband

of the Service technician
 placing the Device or components on ESD mat connected to ESD wristband of the
Service technician
 connecting the ESD mat and ESD wristband of the Service technician to common
grounding point and placing the Device or components on ESD mat
Before handling (manipulating, soldering) with PCBs or other ESD sensitive components
the Service technician must touch edge of the PCB to equalize the electric potentials and
protect on-board sensitive components from ESD. Thereafter above mentioned ESD
precautions must be taken (placing the part on ESD mat connected to the Service
technician or interconnecting the part with Service technician).
Non-conforming electronic parts (PCBs, displays etc.) must be handled in accordance with
ESD precautions too not to cause any additional damage to the part. For more details about
Non-conforming parts see subsection 1.10.9 Non-conforming Parts.
2-29
DISASSEMBLING
Stick to safety recommendation in specific Device “Service Manual” before turning OFF the
Device and opening of its covers. In some cases the period can be up to 10 minutes!
Lay down parts of the Device to soft underlay to

prevent scratching of its surfaces.
Place all screws, nuts, washers and other small parts

to an organizer. Sort the parts according to step of
disassembly. It will facilitate you to use right parts in
the right time.
Make a photo of internal parts and interconnections of repaired Device before disassembly.
Pictures facilitate you to place the parts back to original location (cables × connectors,
layout of cables, placement of mechanical parts etc.)
ASSEMBLING
If a screw was originally secured against loosening by lacquer (paint), apply drop of lacquer
on the same place during assembly to secure it again.
Check that all connectors, which were fastened by hot glue and disassembled during the
service action, are re-secured by hot glue. Apply the hot glue on secured parts in the same
manner as originally.
During assembling the connectors secured by latch should be firmly pressed together until
a click can be heard when the latch reaches its final position.
Perform calibration of Devices in accordance with relevant service documentation. Always

use recommended service tools.
2.6.4 Connectors Fastening

Devices are equipped by several types of connectors with different way of fastening –
using lockers and using hot glue.
FASTENING BY LATCHES
Connectors with latches are secured in connected

position by locking system. Pay attention during
connecting such types of connectors to push them firmly
to the final position. Audible click of the latch should be
heard when the connector is in correct position.
FASTENING BY HOT GLUE
2-30 990-82GICSTEN103
Some connectors, cables and surfaces in Devices are secured by hot melt adhesive, further
referred as “hot glue”. The hot glue is generally applied on connectors, which do not have
any mechanical lock or other parts to prevent them from loosening or unwanted
movement.
All glued surfaces must be clean, dry and free of any grease and dust.
Surfaces that are to be bonded together should be close to each other and the hot glue
should cover borders and centers of both surfaces.
Glued connectors must be plugged in, well fixed and flooded with hot glue. At least 30s
must be allowed for the glue to harden so the connectors cannot be moved. The hot glue
should cover both parts of the connector along their longer side.
Do not glue any other electronic components, moving parts and technological holes
around the connector.
NOTE: Check that all connectors, which were fastened by hot glue and disassembled
during the repair, are re-secured by hot glue.
Apply the hot glue on secured parts in the same manner as originally.
2-31
Use a hot glue gun with minimal heating power 20W, maintaining heating power 16W,
heating temperature 200°C and output glue capacity at least 15g/min.
Hold the feed trigger until the glue flows smoothly from the output nozzle.
IMPORTANT: Always disconnect the hot glue gun from the mains after finishing
the task.
REMOVING OF HOT GLUE
Hot glue can be removed by technical alcohol (such as isopropyl alcohol - IPA). The most
effective way of applying the alcohol is by spraying it on the boundary between the glued
part and mass of the hot glue. The alcohol penetrates under the hot glue and releases it
from glued surface. Carefully remove the hot glue using forceps or by a tweezers. After
removing the glue dry all affected surfaces from applied alcohol.
IMPORTANT: Never use force – the hot glue should peel off easily out from the
surface. If necessary, more alcohol should be applied on the glued spot.
2.6.5 Applicator’s Labels

