Hylite installation manual-0426.pdf

HyLite 6700/HyLite 6500 Series

Surgical Lights

Installation Manual

I

Copyright

The device bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The device complies with the requirements of EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”.

© 2009 Nanjing Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.

For this Operator’s Manual, the issued Date is 2009-02 (Version: 1.0).

Intellectual Property Statement

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)

owns the intellectual property rights to this Mindray device and this manual. This manual may

refer to information protected by copyrights or patents and does not convey any license under

the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written

permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaption and translation or any other

derivative work of this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

, are the registered trademarks, registered or otherwise of Mindray in China

and other countries. All other trademarks that appear in this manual are used only for

informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

II

All information contained in this manual is believed to be correct. Mindray shall not be liable

for errors contained herein or for incidental or consequential damages in connection with the

furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this device, only

if:

n all installation operations, expansions, changes, modifications and repairs of this device are conducted by Mindray authorized personnel.

n the electrical installation of the relevant room complies with the applicable national and local requirements, and

n the device is used in accordance with the instructions for use.

l This device must be operated by skilled/trained clinical professionals.

l It is important for the hospital or organization that employs this device to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

III

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Definitions

l Main unit: Integrated facilities which implement the specified function separately.

Generally speaking, the main unit should include power supply, control system and some

functional modules.

l Accessories: Materials connected to the main unit to extend or implement specified

function.

l Consumables: Disposable or short-life parts which should be replaced each time after

use or periodically.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the device or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to:

Ø Malfunction or damage caused by improper use or man-made failure.

Ø Malfunction or damage caused by unstable or out-of-range power input.

Ø Malfunction or damage caused by force majeure such as fire and earthquake.

Ø Malfunction or damage caused by improper operation or repair by unqualified or

unauthorized service people.

Ø Malfunction of the device or part whose serial number is not legible enough.

Ø Others not caused by device or part itself.

The standard warranty period is as below:

Ø Main unit: 18 months from shipment

Ø Accessories: 6 months from shipment

Ø Consumables: Halogen Bulb

IV

Return Policy Return Procedure

In the event that it becomes necessary to return this device or part of this device to Mindray, the following procedure should be followed: Return authorization: Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. Freight policy: The customer is responsible for freight charges when this device is shipped to Mindray for service (this includes customs charges). Return address: Please send the part(s) or device to the address offered by the Customer Service Department.

V

Contact Information

Manufacturer: Nanjing Mindray Bio-Medical Electronics Co., Ltd. Address: BLK C#01/04 Ascendas iHUB Center, 55# Jiangjun Road, Jiangning,

Nanjing, Jiangsu, 211100, P.R.China Tel: +86 25 52076001

Fax: +86 25 52076002

EC-Representative: Shanghai International Trading Corporation GmbH (Hamburg)

Address: Eiffestrasse 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

This page is intentionally blank.

1

Table of Contents 1 System Overview....................................................................................... 1-1

1.1 Safety .................................................................................................1-1 1.1.1 Safety Notes .............................................................................1-1

1.2 Safety Instructions...............................................................................1-2

2 Preparing for Installation.......................................................................... 2-1 2.1 Overview of Installation Procedure ......................................................2-1 2.2 Preparations by Clients .......................................................................2-2

2.2.1 Preparation Explanation............................................................2-2 2.2.2 Determining Loading Capacity of Ceiling ...................................2-2 2.2.3 Determining Electrical Characteristics .......................................2-3 2.2.4 Determining Installation Method of Flange Tube ........................2-3 2.2.5 Determining Installation Height..................................................2-4

2.3 Main Components ...............................................................................2-6 2.4 Tools Needed ......................................................................................2-7

3 Installation Procedure............................................................................... 3-2 3.1 Instruction ...........................................................................................3-2 3.2 Installing Flange Tube .........................................................................3-3 3.3 Installing Swivel Arms..........................................................................3-5 3.4 Installing Power and Fuse Module .......................................................3-7 3.5 Installing Spring Arms........................................................................3-10

3.5.1 Installing Lower Spring Arm.....................................................3-10 3.5.2 Installing Middle and Upper spring arm ................................... 3-11

3.6 Installing Light Head..........................................................................3-13 3.6.1 Installing Lighthead .................................................................3-13 3.6.2 Installing Focusing Mechanism ...............................................3-14 3.6.3 Installing Central Handle .........................................................3-15

3.7 Adjustment ........................................................................................3-16 3.7.1 Power on ................................................................................3-16 3.7.2 Installing Ceiling Cover ...........................................................3-16 3.7.3 Adjusting Height Stop..............................................................3-17 3.7.4 Adjusting Counterweight .........................................................3-17 3.7.5 Adjusting Braking Force of Spring Arms ..................................3-18 3.7.6 Adjusting Braking Force of Swivel Arms ..................................3-20 3.7.7 Adjusting Braking Force of Horizontal Gimbal Joint .................3-21 3.7.8 Adjusting Braking Force of Lighthead ......................................3-22

3.8 Check after Installation ......................................................................3-24

4 Operation Training .................................................................................... 4-1

Table of Contents

2

4.1 Control Panel ......................................................................................4-2 4.1.1 Keys .........................................................................................4-2 4.1.2 Status Indicator .........................................................................4-3

4.2 Adjusting Light Field ............................................................................4-4 4.3 Adjusting the Lighthead Position..........................................................4-5 4.4 Maintenance .......................................................................................4-6

