Zeiss OPMI® Sensera User Manual

Name: Zeiss OPMIu00ae Sensera
Brand: Zeiss
SKU: 4645972
Rating: 5 (4 reviews)

5 (4)

OPMI® Sensera

on S7 Suspension Systems

Instructions for use

G-30-1434-en

Issue 10.0

Printed on 30. 01. 2009

Key to symbols

Different symbols used in this manual draw your attention to safety aspects and useful tips. These symbols are explained in the following.

Warning!

The warning triangle indicates potential sources of danger which may constitute a risk of injury for the user or a health hazard.

Caution:

The square indicates situations which may lead to malfunction, defects, collision or damage of the instrument.

Note:

The hand indicates hints on the use of the instruments or other tips for the user.

OPMI® is a registered trademark of Carl Zeiss.

Contents

–	Key to symbols	2
Functions at a glance		7
– OPMI Sensera surgical microscope		8
–	Illumination systems	10
–	S7 floor stand	11
– S7 ceiling mount with rigid column		12
– S7 ceiling mount with lifting column		13
Safety		15
– Notes on installation and use		17
– Safety devices of the suspension system		22
– Warning labels and notes		26
Description		31
Sensera surgical microscope on S7 suspension systems		34
–	Intended use	34
– Description of the system		34
–	System components	36
OPMI Sensera surgical microscope		38
–	Design	38
–	Controls, displays, connections	40
– Tiltable binocular tube and eyepieces		46
S7 floor stand		50
–	Design	50
–	Controls, displays, connections	52
–	Suspension arm	52
– Carrier arm, stand column, stand base		54
– Connector panel of S7 floor stand		56
–	Instrument tray (option)	58
S7 ceiling mount		60

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–	Design	60
–	Controls, displays, connections	62
– Carrier and suspension arms		62
– Connector panel of S7 ceiling mount		64
S7 ceiling mount with lifting column		66
–	Design	66
–	Controls, displays, connections	68
– Ceiling flange with lifting column		68
– Carrier and suspension arms		70
– Connector panel of S7 ceiling mount with lifting column		72
Illumination system		74
–	Halogen illumination system	76
–	Xenon illumination system	78
Control panel and menu overview		82
– Structure of the menus		84
Foot control panel (option)		104
–	Intended use	104
–	Design	104
– Foot control panel with 14 functions		106
– Foot control panel with 8 functions		107
Preparations for use		109
Attaching the equipment		112
– Mounting the tube and eyepieces		112
Connections		114
– Connecting the strain relief device		114
– Connecting the suspension system - S7 floor stand		116

–Connecting the suspension system - S7 ceiling mount with

rigid column

118

–Connecting the suspension system - S7 ceiling mount with

lifting column		120
– Connecting video monitor and MediLive ImageBox (option)		122
Adjusting the system - S7 floor stand		124
–	Balancing the suspension arm	124
–	Setting the limit of downward travel of the suspension arm	124

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Adjusting the system - S7 ceiling mount with rigid column		126
– Balancing the suspension arm		126
–	Setting the limit of downward travel of the suspension arm	126
Adjusting the system - S7 ceiling mount with lifting column		128
–	Setting an ergonomic working height	128

–Balancing the suspension arm (ceiling mount with lifting column) 130

– Setting the limit of downward travel of the suspension arm		130
Balancing the surgical microscope		132
Surgical microscope with a laser micromanipulator		136
Adjusting the surgical microscope		138
Configuring the camera settings (config)		139
Configuring Image Capture		144
Relocating the S7 floor stand		152
Operation		155
Checklist for S7 floor stand		156
Checklist for S7 ceiling mount with rigid column		160
Checklist for S7 ceiling mount with lifting column		164
Procedure		168
– Working with the SpeedFokus autofocus option		169
– Display and deletion of images (USB option)		170
What to do in an emergency		172
– Failure of the focusing function		172
– Failure of the zoom function		174
– Failure of the halogen lamp		176
– Lamp failure of the xenon illumination		178
– Failure of the SpeedFokus autofocus option		182
Maintenance / Further information		183
–	Trouble-shooting	184
– Replacing the halogen lamp		190
– Changing the xenon lamp module		194
– Magnifications / Fields of view		198
– Care of the unit		200
–	Cleaning optical surfaces	200

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–	Auxiliaries from Zeiss	201
–	Cleaning mechanical surfaces	201
–	Sterilization	201
– Disinfecting the control keys		203
–	Ordering data	204
–	Spare parts	207
–	Accessories	209
–	Disposal	210
Technical data		211
–	Technical data	212
– Integrated 1 CCD PAL video camera (option)		219
– Integrated 1 CCD NTSC video camera (option)		219
–	Ambient requirements	220
– Changes to the system		220
Index		221