In case exchange of applicator’s cable is necessary, the Serial number label has to be
transferred. For this purpose, transparent label for relabeling is supplied with spare
applicator’s cable.
2-32 990-82GICSTEN103
 Cut the label from old applicator’s

cable, width of the about 70 mm from
its edge.
 Place the cut label to the transparent label, margins around the label should be
around 5mm.
 Begin sticking of the transparent label

from outer edge. Center both parts
and press them together. Transparent
label creates a loop through which the
applicator’s cable is pulled.
 Place the transparent label about

30mm from the connector and finish
sticking of the label.
2-33
2.6.6 Touch Panel Calibration
Touch panel calibration process described in this chapter is common for all Devices. The
calibration should be performed in case the response of Touch panel is inaccurate or the
Touch panel does not respond at all.
The calibration function can be run from location specified in Device “Operator’s manual”.
IMPORTANT: For precise touch panel calibration always use the stylus pen
supplied with the Device or alternatively pen-like tool with plastic tip.
Follow instructions on calibration screen until the process is finished.
2-34 990-82GICSTEN103
When the calibration has been finished, it can be checked by function “Touch panel
function test”. In case of any problems, repeat the calibration process or refer chapter
Troubleshooting Guide of the Device “Service Manual“.
In case the Touch panel does not respond correctly and is not possible to start the
calibration function, use alternative way to start the function without need of Touch panel.
BTL-4000 SERIES, BTL-4000 SMART / PREMIUM, BTL-5000 SERIES, BTL-6000 SERIES:
Start the Unit in Safe mode as described in subsection 2.1.1 Key Combinations. During
entering the mode the Touch panel calibration function is automatically started.
BTL-08 ECG MT+ / L:
Start the Unit in Safe mode and press „enter“ to start Touch panel calibration.
2.7 Periodical Inspection

Periodical inspection is procedure for periodical verification of safety and functionality of
customer’s Device. The inspection may be performed only by certified service technicians
certified on level Inspector or higher. For details about certification levels see section
1.4 Technical Training.
Periodical inspection contains performing of visual inspection of the Device (condition of

its covers, cables, Accessories etc.), electrical safety measurement, verification of
functionality of safety and essential performance elements and other features of the
Device. The last steps of Periodical inspection are Unit log data export and cleaning of the
Device.
IMPORTANT: Unit log data must be downloaded during each Periodical

inspection. The data are saved to a compressed file (e.g. ZIP file) and archived in
a structured folder dedicated for data from service cases. The Unit log data must
be also sent to BTL. For more details refer to subsection 2.2.3 Unit Log Data
Export.
“Maintenance and Safety Report” describes steps for performing the inspection with
respecting requirements of standard IEC 62353. The document is divided into two parts.
First part (first two pages) of the document is form which contains all necessary data about
tested Device and steps of the inspection. In header of the form, besides of details about
2-35
checked Device and used equipments, is field for filling of Report number what uniquely
bind the Report with certain service case. Rest of first part contains individual steps of the
inspection. Result of each step of inspection has to be marked in check boxes in the end
of each row. The first part is intended to be printed, filled and given to customer. Copy of
the Report should be archived for evidence.
Second part “Appendix” contains detailed description of all steps listed in the first part.
Following of these steps in given order is recommended to prevent any security risk for
service technician and tested Device. The Appendix should be printed and added to
a binder for daily use of the document.
Period for performing of “Maintenance and Safety Report” is stated in “Operator’s Manual”
of each Device. According to IEC 62353, the service technician is allowed to shorten term
of next inspection in case shorter period is required by local regulations or the regular
period can mean security risk for patient or operator (e.g. results of electrical safety
measurement are near to limits, Unit or its Accessories seems to be worn etc.).
2.8 Electrical Safety Measurement

Electrical safety measurement of Devices has to be performed by electrical safety analyzer,
which meets requirements of IEC 62353. For this purpose Fluke ESA 612 is recommend
for testing of Devices. The Unit is able to perform measurement of mains voltage, current
consumption, Protective earth resistance, Leakage currents and Insulation resistances and
acts as a generator of ECG or other signals for ECG Devices as well. For measurement is
recommended to use set of measuring cables designed for using with all types of Devices.
Find details about the set in part “Specific tools” in section 1.6 Service Tools. ESA 612 can
work in automatic and manual mode.
2.8.1 Measuring with ESA612