4.4.1 Cleaning/Disinfecting/Sterilization..............................................4-6 4.4.2 Cleaning/Disinfecting/Sterilizing Handle ....................................4-7 4.4.3 Cleaning/Disinfecting/Sterilizing Period .....................................4-7

4.5 Replacing Bulb ....................................................................................4-8 4.6 Regular Checks................................................................................. 4-11 4.7 Troubleshooting.................................................................................4-12

5 Appendices ................................................................................................ 5-1 A Installing Foundation Pieces above Ceiling..........................................5-1

A.1 Determining Flange Tube Length ..............................................5-1 A.2 Installing Foundation Pieces......................................................5-2 A.3 Special Installation of Other Parts............................................5-12

B Installation Notice ..............................................................................5-14

1-1

1 System Overview

1.1 Safety

1.1.1 Safety Notes

Table 1-1 Definition of safety notes

Note Meaning

Read the statement below the symbol. The statement alerts

you to an operating hazard that can cause personal injury.


you to an operating hazard that can cause personal injury.


you to a possibility of operating table damage or unreliable

analysis results.

System Overview

1-2

1.2 Safety Instructions

l Read this manual and make sure you understand every instruction before installing the surgical light. Strictly follow instructions given in this manual to install the surgical light.

l Do not use the surgical light in a flammable or explosive environment.

l The surgical light is to be installed by personnel authorized by Nanjing Mindray only. Non-authorized installation will compromise product safety and effectiveness and invalidate the warranty.

l Danger of electric shock. Do not open the light housing. The surgical light can only be serviced or upgraded by personnel trained and authorized by Nanjing Mindray.

l Before installing or servicing the surgical light, make sure the mains supply has been disconnected from the light. The switch that completes this function is not a part of the light.

l Use spare parts and accessories specified by Nanjing Mindray only. Otherwise, safety and effectiveness of the light may be compromised.

l Exercise caution when transporting/moving the surgical light. Otherwise, it may result in property damage.

l During the installation, be sure to keep the parts from colliding with each other or other things.

l If the customer finds any sign of damage, do not use the surgical light. Contact the customer service department authorized by Nanjing Mindray for help.

l Do not direct the light column toward human eyes. Do not lay any light reflector in the illuminated area.

l Do not place anything on the lamp housing or hang anything on the light arms or lamp housing.

System Overview

1-3

l Refer to the operator’s manual for more information on using the light.


2-1

2 Preparing for Installation

2.1 Overview of Installation Procedure The following figures show the main installation procedures.

Figure 2-1 Installation Procedure

Sign the sales contract.

Check the installation site and make the installation plan.

Check preparations.

Inspection by Mindray engineer

Install the light according to the plan

Deliver equipment

Train the operators

Ready for use.

A happy

cooperation！

Obtain the installation site information before signing the sales contract.

Preparing for Installation

2-2

2.2 Preparations by Clients

2.2.1 Preparation Explanation Before installing the surgical light, the customer needs to provide such as foundation pieces as embedded pieces and extension pieces, and electrical power meeting the light’s requirements. The preparations should be completed by the hospital before the light is delivered. The customer should guarantee that all the preparations meet the requirements listed in the Chapter 2 of this manual. The above-mentioned foundation pieces are not included in the standard installation service. If the customer does need extra service on preparing these items, extra fee will be charged. Details on designing and installing those items are listed in Appendix A. Before installing the light, make sure the customer has read and signed the installation notice (see Appendix B). The notice should be signed in duplicate, one for the customer and the other for the contractor.

2.2.2 Determining Loading Capacity of Ceiling The ceiling to bear the HyLite 6700/HyLite 6500 series surgical lights and the associated embedded pieces (plates, bolts, etc.) should meet the requirements listed in the table below. Note that safety factors are not included in the listed values. Take local requirements into consideration when installing the lights.

Table 2-1 Loading capacity requirements

Configuration Vertical force Torque

Single lighthead About 600N About 400Nm Double lightheads About 1000N About 700Nm Triple lightheads About 1400N About 1200Nm

l Make sure that both the foundation pieces and the ceiling meet the loading capacity requirement.

l Only the qualified personnel can evaluate the loading capacity of the ceiling.

l In China, the safety factor should be 4 times the nominal load.


2-3

2.2.3 Determining Electrical Characteristics The mains supply wiring should be prepared by the hospital, and meet the following requirements:

n The mains supply should be 100-240V and 50/60Hz. The power cable should be the multistrand copper core, the section of which should be 2.5 mm2.

n Make sure that the mains supply wire is protected by plastic pipe, and laid to the installation location of the power module.

n Make sure the power switch meets the requirements of IEC 328. Note that Mindray does not supply the mains power switch.

n The overall electrical environment should meet the requirements of IEC 60364-7-710 and other applicable regulations.

2.2.4 Determining Installation Method of Flange Tube Besides the foundation pieces, the hospital should also provide 4 M16 bolts for the installation of the single-lighthead or double-lighthead model, or 6 M16×150 bolts for the triple-lighthead model. To connect the flange tube, the embedded bolts should be uniformly distributed within a circle with a diameter of 240mm. These figures below are shown how to install the bolts.

Figure 2-2 Embedded bolts

If the embedded bolts are uniformly distributed within a circle with a diameter of 320mm, the bolts should be installed on the ceiling fixing piece, and then connected with the flange tube.

l All the connection methods should meet the loading capacity requirements listed in 2.2.2. Make sure the connection is reliable. Otherwise, accidents


2-4

may occur.

l Make sure the mechanical performance of the bolt is Class 8.8.

