is manual contains con dential information that shall not be disclosed or duplicated for any reason
other than to use and maintain a Stryker Surgical Table. is restriction does not limit the right to use
information contained in this manual, if it is obtained from another source without restriction. e
information subject to this restriction is contained in all pages of this manual.
15. Contact Information ............................................................................................................ 354
10
1. Warnings, Cautions, and Notes
Please read this manual and follow its instructions carefully. The words WARNING, CAUTION, and
Note carry special meanings and should be carefully reviewed:
WARNINGThe personal safety of the patient or user may be involved. Disregarding
this information could result in injury to the patient.
CautionSpecial service procedures or precautions must be followed to avoid damag-
ing the instrument.
WARNINGA lightening bolt within a triangle is intended to warn of the presence of
hazardous voltages. Refer all service to authorized personnel.
NoteSpecial information to make maintenance easier or important information more
clear.
1.1 Warnings
To avoid potential serious injury to the user and the patient and/or damage to this device, the user
must:
Read this manual thoroughly, and be familiar with its contents prior to using this equipment.1.
Be qualifi ed medical personnel, having complete knowledge of the use of this equipment.2.
Always wear disposable gloves and a mask when working on used tables, due to risk of infec-3.
tion or disease. If the table appears to have an excess of biowaste, you may need to clean and
disinfect the table prior to service.
Test this equipment prior to a surgical procedure. This product was fully tested at the factory 4.
before shipment.
Disconnecting any of the hydraulic hoses can cause uncontrolled and dangerous movement 5.
of the table. Support the table parts before disconnecting any hoses. Only trained personnel
should maintain hydraulic components.
Avoid removing covers on the product to avoid electric shock.6.
Attempt no internal repairs or adjustments unless specifi cally instructed to do so in this oper-7.
ating manual.
The table weighs 600 lbs (300 kg), as such it is necessary to have two people to unpack/pack it. 8.
Use work gloves when handling the crate to avoid injury.
NEVER PLACE ITEMS ON THE TABLE BASE DURING ARTICULATION. THIS WILL 9.
CAUSE DAMAGE TO THE TABLE.
The Vertier™ Surgical Table should only be used in facilities made for medical purposes.10.
Connect the Mains Cord only to a grounded power supply.11.
The Vertier™ shall be operated from its internal battery if the integrity of the protective 12.
grounding conductor arrangement is in doubt.
Place the patient in the longitudinal center line of the table top. 13.
11
In NORMAL mode maximum patient weight is 275 kg (600 lbs).14.
In REVERSE mode maximum patient weight is 180 kg (400 lbs).15.
DO NOT attempt to clear errors and troubleshooting during surgery. Use the Override Panel.16.
Adjust the table top to the horizontal position (0-position) with the Hand Control Unit before 17.
transporting a patient on the surgical table.
Transporting of patients weighing up to 180 kg (400 lbs) is only allowed when table top is in 18.
horizontal position (0-position) and the height of the table is max 900mm (3 ft).
Transporting of patients weighing 180-225 kg (400-500 lbs) is only allowed when the table is in 19.
NORMAL mode, in horizontal position (0-position), and in the lowest position.
Transporting of patients weighing 225-275 kg (500-600 lbs) is not allowed.20.
Use extreme caution when transporting the table with a patient. Transporting of the table with 21.
a patient requires two persons. To maximize patient safety utilize proper restraint methods
during transport.
To avoid endangering the patient’s respiratory system, nerve pathways, and circulatory system, 22.
the patient should be positioned properly and kept under observation!
Check that table top sections catches lock correctly. Incorrect attachment of table sections is 23.
dangerous and can cause personal injury or equipment damage!
Use only accessories recommended by the table manufacturer.24.
To avoid injury to the patient or user, do not attach large accessories to the rails of the head 25.
rest.
Do not use worn or damaged accessories. When using the table, ensure that all accessories are 26.
properly mounted and check the function of accessory locking and adjustments.
Do not attempt to remove or attach more than one section at a time.27.
When adjusting the surgical table, take care that fi ngers, hands, or other parts of the patient’s 28.
body are not placed between edges of back, leg, or seat section frames and pivoting points.
Always handle sections by the rains on the side, especially the head rest.29.
Use care when attaching sections, fi ngers or appendages can be trapped between two sections, 30.
causing harm to the patient or user.
