BLACK & BLACK SURGICAL B89055 User manual

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B89055
VITRUVIAN INFILTRATION
PUMP OPERATING MANUAL

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CONGRATULATIONS
Thank you for choosing Black & Black’s Vitruvian Infiltration Pump. The Vitruvian Infiltration Pump
is a peristaltic pump using three rollers to create pumping action to deliver tumescent fluid to the
operative site.
This manual provides instructions for operation, maintenance, and troubleshooting assistance for
the Black & Black Vitruvian Infiltration Pump. Users should be trained in its use and applicable
medical procedures.
Please read this entire booklet before trying to use your pump.
CALL US
Our customer service department is staffed with friendly, knowledgeable people who are ready to
help. Whether you need replacement disposables or assistance in troubleshooting an issue, they
will help you or put you in touch with someone who can.
TOLL FREE: 1-877-252-2517
PHONE: [phone]
FAX: [phone]
EMAIL: [email protected]
Caution: Federal (USA) Law restricts this device to use by or on the order of a physician.
0297
MEDAGENT International
GmbH
Griesweg 47
78570 Mühlheim
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]

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Table of Contents
Symbols .............................................................................................................................................................. 4
Indications For Use............................................................................................................................................. 5
Intended User /Patient Population / Environment............................................................................................ 5
Contraindications ............................................................................................................................................... 5
Warnings ............................................................................................................................................................ 5
Precautions......................................................................................................................................................... 6
Modifications ..................................................................................................................................................... 6
Description of Components ............................................................................................................................... 7
Description of Components contd. .................................................................................................................... 8
Setup Instructions ............................................................................................................................................10
Operating Procedures ...................................................................................................................................... 13
Unloading Tubing .............................................................................................................................................13
User Maintenance............................................................................................................................................13
Cleaning the Pump Case...................................................................................................................................13
Troubleshooting Guide.....................................................................................................................................15
Technical Specifications ...................................................................................................................................16
Damaged or Loss in Shipment..........................................................................................................................17
Incorrect Items Shipped by Black & Black Surgical ..........................................................................................17
Returns ............................................................................................................................................................. 18
Return Shipping................................................................................................................................................18
Repair Program ................................................................................................................................................19
Service Life .......................................................................................................................................................19
Warranty ..........................................................................................................................................................19
APPENDIX – A ...................................................................................................................................................20

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Symbols
For Prescription Use Only
CONSULT OPERATING MANUAL
POWER ON
POWER OFF
TYPE B APPLIED PART
Waste Electrical Products should not be disposed of in landfill. Please
recycle where facilities exist. Check with your Local Authority for
recycling advice.
IPX1 Degree of protection against the ingress of water
CAUTION- NOT FOR INTRAVENOUS USE

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Indications For Use
The Vitruvian Infiltration Pump is intended to be used for: Aesthetic Body Contouring
Intended User /Patient Population / Environment
Black & Black Surgical’s Vitruvian Infiltration Pump should be handled and operated by healthcare
professionals completely familiar with use of the device.
The intended patient population for this device includes persons seeking surgical, plastic, or liposuction
procedures for body contouring.
This device should be used in a hospital, clinical, surgical environment. NOT INTENDED FOR
HOME USE.
Device should be operated outside of the sterile field and should therefore not come in contact with
healthcare professional operating on patients.
Contraindications
This device is contraindicated for all the intended uses other than the ones claimed in this manual.
Warnings
All warnings and cautions should be familiar to, and reviewed by, all personnel prior to a procedure. These
cautions and warnings are considered essential to the safety of personnel, patients, equipment, and
property. If you have any questions, please contact Black & Black.
This device will not, in and of itself, produce significant weight reduction.
This device should be used with extreme caution in patients with chronic medical conditions, such as
diabetes; heart, lung, or circulatory system disease; or obesity.
The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or
postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely
replacement is essential for patient safety.
There should be NO direct patient contact by anyone touching this device at the same time, specifically,
the Reverse Switch or other exposed metal objects on the device.
Do not install tubing while pump is running; be sure pump is in off position before installing.
Close pump head before turning the device on. Do not place body parts near moving parts