2.2.5 Determining Installation Height

l This section deals with the case in which the flange tube is installed below the ceiling. If the flange tube is installed above the ceiling, please refer to Appendix A.

Three flange tube lengths are available. Choose the suitable length according to the ceiling height.

Figure 2-3 How to determine flange tube length

The ceiling is a reference plane. If the upper surface of the flange tube is flush with the ceiling, look up the suitable length in the table below.


2-5

Table 2-2 Relationship between the ceiling height and the flange tube length

Ceiling height (A)/mm Flange tube length (B)/mm Remark

<2940 225

If the ceiling height is less than 2740mm,

choose the single gimbal joint

configuration

2940-3140 350 Double gimbal joints


If the upper surface of the flange tube is not flush with the ceiling, choose the suitable flange tube length according to the actual installation location. See the table below for details.

Table 2-3 Relationship between the ceiling height and the flange tube length

The installation height

of flange tube upper

surface /mm

Flange tube length (B)/mm Remark

<2940 225

If the installation height of the flange

tube is less than 2740, choose the

single gimbal joint configuration.



l The flange tube length should be determined before signing the sales contract.


2-6

2.3 Main Components Before installing the surgical light, make sure no component is missing. Main components of the HyLite 6700/HyLite 6500 series surgical lights are shown in the figure below.

Figure 2-4 HyLite 6700/HyLite 6500 series surgical lights components

1 Ceiling cover (including power modules and

fuse modules)

2 Flange tube

3 Horizontal swivel arm 4 Spring arm

5 Vertical gimbal joint(6700) 6 Control panel

7 Horizontal gimbal joint 8 Lamp housing hood(6700)

9 Lamp frame(6700) 10 Focusing mechanism/Central handle

assembly

11 Lamp housing hood(6500) 12 Lamp frame(6500)


2-7

2.4 Tools Needed The following tools are needed for installing the HyLite 6700/HyLite 6500 series surgical lights.

Table 2-4 Tools needed

Tool Quantity Model/Type

Snap ring gripper １(necessary) 7"/175mm

Snap ring gripper – bended

nose １(necessary) 7"/175mm

Spirit level 1 (necessary) Magnetic with horizontal and

vertical bubbles

Wrench set 1 (necessary) 23mm

Allan key 3 (necessary) 2mm/3mm/5mm (one for each

type)

Open-end Wrench 1 23mm

Adjustable wrench 1 (necessary) Not specified

Needle-nose pliers 1 Not specified

Wire stripper 1 Not specified

Diagonal pliers 1 Not specified

Flat-headed screwdriver 2 3.5mm/5mm (one for each type)

Philips screwdriver 1 5mm

Tape ruler １ 5m

Soldering iron 1 Not necessary

Multimeter 1 Not necessary

Besides the above tools, during the installation procedure, the personnel need to climb up and down. Certain climb tools should be prepared.


Installation Procedure

3-2

3 Installation Procedure

3.1 Instruction

l Strictly follow the steps introduced in this chapter to install every part. Otherwise, the light may fall and cause personal injury and/or property damage.

l Before installing the surgical light, make sure the mains supply has been switched off.


3-3

3.2 Installing Flange Tube After all the preparations mentioned in the Chapter 2 are completed, the installation can start. First, screw an M16 nut and flat washer onto every bolt from the bottom. Then, align the holes on the flange tube to the bolts and insert the flange tube onto the bolts. After adjusting the bolts to a suitable height, screw a flat washer, spring washer and nut onto every bolt in the given order. Level the flange tube with the spirit level（the location of the bubble in the spirit level is shown in the Figure 3-2）, and then tighten the nuts with a torque wrench (60±5 Nm). An installed flange tube is shown in the figure below.

Figure 3-1 Installed flange tube

Figure 3-2 Bubble in the spirit level


3-4

l Use the spirit level to make sure the flange tube is vertical in every direction. Otherwise, the swivel-arm assembly cannot be adjusted properly.

l During the installation, make sure that neither the flat washer nor spring washer is missing.

l Make sure that the upper part of the bolt (above the flange) is less than 120mm, and the lower part (below the flange) greater than 40mm.


3-5

3.3 Installing Swivel Arms Insert the shaft of the arm assembly into the flange tube. Pull the cables connected to shaft through the flange tube without damaging them. Align the holes on the shaft to those on the flange tube. Fix the shaft to the piece with 8 M8×20 screws (stainless steel; countersunk) and tighten the screws with a torque wrench (11±2Nm). An installed arm assembly is shown in the figure below.

Figure 3-3 Swivel arm assembly

Use a spirit level to make sue the shaft of the arm assembly is vertical. .

Figure 3-4 Make sure swivel arm assembly vertical

Swivel arm assembly

Screws

Flange tube

Swivel arm


3-6

l Use the spirit level to make sure the flange tube is vertical in every direction. If not, readjust every nut on the flange tube.

l Before leaving factory, fix the straps between swivel arms to facilitate to install them. Be sure to remove the straps after installed swivel arms.

l The swivel arm assembly is heavy and needs to be lifted for installation. Do not install it alone. Always use extra helpers and exercise caution when installing it.


3-7

3.4 Installing Power and Fuse Module

l Electric connection can only be made by qualified personnel!

l Before starting electric connection, make sure the mains supply is switched off!

l To prevent electrical shock, the protective earth should be properly connected.

l The 6700 lighthead and the 6500 lighthead use different power modules. Be sure to notice the differences and make the right connections.

