WalkMed 350VL User manual

Manufactured by: WalkMed Infusion LLC
6555 S. Kenton Street, Suite 304 •Centennial, Colorado
Telephone: [phone] •Fax: [phone] •walkmed.net
Operation Manual
for the Clinician
WalkMed 350VL
Ambulatory Infusion Pump

WalkMed 350VL Operation Manual • 204878 E
IMPORTANT NOTICE
©2013 WalkMed Infusion LLC.
All rights reserved. Printed in USA. WalkMed and the walking legs
design are registered trademarks of WalkMed Infusion LLC.
Disclaimer
The information in this manual is accurate and reliable as of the time
of its release for this specic version of the pump. However, WalkMed
Infusion LLC reserves the right to change the specications of the
product described in this manual without notice at any time. As such, the
descriptions and data included in this document may not be current if a
different revision of the manual is used. Therefore, it is important that the
user ensure they are using the most up to date revision of this manual.
Federal (USA) law restricts this device to sale by, or on the order of,
a physician.
Not for Patient Use: This manual is intended for use by qualied
healthcare professionals only. A certied, licensed healthcare practitioner
must supervise all infusion therapies. An adequate level of prociency
must be demonstrated by caregivers and patients according to policies set
by Clinical Facility.
Indications for Use
The WalkMed 350VL pump is indicated for intravenous, subcutaneous,
arterial, enteral, and epidural infusion of: antibiotics, analgesics,
chemotherapeutic agents, and other medications or uids requiring
precisely-controlled infusion rates.
Contraindications for Use
The WalkMed 350VL pump is contraindicated for: Infusion of blood and
blood products, Infusion of insulin, Infusion of critical medications whose
stoppage or interruption would cause serious injury or death
Use in ambulatory regimens by patients who do not possess the mental,
physical, or emotional capability to operate the pump properly; or who are
not under the care of a responsible individual
WalkMed Infusion LLC Priory Analysts Ltd.
6555 South Kenton Street, Suite 304 Mazars, The Pinnacle
Centennial, CO 80111, USA 160 Midsummer Boulevard
303-420-9569 Milton Keynes, MK9 1FF
United Kingdom
1275
1275

Table of Contents
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WalkMed 350VL Operation Manual • 204878 E
INTRODUCTION
01 Features and Controls 4
Pump Unit 4
Accessories 6
Pump Signals 7
Keypad Function Table 8
02 Technical Specications 9
03 Indications and Contraindications 11
04 Precautions 12
OPERATION INSTRUCTIONS
05 Removing and Attaching the Front Cover 17
06 Opening and Closing the Reservoir Cover 18
07 Inserting and Removing the Battery 19
08 Installing the Reservoir/Tubing Set 21
09 Programming the Pump 25
Keypad Function Table 26
Turn Pump Power On 28
Enter Programming Mode 29
Programming Basal Flow Rate 29
Resetting Volume Delivered to Zero 32
Programming Total Volume Limit 33
Changing the Lock/Unlock 35
10 Delivering Medications 36
To Prime Tubing Set 36
To Start Delivery 37
During Delivery 37
To Stop Delivery 38
Total Volume Limit Reached and End KVO 39
11 Using the Carrying Pouch 40
12 Discontinuing Use of the Pump 41

Table of Contents
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WalkMed 350VL Operation Manual • 204878 E
MAINTENANCE
13 Cleaning and Care 42
14 Functional Test Procedures 43
Functional Verication Test 44
Functional Verication Test Check-Off Form 46
TROUBLESHOOTING
15 Problem-Solving Procedures 47
If a Problem Occurs 47
Problem-Solving Table 48
16 Obtaining Service Assistance 50
17 Limited Warranty 52
TECHNICAL SPECIFICATIONS
18 Technical Description 54
Electromagnetic Emissions 54
Electromagnetic Immunity 55
18 Key to Symbols 57
Index 58

Features and Controls
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WalkMed 350VL Operation Manual • 204878 E
WalkMed 350VL
Pump Unit
1. Control keypad. Use to program, review, and change
pump settings; and to control operation of the pump.
2. Display screen. Shows messages describing normal
operation functions and alarm events.
3. Status light. Blinks green, yellow, or red to show pump
operating status or system alert conditions.
4. Malfunction light. A continuous red light that shows
when a system malfunction occurs, system alarms.
5. Battery compartment. One 9-volt alkaline battery ts here.
2
1 3 4
6 811
10
Front View
Bottom
7
INTRODUCTION