The head rest utilizes pressurized gas springs to assist in movement of the head. Use extreme 31.
caution while articulating to avoid patient or user injury. Never press the release bar while the
head rest is not connected to the table. Always keep fi ngers away from articulating pins.
To avoid injury to the patient and user, keep fi ngers, hands and body parts clear of the pinch 32.
points.
Use only permitted table top confi gurations illustrated in the user manual.33.
Before adjusting the surgical table ensure that table top will not hit external obstacles.34.
Before adjusting the surgical table ensure that NORMAL/REVERSE mode has been chosen 35.
correctly and is the same as patient’s orientation on the table top. After use of Main Switch, the
NORMAL mode is set by default.
Always follow manufacturer instructions when using diathermy or defi brillation equipment.36.
When using high frequency surgical equipment take care to prevent the patient coming into 37.
contact with metal parts of the surgical table or accessories. Do not place the patient on wet or
damp surfaces or electrically conductive pads due to hazard of burn injuries!
Combustible anaesthetic gases must not be used with the Vertier™ Surgical Table.38.
Use potential equalization conductor with patient monitoring equipment. Connector placed at 39.
12
the table base.
When recharging the battery, plug the Mains Cord to table receptacle, and then to the wall 40.
socket.
When recharging is completed, disconnect the Mains Cord fi rst from the wall socket, and then 41.
from the table receptacle.
The Main Switch can be used as an emergency stopping device (demanded by the standards). 42.
Normally the switch lever is in up position. When the lever is turned down (in the STOP position) all table functions are cancelled and table movement stops immediately.
Disconnect the Mains Cord from the table and turn the Main Switch to STOP position before 43.
cleaning the table.
Disconnect the Mains Cord from the table before any service procedures. 100-240 V~ is used in 44.
power unit placed in the table base. Hazard of electric shock!
The Vertier™ Surgical Table has been tested to IEC601-1-2 to ensure proper electromagnetic 45.
compatibility. Other products used in the vicinity of the Vertier™ Surgical Table should also
comply with this standard. If they do not comply, interference between products in unintended
responses may occur. Please contact the appropriate manufacturer if any problems arise.
Portable and mobile RF-communications equipment can affect the Vertier™ Surgical Table.46.
Do not attempt to remove or attach more than one section at a time.47.
Always handle sections by the rails on the side, especially the head rest.48.
To avoid injury to the patient or user, do not attach large accessories to the rails of the head
rest.
1.2 Cautions
If the surgical table has been in the cold, allow it to warm up at room temperature for at least 1.
6 hours before recharging the battery or switching on, to allow any condensation formed to
evaporate.
Recharge the battery prior to use. See the starting instructions attached to table base panel.2.
Take care to not catch the edges of the table or contents while packing/unpacking the crate.3.
If the table is not plugged in when a solid red light is illuminated, the batteries may be damaged 4.
by a complete discharge.
When adjusting the surgical table, take care to avoid collision between accessories and the sur-5.
gical table.
Take precautions while using the Override Panel. None of the software limitations are active 6.
during manipulations.
Always remember to disconnect the power cord prior to moving the table.7.
Static charges can harm sensitive electronic components. Ground yourself to metallic parts of 8.
the table before touching components.
The Override panel is only for returning the table top to the horizontal position in the case of 9.
electronic malfunction. Override makes it possible to adjust the table without the controlling
processor if any of the programmed restrictions are not functioning.
If the surgical table surface is not raised high enough when trendelenburg and side tilt are in 10.
their extreme positions, the back section may impact the table base casing, damaging the surgical table and creating pinching hazard.
The best place to store the Hand Control Unit, especially during transport, is the lever under 11.
the head section. Be careful not to smash the hand controls on doors or walls during transport.
13
The surgical table has been classifi ed as splash proof equipment. Use of pressurized water to 12.
clean the table is not allowed.
Cleaning and disinfecting should be performed according to the user manual.13.
Do not pull or push the shields of back and leg section joints. Check during adjustment that 14.
there are no foreign obstacles between shields.
It is possible to adjust the Slide adjustment only when back or leg section are in horizontal or 15.
above horizontal position. Slide adjustment will stop automatically before collision if back or
leg section is under the horizontal position.
