KLS Martin IDP 101 S air plus User manual
English
Suspension Arm System
s Independant®
IDP
101 S air plus
Mounting Instructions
90-061-72-10
Revision 1
Date of Release: 2016-06
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 29.
Fire hazard
Warns against improper handling of oxygen, see section 4.2.4
“Safe Handling of Oxygen”, page 29.
Warning: dangerous electric voltage
Falling parts
Warns against falling parts when standing under the suspension
arm system while assembly/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 remove end device or adaption before the
spring arm is adjusted to a horizontal position (0 degree position)
and secured.”
Revision 1 3
Danger of crushing
Warns against trapping limbs during assembly/disassembly work.
Danger of collisions
Warns against collisions with components of the suspension arm
system during assembly/disassembly work.
Non-ionizing electromagnetic radiation
Cautions against disturbance of medical devices and electronic
implants by the high-frequency electromagnetic radiation emitted
by cellular and radio transmitters.
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 9.2 “Technical Data”, page 100.
Information on minimum and maximum atmospheric pressure for
storage and transportation.
See section 9.2 “Technical Data”, page 100.
Information on minimum and maximum atmospheric humidity for
storage and transportation.
See section 9.2 “Technical Data”, page 100.
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 11.2 “Disposal of the Device”, page 105.
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Contents
Terms & Acronyms.................................................................................. 7
1Product Liability and Warranty ...................................................... 7
1.1 General Information..............................................................................7
1.2 Scope of Delivery..................................................................................8
1.2.1 Overview and Scope of Delivery for IDP101 S air plus, Single Arm ........................ 8
1.2.2 Overview and Scope of Delivery IDP 101 S air plus, Dual Arm..............................11
1.2.3 Overview and Scope of Delivery of Optional Equipment.......................................14
1.2.4 Additional Optional Equipment .........................................................................14
1.3 Intended Purpose................................................................................15
1.3.1 Improper Use ................................................................................................16
1.3.2 Contraindications ...........................................................................................16
1.4 Warranty ...........................................................................................16
1.5 User’s Inspection ................................................................................16
1.6Hotline...............................................................................................17
2Notices Concerning this Document................................................18
2.1 Validity of this Document.....................................................................18
2.2 Applicable Mounting Instructions...........................................................18
2.3 Symbols Used in this Document............................................................20
3Instructions for Safe Installation ..................................................21
3.1 Information on Device Identification......................................................21
3.2 Required Installation Equipment ...........................................................21
3.3 Requirements.....................................................................................21
3.3.1 Requirements for the Qualifications of the Service Technician ..............................21
3.3.2 Requirements before Installation......................................................................21
3.3.3 Assembly Process...........................................................................................22
3.3.4 Unauthorized Modifications or Adjustments........................................................22
3.3.5 Qualified Medical Staff ....................................................................................22
3.4 Notes for Operators.............................................................................23
3.5 Standards and Guidelines.....................................................................23
3.6 Combination with Products by Other Manufacturers.................................23
3.7 Patient Environment............................................................................24
4Safety Notes..............................................................................25
4.1 Data on the Rating Plate ......................................................................25
4.2 The Most Important Safety Information at a Glance ................................26
4.2.1 Operation......................................................................................................26
4.2.2 Assembly/Disassembly....................................................................................27
4.2.3 Maintenance Work..........................................................................................28
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4.2.4 Safe Handling of Oxygen.................................................................................29
5Commissioning ..........................................................................30
5.1 Initial Commissioning and Handover......................................................30
6Load Data .................................................................................31
6.1 Load Data for IDP 101 S air plus...........................................................31
6.2 Load Data for Suspension Arm Combinations..........................................32
7Mounting...................................................................................33
7.1 Mounting the Threaded Bolts on the Interface Plate.................................33
7.1.1 Mounting Conditions: Interface Plate on the Raw Ceiling without Intermediate
Ceiling ..........................................................................................................33
7.1.2 Mounting Conditions: Interface Plate on the Raw Ceiling with Intermediate Ceiling.36
7.1.3 Mounting Conditions: Interface Plate on the Intermediate Ceiling Mount ...............40
7.2 Pre-assembly: Mounting the Longer Ceiling Tube on the Extension Arm.....43
7.2.1 Overview of the Components in this Section ......................................................43
7.2.2 Mounting the longer Ceiling Tube .....................................................................44
7.3 Mounting the Ceiling Tube on the Threaded Bolts of the Interface Plate .....48
7.3.1 Overview of the Components in this Section ......................................................48
7.3.2 Mounting the Ceiling Tube...............................................................................49
7.3.3 Adjusting the Spring Arm/Extension Arm on the Single Interface Plate..................51