AUTOMATIC MODE
In automatic mode the service technician uses PC for controlling of ESA 612. For
automatic mode there are accessible sequences which can be loaded in PC and perform
whole measurement with ESA 612 automatically. When the measurement is finished, it is
possible to save result of measurement in PC and print Test report with results of all steps
of the measurement.
Required equipment and documents
 Electrical safety analyzer Fluke ESA612
2-36 990-82GICSTEN103
 Measurement test sequence file
 Set of measuring cables (universal for Devices)
 PC with Ansur Test Automation Software and ESA612 Plug-in, USB cable
Connecting the DUT with Fluke ESA 612
IMPORTANT: The Device Under Test (DUT) must be connected exactly according
to the pictures. Keep the mains power switch in “ON” position during the
measurement.
DO NOT TOUCH THE DUT AND CONDUCTIVE PARTS OF TEST EQUIPMENT

Begin with unplugging the power cord from the standard mains socket. Plug it directly to
DURING TESTING AS THERE IS A RISK OF ELECTRIC SHOCK!
appropriate socket on the Fluke meter. Plug in rest of test cables to the Unit and
interconnect them with Fluke meter according to the picture, which is present in each
description of electrical safety measurement. Turn ON the Fluke and interconnect it with
PC using USB-A – USB mini B cable.
Find below example of interconnection between Device and ESA 612 using Set of
measuring cables for Fluke.
2-37
IMPORTANT: If warning message about reverse polarity in the mains appears on
the Fluke ESA612 use pigtail reversing polarity on standard mains socket side
(only for measurement purposes) or if possible connect mains plug of Fluke’s
mains cable into socket conversely. It ensures correct polarity on the tested parts
of the DUT and helps to protect internal circuits of ESA 612 against burning.
Running the Automated Electrical Safety Measurement
Start the “Ansur.exe” software from your

computer. In the Ansur Executive main screen
go to (“File > Open”) and locate the
measurement test sequence file according to
the type of DUT and type of Fluke meter used.
Select and open the sequence. A new screen
will appear. Start the sequence with the
“Start” button.
2-38 990-82GICSTEN103
If a message “COM Port communication error”

appears on the display of the Fluke meter, turn 1. 2.
the meter OFF and ON and continue with the
testing procedure.
In case a message “Instrument not found.

Please check that ESA 612 is connected and
powered ON” appears in PC, check if the
3.
ESA 612 is properly connected with PC. Then
run Ansur MLS software and perform scanning of COM ports for connected Devices. If the
ESA 612 is properly connected to PC it will be detected.
Fill in the Report No., Device Serial No. and the ambient temperature. Confirm each step
by pressing the “Next” button till the first measurement sequence is reached.
Press the “Start” button to start the electrical safety measurement sequence and wait until
the sequence finishes. Press the “Next” button twice (go through the “Test summary
screen”).
2-39
Go to the “Result data” tab and check that the test ended with “Test passed” status.
Saving and Exporting the Test Report
Save the test report in a format

“SerialNumber.mtr” in order to keep it for
internal or archiving purposes. Click on the
“Print” button. Print report setup window will
appear. Choose the best suitable options for
exporting / printing the Test Report. Check
the “Detailed” option in the “Report type”
selection. Various language options for the
Test Report are available when clicking on the
tab “Report Configuration”.
IMPORTANT: Printed and signed copy of the “Test Report” must be attached to
the report every time electrical safety measurements have been performed.
Finishing
Disconnect all measuring cables from the Unit, connect back Accessories (applicators) and
ensure the Device is in working order.
2-40 990-82GICSTEN103
MANUAL MODE
In manual mode service technician can directly control ESA 612. This mode is suitable for
analysis of faulty parts when the test performed in automatic mode has failed. For
performing of manual measurement deep knowledge of standard IEC 62353 is assumed.
In manual mode of ESA 612 is not possible to export PDF test report as from automatic
mode. Therefore, automatic mode is preferred over the manual mode for performing of
electrical safety check during Inspections.
2.8.2 General recommendations for ESA612

