• Using administration sets that have active and integral anti-free-flow devices.
• Using an upstream pressure sensor which monitors the reservoir pressure, providing immediate alert whenever an excessive pressure occurs.

• Requiring affirmative entry of Rx values, or accepting the safe default values.
  
• Default values that are set to safe values anytime "New Program" is selected.
• In the PCA mode, setting the default value for "New Program" in milligram (mg). This can prevent serious over-infusions based on erroneous ml/hr programming, when in fact the prescription is in mg/hour.
• Both in the PCA and Continuous modes, providing the option to set the maximum infusion rates in the MedLimits, thus limiting the maximum rate that can be infused within the therapy.
• In the PCA mode, setting the maximum infusion rates to appropriate default values based on the clinician's choice of intravenous, epidural or subcutaneous route of infusion.
• In the PCA mode, providing the option to set the "Delta-rate" and "Delta-time" features that limit the extent that a user can increase the dosage within a fixed period of time.
• In PCA mode, providing the option to set a maximum setting for patient doses, number of doses, and intervals between doses which help prevent the user from making unusually large changes in the prescription settings. Requiring the clinician to confirm each line of the programmed Rx before beginning an infusion.

How do you reduce the risk of medication errors?
Using the CMS™ Gold software program that stores all the institution's protocols and prescriptions on a PC and/or PDA. The stored protocol or prescription can then be uploaded directly into the pump (see CMS™ Software Program). The CMS™ Barcode technology provides even a higher degree of error reduction by preventing a clinician from choosing the wrong medication in the medication library file.

What do you mean when you say that Curlin pumps have a high resolution of flow? How does that help the patient?
The resolution of flow is the smallest volume that can nominally be displaced by the pump. Curlin Medical resolution of flow is 2 micro-liters (0.002 ml). To put this number in perspective, CADD Prism™ VIP has a resolution of flow of 50 micro-liters (0.05 ml). Curlin Medical's resolution of flow is 25 times better than that of CADD Prism™ VIP. A higher resolution of flow results in a more consistent drug levels, a smoother delivery profile and fewer catheter patency problems.

How does the new Daylight Savings Time affect Curlin pumps?
There is no need for concern about modifying the Curlin pump, or providing a "software patch" to correct the automatic time change routine for Daylight Savings Time. There simply isn't one, and there has never been one on the Curlin pump.

The Curlin pump is not affected by the change in date implementation of Daylight Savings Time.

It will be necessary to reset the Curlin pump's internal clock (just like you would for your own watch and alarm clock) when the time change occurs. Instructions for setting the pump's internal clock are provided in the user/operations manual. It can be done manually via keypad entries, or via CMS™ software.

Product Advisory

1. Resume should be used if a therapy is interrupted. The pump picks up where it left off, and continues the therapy.
   
2. Repeat Rx should be used to hang a new bag and repeat the same therapy over again. The infusion history displayed is reset (volume infused, boluses requested, boluses received, etc.). Shift totals and hourly totals continue to accrue.
   
3. New program should be used to program a totally new Rx. All the therapy parameters in the pump are set to factory default and must be reentered by the clinician.
   

The judicious choice of "Resume", "Repeat" and "New Program" can help speed up programming.

What happens when you choose to prime with the pump?
When the pump is priming, the Air-In-Line sensor is temporarily turned off, and the amount primed is reduced from the bag, but not counted as delivered to the patient. The assumptions here are that the patient is not connected to the set, the set is connected to the I.V. reservoir, and fluid is displacing air from the set. Priming is not permitted when pump is placed in Lock Level 3.

How does the downstream occlusion alarm work, and what degree of
occlusion sets it off?
The downstream pressure sensor will alarm when the pressure reaches 400 mmHg or 900 mmHg (±150 mmHg) depending on the low or high setting. The alarm will cause the infusion to stop. The infusion will resume automatically when the occlusion is cleared. The ability to adjust from low to high setting eliminates annoying false "down occlusion alarms" when using smaller catheters.

