KLS Martin Independant IDP 101 S User manual

English
Suspension
Arm System Independant®IDP 101 S,
IDP
101 S air plus and IDP 101 S XL
Instruct
ions for Use
90-030-52-10
Revision 1
Date of Release: 2016-05

2 Revision 1
Symbol Explanation
Safety alert symbol
CAUTION Indicates a situation which, if not avoided, could result
in minor or moderate injury.
WARNING Indicates a situation which, if not avoided, could result
in death or serious injury.
DANGER Indicates a situation which, if not avoided, will result in
death or serious injury.
Follow Instructions for Use
Reference number for ordering Gebrüder Martin products (item
number)
Serial number
Manufacturing date
Manufacturer
Risk of explosion
Warns against improper handling of oxygen, see section 4.2.4
“Safe Handling of Oxygen”, page 22.
Fire hazard
Warns against improper handling of oxygen, see section 4.2.4
“Safe Handling of Oxygen”, page 22.
Warning: Dangerous electric voltage
Falling parts
Warns against falling parts when standing under the suspension
arm system while assembly or disassembly work is being
performed.
Snapping upwards of the spring arm
Warns against sudden snapping upwards of the spring arm upon
removal of the end device (e.g. TFT monitor, medical device, etc.)
from the M6 service head or CEMOR®.
“Personal injury: Do not take off end device or adaption before the
spring arm is adjusted to the horizontal position (0 degree position)
and secured.”

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Tightening torque
Warns against falling down of the suspension arm system due to
insufficiently tightened fastening screws.
Information on minimum and maximum temperature for storage
and transportation.
See section 12.2 “Technical Data”, page 56.
Information on minimum and maximum atmospheric pressure for
storage and transportation.
See section 12.2 “Technical Data”, page 56.
Information on minimum and maximum atmospheric humidity for
storage and transportation.
See section 12.2 “Technical Data”, page 56.
Do not exceed the maximum load-bearing capacity or payload:
Warns against sudden falling due to exceedance of the maximum
load-bearing capacity or loading capacity (payload).
The maximum value is specified in kg or Nm.
CE marking of conformity
This symbol describes the product as being a component approved
by a “Nationally Recognized Testing Laboratory”, fulfilling both the
Canadian and USA deviations from the applicable standards.
This product may not be disposed of as normal household garbage,
see section 14.2 “Disposal of the Device”, page 62.

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Contents
Terms & Acronyms.................................................................................. 7
1Product Liability and Warranty ...................................................... 7
1.1 General Information..............................................................................7
1.2 Scope of Delivery..................................................................................8
1.3 Intended Purpose..................................................................................9
1.3.1 Improper Use ................................................................................................10
1.3.2 Contraindications ...........................................................................................10
1.4 Warranty ...........................................................................................11
1.5 User’s Inspection ................................................................................11
1.6 Hotline...............................................................................................12
2Notices Concerning this Document................................................13
2.1 Validity of this Document.....................................................................13
2.2 Symbols Used in this Document............................................................14
3Notes for Safe Usage ..................................................................15
3.1 Information on Device Identification......................................................15
3.2 Designation of Person Groups...............................................................15
3.3 Notes for Operators.............................................................................16
3.4 Standards and Guidelines.....................................................................16
3.5 Combination with Products by Other Manufacturers.................................17
3.6 Patient Environment............................................................................17
4Safety Notes..............................................................................18
4.1 Data on the Rating Plate ......................................................................18
4.2 The Most Important Safety Information at a Glance ................................19
4.2.1 Operation......................................................................................................19
4.2.2 Assembly/Disassembly....................................................................................20
4.2.3 Maintenance Work..........................................................................................21
4.2.4 Safe Handling of Oxygen.................................................................................22
5Description of the Device and its Functions....................................23
5.1 Overview ...........................................................................................23
5.2 Description.........................................................................................25
6Load-Bearing capacity and Loading Capacity (Payload) ...................28
6.1 Maximum Load-Bearing Capacity ..........................................................28
6.2 Maximum Loading Capacity (Payload)....................................................29
6.3 Structural Changes to the Suspension Arm System .................................30
7Commissioning ..........................................................................31