When using electrical safety analyzer ESA612, there are several recommendations which
help to protect the analyzer from internal failure.
Internal mains polarity reversing circuits can be damaged when specific conditions are
present. As a result, the analyzer provides incorrect measured values for the Device Under
Test (further referred as DUT).
The damage can happen when using the analyzer under these conditions:
 The analyzer is used with active “reversed polarity” function on start-up.
 The DUT is connected to the analyzer at the time of turning the analyzer ON.
 Option “polarity delay” for manual measurement is set to value lower than 2s.
To avoid risk of internal circuits damage, follow these recommendations:
 Do not reverse polarity by pressing button F1 (“Reverse“) during start-up of the

analyzer. If possible, reconnect the mains plug to required polarity (e.g. for power
socket of „Schuko“ type) or use mains socket where the required mains polarity is
present.
„Schuko“ type power socket

180°
2-41
 If there is no mains socket with the required mains polarity, supply the analyzer
from an extension cord (pigtail) which reverses the mains polarity as shown in the
picture below.
 If the analyzer is used in manual mode it is important to set the parameter “polarity
delay” at least to 5 seconds.
For detailed instructions refer to related “Service bulletin”.
2.9 Advanced Repairs

Advanced repairs are generally more complex and skills demanding compared to common
repairs. To Advance repairs belong exchange of electronic components instead of whole
functional blocks (e.g. PCBs), soldering on PCBs or difficult replacement of components.
The Advance repair must be carried out by experienced and qualified service technician
with valid Certificate of level Standard or higher.
Holder of Certificate of level Standard is allowed to carry out all basic repairs, advanced
repairs stated in section “Advanced repairs” of Device specific “Service Manual” and
perform other service in accordance with the Technical training and additional instructions
given by BTL ISC.
Advanced certificate holder is allowed to carry out service operations allowed to holder of
Standard certificate and additionally to carry out repairs which are not described in Service
documentation. After such repair the Device must be in compliance with production
documentation and tested according to production final inspection procedure.
2-42 990-82GICSTEN103
2.10 Troubleshooting Basics

There are a few steps which can be applied during finding cause of a problem.
 Try to simulate the error described by customer to locate failing components.
 Check Dialog history of the Device for occurrence of any error message. For details
about Dialog history and Runtime errors see subsections 2.2.2 Dialog History and
2.3.1 Runtime Errors.
 Check results of self-tests of generators. See details in 2.3.2 Selftest Errors.
 Follow procedures described in Troubleshooting of specific Device “Service

Manual” or other service documentation.
 For testing it is possible to use also some steps from “Final Inspection Report” or
“Maintenance and Safety Report”.
During the analysis BTL ISC can be asked for an advice. Prepare all necessary information
about the analyzed Device and analyzed error as described in subsection 1.3.2 Support
Request.
NOTE: Using comparative method you can check functionality of the Device with
parts which functionality have been verified (e.g. from Reference device). If the error
disappears when fully functional part has been used, problem is highly probably in
replaced part (e.g. the Device is functional with brand new Power adaptor and cannot
be turned ON with the original one).
2-43
2-44 990-82GICSTEN103
BTL SERVICE
3 TECHNICAL SUPPORT CONTACT
3-1
Please prepare following information with any service enquiry:
Device Model, Type.
Complete Serial Number. Device S/N is on the system’s rear panel.
Firmware version. This can be found in the Device menu.
Detailed description of the problem. Include information such as description of the