Slide adjustment is only possible when table top is in horizontal position. Use of Slide adjust-16.
ment is restricted with tilted table top.
Mattresses should be cleaned only with neutral detergent (pH 7-8).17.
The antistatic properties of the surgical table require the use of original brand mattresses and 18.
antistatic fl ooring.
1.3 Notes
It is recommended to recharge the battery overnight after one day’s use to ensure the table will 1.
be always ready for use, and to maintain the battery life.
If the Main Switch is turned to STOP position (downward), all table functions are blocked, in-2.
cluding the battery recharging ability. Check that the green LED above the charging inlet lights
up when the Mains Cord is connected to the table.
When Mains Cord is connected to the surgical table, the cooling fan of the power unit is ac-3.
tivated causing a humming sound. After disconnecting the Mains Cord, the cooling fan will
continue to run for a few seconds.
Turn the Main Switch to the STOP position (downward) when the table is not in use or stored 4.
for a long period of time. This eliminates the possibility of unintended use and also saves the
battery capacity.
Activate the fl oor lock before adjusting the table. Only the trendelenburg and back rest adjust-5.
ments will function if fl oor lock is not activated. A red LED will blink on the Hand Control
Unit if another button is pressed. Press the ON/OFF button to stop the blinking.
Cardboard packing material should be recycled. Wood and plastics are energy waste.6.
Batteries contain lead and need to be recycled in accordance with local environmental regula-7.
tions if replaced.
Hook and loop tapes on table top plates can be cleaned with pressurized air. Hook and loop 8.
tape can also be replaced; spare parts and instructions are available from Stryker Technical
Support.
Floor lock can be deactivated with a release lever placed at the table base if normal deactivating 9.
with Hand Control Unit or Override Panel can’t be done. Turn the lever or knob located at the
front side of the base 90° clockwise and the table will descend on to its castors. Turn the lever
back to its original position after releasing.
Only trendelenburg and back rest adjustments are possible when the fl oor locks are deacti-10.
vated.
To articulate the legs down a full -105°, press Slide Reverse until the table reaches a preset stop 11.
about half way through the full range of slide motion. Once past this position, a full -105° can
be reached.
The individual leg manipulation is only possible when the optional separate leg sections are at-12.
14
tached to the foot end of the seat section, or when no section is attached.
Memory buttons are dependant on orientation. The buttons can be programmed in both the 13.
normal and reverse orientation and pertain to the particular orientation mode, respectively.
Simultaneous maximum angles of trendelenburg/reverse trendelenburg and side tilt are limited 14.
with software.
Head section gas spring can be disposed of as metal waste after nitrogen gas and oil have been 15.
removed.
Instructions for gas releasing are available from your sales representative.16.
1.4 Table Pinch Points
WARNINGTo avoid injury to the patient and user, keep fi ngers, hands, and body parts
clear of pinch points.
7
5
1
2
6
4
3
8
9
Figure 1.1 - Pinch Point Locations
15
1.4.1 Pinch Point Zones
A pinch point exists at the connection interface
of all modular sections when the sections are attached to each other or to the table.
A pinch point exists on the top edge of both head
rest joints when the head rest is articulated upward. This pinch point also exists when the head
rest is disconnected from the table. Keep fi ngers
and hands clear of this zone at all times. Do not
press the release bar when the head rest is disconnected from the table.
A pinch point exists on the bottom edge of both
head rest joints when the head rest is articulated
downward.
Pinch Points exist under the four articulating
joints of the table behind the joint shields. Do
not put fi ngers or hands underneath the joints of
the table.
A pinch point exists at all four articulating joints
of the table as a gap between the joint and the
main body of the table. Keep fi ngers away from
the articulating joints of the table during movement.
16
Pinch points exist between all accessory rails of
a 25cm section and a 40cm section. Keep fi ngers
and hands clear when connecting a 25cm section
to a 40cm section.
Pinch points exist between the sections and the
column of the table while the table is sliding.
Keep hands and body parts out of this area during articulation of the table.
Pinch points exist under all column casing edges
when it is articulated downward toward the base
of the table.
A crush zone exists beneath all four fl oor locks.
Do not position fi ngers, feet, or hands underneath the fl oor locks.
Pinch points exist on both sides of the table at
the accessory rails when the leg section is articulated downward to the maximum 105°.