Features and Controls
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WalkMed 350VL Operation Manual • 204878 E
14
13
12
Right Side View
6. Pumping chamber. Applies mechanical pumping action to
the tubing in order to deliver medications to the patient.
7. Clamp bar. Secures the elastic segment of the pump
tubing into place in the pumping chamber.
8. Clamp bar release. Press to release clamp bar.
9 Clamp bar lock pin. Locks the clamp bar securely in place.
10. Elbow seat. The right-angle elbow tting of the pump
tubing set ts here.
11. Pressure cell seat. The pump tubing set pressure cell
diaphragm ts here to enable proper functioning of the
pump occlusion alarm.
12. Front cover. Protects the control keypad during pump
use and storage.
13. Reservoir cover. Holds the reservoir bag in place during use.
14. Reservoir cover hinge release. Use to remove the
reservoir cover from the pump.
INTRODUCTION

Features and Controls
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WalkMed 350VL Operation Manual • 204878 E
Standard Pump Accessories
The WalkMed Pump is packaged with the following
standard accessories:
• WM 350VL Infusion Pump
• Front Cover
• Small Reservoir Cover
• Large Reservoir Cover
• Operation Manual (this document)
• Carrying Pouch
• 9-volt Battery
• Clinician Quick Start Guide
• Patient Quick Reference Cards
Optional pump accessories:
• Locking Reservoir Covers
• Disposable Carrying Pouch & Belt
• Adjustable Waist Belt
• 1 Liter Carry Case
• Back Pack
INTRODUCTION

Features and Controls
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WalkMed 350VL Operation Manual • 204878 E
WalkMed 350VL
Pump Signals
The WalkMed 350VL pump provides visual and audible
information to the user during normal operation and in the
event of system problems. The pump communicates this
information by 3 types of signals:
1. Display screen. The front panel screen shows messages
describing normal operation functions and alarms.
2. Lights. Two lights labeled and are
located on the pump front panel. Depending on the
operating function or alarm being signaled, the
light may blink green, yellow, or red. The
light comes on in a continuous red when a System
Malfunction occurs.
3. Audio tones. The pump emits beep tones singularly,
continually, or in various patterns, depend ing on the
operating function or alarm being signaled.
Signals of normal operation are described where appropriate
in Chapter 10 “Delivering Medications.” For descriptions
of signals indicating
problems, see
Chapter 15,
“Problem-Solving
Procedures.”
3
INTRODUCTION

Features and Controls
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WalkMed 350VL Operation Manual • 204878 E
Control Key Function
Power
Press to turn pump power on or off.
Start
Press to start medication delivery.
Stop/Undo Press to stop medication delivery.
Press to undo a new number setting while
in programming mode changing rates.
Press to stop prime.
Prime Press to enter Prime mode,
then press within 7 seconds to prime.
Enter Press to save setting and advance to
next programming screen.
Press any key to change setting in
screen display above that key.
+
Press any 2 keys together to clear rate
setting to zero, and to change decimal
point position.
Status
System Alerts
Malfunction
System Alarms
Note: , and keys are inactive during
medication delivery, regardless of lock status.
INTRODUCTION

Technical Specications
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WalkMed 350VL Operation Manual • 204878 E
Dimensions
L x W x H:
11.2 x 10.2 x 3.8 cm/4.4 x 4.0 x 1.5 inches
(includes front cover)
Weight: 360 g/12 oz.
(Includes battery and front cover)
Drive mechanism: DC motor, microprocessor-controlled,
linear peristaltic drive mechanism
Infusion mode: Continuous (basal) rate infusion
(with or without KVO infusion)
Accuracy: ± 5%
Basal ow rate
range:
0.10 to 19.99 ml/hr (in resolution of 0.01 ml)
00.1 to 30.0 ml/hr (in resolution of 0.1 ml)
Total volume
delivered:
0.00 - 1999 (automatic decimal point
adjustment on display). After reaching
1999 ml the volume delivered display
restarts at 0.00 ml.
Total volume
limit:
1 to 1999 ml resolution of 1 ml
End of infusion
KVO rates:
Basal Rate ≥1.0 ml/hr = 0.5 ml/hr
Basal Rate <1.0 and ≥ 0.2 ml/hr = 0.2 ml/hr
Basal Rate <0.2 ml/hr = Basal Rate
Power source: One (1) 9-volt alkaline battery
(Duracell® brand MN1604, Medline
MPHB, or equivalent).
Typical battery
capacity:
- 450 ml at 1 ml/hr - 18.7 Days
- 650 ml at 10 ml/hr - 2.7 Days
- 500 ml at 30 ml/hr - 0.7 Days
Reservoir bags: Available reservoir sizes include 65,
150 and 250 ml.
Tubing sets: Use only dedicated WalkMed pump
tubing sets manufactured by
WalkMed Infusion LLC.
INTRODUCTION