therapy during which the fault occurred, type of the applicator (s) used.
 LOG files downloaded from the concerned Device
Other supporting materials: pictures or videos describing the problem
BTL International Service Center (BTL ISC)
E-mail: service@btlnet.com
Tel: +359 32 624 440
Address:
BTL Industries LTD
30 Peshtersko Shouse Blvd
4002 Plovdiv
Bulgaria
3-2 990-82GICSTEN103
BTL SERVICE
4 INDEX
4-1
accessories .........................................ii, 2-12 multifirmware ........................................ 2-17
advanced repairs ................................... 2-42 non-conforming parts ............... 1-43, 2-29
adverse event ................................ 1-4, 1-27 operation modes ............................. 2-3, 2-4
appendix .................................................. 1-16 other tools ............................................... 1-20
applicator.................................... ii, 1-5, 2-12 part number............................................ 1-43
applicator's label .................................... 2-32 periodical inspection .................... 1-4, 2-35
applied part leakage current ................ 1-6 phone .......................................................... 3-2
blue part................................................... 1-14 protective earth resistance .................... 1-6
BTL CardioPoint license....................... 2-16 red part .................................................... 1-15
BTL ISC............................................... 1-7, 3-2 reference device.................................... 1-42
BTL license server ......................2-16, 2-26 report number ........................................ 1-29
BTL service info ..................................... 1-20 reporting.................................................. 1-29
BTL service server ......................1-16, 2-17 RMA number .......................................... 1-10
certificate................................................. 1-13 runtime error .................................... 2-6, 2-9
cleaning ................................................... 1-37 safe mode ....................................... 2-3, 2-15
color parts ............................................... 1-14 safety instructions ................................... 1-3
complaint................................................. 1-27 safety related complaint ..................... 1-27
decontamination ................................... 1-37 sales mode...................................... 2-3, 2-14
device .............................................................. ii selftest error ........................................... 2-10
device inspection .............. 1-4, 1-34, 2-35 serial programming .............................. 2-21
device safety.................................. 1-4, 2-28 service bulletin....................................... 1-15
dialog history ............................................ 2-7 service documentation structure ...... 1-14
distributor mode ........................... 2-3, 2-14 service info ............................................. 1-20
document structure .................................... iii service manual....................................... 1-14
electrical safety measurement.. 1-5, 2-36 service manual appendix .................... 1-15
equipment leakage current................... 1-6 service mode .................................. 2-3, 2-14
error code .......................................... 2-6, 2-9 service record ........................................ 1-30
ESD protection ....................................... 2-29 service reporting ................................... 1-29
event logging............................................ 2-6 service tools ........................................... 1-20
final inspection .............................. 1-4, 1-34 spare parts .............................................. 1-42
final inspection report ................. 1-4, 1-35 specific tools .......................................... 1-20
firmware loader ..................................... 2-18 support request ........................................ 1-9
firmware restore mode ............... 2-4, 2-15 technical support ............................ 1-7, 3-2
firmware update .................................... 2-17 technical training .................................. 1-11
fluke ESA 612 ........................................ 2-36 technical training certificate .............. 1-13
generator programming ...................... 2-23 time limitation ........................................ 2-26
generators information ........................ 2-12 tool set ..................................................... 1-20
green part ................................................ 1-14 touch panel calibration ........................ 2-34
handpiece ................................... ii, 1-5, 2-12 transportation ........................................ 1-36
hot glue .................................................... 2-31 unit ................................................................... ii
HW key..................................................... 2-11 unit information ..................................... 2-12
information message.............................. 2-6 unit log data export ...................... 2-7, 2-35
insulation resistance ............................... 1-6 unlock code ............................................ 2-26
key combinations .................................... 2-4 USB programming ................................ 2-19
label .......................................................... 2-32 user mode .................................................. 2-3
leakage current ........................................ 1-6 warranty .................................................. 1-44
license server...............................2-16, 2-26 yellow part .............................................. 1-15
loaner device .......................................... 1-41
maintenance and safety report. 1-5, 2-35
master code ............................................ 2-27
4-2 990-82GICSTEN103
BTL SERVICE
5 APPENDIX
Tools from Tool Set ........................................................................................................................ 5-2
Specific Tools for Service Technician........................................................................................ 5-4
Other tools ..................................................................................................................................... 5-11
5-1
Tools from Tool Set
In table below is list of tools contained in Tool set for service technicians. Due to duplicity
of content of Tool set with common service office equipment several items have been
removed from Tool set package.
Complete Tool set R-59TOOLSETXXX or individual items can be ordered from the BTL ISC
(see chapter 3 Technical Support Contact).
Content of the Tool set