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8Replacing an End Device .............................................................32
9Adjustment Work .......................................................................33
9.1 General Safety Notes...........................................................................33
9.2 Adjusting the Mechanical Brake of the Extension Arm and Spring Arm
(IDP 101 S air plus only)......................................................................34
9.3 Adjusting the Mechanical Brake for the CEMOR®or the M6 service head ....35
9.4 Selecting the Load-Bearing Capacity on the Spring Arm...........................36
9.4.1 Opening the Lower Cover on the Rear...............................................................36
9.4.2 Setting the Load-Bearing Capacity....................................................................37
9.4.3 Closing the Lower Cover on the Rear ................................................................38
9.5 Adjusting the Vertical Lift on the Spring Arm ..........................................38
9.5.1 Opening the Upper Cover on the Front..............................................................39
9.5.2 Adjusting the Vertical Lift ................................................................................39
9.5.3 Closing the Upper Cover on the Front ...............................................................39
9.6 Vertical Alignment of the CEMOR®or the M6 service head........................40
9.6.1 Opening the Lower Cover on the Rear...............................................................41
9.6.2 Correcting the Vertical Alignment .....................................................................41
9.6.3 Closing the Lower Cover on the Rear ................................................................41
9.7 Adjusting the Swivel Stop on the Extension Arm and the Spring Arm.........42
9.7.1 Overview.......................................................................................................42
9.7.2 Installing the Swivel Stop................................................................................44
9.7.3 Removing the Swivel Stop...............................................................................46
10 Cleaning and Disinfection ............................................................47
10.1 General Safety Notes...........................................................................47
10.2 Cleaning ............................................................................................48
10.3 Disinfection ........................................................................................48
11 Maintenance..............................................................................49
12 Technical Specification................................................................50
12.1 Dimensional Drawings .........................................................................50
12.1.1 Spring Arm, IDP 101 S Single Arm, with CEMOR®...............................................50
12.1.2 Spring Arm, IDP 101 S Single Arm, with M6 service head....................................51
12.1.3 Extension Arm with Spring Arm, IDP 101 S Dual Arm, with CEMOR®.....................52
12.1.4 Extension Arm with Spring Arm, IDP 101 S Dual Arm, with M6 service head..........53
12.1.5 Extension Arm with Spring Arm, IDP 101 S XL Dual Arm, with CEMOR®................54
12.1.6 Extension Arm with Spring Arm, IDP 101 S XL Dual Arm, with M6 service head .....55

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12.2 Technical Data....................................................................................56
12.2.1 Dead weight ..................................................................................................56
12.2.2 Maximum Load-Bearing Capacity......................................................................57
12.2.3 Brake torque .................................................................................................57
12.2.4 General Technical Data ...................................................................................58
12.3 Permissible Adaptions..........................................................................59
13 Inspection Plan ..........................................................................60
14 Ecological Information ................................................................62
14.1 Disposal of Packing .............................................................................62
14.2 Disposal of the Device .........................................................................62

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Terms & Acronyms
Designation Description
Adaption M6 service head or CEMOR®or a possible combination with products from
other manufacturers
BrakeGuide A colored LED lamp optically indicates the bearing point at which a brake has
been released
CEMOR®Monitor support for large screens or up to 8 TFT monitors
End device E.g. TFT monitor or medical device on the adaption
MOOP Means of Operator Protection
MOPP Means of Patient Protection
NRTL Nationally Recognized Testing Laboratory
SurroundLED Dimmable LED lamps in the upper extension arm and in the base of the
M6 service head as indirect light source in the OR
SW 24 Spanner width 24 for Allen spanner, ring spanner and flat spanner
1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy one of our products. This product bears the CE-
marking, which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com