Technical Specications
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WalkMed 350VL Operation Manual • 204878 E
Occlusion
detection:
517 ±155 mmHg / 10 ±3 psi immediately
distal to drive mechanism.
If the occlusion is cleared while in delivery
mode the pump will automatically cancel
the alarm and resume delivery.
Occlusion Detection Time
Basal Rate
ml/hr
Maximum
Time for
Occlusion
Alert
Occlusion
Bolus
Volume
0.1 55 Minutes NA
15.0 37 Seconds 0.07 ml
Operating
environment:
2° to 50° C (35° to 122° F)
Storage: -10° to 50° C (14° to 122° F)
Alerts: - Low battery
- Not Delivering
- Clamp Bar open
- Occlusion
- End of Infusion
- KVO - Total Volume Limit reached
Alarms: - Under-Delivery
- Over-Delivery
- System Malfunction
- Depleted battery
Memory
Backup:
The last entered settings are retained in
the pump memory.
INTRODUCTION

Indications and Contraindications
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WalkMed 350VL Operation Manual • 204878 E
Indications for Use
The WalkMed 350VL pump is indicated for intravenous,
subcutaneous, arterial, enteral, and epidural infusion of:
• antibiotics
• analgesics
• chemotherapeutic agents
• and other medications or uids requiring
precisely-controlled infusion rates
Contraindications for Use
The WalkMed 350VL pump is contraindicated for:
• Infusion of blood and blood products
• Infusion of insulin
• Infusion of critical medications whose stoppage or
interruption would cause serious injury or death
• Use in ambulatory regimens by patients who do not
possess the mental, physical, or emotional capability to
operate the pump properly; or who are not under the
care of a responsible individual
INTRODUCTION

Precautions
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WalkMed 350VL Operation Manual • 204878 E
Precautions
• Before use, the user must become thoroughly
familiar with the information contained in the device
operating instructions.
•Danger: Do not use the WalkMed 350VL pump in the
presence of ammable anesthetics or explo sive gases.
The WalkMed 350VL pump presents a possible explosion
hazard if used in the presence of such materials.
• Before connecting to the patient, purge all air from the
infusion lines.
•The WalkMed 350VL pump does not have an air-in-line
detection alarm. Periodic visual inspection for the presence
of air in the infusion lines during use is recommended.
•Do not operate the WalkMed 350VL pump in the Prime
function while connected to a patient. In the Prime function,
the pump infusion rate is equal to or greater than 30.0 ml/hr.
Using the pump in the Prime function while connected to a
patient may cause over-infusion of medications.
•Do not use the WalkMed 350VL pump in the presence
of high-intensity magnetic elds (e.g., MRI scanners).
Exposure to strong magnetic elds may adversely affect
the pump’s infusion accuracy, possibly causing over-
infusion of medications to the patient.
• Do not drop the WalkMed 350VL pump, strike it against
hard objects, or place heavy weight on top of it. If the
pump is dropped or damaged, test it thoroughly before
use to assure that it is functioning properly.
Use of a damaged pump may cause over-infusion or
under-infusion of medications to the patient.
INTRODUCTION

Precautions
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WalkMed 350VL Operation Manual • 204878 E
•The WalkMed 350VL pump clamp bar must be securely
closed by fully engaging the clamp bar lock pin so that an
audible “click” sound is heard. Before using the pump,
conrm secure closure of the clamp bar by pulling up
rmly on the end of the bar with a thumb or index nger.
The clamp bar should open only when the lock pin
is released. Failure to securely close the clamp bar may
cause over-infusion or under-infusion of medications to
the patient.
•Always clamp the tubing between the WalkMed 350VL
pump and the patient’s access device before opening
the pump clamp bar. Uncontrolled uid ow can occur
when the administration set is not clamped before
opening the clamp bar; or is not properly installed in,
or is removed from, the pump. Uncon trolled uid ow
may cause over-infusion of medications to the patient.
•The WalkMed 350VL pump must be maintained according
to the instructions given in this operation manual.
Failure to adhere to the recommended maintenance
instructions may damage the pump, making it inoperable
or causing it to malfunction.
• Medications or uids infused by the WalkMed 350VL
pump must be prescribed by the physician. It is the
responsibility of the clinician using this pump to ensure that
the medications or uids are used only according to the
physician’s infusion therapy prescription.
•As with any programmable infusion pump, before
starting medication delivery, check to ensure that the
programmed infusion settings are appropriate for the
selected application.
INTRODUCTION