Do you have to enter the entire Rx before you can access the OPTION Menu?
Yes. However, once the infusion has started running, you may access the Option menu at anytime (assuming the Lock Level will permit) by pressing the "Option" key.

If the same program is used for the next patient, after the pump has been shut off, does the "Air In Line" alarm option setting stay fixed with the program?
If you choose Repeat to repeat a therapy, then the OPTION Menu settings (including air-in-line) will remain as they were. If you choose "New Program" then the OPTION menu values will return to the default setting ("Air In Line" defaults to 0.5 ml).

I am seeking to minimize the steps clinicians have to go through to program the pump. Can I set the default choice to PCA-IV, PCEA, or Subcutaneous only?
Yes. You can purchase PainSmart® IOD™'s, Curlin's pain management system, or set any Curlin pump to operate as a PCA-IV, PCEA or Subcutaneous only (or any other single therapy) pump, or operate it in multi-therapy mode. When you turn the pump into a PainSmart® IOD™ pump, the menus related to the other therapies will not appear. If you use a 4000 CMS™ pump, your clinicians can use a PDA or PC to electronically program the pump. You can also purchase a Custom PCA pump and have it configured to your specific requirements (see PCA therapy).

• Basal only infusion
• Bolus Only infusion
• Basal infusion with bolus

In PCA mode, what are the common measurement choices?
In the PCA mode, the common unit choices are milliliters (ml), milligrams (mg) and micrograms (mcg). Similarly, common delivery rates are in ml/hr, mg/hr and mcg/hr.

Why did Curlin Medical set the default in PCA as milligram (mg) as opposed to milliliter (ml)?
In the multi-therapy pumps, the decision to set the default to mg was safety based, as this can prevent serious over-infusions based on erroneous ml/hr programming, when in fact the prescription is in mg/hour.

What can I do if I want to set the default to ml rather than mg?
In the PCA mode, if you require a specific configuration, Curlin Medical suggests three options:

1. Purchase a PainSmart® IOD™ system and have Curlin Medical customize it to your requirements.
2. Purchase or upgrade to a custom PCA pump and request that factory defaults be set to your requirements.
3. With the multi-therapy pumps (Curlin 4000 CMS), let us make a simple suggestion that might work for you. Set all your configuration values in the Pre-Prescription Screen and set the pump in Lock Level 1. Any time you want to use the pump, choose REPEAT to reprogram the pump. REPEAT will prevent the programmer from choosing any other unit of measure or change the pre-prescription screen, but it will allow the user to change any of the values in the prescription screen (bag volume, rate, bolus, etc.). Anytime you need to reenter all new values, choose NEW PROGRAM and start with a clean slate.

What is the fastest way (in PCA mode) to use the pump from one patient to the next?
Use a pre-configured Custom PCA pump, or set your multi-therapy pump to PCA only mode, the lock level to "Lock Level 1" and use the REPEAT function. When the auto-scroll is occurring and you want to make a change in the program, press any key (except ON/OFF) and the auto-scroll will stop. You can then use the UP or DOWN arrow keys to move the cursor to the line you want to change, make the change, then confirm each line with a YES to confirm and exit the program.

In PCA mode, how can you disable the basal rate when the route of choice is IV?
In the pre-prescription menu, turn "medLimits" ON and choose 0.00 as the basal rate and 0.00 for the delta functions. Be sure to put maximum values in for all the other options in the bolus area or you will not be able to manage the bolus system. Leave the pump in Lock Level 1. In this setting, you cannot make any changes to basal rate. Lock Level 1 will prevent any un-authorized access to new program, but allow the user to make changes only to the prescription it self, but not to any of the pre-prescription items (concentration, medLimits, units, etc.).

• In the user's manual
• On the insert that is included in the packaged administration set
• In the clinician's guides for each therapy
• In the patient guide
• In the patient and clinician training videos

Do the sets have needle-less ports?
YES. Curlin Medical has administration sets with needle-less ports. Please see our catalog for specific administration set needs.