17
Pinch points exist at any zone where the table top
collides with the base of the table or the fl oor.
Keep all body parts out of these zones when articulating the table.
Pinch points exist inside the fl exible bellows of
the table column. Keep fi ngers and hands away
from the bellows during table articulation.
18
2. Product Symbol Defi nition
The following symbols may be found on the Vertier related equipment:
An exclamation mark within a triangle is intended to alert the user to the presence
of important operating and maintenance (service) instructions in the literature accompanying the product.
Denotes the presence of a pinch point.
A lightning bolt within a triangle indicates the presence of hazardous voltage. Refer
all service to authorized personnel.
Denotes compliance to European Community Directive 93-42-EEC.
Indicates the product is compliant “Medical Electrical Equipment with Respect to
Electrical Shock, Fire, and Mechanical Hazard only in accordance with UL60601-1.
19
(13PZ)
Indicates the product is compliant “Medical Electrical Equipment with Respect to
Electrical Shock, Fire, and Mechanical Hazard only in accordance with UL60601-1,
CAN/CSA C22.2 No601.1.
Indicates hot surfaces.
Denotes compliance to CSA Standard C22.2, 60601.1 - M90, AS 3200, IEC 60601,
IEC 60601-2-46, UL 60601, EN 60601
Denotes the date the equipment was manufactured.
Denotes the manufacturer of the device.
A yellow box with a hand within a triangle is intended to warn the user of the presence of an electrostatic sensitive device. Follow ESD prevention procedures.
Denotes product/part number.
Denotes product/serial number.
Denotes lot or batch number.
Denotes European Representative.
For U.S. audience only - Caution: Federal Law (USA) restricts this device to sale by
or on the order of a physician.
Denotes quantity.
Denotes Class 1 and Type B Equipment.
Class 1 Equipment: equipment in which the protection against electric shock does
not rely on Basic Insulation only, but includes an additional safety precaution in
such a way that means are provided for the connection of Accessible Conductive
Parts to Protective (ground) Conductor in the fi xed wiring of the installation in
such a way that Accessible Conductive Parts cannot become Live in the event of a
failure of the Basic Insulation.
Type B Equipment: equipment is suitable for international external and internal application to the patient excluding Direct Cardiac Application.
20
In accordance with European Community Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be
disposed of as unsorted municipal waste but should be collected separately.
Note: The device does not contain any hazardous materials.
Legal regulations may include specifi cations regarding the disposal of this product. We request that you contact Stryker when planning to withdraw this device
from service for discard.
Denotes the device contains more than .002% cadmium.
Denotes the device contains more than .0005% mercury.
Denotes the device contains more than .004% lead.
2.1 EMC Precautions
This device is considered medical electrical equipment and requires special precautions regarding
EMC and needs to be installed and put into service according to the information provided.
Portable and mobile RF communications equipment can affect the performance of this device and
must be used in accordance with the information in this manual.
21
3. Indications for Use
Stryker conforms to the quality certi cation ISO13485. In addition, the Vertier™ Surgical Table meets
the requirements of UL 60601-1, IEC 601-1-2, and IEC 601-2-46, as certi ed by Intertek ETL Semko.
e Vertier™ Surgical Table is intended for general surgical use. It is also well suited for:
Day surgery•
ENT surgery•
Plastic surgery•
Orthopedics•
Arthroscopy•
Gynecology•
Urology•
Pediatrics•
Neurosurgery•
3.1 Prior to Servicing Tables
WARNINGAlways wear disposable gloves and a mask when working on used tables
due to a risk of infection or disease. If the table appears to have an excess
of biomaterial, it may need to be cleaned and disinfected the table prior to
service.
Connect to the table via the USB-B service port located at the bottom of the Override Panel. •
See Section 8 for details.
Launch the PC Service software and log into the program; see Section 8 Service Software on •
how to login to the service software.
Verify the Software version. To ensure usage of the most up-to-date version, log on to Agile •
and view Document Number 0100223109. For instructions on how to identify the software/
fi rmware revisions on the table, see Section 8.3 Service Software Identifi cation.
Save the table confi guration data as a safety step in the event that the MPC becomes corrupted •
during service. For instructions on saving the table confi guration data, see Section 8 Service
Software.
View and capture the error data.•
- Go to the Logged Data tab and click on “Read from MPC” and then “Write to File.”