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Functions at a glance

OPMI Sensera surgical microscope	8
Illumination systems	10
S7 floor stand	11
S7 ceiling mount with rigid column	12
S7 ceiling mount with lifting column	13

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8	Functions at a glance

OPMI Sensera surgical microscope

1	Adjusting the eyecup and the prescription	Pages 36/87
2	Adjusting the interpupillary distance	Page 34
3	Manually adjusting the friction of the front-to-back tilt	Page 84
4	Motorized adjustment of tilt axis B
	(microscope tilts downward)	Page 84
5	Motorized adjustment of tilt axis B
	(microscope tilts upward)	Page 84
6	Manually adjusting the friction of lateral tilt axis A	Page 82
7	Manually adjusting the balance of lateral tilt axis A	Page 82
8	Manually adjusting the friction of the microscope's	Page 82
	axis of rotation
9	Locking the handgrip in a convenient position	Page 32
10	Manually adjusting zoom (emergency mode)	Pages 30/98
11	Manual focusing	Pages 30/96
12	Adjusting the spot illumination	Page 30
13	Triggering motorized microscope functions	Page 32
14	External focus (option)	Page 30

G-30-1434-en	OPMI® Sensera on S7 Suspension Systems	Issue 10.0
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Functions at a glance

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10	Functions at a glance

Illumination systems

	Halogen illumination system
1	Closed flap: main lamp is on - Open flap: backup lamp	page 76
	is on
2	Selecting a filter	page 76
3	Opening the lamp module	page 76
4	Manual activation of the backup lamp	page 76
	Xenon illumination system
5	Selecting a filter	page 78
6	Resetting the counter	page 80
7	Manual activation of the backup lamp	page 78
8	Opening the lamp module	page 78
9	Red segment is lit - backup lamp is in use	page 78








1	2	3	4	5	6 7	8	9

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Functions at a glance

S7 floor stand

9	Lamp housing with halogen or xenon illumination	Page 40
10
10	Control panel	Page 54
11	Maneuvering handle with hooks on which to hang the	Page 88
12	foot control panel
12	Connector panel	Page 46
13
13	Casters with locking tabs (4 x)	Page 44
14
14	Adjusting the friction of the carrier arm's swivel	Page 44
15	movement
15	Adjusting the friction of the suspension arm's	Page 44
16	swivel movement
16	Balancing the suspension arm	Page 80
17	Adjusting the limit of downward travel	Page 80
18
18	Adjusting the friction of upward/downward movement	Page 42

9		18
		17
		16
10		15
10
		14
11
12
13
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12	Functions at a glance

S7 ceiling mount with rigid column

9	Control panel	Page 50
10	Power switch	Page 50
11	Connector panel	Page 44
12	Lamp housing with halogen or xenon illumination	Page 46
13	Balancing the suspension arm	Page 78
14	Adjusting the limit of downward travel	Page 78
15	Adjusting the friction of upward/downward movement	Page 42
16	Adjusting the friction of the suspension arm's	Page 42
	swivel movement
17	Adjusting the friction of the carrier arm's swivel	Page 42
	movement

16 17

13 14 15

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Functions at a glance

S7 ceiling mount with lifting column

9	Control panel	page 82
10	Power switch	page 82
11	Connector panel	page 72
12	Lamp housing with halogen or xenon illumination	page 74
13	Balancing the suspension arm	page 130
14	Adjusting the limit of downward travel	page 130
15	Adjusting the friction of upward/downward movement	page 62
16	Lifting/lowering the lifting column	page 68
17	Adjusting the friction of the carrier arm's swivel	page 62
	movement
18	Adjusting the friction of the suspension arm's	page 62
	swivel movement

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14	Functions at a glance

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Safety

Notes on installation and use	17
Safety devices of the suspension system	22
Warning labels and notes	26

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Safety

The device described in this manual has been designed and tested in accordance with Carl Zeiss safety standards as well as German and international standards. This guarantees a high degree of instrument safety.

The system described in this user manual has been designed in compliance with the requirements of:

– EN

– IEC

– UL

– CSA

In accordance with Directive 93/42/EEC for medical devices, the complete quality management system of the company Carl Zeiss Surgical GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a notified body, under registration number 250758 MP23.

–As per Directive 93/42/EEC, the unit is a Class I instrument.

–For USA: FDA classification Class I.