7.3.4 Adjusting the Spring Arm/Extension Arm on the Duo Interface Plate.....................53
7.4 Mounting the Console Tube on the Spring Arm........................................55
7.4.1 Overview of the Components in this Section ......................................................55
7.4.2 Mounting the Console Tube on the Spring Arm...................................................56
7.5 Mounting Optional Equipment...............................................................57
7.5.1 Mounting the Extension Arm Light (only for Retrofitting) .....................................57
7.6 Installing the Cables............................................................................58
7.6.1 Safety Notes..................................................................................................58
7.6.2 Connecting the Cables on the Extension Arm with Spring Arm, Dual Arm, to the
M6 Service Head ............................................................................................59
7.6.3 Laying and Connecting the Pneumatic Brake Pipes..............................................60
7.6.4 Connecting the Optional Extension Arm Lighting ................................................62
7.6.5 Connecting the Earthing Cables on the Extension Arm with Spring Arm, Dual Arm,
to the M6 Service Head...................................................................................63
7.6.6 Feeding the Supply Cables Through the Extension Arm with Spring Arm,
Dual Arm, to the M6 Service Head....................................................................64
7.6.7 Connecting the Cables on the Spring Arm, Single Arm, to the M6 Service Head......65
7.6.8 Laying and Connecting the Pneumatic Brake Pipes..............................................66
7.6.9 Connecting the Earthing Cables on the Spring Arm, Single Arm, to the
M6 Service Head ............................................................................................68
7.6.10 Feeding the Supply Cables Through the Spring Arm, Single Arm, to the
M6 Service Head ............................................................................................69
7.7 Connecting the Supply Cables...............................................................70
7.7.1 Safety Notes..................................................................................................70
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7.7.2 Installing the Cables for the Gas Supply and Exhaust Air.....................................71
7.7.3 Connecting the Earthing Cables........................................................................73
7.7.4 Connecting the Power Cables...........................................................................73
7.7.5 Checking the Supply Cables.............................................................................74
7.8 Checks ..............................................................................................74
7.8.1 Gas Type Check (M6 Service Head only) ...........................................................74
7.8.2 Mechanical Collision Check ..............................................................................74
7.9 Mounting the Canopy, Cover Caps and Claddings ....................................75
7.9.1 Mounting the Single/Duo Canopy .....................................................................75
7.9.2 Mounting the Single Canopy ............................................................................77
7.9.3 Installing/Uninstalling the Cover Caps on the Extension Arm................................79
7.9.4 Mounting the Plates on the Spring Arm .............................................................81
7.9.5 Mounting the Side Cladding on the Spring Arm ..................................................82
7.9.6 Mounting the Lower Rear Cover Panels on the Spring Arm...................................83
7.9.7 Mounting the Front Side Claddings on the Spring Arm.........................................84
7.9.8 Mounting the Upper Front Cover Panel on the Spring Arm ...................................85
8Adjustment Work .......................................................................86
8.1 Safety Notice for Adjustment Work........................................................86
8.2 Adjusting the Mechanical Brake for the M6 service head ..........................86
8.3 Selecting the Load-Bearing Capacity on the Spring Arm...........................87
8.4 Adjusting the Vertical Lift on the Spring Arm ..........................................91
8.5 Correcting the Vertical Alignment of the M6 Service Head ........................93
8.6 Swivel Stop on the Extension Arm and Spring Arm..................................94
8.6.1 Installing the Swivel Stop................................................................................95
8.6.2 Removing the Swivel Stop...............................................................................97
9Technical Specification................................................................98
9.1 Dimensional Drawings .........................................................................98
9.1.1 Spring Arm, IDP 101 S air plus, Single Arm, with M6 Service Head.......................98
9.1.2 Spring Arm, IDP 101 S air plus, Dual Arm, with M6 Service Head .........................99
9.2 Technical Data.................................................................................. 100
9.2.1 Dead Weight................................................................................................100
9.2.2 Maximum Load-Bearing Capacity....................................................................100
9.2.3 Brake Torque...............................................................................................100
9.2.4 General Technical Data .................................................................................101
9.3 Permissible Adaptions........................................................................ 102
10 Inspection Plan ........................................................................103
11 Ecological Information ..............................................................105
11.1 Packaging ........................................................................................ 105
11.2 Disposal of the Device ....................................................................... 105
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Terms & Acronyms
Designation Description
Adaption M6 service head or a possible combination with products from other
manufacturers
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
RF Radio frequency
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 2 Spanner width 2 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. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
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1.2 Scope of Delivery
1.2.1 Overview and Scope of Delivery for IDP101 S air plus, Single Arm
Fig. 1-1: Overview of IDP 101 S air plus, single arm
Overview
Interface plate (Single/Duo) – already installed
Intermediate ceiling – installed on site
Mounting Instructions
Suspension Arm Systems Independant®
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Scope of delivery
The scope of delivery may vary depending on the order.