Fix the power module to the flange bottom with 4 M4×12 combination screws. Note that every lighthead is equipped with a power module. Fix the fuse module to the flange bottom with 2 M4×12 combination screws. Installed power modules and fuse module are shown in the figure below.

Figure 3-5 Power modules and fuse modules


3-8

After all the power and fuse modules are in place, locate the brown wire (without wiring terminal) on the power module and insert it to the L port of the fuse module, and then locate the blue wire and insert it to the N port of the fuse module. Tighten the wires with a flat-headed screwdriver. Fix the wires to the flange with cable ties. An installed power module is shown in the figure below.

Figure 3-6 Installed power module

As the same as the above method, connect the L, N and PE wires from the mains supply with the port of the fuse module without sign. If the wires are too long, be sure to fix them to the flange by cable ties. The three cables running through the swivel arm assembly are marked “1”, “2” and “3”, which respectively corresponds to the lower, middle and upper spring arm. Make sure the power module marked “6700” is connected to the 6700 lighthead and that marked “6500” to the 6500 lighthead. For the light system with more than one lighthead type, make sure the 6500 lighthead is always installed above the 6700 lighthead. Make sure the power modules are correctly connected to the corresponding cables before turning on the light. Pull the cables through the opening of the flange tube, and then plug them into the 3-pin port shown in the figure below:


3-9

Figure 3-7 Connected power module


3-10

3.5 Installing Spring Arms

3.5.1 Installing Lower Spring Arm Slide the shaft end of the spring arm into the bearing seat of the short swivel arm from below and push the spring arm upward. Put the washer and the circlip in place and make sure the circlip is completely engaged in the groove of the spring arm. Be sure to press the circlip flat until it clicks. After installing the circlip, be sure to check that it has been engaged in the groove of the spring arm. Use the bottom of screwdriver to press the whole surface of the circlip. Insert the male-end of the sliding contact into the shaft end of the spring arm. Place the restraint cap on the top of the sliding contact and fix the cap with 2 M3×25 screws. Push the cable into the swivel arm and put on the arm cap. A spring arm is shown in the figure below.

Figure 3-8 Installing lower spring arm

l The circlip is the load-bearing part. Be sure to install it flat and fix it firmly. Otherwise, lighthead may fall off.

l The circlip is for single use only. Do not use it again once you have removed it.

Spring

arm

Circlip and washer

Restraint cap

Male end of sliding

contact

Short swivel

arm

Shaft end of spring

arm

Bearing seat of

short swivel arm


3-11

3.5.2 Installing Middle and Upper spring arm The middle spring arm and the upper spring arm are installed the same way. The following introduction uses installation of the upper spring arm as the example. . Remove the 2 5mm braking screws and the 4 M5×15 countersunk screws from the long swivel arm. Take out the bearing seat of the end of the long swivel arm and insert it into the shaft end of the spring arm. Put the washer and the circlip in place and make sure the circlip is completely engaged in the groove of the spring arm. Be sure to press the circlip flat until it clicks. After installing the circlip, be sure to check that it is completely engaged in the groove of the spring arm. Use the bottom of screwdriver to press the whole surface of the circlip. The installed circlip is shown in the figure below.

Figure 3-9 Installed circlip

Insert the male-end of the sliding contact into the shaft end of the spring arm. Put on the restraint cap and fix it with 2 M3×25 screws. The installation is shown in the figure below.

Figure 3-10 Installed restraint cap


3-12

Push the cables into the swivel arm and put on the arm cap. Press the bearing seat back into the swivel arm and align the holes of the braking screws to those on the bearing seat. Screw the 2 3mm braking screws and 4 M5×15 countersunk screws back onto the swivel arm. A spring arm is shown in the figure below.

Figure 3-11 Installing upper spring arm

l The circlip is the load-bearing part. Be sure to install it flat and fix it firmly. Otherwise, lighthead may fall off.

l The circlip is for single use only. Do not use it again once you have removed it.


3-13

3.6 Installing Light Head

3.6.1 Installing Lighthead Remove the fixing screw from the aluminum cover, push the cover upward and pull out the locking piece. Slide the shaft end of the vertical gimbal joint into the spring arm. Re-install the locking piece and the aluminum cover and then tighten the fixing screw.

Figure 3-12 Installing lighthead

l The locking piece must be completely engaged in the slot.


3-14

l For the light system with more than one lighthead type, make sure the 6500 lighthead is always installed above the 6700 lighthead.

l During the installing process, be sure to protect glass surface from damage. Do not directly touch the glass surface with your hands directly. Otherwise, it may become dirty.

3.6.2 Installing Focusing Mechanism Insert bulbs into the bulb holder on the focusing mechanism. Every focusing mechanism needs two bulbs. See the figure below for how to install the bulb.

Figure 3-13 Bulb installation

l Do not directly touch the new bulb. Insert the new bulb into the bulb holder with the plastic bag on. Make sure the bulb is reliably installed, and then remove the plastic bag.

l Make sure the bulb’s pins are reliably inserted into the bulb holder.

Insert the focusing mechanism into the lighthead and tighten the 3 knurled screws, as the figure below shows. Note that the focusing mechanism is mistake-proof. To install the focusing mechanism, first locate the banana connector that is marked by a red dot, and then align it with corresponding installing hole, which is also marked by a red dot, on the lighthead.


3-15

Figure 3-14 Installing focusing mechanism

l During the installing process, be sure to protect glass surface from damage. Do not directly touch the glass surface with your hands directly. Otherwise, it may become dirty.