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1.2 Scope of Delivery
•Canopy
•Extension arm ,
for dual-arm version in differing lengths
•Spring arm ,
height-adjustable
•Console tube ,
in variable length for compensating differing ceiling heights
•CEMOR®,
see corresponding instructions for use
•M6 service head ,
see corresponding instructions for use
•Optional: Indirect extension arm lighting (SurroundLED basic C),
with on/off switch on the M6 service head
•Option: BrakeGuide ,
on the pivot point of the extension arm

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1.3 Intended Purpose
•The suspension arm systems IDP 101 S are individually equipped. Depending on version
and fitted equipment, they can be used for the following:
—carrying and positioning of medical end devices in the operating room, in intensive
care, and in other medical environments.
—transport and withdrawal of media such as medical gases, vacuum and compressed air
(M6 service head only), electricity and data.
•The suspension arm system is suitable for continuous operation.
•The suspension arm system may be operated only by qualified medical staff with
appropriate qualifications.
•The suspension arm system may be cleaned and disinfected only by instructed hygiene
specialists.
•The suspension arm system may be serviced only by the operator’s technical specialists on
the basis of the applicable instructions.
The operator may operate a suspension arm system only if an on-site functional test has
previously been performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In
addition, a responsible person designated by the operator must have been instructed in the
proper handling, application and operation of the device, as well as in its permissible
combination with other medical devices, objects and accessories. This duly instructed officer
shall subsequently be responsible for familiarizing the operator’s staff with the device as the
need arises.
We recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
The operational safety of the device must be verified at regular intervals, see section 11
“Maintenance”, page 49 and section 13 “Inspection Plan”, page 60.
If the device is not functionally reliable and/or safe to operate, it must be marked as such and
withdrawn from service. A technical check is mandatory in any such case.

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1.3.1 Improper Use
The suspension arm system and its components must not be loaded beyond their maximum
load-bearing capacity, see section 12.2 “Technical Data”, page 56.
The maximum switch-on time of the electromagnetic brakes of the suspension arm system
must not exceed 1 min:
•If the electromagnetic brakes are actuated for more than 1 min, the power supply unit
may switch off automatically to prevent overheating.
•If the power supply unit has switched off, then it must cool down for 10 min before it can
be switched on again, and must then be disconnected from the building’s power supply for
10 seconds. Only then can the standard operation of the system be continued. The
maximum switch-on time must not be exceeded, as this could result in safety shut-downs.
1.3.2 Contraindications
The suspension arm system must not be used in the proximity of strong magnetic fields.
No applied parts of type BF or CF in accordance with IEC 60601-1 may be directly connected to
the suspension arm system.

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1.4 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di-
verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.
Important Notices
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly
authorized by Gebrüder Martin to perform such work.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the
operator of the product is required to obtain from the repairer a certificate with details about
the nature and scope of the repair work done. This certificate must show the date of the repair
and the details of the person or firm carrying out the work and must be signed.
In all cases where a party other than the product manufacturer performed the work, repaired
products must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation
shall void any and all warranty claims. Performing unauthorized actions on the product is
strictly prohibited at any time. Non-compliance will void any liability claim against
Gebrüder Martin.
Gebrüder Martin guarantees the safety and functional capacity of the system only if an initial
commissioning is carried out and the device is approved for operation with a declaration of
handover.
1.5 User’s Inspection
•Immediately upon receipt, the goods must be checked for completeness and potential
damage in transit.
•Notice of any such damage must be given immediately.

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1.6 Hotline
•Should you have any questions on how to handle the product or use it for clinical
applications, please do not hesitate to contact the Product Management:
Tel: [phone]
Fax: [phone]
•Should you have any technical questions or questions concerning maintenance contracts or
training courses, please contact our Martin Service Center:
Tel: [phone]
Fax: [phone]
E-Mail: [e-mail]
NOTICE
To answer your technical questions as efficiently as po
ssible, our service technicians require
the serial number of the product. Therefore, please have this number at hand when
contac
ting our hotline. It is part of the information provided on the rating plate; see
section
4.1 “Data on the Rating Plate”, page 18.