Canopy (Single/Duo) (flat/high) (depending on version)
−1 Single canopy Ø 600 mm x 150 mm, 1 canopy cap 110 mm height
−1 Single canopy 700 mm x 700 mm x 150 mm height
−1 Duo canopy (installation with intermediate ceiling) 700 mm x 700 mm x 50 mm
−1 Duo canopy (installation with intermediate ceiling) 700 mm x 700 mm x 150 mm
−1 canopy cap 700 mm x 700 mm x 120 mm height
Canopy fastening elements
−4/6 threaded bolts M10 x 360 mm, 4/6 hexagonal nuts M10,
−4/6 self-tapping screws, 4/6 cladding screws and 1 profile strip
For assembly, see section 7.9 “Mounting the Canopy, Cover Caps and Claddings”, page 75.
Spring arm with ceiling tube (pre-assembled)
−1 spring arm
Pre-installed components
−3 2 pneumatic pipes for pneumatic brake control
−2 earthing cables 4 mm²
Included components
−1 setscrew M16 DIN EN ISO 4028, 2 ball stops Ø 12.7 mm
−2 side panels, front right/left joint, for spring arm
−1 cover panel, front joint, for spring arm
−2 cover flaps, front joint, for spring arm
−2 side panels, rear right/left joint, for spring arm
−1 cover panel, rear joint, for spring arm
−2 cover flaps, rear joint, for spring arm
Spring arm fastening elements
−12 hexagonal nuts M16 and 6 spring washers
−12 washers, external Ø 34 mm
−12 plastic insulating washers and 6 threaded bolts M16 x 330 mm
For assembly, see section 7.3 “Mounting the Ceiling Tube on the Threaded Bolts of the
Interface Plate”, page 48.
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Longer ceiling tube for spring arm
−1 ceiling tube (customized length)
−1 earthing cable 4 mm²
Included components
−1 socket wrench extension (only for ceiling tube lengths 500 and 700 mm)
Fastening elements for additional ceiling tube
−8 Allen cylinder screws M10 x 25 mm (8.8) DIN EN ISO 4762
−8 retaining washers S10
For pre-assembly, see section 7.2 “Pre-
assembly: Mounting the Longer Ceiling Tube on the
Extension Arm”, page 43.
Console tube
−1 console tube (customized length)
Pre-installed components
−1 earthing cable 4 mm²
Fastening elements for service head
−8 countersunk screws with hexagon socket M10 x 20 mm (10.9) DIN EN ISO 10642
Fastening elements for installation of console tube to M6 service head:
−in scope of delivery of M6 service head
For assembly, see section 7.4 “Mounting the Console Tube on the Spring Arm”, page 55.
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Scope of delivery
The scope of delivery may vary depending on the order.
Canopy (Single/Duo) (flat/high) (depending on version)
−1 Single canopy Ø 600 mm x 150 mm, 1 canopy cap 110 mm height
−1 Single canopy 700 mm x 700 mm x 150 mm height
−1 Duo canopy (installation with intermediate ceiling) 700 mm x 700 mm x 50 mm
−1 Duo canopy (installation with intermediate ceiling) 700 mm x 700 mm x 150 mm
−1 canopy cap 700 mm x 700 mm x 120 mm height
Canopy fastening elements
−4/6 threaded bolts M10 x 360 mm, 4/6 hexagonal nuts M10,
4/6 self-tapping screws, 4/6 cladding screws and 1 profile strip
For assembly, see section 7.9 “Mounting the Canopy, Cover Caps and Claddings”, page 75.