What is the priming volume in Curlin Medical's administration sets?
The priming volume is only 3 ml for sets without filter, and 7 ml for sets with filter (see administration sets).

Is the filter defective when it does not fill up during priming?
No. To purge the air from the flat side of the filter, hold the filter vertically with the air vent at the top, then prime with gravity or with a pump. If the air does not purge, close the slide clamp. This will force the fluid to push the air out of the filters air vent. If the air does not purge by gravity, use the pump's priming function to push the air out of the filters air vent. Stop priming when all the air has been purged. If priming with the pump is continued after the air has been purged from the filter, the pump may alarm a down stream occlusion. To clear a down stream occlusion press the "PAUSE" key, open the slide clamp, open the pump door (to relieve the pressure) and close. Press "RESUME" and continue with the normal set up procedure.

To purge air from the inlet / outlet side of the filter, hold the filter up with the air vent at the top, then prime with gravity or with a pump. If an air pocket gets trapped and will not float to the top by itself, tap the filter housing while priming to dislodge the air bubble. Once the air is out of the filter housing, continue priming until the air is completely purged from the set.

Are all Curlin administration sets non-DEHP, latex and surfactant free?
Yes. All Curlin sets are non-DEHP and latex free. Although not indicated on the labels the sets are also surfactant free.

What can cause a false "Air In Line" alarm?
Cold infusates may cause false AIL alarms. To prevent these nuisance alarms, unless otherwise directed by your health care provider, bring your solutions to room temperature. This typically requires removing the solution from the refrigerator 1 to 2 hours prior to infusion.

• Nominal 85 hours at a rate of 2 ml/hr
• Nominal 30 hours at a rate of 125 ml/hr
• Nominal 10 hours at a rate of 400 ml/hr

How can I determine how much battery power is remaining in the pump?
Read the power bar graph when you first turn on the pump. Use the options menu and select "PWR CK" to view the power bar graph while the pump is running.

Are the DuraCell Pro C-cell batteries in the pump rechargeable?
No. A rechargeable external battery pack and an Adapter/charger are, however, available for use with the pump.

Where does the "External Battery Pack" or "AC Adapter/Charger" (with a
blue ring) plug into the pump?
The port on the bottom of the pump labeled POWER is for the External Battery Pack and/or AC Adapter.

How long should the "External Battery Pack" be charged prior to use?
The "External Battery Pack" should be charged initially for 24 hours using the "AC Adapter/Charger". When the green light is on, the battery pack is charged.

Does the subsequent charging time for the "External Battery Pack" need
to be as long as the initial charge period?
No. However, it is recommended that the "External Battery Pack" be charged for at least 8 hours prior to each subsequent use. The "AC Adapter/Charger" can be plugged into the "External Battery Pack" while the "External Battery Pack" is plugged into the pump. This allows the pump to be fully operational and provides a continuous charge to the "External Battery Pack".

What are the technical specifications of the Curlin Medical AC adapter
model 340-2022?
Input: 100-240 VAC, 50-60 Hz, 0.4 A
Output: 6.9 VDC., 1.45 A, 10 W max
CE Marked, UL2601-1, IEC 601-1, EN 60601-1, CSA C22.2 601.1 classified when used with a "Hospital Grade" power cord.

How do I properly change the batteries?
Follow instructions in the Battery Replacement Guide

What kind/brand of batteries should I use?
You should only use C size DuraCell ProCell® alkaline batteries.

What should I do if the batteries or pump become excessively warm to the touch?
Very rarely, batteries other than the recommended Duracell Procell® batteries can be "shorted out" when placed in Curlin pumps. This is because the wire spring that makes contact with the negative end of the battery can scrape away the plastic film at the edge of other brands of batteries. Although not dangerous, this situation can cause concern and inconvenience to the user. Should the batteries or battery compartment of your pump ever become overheated, please do the following:

1. Press pause and then turn the pump off.
2. Allow the pump to cool down.
3. Open the battery compartment and determine if it contains Duracell Procell® batteries. Do not throw the batteries away.
4. Contact your home care provider and follow their instructions.