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2Notices Concerning this Document
Failure to observe this
document can lead to serious or even lethal injury to the
patient or the user!
Improper handling and care as well as non
-intended use can lead to premature wear and/or
pose a risk to patients and users!
It is the operator’s responsibility to ensure that al
l personnel handling the product have
u
nderstood and do observe the notes and instructions in this document.
•Every user is required to read this document completely and follow it carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.
2.1 Validity of this Document
This document applies to the Independant®IDP 101 S, IDP 101 S air plus and IDP 101 S XL
that are used as suspension arm systems for the M6 service head or the CEMOR®.
This document is valid only following a properly performed initial commissioning, see section 7
“Commissioning”, page 31.
This document is valid only in conjunction with:
•Instructions for use of the M6 service head
•Instructions for use of the approved accessories for the M6 service head
•Instructions for use of the CEMOR®

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2.2 Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is
marked with the following symbols and signal words:
DANGER
Life hazard or serious injury!
Indicates a situation which, if not
avoided, will result in death or serious injury!
WARNING
Life hazard or serious injury!
Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION
Risk of injury!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE
Risk of material damage!
Indicates a situation which, if not avoided, could lead to material damage (loss of time, data
loss, device/machine failure, etc.)!

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3Notes for Safe Usage
3.1 Information on Device Identification
These instructions for use are intended solely for devices identified on the rating plate by the
following data:
•Type designation: Suspension arm system IDP 101 S, IDP 101 S air plus and IDP 101 S XL
3.2 Designation of Person Groups
The following groups of persons are specified in these instructions for use:
Operators
Operators include all persons or entities who use the device themselves or allow its
usage/application by a third party in a medical practice, hospital, etc., and who are in actual
possession of the device during operation.
It is up to the operator to provide a safe device and properly instruct the user on operating the
device and using it for its intended purpose.
Users
Users include persons who, by reason of their training and appropriate instruction, have been
authorized by appointees of the operator to use the device and work with it.
Users are fully responsible for ensuring that the device is used safely and for its intended
purpose.
Qualified medical staff
Qualified medical staff include persons who
•have acquired their knowledge through completed professional training in the medical or
medical-technical field,
•can judge the tasks they perform by reason of professional experience and instruction in
the safety regulations, and can detect possible hazards during their work.
In jurisdictions where practice of an activity in the medical or medical-technical field is
certified, qualified medical staff rating requires appropriate certification.

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3.3 Notes for Operators
•The device is manufactured according to the current state of technology and is safe to
operate. Potential dangers may still be present, however, when using this device. This
applies in particular if the device is operated by personnel without the necessary
qualifications, or if it is used improperly and not in accordance with its intended purpose.
•The device may be operated, cleaned, and disinfected solely by qualified medical staff.
•All the assembly, disassembly and adjustment work described in these instructions for use
may be performed only by qualified staff assigned and instructed by the operator.
•For reasons of safety, any actions or interventions extending beyond this scope may be
carried out only by Gebrüder Martin or by a company authorized by Gebrüder Martin.
Authorization of a company requires successful participation of the company’s service
technicians in a technical training course conducted by Gebrüder Martin. The authorization
is granted for a limited time period.
3.4 Standards and Guidelines
The device meets the safety requirements of the following standards, regulations and
guidelines:
Abbreviation Designation
MPG German Medical Devices Act (German: Medizinproduktegesetz)
93/42/EWG German Medical Devices Directive (German: Medizinprodukterichtlinie)
IEC 60601-1 Electrical medical devices, Part 1: General specifications for safety, including the
essential performance features
DIN EN 62353 Medical electrical equipment – Recurrent test and test after repair of medical
electrical equipment