3.6.3 Installing Central Handle Place the central handle onto the handle of the focusing mechanism. Push the central handle forward along the handle of the focusing mechanism. Turn the central handle until it clicks.

Figure 3-15 Installing Central handle

Central handle

Focusing mechanism


3-16

3.7 Adjustment

3.7.1 Power on Switch on the light to make sure it can work normally. If not, follow the steps below to locate the problem, and then refer to the service manual for solutions.

1. Check the control panel for alarm indications and then follow the instructions given in the service manual to solve the problem.

2. If there is no alarm indication on the control panel, check the fuse and replace the broken one. Note that only the L port is equipped with a fuse.

3. Open the back of the control panel, and check input voltage. The input voltage should be 20±1V when the bulb is not on. Otherwise, something is wrong between the power module and the control panel.

4. Check the indicators on the control board. If they work properly, the power module is fine.

5. Check every wire and make sure that they are tightened.

3.7.2 Installing Ceiling Cover Install the ceiling cover only when you are sure that the light can work properly. Put together the two halves of the ceiling cover at the flange tube and fix the cover with 6 countersunk M4×12 screws. Fix the silica gel ring on the upper edge of the ceiling cover. Put together the two halves of the fixing ring and loosely screw the ring with 2 hex M4×12screws. Slide the ring all the way up to the ceiling cover. Make sure that the ceiling cover is flush with the ceiling. Make sure the fixing ring and the ceiling cover are completely engaged, and then tighten the hex screws on both sides of the ring. The installation is shown in the figure below.

Figure 3-16 Installing ceiling cover

Fixing ring

Ceiling cover


3-17

3.7.3 Adjusting Height Stop Vertical movement of the light is limited by a fixed lower and adjustable upper stop. The adjustable upper stop can be adjusted with a 5mm Allan key. The adjustment hole is shown in the picture below. To raise the stop, turn the Allan key counterclockwise. To lower the stop, turn the Allan key clockwise. The adjustable range is from horizontal to 45º up. After adjusting the stop, make sure the spring arm does not collide with anything.

Figure 3-17 Adjusting height stop

l When adjusting the height stop, pay attention to the distance between the floor and the ceiling. Make sure the lightheads collide with neither of them.

3.7.4 Adjusting Counterweight The loading capacity of the spring arm is adjustable with a 5mm Allan key. The adjustment hole is shown in the picture below. The loading capacity must be adjusted if the lighthead cannot remain at any desired position. If the lighthead moves down, the loading capacity needs to be increased. Insert the Allan key into the adjustment hole and turn it counterclockwise to do so. If the lighthead moves up, the loading capacity needs to be decreased. Insert the Allan key into the adjustment hole and turn it clockwise to do so.


3-18

Figure 3-18 Adjusting counterweight

l When adjusting counterweight, be sure to test 2 or 3 height points other than the upper and lower limits, and make sure the lighthead can stay stably at all the tested positions.

3.7.5 Adjusting Braking Force of Spring Arms The braking force of the spring arms is adjustable with a 5mm Allan key. Adjust the braking force to adjust the mobility of the spring arms. After adjustment the lighthead should be able to remain at any desired position. The adjustment hole is shown in the figure below.


3-19

Figure 3-19 Adjusting braking force of spring arms

Theoretically speaking, if the spring arm can be rotated by a horizontal pushing force that is 5±1N and vertically imposed on the spring arm at the point shown in the figure below, the braking force is appropriately optimized.

Figure 3-20 Testing braking force of the spring arm

l Make sure the spring arm moves prior to the swivel arm.

l Be sure to adjust the braking screws on both sides.


3-20

3.7.6 Adjusting Braking Force of Swivel Arms The braking force of the swivel arms is adjustable with a 5mm Allan key. Adjust the braking force to adjust the mobility of the swivel arms. After adjustment the lighthead should be able to remain at any desired height. The adjustment hole is shown as the figure below.

Figure 3-21 Adjusting braking force of swivel arms

Theoretically speaking, if the swivel arm can be rotated by a horizontal pushing force that is 14±1N and vertically imposed on the swivel arm at the point shown in the figure below, the braking force is appropriately optimized.

Figure 3-22 Testing braking force of swivel arms

l Make sure the spring arm moves prior to the swivel arm.

l Be sure to adjust the braking screws on both sides.


3-21

3.7.7 Adjusting Braking Force of Horizontal Gimbal Joint The braking force of the horizontal gimbal joint is pre-adjusted at factory. Follow the figures below to check its braking force. If the lighthead can stably stay at all the three positions, the braking force does not need to be adjusted.

Figure 3-23 Test braking force of control panel

Otherwise, adjust the braking screws on the back of the control panel with a 5mm Allan key. The adjustment hole is shown in the figure below.

Figure 3-24 Adjustable hole

l Be sure to adjust the two braking screws equally.


3-22

3.7.8 Adjusting Braking Force of Lighthead The braking force of the horizontal gimbal joint is pre-adjusted at factory. Follow the figures below to check the braking force. If the lighthead can stably stay at both the positions, the braking force does not need to be adjusted.

Figure 3-25 Test braking force of horizontal gimbal joint

Otherwise, loosen the fixing screws with a 2mm Allan key to expose the adjustment screw. Adjust the adjustment screw with a 5mm Allan key until the desired braking force is achieved. Turn the rubber sleeve back to its original position, and then tighten the four screws. The adjustment hole is shown in the figure below.


3-23

Figure 3-26 Adjusting braking force of lighthead


3-24

3.8 Check after Installation Check and make sure the lighthead and the light arms can stay at any desired position. It is recommended asking the medical professionals to check the light according to their usual practices.

l Pay attention to the spring arms and the swivel arms. Make sure they can stay at any desired position.

l Check as many positions as possible.