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Precautions
Use of this device is limited to those physicians who, by means of formal professional training or
sanctioned continuing medical education (including supervised operative experience), have attained
proficiency in suction lipoplasty.
Results of this procedure will vary depending upon patient age, surgical site, and experience of the
physician.
Results of this procedure may or may not be permanent.
The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect.
All reusable components used with the device must be sterilized and all disposable components
replaced before using the device system on another patient.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
No user serviceable parts inside. Refer servicing to qualified personnel.
Do not position device to make it difficult to unplug device.
LED display of volume is secondary to using fluid bag to determine total volume infiltrated into patient.
Modifications
Modifications to any component of this device can create possible hazards and/or impair the safe use of
this product during its use and will void the warranty.

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Description of Components
FRONT VIEW
Flow Rate Adjusting Knob
In manual control mode, turn the Speed Adjusting Knob clockwise to increase the speed; Turn the Speed
Adjusting Knob counter clockwise to decrease the speed.
Prime Key
In manual control mode press down the Prime Key to enter Prime status where the pump runs at full speed
(525 mL/min) for quick filling or emptying of the tubing. Release the Prime Key so that the pump returns to
its normal operating status.
Lever
This is a locking and releasing lever to hold the tubing in place
Reverse Switch
The reverse switch controls the direction of the pump rotor, so the operator can decide which direction
they want to set up the fluid flow. Move switch right or left for desired direction.
Power Switch
ON/OFF Switch.
Head
The rotor in the head with its three rollers, combined with the enclosed tubing, creates the pumping action
which moves the fluid through the tubing.

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Description of Components contd.
REAR VIEW
Food Switch Mode
Choose momentary or maintained mode.
In the momentary mode, the pump will only run as long as the foot switch is pressed. Once
pressure is removed, the pump stops. Factory settings are in momentary mode.
In maintained mode, the pump turns on when the foot switch is pressed and runs until the
foot switch is pressed again.
Power Socket
Insert any approved hospital-grade power cord with a C-14 connector.
Footswitch ports
These are the Pneumatic switches activated by the pneumatic foot pedals for easy safe operation.
(2)

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Items included
The Vitruvian Infiltration Pump comes with:
Hospital grade power cord
(2) Foot pedals
Suggestions
Recommended Black & Black items:
B89213 - 13' SOFTOUCH PUMP TUBING SET-SINGLE SPIKE, BOX OF 10
Some types of cannulas that may be purchased separately from Black & Black include:
oB8TI-1215-LL - TUMESCENT INFILTRATION CANNULA; LUER LOCK, 12GAX15CM
oB8TI-1426-LL - TUMESCENT INFILTRATION CANNULA; LUER LOCK 14GAX26CM
oB8TI-1632-LL - TUMESCENT INFILTRATION CANNULA; LUER LOCK, 16GAX32CM
For more parts see catalog or visit www.blackandblacksurgical.com

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Setup Instructions
1. The infiltration fluid, tubing set, and handle / cannula that are used with the Black & Black Vitruvian
Infiltration Pump must be sterile. (Not supplied with this device)
2. Open the pump head by lifting or raising the lever counter clockwise to the left 180°.
3. Tubing recommendations:
Size: (7.5mm)Outer Diameter x (4.75mm) Inner Diameter
Type: Soft
4. Place tubing on rollers by pulling up on spring loaded security latch and setting tubing in place as
shown below:

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5. Repeat step 4 with the other end of the tubing as shown below. Make sure there isn’t excess tubing
or slack inside pump head by gently pulling on both ends of the tubing.
6. Lower pump head by moving the lever clockwise 180° to the right to lock in place. Your unit will
now look like this:

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7. Connect pneumatic foot switch tubing to port located on the rear of the pump:
Turn connector clockwise to tighten onto port

Repeat this step for the second foot pedal.