Extension arm with spring arm and ceiling tube (pre-assembled)
−1 extension arm in the lengths 600, 800, 1,000 and 1,200 mm
Pre-installed components
−3 pneumatic pipes for pneumatic brake control
−3 earthing cables 4 mm² (2 earthing cables if ceiling tube is not installed)
Included components
−2 setscrews M16 DIN EN ISO 4028, 2 ball stops Ø 12.7 mm
−2 profile end caps for extension arm
−2 side panels, front right/left joint, for spring arm
−1 cover panel, front joint, for spring arm
−2 cover flaps, front joint, for spring arm
−2 side panels, rear right/left joint, for spring arm
−1 cover panel, rear joint, for spring arm
−2 cover flaps, rear joint, for spring arm
Extension arm fastening elements
−12 hexagonal nuts M16 and 6 spring washers, 12 washers, external Ø 34 mm and
12 plastic insulating washers, 6 threaded bolts M16 x 330 mm
For assembly, see section 7.3 “Mounting the Ceiling Tube on the Threaded Bolts of the
Interface Plate”, page 48.
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Longer ceiling tube
−1 ceiling tube (customized length)
−1 earthing cable 4 mm²
Included components
−1 socket wrench extension (only for ceiling tube lengths 500 and 700 mm)
Fastening elements for additional ceiling tube
−8 Allen cylinder screws M10 x 25 mm (8.8) DIN EN ISO 4762
−8 retaining washers S10
For pre-assembly, see section 7.2 “Pre-
assembly: Mounting the Longer Ceiling Tube on the
Extension Arm”, page 43.
Console tube
−1 console tube (customized length)
Pre-installed components
−1 earthing cable 4 mm²
Fastening elements for service head
−8 countersunk screws with hexagon socket M10 x 20 mm (10.9) DIN EN ISO 10642
Fastening elements for installation of console tube to M6 service head:
−in scope of delivery of M6 service head
For assembly, see section 7.4 “Mounting the Console Tube on the Spring Arm”, page 55.
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1.2.3 Overview and Scope of Delivery of Optional Equipment
Fig. 1-3: Overview of optional equipment
On delivery of the system from the factory, the listed options are already installed.
Indirect extension arm light (extension arm lengths 1,000 and 1,200 mm)
−1 extension arm light (length 600 mm, input voltage 12 VDC)
Pre-installed components
−3 closing plugs on the extension arm top
−1 base support with LED and connection cable
−1 electrical signal cables, equipped with plugs on both sides
−1 cover panel
Extension arm light fastening elements
−2 countersunk screws M4 x 16 mm with hexagon socket DIN EN ISO 10642
For retrofitting: For assembly, see section 7.5.1 “Mounting the Extension Arm Light (only
for Retrofitting)”, page 57.
1.2.4 Additional Optional Equipment
•1 telescopic magnet pick-up tool set
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1.3 Intended Purpose
•The suspension arm system IDP 101 S air plus is individually equipped. Depending on
version and fitted equipment, it 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 (e.g. telephone, nurse call, computer data,
etc.).
•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 the device 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 10
“Inspection Plan”, page 103.
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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 9.2 “Technical Data”, page 100.
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.
1.4 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements
diverging 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: +49 7461 706-321
Fax: +49 7461 706-190
•Should you have any technical questions or questions concerning maintenance contracts or
training courses, please contact our Martin Service Center:
Tel: +49 7461 706-343
Fax: +49 7461 706-408
E-Mail: service@klsmartin.com
NOTICE
To a
nswer your technical questions as efficiently as possible, our service technicians require
the serial number of the product. Therefore, please have this number at hand when
contacting our hotline. It is part of the information provided on the rating plate;
see
section 4.1 “Data on the Rating Plate”, page 25.
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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 all personnel handling the product have
understood 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 Independant®IDP 101 S air plus, which is used as suspension arm
system for the M6 service head.
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
2.2 Applicable Mounting Instructions
The Mounting Instructions of the M6 service head system comprise four separate parts and are
only valid if all parts are available and complete at the site of assembly.
The four separate parts are as follows:
Fig. 2-1: Ceiling mount
•Part 01:
Ceiling mount
Interface plate on the raw ceiling
Intermediate ceiling set and interface plate
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20 Revision 1
2.3 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 ma
terial 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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