Halyard ON-Q Select-A-Flow User manual

PUMP
WITH SELECT-A-FLOW* VARIABLE RATE CONTROLLER
Instructions for Use
X ml/Y min

1
ON-Q* Pump with SELECTAFLOW*Variable Rate Controller 3
Pompe ON-Q* avec régulateur de débit variable SELECTAFLOW* 9
ON-Q* Pumpe mit SELECTAFLOW* variabler Durchflusssteuerung 16
Bomba ON-Q* con regulador de flujo variable SELECTAFLOW*23
PumpaON-Q* Pumps variabilním regulátorem infuze SELECTAFLOW* 30
ON-Q* pumpe med SELECTAFLOW* variabel hastighedsregulator 36
Αντλία ON-Q* ε ρυθιστή ελέγχου εταβλητού ρυθού SELECTAFLOW* 43
ON-Q* dæla með SELECTAFLOW* stýringu fyrir breytilegan hraða 50
Pompa ON-Q* con regolatore di portata variabile SELECTAFLOW* 56
ON-Q*-pomp met SELECTAFLOW* variabele snelheidsregelaar 63
ON-Q*-pumpe med SELECTAFLOW* variabel hastighetskontroller 70
Pompa ON-Q* z regulatorem zmiennej prędkości SELECTAFLOW* 77
Bomba ON-Q* com controlador de débito variável SELECTAFLOW* 84
Насос ON-Q* с регулятором переменной скорости SELECTAFLOW 91
ON-Q*-pumppu, jossa on SELECTAFLOW*-virtaussäädin 99
ON-Q* Pump med SELECTAFLOW* reglerbar hastighetskontroll 106
SELECTAFLOW* Değişken Hız Kontrolörlü ON-Q* Pompası 113
SELECTAFLOW*可変流速調節器付きON-Q*ポンプ 120
SELECTAFLOW* 가변 속도 제어기가 설치된 ON-Q* Pump 127
配有SELECTAFLOW*变速控制器的ON-Q*药泵 134
ON-Q* Pump with SELECTAFLOW*Variable Rate Controller
Instructions for Use
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Important Information
Please read the entire document before operating the
ON-Q* device. Follow all instructions carefully to ensure
the safety of patient and/or user.
User Information
• For 24-hour Product Support, call 800-444-2728 or
[phone] (English only).
• Visit www.halyardhealth.com or contact your sales
representative for the latest product information and
Technical Bulletins (English only), including but not
limited to:
• ON-Q* with SELECTAFLOW*, Drug Dosing
InformationTechnical Bulletin
• Use of ON-Q* Pump in Magnetic Resonance (MR)
environment
• Latex Sensitivity
• Continuous Infusion in Pediatric Patients
• Use of ON-Q* Pump in Hand and Foot Surgery
Volume and Flow Rate Selection
• WhatWe Know About ChondrolysisToday
• Use of ON-Q* with Perioperative Autologous Blood
Transfusion Systems
• USP 797
• Eect of StorageTimes on Flow Rate on Pre-lled
ON-Q* Elastomeric Pumps
• Patient Guidelines
Warning
Flow rate is adjustable. Medication dosage should be
based on maximum flow rate. To reduce potential
adverse events:
• Medication dosing should be based on the
maximum flow rate (7 or 14 ml/hr).
• The amount of medication over the therapeutic
period and delivery time can vary by as much as
20%. Take this variance into consideration when
determining medication delivery.
• Regardless of the prescribed flow rate,
only fill the pump with medication dosage that
is appropriate to administer at the maximum
flow rate.
• Due to risk of ischemic injury, vasoconstrictors
such as epinephrine are not recommended for
continuous infusions for the following routes of
administration: intraoperative site, perineural and
percutaneous (excluding epidural).
• Medications or fluids must be administered per
instructions provided by the drug manufacturer.
Physician is responsible for prescribing drug based
on each patient’s clinical status (such as age, body
weight, disease state of patient, concomitant
medications, etc.).
• There is no alarm or alert when flow interruption
occurs, therefore, life-supporting medications
whose usage may cause serious injury or death
due to stoppage or under-delivery are not
recommended for infusion with the ON-Q* device.
• There is no indicator of pump infusion status,
therefore, use caution where over-delivery of
medications could result in serious injury or death.