Type Part number Tool Description
RSC-TX6XXX Screwdriver Torx TX6
Torx
screwdrivers
RSC-TX20XXX Screwdriver Torx TX20 long
RSC-PH0XXX Screwdriver Phillips PH0
Philips RSC-PH1XXX Screwdriver Phillips PH1
screwdrivers RSC-PH1XXX Screwdriver Phillips PH1 isolated
RSC-PH2XXX Screwdriver Phillips PH2
RSC-SL2.5XXX Screwdriver Slot 2.5 mm
RSC-SL3XXX Screwdriver Slot 3 mm
Slot
RSC-SL4XXX Screwdriver Slot 4 mm isolated
screwdrivers
RSC-NT5.5XXX Screwdriver for nut 5.5 mm
Nut
RSC-NT7XXX Screwdriver for nut 7 mm
screwdrivers
RRTS-SETXXX Ratchet Screwdriver Set
RSP-5.5_7XXX Spanner 5.5x7 mm
RSP-8_10XXX Spanner 8x10 mm
Spanners
RSPT-16_17XXX Spanner Tube 16x17 mm
214-4101WRENCHXXX Wrench of body nut for shockwave
Special 214-4102NUTWRENCHXXX Wrench of transmitter nut for shockwave
230-WRENCHSXXX Wrench for patient panel connectors binder
5-2 990-82GICSTEN103
Appendix
RPL-NOSEXX0 Needle nose pliers (Electric) 160 mm

RPL-NOSEXX1 Needle nose pliers (small)
RPL-PEAN200XX0 Hemostat clamp
Pliers RPL-COMBI200XXX Combination pliers (Electric) 200 mm
RPL-CUTTER160XXX Cutting pliers (Electric) 160 mm
RPL-CUTTER125XXX Cutting pliers for electronic 125 mm
RPL-CIRCLIPXXX Circlip pliers 1.3 mm
EKAB-USBAM-AMBKXXX Extension cable USB A-A - 1.8 m
EKAB-USBAM-BMBKXXX Load cable for USB upload
EKAB-USBA-MINI5XXX MiniUSB cable for BTL-08 Holter
Cables/convert. Loader cable for BTL-5000 SWT
214-55LOADXXX
- air compressor update
270-232-USBSETXXX Set of converter of USB to serial port
300-55LOADXXX Loader cable for BTL-4000/5000
RTWZ-130MMXXX Tweezers straight 130 mm
RFIL-SET6PCXXX Needle file set 14cm/ 6 pcs.
EKON-BOTTLE115MLXXX Spray bottle for alcohol (empty)
Safety eyewear 630-730nm L4,
EKON-GLASALLXXX
770-1070nm L4
EMTR-ESDWRISTSTRAPXXX ESD Snap anti-allergic Wrist band
Others RKTR-18MMXX Knife trimming 18 mm
EBAT-ALK1.5VXXX Battery for torch AAA
EKON-MFL02XXX Torch
RSP-HXKEYSETXXX Allen keys 7 pcs. HX1.5 - HX6.0
RHOL-HELPINGHANDXX0 Clamp tool with magnifier - Helping hand
RBOX-GTLINEXXX Tool case
5-3
Specific Tools for Service Technician
Available Specific tools are listed in table below. These tools are not a part of Tool set for
service technician.
Specific tools can be ordered from the BTL ISC (see chapter 3 Technical Support Contact).
List of Specific Tools

Part number Tool Description Notes
BTL-6000 Shortwave
113-DUMMYLOAD -----
dummy load
Exilis tool for extracting coolant from
115-COOLEXT -----
the Unit
115-DUMMYLOAD Exilis/Exilis-Protégé dummy load -----
116-CALBOX Flash energy measuring tool -----
BTL-5000/BTL-4000
136-DUMMYLOAD -----
dummy load for electro generator
Testing tool
139-TESTCABBREAK -----
for Magnet applicator cable
Wrenches for tightening of glass and
145-59WRENCH inner nut for BTL-444 LED cluster and -----
BTL-445
190-PRESSUREMETER Vacuum/Pressure meter -----
Calibration syringe 3 litres for BTL-08
203-SYRINGE3L -----
Spiro
216-FILLTOOL Exilite Funnel
237-WRENCHS Wrenches for ultrasound head -----
713-DUMMYLOAD Vanquish dummy load -----
713-RFVLOAD Vanquish RFV load
Fluke ESA612/620 cables set
990-59CABLESFLUKE -----
for electrical safety measuring
5-4 990-82GICSTEN103
Appendix
BTL-6000 SHORTWAVE DUMMY LOAD
Dummy load is a testing tool designed for testing of correct functionality of