Precautions
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WalkMed 350VL Operation Manual • 204878 E
• As with any infusion system, examine the uid pathway
connections for damage or leaks. Leakage may cause
blood or uid precipitation/loss. Continue to observe for
leaks during use.
• The WalkMed 350VL pump ow rate and occlusion
sensitivity may vary according to the administration
set used. Use only those sets recommended for use
with the WalkMed 350VL pump.
•A security code may be keyed-in to lock the WalkMed
350VL pump’s infusion programming function. This code
is designed to allow programming access to the clinician
only, and must not be given to the patient. Tampering with
programmed settings by a patient possessing the security
code may cause over-infusion or under-infusion of
medications to the patient.
• Do not sterilize or autoclave the WalkMed 350VL pump,
pump tubing set, or pump reservoir. Sub jecting them to
sterilization or autoclaving may damage them, making
them inoperable or causing them to malfunction.
•The WalkMed 350VL pump is not waterproof.
Do not immerse the pump in water or other uids.
Do not allow water or other uids to enter the pumping
chamber or battery compartment. Entry of uid into the
pump may damage it, making it inoperable or causing
it to malfunction. If the pump gets wet, have it serviced
before reuse. When showering or bathing, the patient
should place the pump in the carrying pouch and keep
the pump out of contact with the water.
INTRODUCTION

Precautions
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WalkMed 350VL Operation Manual • 204878 E
•Do not attempt to disassemble or repair the WalkMed
350VL pump. Refer all service to an authorized Walk-
Med service center.
•Do not use the WalkMed 350VL pump if you suspect it
may have been damaged or is not operating properly.
•Always keep the front cover installed on the WalkMed
350VL pump during use and storage to prevent damage
to the battery terminals, clamp bar release, and keypad.
Such damage could make the pump inoperable or
cause it to malfunction.
•The WalkMed 350VL pump measures for line occlusion
only between the pump and the patient. The occlusion
alarm will sound only if occlusion occurs between the
pump and the patient. The pump does not measure or
alarm for line occlusions that may occur between the
reservoir bag and the pump. Always check for possible
line occlusions (e.g., a closed clamp) between the reservoir
bag and pump during use. An occluded line may cause
under-infusion or non-infusion of medications to the patient.
• As with any sterile product, use aseptic technique when
handling the dedicated WalkMed 350VL pump tubing set
and reservoir bag.
•Do not twist the elastic segment of the dedicated WalkMed
350VL pump tubing set when installing it into the pump.
Twisting of the elastic segment may cause ow inaccuracy,
possibly resulting in under-infusion of medications to
the patient.
INTRODUCTION

Precautions
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WalkMed 350VL Operation Manual • 204878 E
•Refer to the infusion system disposable product labeling
for instructions on preparation of that product for use.
•Patients using the WalkMed 350VL pump in ambulatory
regimens must be instructed in its proper use.
•Do not use sharp objects to depress the control keys
on the WalkMed 350VL pump keypad. Doing so may
damage the keys, possibly making the pump inoperable
or causing it to malfunction.
• As with any infusion system, medications or uids may
interact with the plastic components of the reservoir/
tubing sets, possibly causing damage or leaks.
Before use, consult the pharmaceutical manufacturer’s
precautions and guidelines for the medications or uids
being used with the WalkMed 350VL pump.
• Federal (USA) law restricts this device to sale by,
or on the order of, a physician.
• “Y” injection sites should not be used.
•Appropriate catheters and medications must be used
according to approved device and medication labeling.
•Recommended use of epidural route is to provide
anesthesia or analgesia for periods up to 96 hours.
INTRODUCTION

Removing and Attaching the Front Cover
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WalkMed 350VL Operation Manual • 204878 E
Removing and Attaching the Front Cover
To Remove Front Cover
1. Pull back latch with nger
and remove top cover.
The cover separates
completely from the pump.
To Attach Front Cover
1. Orient the cover so that
the frosted area of the
cover is over the battery.
2. Insert the top of the
cover into the groove at
the top of the pump.
3. Push on the cover tabs
at the bottom to snap
the cover securely into
the latch.
WalkMed 350 V L
OPERATION

Opening and Closing the Reservoir Cover
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WalkMed 350VL Operation Manual • 204878 E
To Open Reservoir Cover
1. Place ngers on the top
of the reservoir cover
and pull back on the
reservoir cover latch.
2. Open the reservoir
cover by lifting up with
thumb.
To Close Reservoir Cover
1. Push the reservoir cover shut until the latch snaps onto
the front cover tab.
Check to make sure that the reservoir bag and
tubing are not pinched by the closed cover.
To Remove Reservoir Cover
1. Slide the hinge release in
toward the pump middle to
retract the hinge release pin.
When the pin is fully retracted,
the cover is released and can
be removed.
OPERATION