• Epidural infusion of analgesics is limited to uses
of indwelling catheters specifically designed for
epidural delivery. To prevent infusion of drugs not
indicated for epidural use, do not use IV set with
additive ports. It is strongly recommended that
devices used for administration of medication via
epidural routes be clearly differentiated from all
other infusion devices.
• To avoid complications, use the lowest flow rate,
volume and drug concentration required to produce
the desired result. In particular:
• Avoid placing the catheter in the distal end of
extremities (such as fingers, toes, nose, ears,
penis,etc.)wherefluidmaybuildupasthismay
lead to ischemic injury or necrosis.
• Avoid placing the catheter in joint spaces.
Although there is no definitive established
causal relationship, some literature has shown
a possible association between continuous
intra-articular infusions (particularly with
bupivacaine)andthesubsequentdevelopment
of chondrolysis.
• Avoid tight wrappings which can limit blood
supply or fluid diffusion.
• en ON-Q* Pump with SELECTAFLOW*Variable Rate Controller
Instructions for Use

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• It is the responsibility of the healthcare provider to
ensure patient is educated on the proper use of the
system.
• It is the responsibility of the healthcare provider to
modify Patient Guidelines provided with the pump
as appropriate for your patients’clinical status and
medication prescribed.
Caution
• Do not use if package is open, damaged or a
protector cap is missing.
• Single use only. Do not resterilize, rell or reuse.
Reuse of the device could result in the following risks:
• Improper functioning ofthedevice(i.e.,inaccurateowrate)
• Increased risk of infection
• Occlusion of the device (i.e., impedes or stops infusion)
• The pump is sterile and non-pyrogenic.
• Product uses Di (2-ethylhexyl) phthalate (DEHP)
plasticized PVC:
• DEHP is a commonly used plasticizer in medical
devices.There is no conclusive scientic evidence
to date that exposure to DEHP has a harmful eect
on humans. However, the risk and benet of using
medical devices with DEHP for pregnant women,
breastfeeding mothers, infants and children should be
evaluated prior to use.
• Certain solutions may be incompatible with the PVC
material used in the administration set. Consult
drug package insert and other available sources of
information for a more thorough understanding of
possible incompatibility problems.
• Do not underll pump. Underlling the pump may
signicantly increase the ow rate.
• Do not exceed maximum ll volume. (Table 1)
• The ll volume and infusion rate are labeled on the ll port.
• Flow rate is unpredictable if it is dialed between rate
settings.
• Clamp is provided to stop the infusion. Do not remove or
break clamp. Do not use clamp as an intermittent
delivery device.
• Roll tubing between ngers to promote ow if clamped
for extended time.
• Avoid contact of cleansing agents (like soap and alcohol)
with the lter because leakage may occur from the air
eliminating vent.
• Do not tape over lter(s) as this could block the air vent
and impede the infusion.
• Do not immerse the pump in water. Take care to protect
the pump during any activities, which could cause the
pump and lter to get wet, such as showering.
• In the event of any leakage from the pump or
administration set, close tubing clamp. Replace pump
if necessary.
• Do not discard the pump and contact Halyard Health for
product return instructions.
• Do not add unvented lter to end of the administration
set as this may impede or stop the ow rate.
• Flow rates may vary due to:
Fill volume
• Fillingthepumplessthan thelabeledvolume resultsin
faster ow rate.
• Filling the pump greater than the labeled results in
slower ow rate.
• Viscosity and/or drug concentration.
• Pump position - position the pump at approximately the
same level as the catheter site:
• Positioningthepumpabovethislevelincreasesow rate.
• Positioningthepumpbelow thisleveldecreasesowrate.
Temperature
• The SELECTAFLOW* device should be worn outside
clothing and kept at room temperature.
• To ensure ow rate accuracy, do not place heat or cold
therapy in close proximity to the ow controller.
• Temperature will aect solution viscosity, resulting in
faster or slower ow rate.
• SELECTAFLOW* device have been calibrated
using Normal Saline (NS) as the diluent and
room temperature (22°C, 72°F) as the operating
environment. Flow rate will increase approximately
1.4% per 1°F/0.6°C increase in temperature and will
decrease approximately 1.4% per 1°F/0.6°C decrease
in temperature.
• If refrigerated, allow pump to reach room temperature
before using.