After the check, clean the light surface. Make sure there is not any dirt or sign of wear. At last, clean the installation site.

l Exercise caution when cleaning the light surface. Do not damage the surface.

4 Operation Training

l Be sure to train customer to operate and maintain surgical light as instructed by this chapter.

l Before operating the surgical light, make sure it is properly installed as instructed in chapter 3.

Operation Training

4-2

4.1 Control Panel

4.1.1 Keys The layout of the control panel is shown in the figure below.

Figure 4-1 the layout of the control panel

1 Power Switch 2 Illuminance Down

3 Illuminance Up 4 Status Indicator

5 Illuminance Indicator 6 Broken-bulb Indicator

You can

1. Push the power switch to turn on/off the surgical light.

2. Push the “Illuminance Down” key to decrease illuminance.

3. Push the “Illuminance Up” key to increase illuminance.

4. Check the light status by the status indicator. See Table 4-1 for details.

5. Check the illuminance level by the illuminance indicator.

6. Check the bulb status. If you see the broken-bulb indicator flashes, it means a bulb is broken and needs to be replaced.

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4.1.2 Status Indicator The status indicator is comprised of a LED. See the table below for details.

Table 4-1 Details of the status indicator

Status of the indicator Status of the light

Green Normal

Red Circuitry fault

Orange Bulb Broken

Green and Flashing Working on backup power

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4.2 Adjusting Light Field You can:

1. Turn the central handle clockwise to enlarge the light field.

2. Turn the central handle counter clockwise to diminish the light field.

Figure 4-2 Adjusting light field

l The central handle is to be used by sterilized personnel only.

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4.3 Adjusting the Lighthead Position You can:

1. Use the encircling handle to move the lighthead to the desired position.

2. Use the central handle to move the lighthead to the desired position.

l Exercise care when adjusting the lighthead position. Do not pull the mechanical arm beyond the limits.

l Non-sterile personnel can only use the encircling handles to move the lighthead to the desired position.

l Sterile personnel can only use the central handle to move the lighthead to the desired position.

l The central handle must be sterilized after every use.

l In case of the double-lighthead or the triple-lighthead configuration, total irradiance of the surgical light may exceed 1,000 W/m2. Long time exposure to the light may cause burns on the patient.

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4.4 Maintenance

4.4.1 Cleaning/Disinfection/Sterilization You can clean/disinfect the surgical light as instructed below:

1. Use a piece of disposable cloth to wipe dust off the lighthead.

2. Use a piece of cloth dipped with disinfectant to wipe the exterior of the lighthead.

3. Use a piece of disposable cloth dipped with water to clean the exterior of the lighthead, and then wipe it dry.

The above-mentioned method applies to the following parts:

n exterior of the lamp housing hood

n exterior of the lamp frame

n glass

n exterior of the mechanical arm

n exterior of the control panel

l When cleaning/disinfecting the lighthead glass, be sure to wipe from the inside to the outside along radius, as 错误！未找到引用源。 shows. Do not wipe back and forth or in circles. Otherwise, the glass surface will be damaged.

l The glass should be cleaned/disinfected each time after use and at least once a week.

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Figure 4-3 How to clean glass

When clean/disinfect/sterilize the surgical light, you should pay attention to:

1. Never use the cleaning agents/disinfectants containing the following components:

n Halogen releasing compounds

n Strong organic acid

n Oxygen releasing compounds

2. When clean and disinfect the interior of the device, use the cleaning agent only. Do not use alkaline or chlorine releasing disinfectants that will result in corrosion.

l Do not use the cleaning agents or disinfectants that contain alcohol.

4.4.2 Cleaning/Disinfecting/Sterilizing Handle The handle is made of a special material that can be autoclaved using 134℃ steam for 8 minutes.

l The sterilized handle should be installed only right before use.

l Do not load any weight onto the handle during the sterilization process. Otherwise, the handle will deform permanently.

l The handle will be worn out after a certain period of service. Be sure to replace the old the handle if you see any sign of wear, such as cracking, fading.

4.4.3 Cleaning/Disinfecting/Sterilizing Period The lighthead should be disinfected/cleaned after every use and at lease once a week. The central handle must be sterilized after every use.

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4.5 Replacing Bulb After removing the central handle, loosen 3 knurled screws by hand, and then remove the focusing mechanism. Replace the bulb as instructed below:

1. Pull out the old bulb.

2. Use a screwdriver to remove the 2 screws fixing the bulb holder, and then remove it from the focusing mechanism.

Figure 4-4 Removing bulb holder

3. Install a new bulb holder.

Figure 4-5 Installing a new bulb holder

4. Insert a new bulb into the bulb holder.

Figure 4-6 Inserting a new bulb

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5. Reinstall the focusing mechanism.

Figure 4-7 Installing focusing mechanism

6. Tighten the knurled screws.

Figure 4-8 Tightening knurled screws

The bulb for the HyLite 6700 is OSRAM HLX64642 24V 150W, and that for HyLite 6500 is OSRAM HLX64638 24V 120W. They are different specification. Be sure to use the right bulb.

l Be sure to turn off the power before changing the bulb.

l Before replacing the bulb, be sure to turn off the light, and wait for the bulb to cool off.

l The replaced bulb should be disposed of properly to avoid environmental pollution.

l It is recommended that the bulb holder be replaced together with the bulb.

l Be sure to use the exact bulb designated by the manufacturer. Using other bulbs may result in property damage or be degraded performance.