We would like to provide you with information about safety aspects which must be observed when handling this device. This chapter contains a summary of the most important information concerning matters relevant to instrument safety.

Important safety information has been incorporated in this manual and is marked with a warning triangle accordingly. Please give this information your special attention.

The correct use of the system is absolutely vital for safe operation. Please make yourself totally familiar with the contents of this manual prior to startup of the instrument. Please also observe the user manuals of any additional equipment. Further information is available from our service department or from authorized representatives.

•Please observe all applicable accident prevention regulations.

•The instrument must be connected to a special emergency backup line supply in accordance with the regulations or directives which apply in your country.

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Safety

Notes on installation and use

Safe working order

•Do not operate the equipment contained in the delivery package in

–explosion-risk areas,

–the presence of inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals.

•Do not station or use the instrument in damp rooms. Do not expose the instrument to water splashes, dripping water or sprayed water.

•Immediately unplug any equipment that gives off smoke, sparks or strange noises. Do not use the instrument until our service representative has repaired it.

•Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids can seep into the instrument.

•Do not force cable connections. If the male and female parts do not readily connect, make sure that they are appropriate for one another. If any of the connectors are damaged, have our service representative repair them.

•Potential equalization: If requested, the instrument can be incorporated into potential equalization measures.

•Do not use a mobile phone in the vicinity of the equipment because the radio interference can cause the equipment to malfunction. The effects of radio interference on medical equipment depend on a number of various factors and are therefore entirely unforeseeable.

•Modifications and repairs on these instruments or instruments used with them may only be performed by our service representative or by other authorized persons.

•The manufacturer will not accept any liability for damage caused by unauthorized persons tampering with the instrument; this will also forfeit any rights to claim under warranty.

•Over longer distances (e.g. removal, return for repair, etc), the instrument may only be transported in the original packaging or in special return packaging. Please contact your dealer or the Carl Zeiss service team.

•Use this instrument only for the applications described.

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Safety

•Only use the instrument with the accessories supplied. Should you wish to use other accessory equipment, make sure that Carl Zeiss or the equipment manufacturer has certified that its use will not impair the safety of instrument.

•Only personnel who have undergone training and instruction are allowed to use this instrument. It is the responsibility of the customer or institution operating the equipment to train and instruct all staff using the equipment.

•Keep the user's manuals where they are easily accessible at all times for the persons operating the instrument.

•Never look at the sun through the binocular tube, the objective lens or an eyepiece.

•Do not pull at the light guide cable, at the power cord or at other cable connections.

•This instrument is a high-grade technological product. To ensure optimum performance and safe working order of the instrument, its safety must be checked once every 12 months. We recommend having this check performed by our service representative as part of regular maintenance work.

If a failure occurs which you cannot correct using the trouble-shooting table, attach a sign to the instrument stating it is out of order and contact our service representative.

Warning!

Do not use the video images for diagnostic purposes, as the video cameras and the monitor have not been calibrated. The visualized images may therefore include deviations in shape, contrast and color.

•Observe the labels showing the symbol "Risk of crushing“!

Notes on EMC (Electromagnetic Compatibility)

The device complies with the EMC requirements of IEC 60601-1-2. For operating the device, observe the EMC precautions specified below.

Only use spare parts approved by Carl Zeiss for this device.

Do not use any portable or mobile HF communication equipment in the vicinity of the device, as it cannot be ruled out that the function of the device will be impaired.

G-30-1434-en	OPMI® Sensera on S7 Suspension Systems	Issue 10.0
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Safety

Requirements for operation

•For ceiling mounts only: Our service staff or a qualified person appointed by us will install the system on ceiling anchors which have been properly mounted by the construction engineers responsible. These ceiling anchors must comply with the specifications contained in our planning manual.

Our service representative or a specialist authorized by us will install the instrument. Please make sure that the following requirements for operation remain fulfilled in the future:

–All mechanical connections (details in the user's manual) which are relevant to safety are properly connected and screw connections tightened.

–All cables and plugs are in good working condition.

–The voltage setting on the instrument conforms to the rated voltage of the line supply on site.

–The instrument is plugged into a power outlet which has a properly connected protective ground contact.

–The power cord being used is the one designed for use with this instrument.

Before every use and after re-equipping the instrument

•Make sure that all ”Requirements for operation” are fulfilled.

•Go through the checklist.

•Re-attach or close any covers, panels or caps which have been removed or opened.

•Pay special attention to warning symbols on the instrument (triangular warning signs with exclamation marks), labels and any parts such as screws or surfaces painted red.

•Do not cover any ventilation openings.