• It may take approximately 8–18 hours for a pump to
reach room temperature. (See table below)
Fill Volume (ml) 100 200 270 400 600
Refrigeratorto
RoomTemp (hr) 8 12 12 15 18
Storage
• Storage of a lled ON-Q* Pump for more than 8 hours
prior to starting infusion may result in a slower
ow rate.

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External pressure
• External pressure such as squeezing or laying on the
pump increases ow rate.
Indications for Use
• The ON-Q* Pump is intended to provide continuous
delivery of medication (such as local anesthetics) to or
around surgical wound sites and/or close proximity to
nerves for preoperative, perioperative and postoperative
regional anesthesia and/or pain management. Routes
of administration include: intraoperative site, perineural,
percutaneous and epidural.
• ON-Q* Pump is indicated to signicantly decrease pain
and narcotic use when used to deliver local anesthetics
to or around surgical wound sites, or close proximity
to nerves, when compared to narcotic only pain
management.
Contraindications
• ON-Q* Pump is not intended for blood, blood products,
lipids, fat emulsions, orTotal Parenteral Nutrition (TPN).
• ON-Q* Pump is not intended for intravascular delivery.
Description of Device Figure 1)
The ON-Q* Pump with SELECTAFLOW* device incorporates
a controller that allows the user to adjust the infusion rate.
1Fill Port
2ON-Q* Pump
3Clamp
4Air-Eliminating Filter
5SELECTAFLOW*Variable Rate Controller
6Flow Rate Dial
7Rate-Changing Dial Key
8Flow RateWindow
9Lockable Cover
Figure 1
Medication Label (Figure 2)
Medication Label Symbol Denitions:
1Patient Name
2Date
3Time
4Medication
5Dosage
1 4
2 5
3
Figure 2
SELECTAFLOW* Device Description
SELECTAFLOW* device is a ow controller that allows the
user to adjust the infusion rate by turning the rate-changing
dial key on the device.The ow rate is within a predetermined
range and is designated on each device.
To discourage tampering: (Figure3)
1. Remove the dial key from the device by pulling it straight
out. Put the dial key in a safe place for later use, e.g.,
attached to a key ring.
2. Close the cover over the SELECTAFLOW*Variable Rate
Controller.
3. For increased tamper resistance, the cover may be locked
to the SELECTAFLOW*Variable Rate Controller using the
tie-wrap.
Plastic Cover Flow Rate Window
Tie Wrap
Rate-Changing Dial Key
Figure 3
Note: If desired, the cover may also be removed from the
SELECTAFLOW* device by fully opening the cover and then
pulling straight up on the plastic feet at the bottom of the cover.
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2
3
4
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Warning: Do not rely on the SELECTAFLOW* dial key
or tie-wrap to prevent patient tampering.
SELECTAFLOW* device is available in two ow rate ranges
and distinquished by color on the face of device:
Blue (1-7 ml/hr)
• Flow rate: 1, 2, 3, 4, 5, 6, 7 ml/hr
Purple (2-14 ml/hr)
• Flow rate: 2, 4, 6, 8, 10, 12, 14 ml/hr
Instructions for Use
Use Aseptic Technique
Filling The ONQ* Pump: (Figure 4)
Note: Follow hospital protocols and applicable regulations for
lling pump.
1. Close clamp.
2. Uncap the ll port.
3. Attach lled syringe to ll port. Invert pump as shown.
4. Grasp syringe with both hands.
5. Push down on plunger continuously until volume is
dispensed. Do not handle pump while lling, as the
syringe tip may break. Repeat as necessary. Syringe
accuracy is ±4%.
Note: Filling Extension Sets are provided with larger
pumps (see product insert).
6. Remove lling device from ll port
7. Replace ll port cap. Label with appropriate
pharmaceutical and patient information.
Figure 4
Fill Volume
Caution: Do not underll pump. Underlling the pump
may signicantly increase the ow rate. Do not exceed
maximum ll volume. (Table 1)
Table 1: Fill Volume (ml)
FillVolume 100 200 270 400 600
Max Fill Volume 125 335 335 550 750
Retained Volume ≤5 ≤11 ≤11 ≤16 ≤23
Warning: Flow rate is adjustable. Medication dosage
should be based on maximum flow rate. Pump is pre-set
at 7 ml/hr or 14 ml/hr (depending on model).