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Operating Procedures
1. Turn power to the Vitruvian Infiltration Pump ON (on front of unit) by flipping the switch to the
“I” position.
2. Depress either footswitch to start the pump’s operation. Release foot from footswitch to
discontinue pump operation. Footswitches can be used interchangeably.
3. Press down the Prime Key to enter prime status when the pump runs at full speed (that is 525
mL/min) and the LED displays the maximum speed for emptying, filling and rinsing operation.
Release the Prime Key so that the pump returns to its primary status.
4. To adjust flow rate, turn the Speed Adjusting Knob clockwise to increase the speed; Turn the
Speed Adjusting Knob counter clockwise to decrease the speed.
5. The LED read out (+/- 15% accuracy) displays the volume infiltrated and the rate of dispensing.
Refer to fluid bag for primary method of determining volume infiltrated.
6. To clear the LED read out, press and hold the speed adjusting knob for 2 seconds.
7. To shut down the unit, turn the power switch to the “O” position.
Unloading Tubing
1. Open pump head by turning lever counter clockwise to the left.
2. Lift up spring loaded security latch and remove tubing from one side then repeat on the other side
User Maintenance
1. NO PUMP MAINTENANCE IS REQUIRED. All components come lubricated. DO NOT lubricate.
2. Check condition of power cord and footswitch after each case. Replace if cracked or worn.
Cleaning the Pump Case
Always turn the pump off and unplug from wall before performing any of the following:
1. Dirt, stains, and dried material can be removed from the case by using any mild non-abrasive
cleaner. Ground in or dried materials should be scrubbed with a soft non-metal bristle brush.
2. The surface should then be wiped clean with a damp cloth then dried with a soft dry cloth.
3. DO NOT IMMERSE THE UNIT IN WATER OR ANY CLEANING SOLUTION.
4. If any substance spills into head, remove head by loosening the tightening screws on the front of
the pump head by turning them counter clockwise. Remove the pump head. Wipe away stains, etc.

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5. To re-install pump head, insert the flat end of the pump head's shaft into the slot of drive's
coupling. Make the positioning hole of the pump head match the positioning pin of the drive.
6. Tighten the screws connecting the pump head and the drive. Tighten the screws to the same
degree. Do not over tighten the screws to prevent damage to the housing.

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Troubleshooting Guide
Please contact Black & Black Surgical for assistance if the following solutions do not resolve the problem.
Problem Possible Causes Solution
Pump not operating
1. Power switch not on. 1. Turn power switch to “on”
2. Power cord not plugged into wall
outlet 2. Plug power cord into outlet
3. Power cord not plugged into unit 3. Plug power cord into connector in
rear or unit
4. Foot switch not activated 4. Depress foot switch
Foot switch will not
activate pump
1. Foot switch tubing not connected 1. Connect foot switch tube to
connector in rear of unit
2. Foot switch broken or leaking 2. Check for tear or broken tubing.
Replace foot switch.
3. Power switch not on. 3. Turn power switch to "ON"
Inadequate flow
when foot pedal is
pressed
1. Speed control set too low. 1. Turn speed adjusting knob clock-wise
to increase speed.
2. Wrong tubing in pump. 2. Check tubing
Pump head not
rotating
1. Tubing is bunched up inside
pump head
1. Straighten out tubing by pulling
on both ends away from the
pump head

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Technical Specifications
Functions
Applicable Pump Head PH-1515
Prime Fast filling (525 mL/min)
Speed Control Variable speed control
Display Displays volume and rate (mL and mL/min)
Specifications
Speed 1 to 525 mL/min
Speed Precision
1 mL/min
Speed Adjusting Continuous adjusting by rotary coded switch
Display Mode Two LED displays reading mL and mL/min.
Applicable Power 100-240VAC, 50/60Hz, 1.8-1.0A
Power Consumption < 48 W
Fuse F2AH250B
Operating Conditions Temperature 0 to 40 deg C (32 to 104 deg F)
Relative humidity < 80%
Atmospheric Pressure 50-106 kPa
Dimensions (L x W x H) 285mm x 207mm x 180mm ( 11” x 8” x 7”)
IP Rating IPX1
Unit Weight 3.2 kg (7.2 lbs )
IEC Class
i
fication
Class I Type B Applied Part