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l After removing the bulb holder, be sure to check whether the bulb holder and wires have burned sign. If you find, be sure to contact with Nanjing Mindray service department.

l The HyLite 6700 lighthead uses 150W bulbs and HyLite 6500 120W. Be sure to use the right bulb.

l Do not touch the new bulb directly. Insert the new bulb into the bulb holder with the plastic bag on. Make sure the bulb is reliably installed, and then remove the plastic bag.

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4.6 Regular Checks The surgical light is a permanently installed suspension device. Its safety is critical. Check the base of swivel arm assembly and the joint pieces above it regularly, and make sure there are no signs of cracking, rusting. The nuts connecting the arm assembly and other fixing/braking screws must be checked regularly. Tighten loose nuts/screws once you find them. Or, you can call Mindray customer service department for assistance.

l The connection parts must be checked at least once a year.

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4.7 Troubleshooting

l The chapter is meant to help you solve common problems only. In case you encounter problems not included in this chapter or following the introduced methods cannot solve the problem, contact the customer service department for help. Unauthorized device servicing is not allowed.

l Device servicing is to be performed by personnel authorized by Nanjing Mindray only. Unauthorized device servicing may result in personal injuries and/or property damage.

Error Cause Solution

The light cannot be turned on.

The fuse is broken. Contact the customer service department authorized by Nanjing Mindray.

The broken-bulb indicator is orange and flashing.

The bulb is broken. Please replace a new bulb.

The status indicator is red. Circuit failure Please connect with the service department authorized by Nanjing Mindray Company.

The size of the light field cannot be adjusted

The method of installing the focusing mechanism assembly is wrong.

Please reinstall the focusing mechanism assembly again.

The illuminance cannot be adjusted

The method of installing the focusing mechanism assembly is wrong.

Please reinstall the focusing mechanism assembly again.

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5 Appendices

A Installing Foundation Pieces above Ceiling

A.1 Determining Flange Tube Length If the ceiling is too high, or laminar flow facilities are installed, or no foundation pieces are pre-installed, both the installation plan and foundation pieces should be made according to the actual environment Anyhow, the HyLite surgical light should be installed with the distance between the bottom of the flange tube and the floor within the ranges specified in the figure below.

Figure 5-1 Installing height requirement

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A.2 Installing Foundation Pieces A.2.1 Installing Steps This following flow chart introduces how to install the flange tube in an operating room in which no foundation pieces has been pre-installed. However, the actual installation procedure may differ depending on the actual conditions. Be sure to make the installation plan according to the actual conditions.

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Figure 5-2 Installing steps

A.2.2 Floor Connection Piercing Ceiling Floor In case that there are no embedded pieces on the ceiling floor, you can pierce the floor to fix the bolts. Note that, the installed pieces may be covered by such layers as the leveling layer and the sound-proof layer.

Figure 5-3 Installing adaptor plate

1 Hex M16 nut 8.8 2 Spring washer and flat washer

3 Ceiling fixing piece 4 M16 bolt 8.8

5 Adaptor plate (for double or triple

lightheads)

6 Ceiling Floor

First, draw a Φ320 circle around the installation location, and mark 6 Φ18 holes uniformly spread (60ºapart) within the circle. Use tools (such as electric drills) to pierce the ceiling floor on the marked locations. Then, place the ceiling fixing piece on the upper surface of the ceiling floor, and align the holes of the ceiling fixing piece with those on the ceiling floor. Insert the bolts into the holes and through the ceiling floor. Slide flat washers, spring washers and nuts onto the upper parts of the bolts (as Figure 5-3 shows). Slide the adaptor plate onto the lower parts of the bolts, and then flat washers, spring washers and nuts. Use a torque wrench (180 Nm) to tighten all the nuts.

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l Be sure to take the actual condition into account, for example interference with the steel bars in the concrete. If necessary, leave the piercing and connection job to the customer.

Installing Expansion Bolt If the floor cannot be pierced, you can use expansion bolts. The floor should be solid concrete floor and meet the requirements below. l Concrete floor classification≥ B 25. l Floor thickness≥15cm. l Distance between the top of an installed expansion bolt and the upper surface of the

ceiling floor ≥15cm.

l Make sure that the floor meets the above requirements.

Figure 5-4 Installing expansion bolt

1 Expansion bolt 2 Adaptor plate ( for double or triple

lightheads)

3 Spring washer and flat washer 4 Nut

5 Ceiling Floor

First, draw a Φ320 circle on the installation location, and mark 6 Φ18 holes uniformly spread(60º apart) within the circle. Drill holes on the marked locations to a depth that suits the expansion bolt, and then clean the holes.

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Figure 5-5 Piercing holes

Then, place the adaptor plate on the ceiling floor and align the holes on the adaptor plate with those on the ceiling floor. Hammer expansion bolts into the holes and through the adaptor plate. Use a torque wrench (180 Nm) to turn the bolts to expand them. Tighten (still 180Nm) the bolts again in an hour.

Figure 5-6 Installing expansion bolt

l Make sure the holes on the ceiling floor are drilled to a depth that suits the expansion bolts, neither too deep nor too shallow.

Other Connection Method In case of other installation conditions, connect the surgical light otherwise. Two connection methods are introduced below as examples. In case there is a beam on top of the installation location, pierce the beam (or use expansion bolts) laterally in a way similar to the one mentioned above. But note that the left and right splints and the adaptor plate are usually welded together.