For every use of the instrument

General

•Never operate the system unattended.

•Avoid looking directly into the light source, e.g. into the microscope objective lens or a light guide.

•When the illumination is on, the light guide must be connected at both ends. Otherwise there is a risk of fire or burn injuries.

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Safety

•Make sure that the instrument has been switched off before you change the xenon lamp module. When switched on, the ignition system generates high voltage.

•The xenon illumination system is a high-intensity light source which - if used improperly - can cause thermal injury to skin or tissue. Keep the exposed tissue moist and provide sufficient irrigation. Carefully monitor the effects of the illumination on the tissue, in particular in the following cases:

–during prolonged procedures on skin and tissue using objective lenses with a short focal length (short working distance),

–during procedures on tissue with a low blood supply,

–with high brightness settings of the xenon lamp.

•Since the xenon lamp provides high light intensity and generates light with a spectrum similar to daylight, it must not be used for ophthalmic applications.

•Any kind of radiation has a detrimental effect on biological tissue.This also applies to the light illuminating the surgical field. Please therefore reduce the brightness and duration of illumination on the surgical field to the absolute minimum required.

S7 floor stand

•Using the brake tabs on the base, secure the stand in position. Make sure that the stand is stable and cannot roll away.

S7 ceiling mount with lifting column

•The lifting column is used to move the microscope into position for sur-

gery prior to the surgical procedure.

Do not constantly move the lifting column up and down, since a thermal cut-out will then automatically switch off the drive motor. If this occurs, the lifting column cannot be moved again until the motor has cooled down.

After every use of the instrument

•Always use the main power switch of the instrument to turn it off.

•The main power switch must always be turned off when the instrument is not in use.

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Safety

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Safety

Safety devices of the suspension system

Lifting column

Selector switch

for setting the optimum viewing height of the surgical microscope or for

downward movement into the working position.

As long as you keep the selector switch in the turned position, the lifting

column moves upward (2) or downward (1), depending on the switch po-

sition. When you release the selector switch, the lifting column stops im-

mediately.

The switching technology causes a delay of approx. 2 seconds at the

upper and lower end positions of the lifting column. After this time, you

can move the column in the opposite direction again by activating the se-

lector switch.

–Before raising or lowering the suspension system, make sure that there is sufficient clearance from other objects so that any collision is avoided.

Warning!

–Do not activate the lifting column during surgery!

–Do not use the lifting column for focusing.

–Make sure that the patient is not put at risk or injured by the motorized adjustment of the lifting column.

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Safety

Halogen illumination system

1Manual switching to the backup lamp

The lamp housing contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails. If this automatic function fails, you can switch on the backup lamp by pressing this button.

2GG 475 retina protection filter

The filter selector knob has four positions:

0no filter

1GG 475 filter: to protect the patient's eye during treatment against unnecessary (blue) radiation (retinal injury).

2KK 40 filter: to increase color temperature

3no filter

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Safety

Xenon illumination system

Warning!

The xenon lamp has a limited service life of 500 h.

If used beyond its maximum service life, the xenon lamp may explode.

Change the xenon lamp in good time.

Warning!

Lamp rupture (audible as a loud bang) may lead to jamming of the lamp module and/or failure of the electronics modules.

•Before opening the lamp housing, make sure that the system is moved to a position where neither the patient nor the user is put at risk by falling items.

•Do not continue using the system if the lamp module is jammed or the illumination is no longer operational due to defective electronics modules. Inform our service department.

1Switching to the backup lamp

The lamp module contains two xenon lamps. The second lamp is used as a backup lamp which has to be swung into the illumination beam path when the first lamp fails.

If the xenon lamp fails, open the lamp module as follows:

Press button (3). The lamp module is slightly ejected. Pull out the lamp module as far as it will go. Turn knob (1) through 180° until it snaps in. This moves the backup lamp into the illumination beam path. Push the lamp module all the way back into the lamp housing.

2Indicator: backup lamp is in use

When the red segment in knob (1) lights up, the backup lamp is in use.

Note:

If the first lamp has failed and the backup lamp is in use, make sure to have a backup lamp module ready at hand as a precaution.

G-30-1434-en	OPMI® Sensera on S7 Suspension Systems	Issue 10.0
		Printed on 30. 01. 2009

Safety

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Safety

Warning labels and notes

Caution:

Observe all warning labels and notes!

If any label is missing on your instrument or has become illegible, please contact us or one of our authorized representatives. We will supply the missing labels.

2 1

OPMI® Sensera

000000-0000-000

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Safety

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S7 floor stand with instrument tray option











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