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Damaged or Loss in Shipment
Examine shipment upon receipt for any external damage. If product package is damaged please contact
Black & Black Surgical immediately.
If concealed loss or damage is discovered, retain all packaging materials, notify the transportation company
immediately, and request an inspection. The agent will make an inspection and grant a concealed damage
notation. A concealed damage report must be made within seven (7) days of shipment delivery. After seven
(7) days, the transportation company reserves the right to refuse any claim for loss or damage.
Incorrect Items Shipped by Black & Black Surgical
Please check your shipment immediately for any shortage or incorrect items. If any discrepancies exist,
notify Black & Black Surgical, [phone], or [email protected], at once. Your prompt
attention will ensure credit or exchange.
ALL DISCREPANCIES BETWEEN THE PACKING LIST AND THE PRODUCTS RECEIVED MUST BE REPORTED
WITHIN 48 HOURS OF RECEIPT OF THE PACKAGE TO QUALIFY FOR A CREDIT.

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Returns
NO RETURNS OR EXCHANGES WILL BE ACCEPTED UNLESS YOU HAVE RECEIVED A RETURN OF
MERCHANDISE AUTHORIZATION NUMBER (RMA) FROM BLACK & BLACK. THIS NUMBER MUST BE ON THE
RETURN SHIPPING LABEL AND ALL WRITTEN COMMUNICATION.
Call Black & Black toll-free at 1-877-252-2517 to get a Return Merchandise Authorization (RMA) number for
your order. You may also send an email to [email protected] to obtain your RMA.
ANY RETURN(S) WITHOUT RMA NUMBERS WILL NOT BE ACCEPTED AND WILL BE RETURNED TO THE
SENDER.
RETURN AUTHORIZATIONS ARE VALID FOR 30 DAYS.
Full credit will be issued for any item returned in 30 days in the original packaging that is in undamaged and
saleable condition.
A restocking charge of 25% will be charged to any product returned between 31-90 days. A credit memo,
based on the dollar amount, will be issued to the account.
OPENED PACKAGES OR BOXES containing disposable items are not returnable for credit or exchange.
NO CREDIT WILL BE ISSUED ON ANY ITEM RETURNED AFTER 90 DAYS.
Return Shipping
Return shipping, insurance, and handling is the responsibility of the customer. Credits will not be issued
until the product is received in acceptable condition. It is strongly recommended that the customer use a
traceable freight shipping method.
Please ship products in their original packaging, including documentation with all tags attached. Failure
to do so may result in a restocking fee to enable us to return the merchandise to a saleable condition.
Black & Black cannot be responsible for return shipping losses.
Each return must include the following information:
• Purchaser's name, telephone number and address
• B&B invoice number
• Invoice date
• RMA Number
• Purchaser purchase order number
• Quantity, catalog number and description of item
• Reason for return

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Repair Program
If repairs are necessary due to damage other than that incurred during initial shipment (see section labeled
DAMAGE OR LOSS IN SHIPMENT), contact Black & Black to return your unit. A Return of Goods
Authorization number must be obtained from Black & Black’s Customer Service Department prior to
returning any merchandise. When requesting a Return Goods Authorization number, please follow the
return policy as listed under the section labeled POLICY ON RETURNED GOODS. Then, please carefully
repack and return it prepaid freight to:
Black & Black Surgical, Inc
Attn: repairs
RMA# _________
5175 South Royal Atlanta Dr.
Tucker, GA 30084
[phone]
[phone]
Repairs must be made by Black & Black Surgical or by an approved authorized agent. Attempting repair
without prior authorization nullifies all warranties.
Service Life
Life span of device is determined by use and care. The service life of this product is 10 years from the date
of purchase. At end of service life, dispose according to local ordinances.
Warranty
The warranty period for this product is one year. If repair or adjustment is necessary within the warranty
period, the problem will be corrected at no charge if it is not due to misuse or abuse on the customer’s
part, as determined by the manufacturer. Repair costs outside the warranty period, or those resulting from
product misuse or abuse, may be invoiced to you.
Black & Black Surgical, Inc.
5175 South Royal Atlanta Dr.
Tucker, GA 30084
Phone: [phone]
Fax: [phone]
Email: [e-mail]
www.blackandblacksurgical.com

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APPENDIX – A - Electromagnetic Compatibility Information