NoteThe error log can be opened in Notepad or WordPad. Notice the Serial Number
is captured and included at the top of the error log; this will only appear if data
has been read from the MPC as outlined in the above step. This step is very important when error data is sent and analyzed later.
Verify the table functionality before taking any actions; click on the Cycle Test tab. Click on the •
‘Read from File key’ and load the fi le “Test_Cycle_Field”. Remove all sections, pads, and accessories from the table except for the 40CM pelvic extension and the 40CM lower back sections. If the column casings are damaged, remove them and the base covers prior to executing
the cycle test. Ensure the table is free from obstruction and then click on the “Play” button to
execute the cycle test.
23
NoteIf any malfunctions are encountered during this cycle test, investigate and at-
tempt to resolve the issue before proceeding.
Update the MPC software if necessary by going to Agile as specifi ed above and view Document •
Number 0100223108 for the most up-to-date version. For detailed instructions see Section 8.
3.2 Following any Table Service
Verify the Vertier Table Default MPC Settings are correct. Updating software, changing MPC, •
or updating to Sidne™ compatibility can corrupt settings if a problem is encountered during
update. To ensure the settings are correct, go to Agile (For instructions on how to get to Agile
see Section 3.1), retrieve document number 0788307000, compare the default settings to the
actual settings, and make changes as necessary. To make changes, see Section 8 Service Software.
Run the “Test_Cycle_Field” cycle test program on the table again to verify there are no errors or •
malfunctions. See Section 8.7 for details on how to execute this program.
Complete the fi eld service form per SOP1902•
3.3 Operating Characteristics
Vertier™ is a transportable, electrohydraulic battery and Mains operated surgical table. It is •
microprocessor controlled and its function parameters are reprogrammable with a special
PC-operated service program. The table can be connected to 100–240 VAC Mains power, and
its secondary voltage is 24 VDC. The table electronics are safely grounded and it has an equipotential connection.
The table top consists of sliding Seat Section and detachable 25 and 40-sections. The sections •
can be rearranged depending on the surgical concept and operation. The width of the table top
is 540mm, (21 1/4 inches) without rails, and the length is 2100mm (82 inches). The table-top
plate is radiotranslucent material.
Vertier™ can be adjusted with a cable connected Hand Control Unit, an IR Hand Control Unit, •
the foot switch, or through Sidne™. The surgical table can also be adjusted with the Override
Panel in case of electronic malfunction (i.e., if the Hand Control Unit or table microprocessor
becomes defective).
Safe and fault-free use and maintenance of the equipment requires careful adherence to these •
instructions. When mounting accessories to the equipment, the instructions provided with
them must be followed closely. Always keep the instructions for accessories together with this
manual.
10788200000Base Cover SetIncludes items a, b, c, d, and e 1
1a0788300045Vertier, Base Cover Leg1
1b0788300046Vertier, Base Cover Back1
1c0788300044Vertier, Base Cover Screw, Plastic Head4
1d0788400006Base Cover ClipNot shown4
1e0788400076Base Cover Hook and Loop TapeNot shown1
20788400004Column Case-to-Base ScrewM4.2X13 A2 F-H DIN 79824
27
30788400025Machined Column Case-to-Base
Washer
CautionDisconnect the Mains Cord from the table and turn the Main Switch to the
OFF position before removing any base covers.
NoteIf replacing either base cover, order Base Cover Set 0788200000.
Articulate the table to the highest position.1.
Turn Main Switch to the OFF position and disconnect the Mains Cord.2.
Remove the M4.2X13 column case-to-base screws (Item 2, Figure 4.4) and the machined col-3.
umn case-to-base washers (Item 3, Figure 4.4) from the lowest protective casing shroud.
Remove plastic head screws (Item 1c, Figure 4.4) from both sides of the base covers.4.
Li up the lower column casing shroud slightly and then pull up on the base covers (Items 1a 5.
and 1b, Figure 4.4) to disconnect the hook and loop tape (Item 1e, Figure 4.4).
Pull the base covers toward the end of the table to remove. See Figure 4.5 for the location of the 6.
base cover hook and loop tape.
Repeat steps 1-6 in reverse order to reinstall the base covers.7.
4
Hook and
Loop Tape
Figure 4.5 - Base Cover Removal and Hook and Loop Tape Location