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3.5 Combination with Products by Other Manufacturers
It is the responsibility of the operator to validate the complete system and, if applicable,
complete a conformity evaluation procedure and submit a declaration in accordance with
Article 12 of 93/42/EWG.
Please refer to the instruction manuals of the respective manufacturer for the information
required to operate the end device.
Power supply units provided for supplying end devices must ensure galvanic separation and be
equipped with two protective measures in accordance with IEC 60601-1.
3.6 Patient Environment
Any electrical medical devices with accessible metal parts
that are attached to the support arm system and located
within the patient environment must be equipped with
2 means of patient protection (MOPP) according to
IEC 606011.
Any accessible parts located outside of the patient
environment must be equipped with 2 means of operator
protection (MOOP) according to IEC 60601-1.
The figure shows the minimum extent of the patient
environment in unrestricted surroundings.
Fig. 3-1: Patient environment as defined in IEC 60601-1

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4Safety Notes
4.1 Data on the Rating Plate
Fig. 4-1: Rating plate, example
The rating plates are located on the top of the extension arm.
•Serial number (SN)
The rating plate displays the serial number of the suspension arm system.
•Power supply
The rating plate displays the data for the power supply to the suspension arm system.
•Load capacity
The load 30–60 kg data, for example, indicate the maximum allowable load-bearing
capacity of the extension arm.
•Manufacturing date
the manufacturing date of the suspension arm system is specified in digits 1–4 of the
serial number (SN).
—The first two digits indicate the week of manufacture, e.g. 11 = calendar week 11.
—The two following digits indicate the year of manufacture, e.g. 14 = 2014.
—The digits after the letters are the serial number.
The data and illustrations are provided as examples and can differ from those on the actual
rating plate.

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4.2 The Most Important Safety Information at a Glance
Please also comply with the safety instructions in the following sections.
4.2.1 Operation
WARNING
Danger of injury from sudden snapping upwards of the spring arm!
Upon removal of end devices from the CEMOR
®or the M6 service head or dismounting the
adaption such as the
M6 service head or the CEMOR®from the spring arm, the spring arm
may snap upwards suddenly!
•
Before removing an end device (e.g. TFT monitor, medical device) from the CEMOR®or
the M6 service head, or before removing the M6 service head or the CEMOR®, or before
removing the M6 service head from the spring arm, set the height adjustment on the
spring arm to the horizontal position (0°) and secure it.
•
Check the height adjustment of the spring arm. After securing the height adjustment in
the horizontal position (0°), it must not be possible to move the spring arm upwards
anymore.
•
The end device (e.g. TFT monitor, medical device) may be removed only when the spring
arm is in the horizontal position (0°) and cannot be moved upwards anymore.
WARNING
Risk of injury from collapse of the suspension arm system if the maximum load
-
bearing capacity is exceeded!
Exceeding the maximum permissible load
-bearing capacity can cause the suspension arm
system or its components to loosen fro
m the anchorage and fall down:
•
Do not exceed the maximum load-bearing capacity of the suspension arm system and its
components, see section 12.2 “Technical Data”, page 56.
•
Do not hang or install any additional loads on the extension arm, M6 service head, or end
devices.
Collisions with other devices, walls or ceilings can damage the suspension arm system and
the
M6 service head and can cause important means of supply to fail:
•
Check the M6 service head and the suspension arm system for possible damage after any
collision.
•
In case of doubt, notify your supplier.

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4.2.2 Assembly/Disassembly
WARNING
Danger of injury from electric shock!
Power supply lines run in the suspension arm system, the CEMOR
®and the M6 service head.
Touching live parts can cause life
-threatening electric shock.
•
In order to avoid the risk of electric shock, the suspension arm system may be connected
only to a supply network with a protective conductor in such a way that all of its phases
can be simultaneously disconnected from the mains.
Disconnect the suspension arm system from the mains before beginning
any
assembly
/disassembly or adjustment work.
•
Disconnect all phases of the customer-side power supply and secure it against
reactivation.
•
Ensure that all the devices connected to the M6 service head are de-energized.
WARNING
Risk of injury from falling parts!
No persons may stay beneath the components of the suspension arm system during any
disassembly/
assembly work.