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If the ceiling cannot be used for the installation, fix two channel steels (5＃ or larger).

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A.2.3 Connection with an Adaptor Plate The adaptor plate can be divided into two types: double-lighthead adaptor (four bolts, PN: 0091-20-102844) and triple-lighthead adaptor plate (6 bolts, PN: 0091-20-102845).

Figure 5-7 Adaptor plate

If other bolts have been prepared on the installation location, the adaptor plate or the extension piece needs to be made accordingly.

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A.2.4 Installation in Laminar-Flow Operating Rooms In case of laminar-flow operating rooms, to run across the pressure boxes above the ceiling, it is necessary to raise the installation location of the flange tube. The floor height (usually greater than 3500mm) determines whether an extension piece is needed.

Determining Height See the tables below for proper dimensions of the extension piece and the flange tube.

For the two-lighthead configuration

For the two-lighthead configuration Floor height

Length of extension piece Length of flange tube

5000-5200 1200 1200

4800-5000 1200 1000

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4600-4800 1000 1000

4400-4600 800 1000

4200-4400 800 800

4000-4200 600 800

3800-4000 0 1200

3600-3800 0 1000

For the single-lighthead configuration.

For the single-lighthead configuration Floor height


4900-5100 1200 1200

4700-4900 1200 1000

4500-4700 1000 1000

4300-4500 800 1000

4100-4300 800 800

3900-4100 600 800

3700-3900 0 1200

3500-3700 0 1000

For the triple-lighthead installation.

For the triple-lighthead installation Floor height


5100-5300 1200 1200

4900-5100 1200 1000

4700-4900 1000 1000

4500-4700 800 1000

4300-4500 800 800

4100-4300 600 800

3900-4100 0 1200

3700-3900 0 1000

3500-3700 0 800

Connection with an extension piece To install the extension piece, use its upper surface as the ceiling fixing piece. See Piercing

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Ceiling Floor or Installing Expansion Bolt for details To connect the flange tube, the extension piece needs to provide 4 or 6 M16 bolts, respectively for the double-lighthead or triple-lighthead configuration. The bolt length between the bottom of the extension piece and the top of the flange tube should be 100mm±20mm.

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A.2.5 Installation in Other Operating Rooms For operating rooms in which there are no laminar-flow facilities and the ceiling floor is high enough, running the flange tube across the pressure boxes is no longer a factor to be considered. If the floor height is greater than 3500mm, install the extension and the flange tube the same way as in the laminar-flow operating rooms. If the floor height is less than 3500mm, see section 2.2.5 .

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A.3 Special Installation of Other Parts A.3.1 Installing Power Module In the laminar-flow operating room, if the power module and fuse module are still installed on the flange tube, it may be difficult for service or maintenance in the future. Install the power module on other locations, such as on the wall.

In this case, first, the customer needs to pull the mains power cable to the location where the power module is to be installed. Then pull the cable from the power module to the flange tube (the cable should be protected by a conduit). The diameter of the cable depends on the distance between the power module and the flange tube (the distance should not be greater than 20m). See the table below for details.

Distance (x) between power

module and flange tube

Cable section

x < 5m 3×2.5mm2

5m < x < 20m 3×6mm2

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A.3.2 Ceiling Cover If the power module is not installed beneath the ceiling, replace the big ceiling cover assembly (PN: 0091-30-102274) with the small ceiling cover assembly (PN: 0091-30-102273). See section 3.8 for installation details.

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B Installation Notice Honorable Customer: You have selected the HyLite Series Surgical Lights. We sincerely appreciate the trust you have placed in us. To install and use the light safely and effectively, be sure to prepare as required below.

1. On the installation site, you need to pre-install the embedded piece, and make sure its loading capacity is greater than 600kg. If the installing environment is different from those listed in this manual, contact the customer service department authorized by Nanjing Mindray. We will appoint engineers to observe the installation site, and then design the installing plan accordingly.

2. Our engineer will check the site before starting the installation. Please provide the architecture drawings and specifications on the materials, main walls and floor types.

3. After the site inspection, please provide (or ask your construction contractor to provide) the three-view installing drawings (including top view, front view and side view). They should include the detail dimensions of the operating room, fixing location of the surgical light, maximum swivel radius of the surgical light, floor height and ceiling height. The drawings should show the detail locations and dimensions (mm) of all the relative objects, such as the surgical light, beam, ventiduct, medical gas pipes, fluorescent lights, smoke detectors, sprinkling system and reference wall. Providing the above-mentioned information can prevent objects from colliding with each other and degrading the clean level of the operating room.

4. Make sure the mains power cable is pulled to a point that is within 15cm away from the fuse module of the light. The prepared power cable should be a three-wire cable (Live, Neural and Earth) The wires inside the cable should be color coded and the section of the wire should be greater than 2.5mm2 For every wire, at least 4cm should be reserved for connection. .

5. Provide names and phone numbers of the in-charge people of such relative parties as the device management department, infrastructure department, and construction contractor. You may also need to coordinate between the above-mentioned parties, provide free access to such facilities as elevators and transporters and make sure no fee will be charged by any party.

6. Because the surgical light is expensive and has many accessories, to prevent losing, wearing or damaging the light, please provide a room with a lock to store it. If you have any other requirements, please contact us a month beforehand.

We agree with the terms mentioned above and will prepare accordingly.

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Hospital Representative (cachet): Date: Nanjing Mindray Bio-medical Electronics CO., LTD.

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P/N:

P/N:

Documents

Hylite installation manual-0426.pdf