Table 2: 24-Hour Dosing Reference
SELECTAFLOW*
Model
Drug Concentration (mg)
0.2% 0.25% 0.5%
7 ml/hr Max Flow Rate 336 420 840
14 ml/hr Max Flow Rate 672 840 1680
Formula:
ml/hr x % drugconcentration x10x24hr=24 hour dose (mg)
Caution: Calculations based on the labeled ow rate.
Flow rate accuracy varies.
Priming the Administration Set
Use Aseptic Technique
Note: SELECTAFLOW* device is packaged with the ow rate
at the highest setting to minimize priming time.
1. Open the plastic cover of the SELECTAFLOW* device
(Figure 5)
2. To begin priming the SELECTAFLOW* device, ensure
highest ow rate setting is selected.
• Make sure the selected ow rate is aligned within the
window below the ml/hr xmark.
• The tactile feel will allow the user to ensure selected
ow rate is set.
3. Open the clamp and remove tubing cap to begin priming.

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Figure 5
Figure 6
Figure 7
4. When all air has been removed from the entire tubing and
uid is observed at end of luer lock, the administration set
is primed.
5. Turn the dial back to ø, o position and close the clamp
(Figure 6).
6. Replace tubing cap until ready for use.
Starting Infusion
Use Aseptic Technique
1. Connect tubing to patient’s catheter. Make sure
connection is secure.
2. Select the appropriate ow rate by turning the dial on
the SELECTAFLOW* device until the ow rate setting is
within the window and aligned with the ml/hr xmark on
the face of the SELECTAFLOW* device (Figure 7, 8).
• The tactile feel will allow the user to ensure selected
ow rate is set.
3. Open clamp.
Figure 8
Examples of ow rate settings
3 ml/hr 6 ml/hr
Caution: Flowratesettingmustbe within window and
alignedwithml/hr▼mark to ensure accurate owrate.Do not
dial between numbers.Flow rateisunpredictable if dialedbetween
numbers(Figure9).
Figure 9 Correct alignmentIncorrect alignment

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Figure 10
Note:Cover will not close if dialed between numbers (Figure 10).
Changing the Flow Rate During an Infusion
1. Insert the dial key into the dial of the SELECTAFLOW*
device.
2. Turn the dial key until the new ow rate is selected. Make
sure the selected ow rate setting is within the window
and aligned with the ml/hr xmark on the face of the
SELECTAFLOW* device (Figure7, 8).
• The tactile feel will allow the user to ensure selected
ow rate is set.
3. Remove the dial key fromthe device and putinasafeplace
forlateruse.
During the Infusion:
• A change in appearance and size of the pump may not be
evident during the rst 24 hours after start of infusion.
• As medication is delivered, the pump will gradually
become smaller.
• Make sure:
• Clamp is open
• There are no kinks in the tubing
• Filter vent is not taped or covered
• Heat, ice or cold therapy is placed away from the ow
controller
End of Infusion:
• Infusion is complete when pump is no longer inated.
• Close clamp, disconnect and dispose of the pump
according to your institution’s protocol.
Note: If pump did not perform as expected do not discard.
Contact Halyard Health for product return instructions at:
[e-mail] or 1-800-448-3569.
Technical Specifications
Delivery Accuracy:When lled to the labeled volume,
SELECTAFLOW* device delivery accuracy is ±20% of the
labeled rates when infusion is started 0-8 hours after ll and
delivering normal saline as a diluent at 22°C/72°F.
Typical Flow Curve
The ow rate may be higher or lower at the beginning and
end of the infusion (Figure 11).
Figure 11
Typical Flow Curve
Flow Rate
Percent DeliveryTime 100%
Nominal
Note:
Latex is not in uid pathway or in contact with human. Refer to
Latex Sensitivity Technical Bulletin at halyardhealth.com.
Storage Conditions
Store under general warehouse conditions. Protect from light
sources and heat. Keep dry.
Rx only = CAUTION: Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician.
Additional U.S. and Foreign Patents may be issued and/or
pending.
*Registered Trademark orTrademark of Halyard Health, Inc. or its
aliates. © 2015 HYH. All rights reserved.
For more information, please call
+1.949.923.2400 • 1.800.448.3569 (English only)
or visit www.halyardhealth.com for the latest product
information andTechnical Bulletins.
To order additional Instructions for Use or
Patient Guidelines please email or call:
HalyardIrvine.ProductInquir[email protected] or
+1.949.923.2400