BTL-6000 Shortwave Unit. The Dummy load is connected to the Unit as a standard
applicator when testing of the Unit is required.
EXILIS TOOL FOR EXTRACTING COOLANT FROM THE UNIT
The tool is intended to be used for extracting coolant from Exilis Unit.
5-5
EXILIS/EXILIS-PROTÉGÉ DUMMY LOAD
Dummy load is a testing tool that is designed for testing of correct functionality of Exilis
and Exilis-Protégé Units and their accessories - the large and small applicator.
In principle, the Dummy load is a passive load, which simulates patient’s body impedance
and neutral patch electrode contact when applicator is connected to the Dummy load.
FLASH ENERGY MEASURING TOOL
The Flash energy measuring tool is intended for calibration of Exilite system. It uses sensor
Gentec Flash for measuring of energy outputting the Exilite applicator during calibration or
during standard therapy.
5-6 990-82GICSTEN103
Appendix
BTL-5000/BTL-4000 DUMMY LOAD FOR ELECTRO GENERATOR
Dummy load for electro generator is a testing tool that is designed for testing of correct
functionality electro generator of Units BTL-4000, BTL4000 Smart / Premium and
BTL-5000. The Dummy load is connected to the Unit as a standard applicator during
testing and simulates impedance of patient’s body.
TESTING TOOL FOR MAGNET APPLICATOR CABLE
Testing tool for magnet applicator cable is designed for testing of magnet applicator cables
for Units BTL-4000, BTL4000 Smart / Premium and
BTL-5000. The tool checks if individual wires of applicator's cable are not broken.
WRENCHES FOR ULTRASOUND HEAD
Wrenches are intended to be used for assembling/disassembling of the ultrasound head

of BTL-237 applicators.
5-7
VACUUM/PRESSURE METER
Vacuum/Pressure meter is a testing tool that is designed for testing correct functionality
of BTL-5000 SWT, BTL-6000 SWT, BTL-6000 Lymphastim, BTL-Vac and BTL-Vac II Units.
The Pressure meter is connected to the Unit as a standard applicator when testing of the
pressure or vacuum output of the Unit is required. The tools can also simulate patient
button on SWT applicators so a common therapy can be run.
CALIBRATION SYRINGE 3 LITRES FOR BTL-08 SPIRO
Calibration syringe is intended to be used for calibration of BTL-08 Spiro.
EXILITE FUNNEL
The tool is intended to be used for filling/draining of coolant of Exilite Unit.
5-8 990-82GICSTEN103
Appendix
WRENCHES FOR GLASS AND INNER NUT FOR BTL-444 LED CLUSTER AND BTL-445
Wrenches are intended for assembling/disassembling of the glass and the inner nut of
BTL-444 and BTL-445 applicators.
VANQUISH DUMMY LOAD
Dummy load is a testing tool that is designed for testing of correct functionality of
Vanquish. The Dummy load is connected to the Unit as a standard applicator when testing
of the Unit is required.
5-9
VANQUISH RFV LOAD
RFV load is a testing tool that is designed for testing of correct functionality of Vanquish
version 200 and higher or Vanquish with installed spare part 713-59TMATCH.
CABLES SET FOR ELECTRICAL SAFETY MEASURING
The set is intended to be used as an equipment of electrical safety analyzer Fluke ESA612
which is recommended to be used for measuring of leakage currents and other safety
parameters on majority of medical devices from the BTL portfolio (after repair or during
periodical maintenance and safety check).
5-10 990-82GICSTEN103
Appendix
Other tools
Other tools have to be purchased separately by each Service facility on local market. They
are not supplied by BTL ISC. List of other tools is always present in description of each
procedure.
Among these tools belong mainly:
 Electrical safety analyzer Fluke ESA612 for measuring of leakage currents,

grounding and other safety parameters of Device
 Multimeter Fluke 289 (alternatively Fluke 117 or 179) which is capable to be

calibrated and can be used as a reference measuring instrument
 Tools for soldering (soldering iron, soldering wire, flux, desoldering braid and
pump)
 Hot glue gun and sticks
5-11

990 82gicsten103

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

990 82gicsten103

Uploaded by

Copyright:

Available Formats

BTL SERVICE

General Instructions And

Document Revisions and History

Date: Date: Previous

Changes in sections 1.8, 1.9, 2.6 2016-12-29 2016-12-29

Changes in sections 1.9, 2.1

Changed reporting in section 1.9 2013-01-02 2013-01-02

General warning, caution, risk or danger

IMPORTANT Please pay close attention to the information given

NOTE Additional recommending information

IMPORTANT: This service documentation has been designed to provide

NOTE: Following terms are used in the document:

Device = Unit + Accessories (Applicator, Handpiece etc.)

IMPORTANT: This document is intended for service facilities at BTL distributors.

Document Revisions and History .................................................................................................... i

Symbols and Comments................................................................................................................... ii

Document Structure ......................................................................................................................... iii

1.1 Safety .................................................................................................................................... 1-3

1.2 Service Standard IEC 62353 .......................................................................................... 1-4

1.3 Technical Support.............................................................................................................. 1-7

1.4 Technical Trainings ........................................................................................................ 1-10

1.5 Service Documentation................................................................................................. 1-13

1.6 Service Tools .................................................................................................................... 1-18

1.7 Service Case Workflow ................................................................................................. 1-19

1.8 Complaints........................................................................................................................ 1-25

1.9 Service Reporting ........................................................................................................... 1-27

1.10 Recommended Practices ......................................................................................... 1-33

1.11 Examples of Service Cases ...................................................................................... 1-40

2 Common Service Tasks ............................................................................................................ 2-1

2.1 Operation Modes ............................................................................................................... 2-3

2.2 Event Logging ..................................................................................................................... 2-6

2.3 Error Codes System........................................................................................................... 2-9

2.4 Common Device System Features ............................................................................. 2-11

2.5 BTL License Server ......................................................................................................... 2-16

2.6 Common Tasks................................................................................................................ 2-17

2.7 Periodical Inspection...................................................................................................... 2-35

2.8 Electrical Safety Measurement ................................................................................... 2-36

2.9 Advanced Repairs ........................................................................................................... 2-42

2.10 Troubleshooting Basics............................................................................................. 2-43

1.1.1 Service Technician Safety ........................................................................................... 1-3

1.1.2 Operator and Patient Safety ....................................................................................... 1-3

1.1.3 Device Safety Checking ............................................................................................... 1-4

1.1.4 Adverse Events .............................................................................................................. 1-4

1.2 Service Standard IEC 62353 .............................................................................................. 1-4

1.3 Technical Support .................................................................................................................. 1-7

1.3.1 Technical Support Structure ...................................................................................... 1-7

1.3.2 Support Request............................................................................................................ 1-8

1.3.3 RMA Number ................................................................................................................. 1-9

1.4 Technical Trainings ............................................................................................................ 1-10

1.4.1 Certificates ................................................................................................................... 1-12

1.5 Service Documentation ..................................................................................................... 1-13

1.5.1 Service Documents.................................................................................................... 1-13

1.5.2 BTL Service Server ..................................................................................................... 1-15

1.5.3 BTL Service Info .......................................................................................................... 1-18

1.6 Service Tools ........................................................................................................................ 1-18

1.7.1 Service Cases Management .................................................................................... 1-23

1.8 Complaints ............................................................................................................................ 1-25

1.9 Service Reporting ................................................................................................................ 1-27

1.9.1 Report Number ........................................................................................................... 1-27

1.9.2 Service Record ............................................................................................................ 1-28

1.9.3 Final Inspection ........................................................................................................... 1-31

1.10 Recommended Practices .............................................................................................. 1-33

1.10.1 Transportation ............................................................................................................. 1-33