How do I move around with the pump?
Curlin pumps have a carry pack specifically designed to allow you to be mobile and active while receiving your therapy. If you are unsure, your healthcare provider will demonstrate how to use the carry pack.

Where do I leave the pump when I want to sleep?
Place the pump at your bedside or next to you on the bed. Your clinician may have special instructions for bedtime use of the pump.

How do I bathe or shower during my therapy?
The pump is water resistant, but not water proof, so it should be placed outside your tub or shower.

How do I exit the help screen?
When the pump is paused and the help/option key is pressed, a help message will appear. Press the help/options key again to exit the help screen.

Where does the remote "Bolus Cable" (with a green ring) plug into on the pump?
The port on the side of the pump labeled BOLUS/DATA is for the remote "Bolus Cable" with switch.

Where does the "Data Interface Cable" (green ring at one end, serial port connector at the other end) plug into on the pump?
The port on the side of the pump labeled BOLUS/DATA is for the "Data Interface Cable".

How do I remove the "AC Adapter/Charger", the "Bolus Cable" or the "Data Interface Cable" from the pump?
Pull on the ring (blue for the "AC Adapter/Charger", green for the "Bolus Cable" and "Data Interface Cable") and the cord will be released from the pump.

What is the proper orientation of the 1.2 rectangular filter in order to completely remove air during priming?
It is recommended that the orientation of the filter be pointing downward, when you are priming the set. (Note: keep blue cap on distal end when priming filtered sets).

How do I extract the patient history from the pump?
Order the Curlin Medical "Data Interface Cable". With a 2000 Plus™ or a 4000 Plus™ pump, all you need is a PC computer with MS Windows 95 or greater. Instructions come with the cable and by accessing the HyperTerminal accessory in your Windows program; you can download directly to your PC and print a hard copy of the history file. However, with a 4000 CMS™ or PainSmart® IOD™ pump you can use either the HyperTerminal or your CMS™ software program and a PC or PDA to down load, store, view and print the patient history.

How do I program a delayed start in the pharmacy before sending the
pump to the patient's home?
Program the delayed start in the pharmacy then install an administration set and press the run key to actuate delay start. Pause the pump and then turn it off. When the user turns the pump on in the home, select the resume feature, then press "RUN" and the delay start with KVO (if programmed) will infuse until time for their therapy to start dosing (see also the "Clinician Quick Guide to Delayed Start Procedures").

• Lock level OFF allows full access to all therapies and programs
• Lock level 1 does not allow you to get into a new program, but it does allow you to change all your program parameters (does not include pre-prescription screen information)
• Lock Level 2 does not allow you to get into a new program, nor change the program parameters; but it will allow you to repeat or resume your program
• Lock Level 3 does not allow you to get into different therapy modes, a new program, change the program parameters nor repeat the same infusion; but it will allow you to resume an interrupted program

What should I do if I have questions about the Curlin pumps?
If you are a user, whenever you have questions about the pump or your therapy, you should call your healthcare provider.

Who is Curlin Medical?
Curlin Medical is an experienced device manufacturer located in Huntington Beach California. For more than 10 years, Curlin Medical and its predecessor companies have provided considerable expertise and experience in manufacturing infusion pumping mechanisms for other major healthcare companies on an OEM basis. The company has significant experience in the design, development, manufacturing and marketing of infusion pumps that are currently in use in both hospital and alternate site markets. Curlin Medical is currently selling a number of pumps: the custom PCA, the 4000 CMS™, PainSmart® IOD™ and the CMS™ Software package.

Does Curlin Medical provide clinical support and a toll free 24-hour "hot line"?
Yes. We have an internal clinical staff and a 24-hour telephone toll free hot line. Call our toll free number at 888.CURL.999 [800.287.5999] to access a member of our clinical staff. This service is available for clinicians and should not be used by your patients.

What is the warranty of the pump and who services it?
The standard warranty is for one year. Should a pump need service, return it to Curlin Medical. We have an 888 toll free technical service line as well. To arrange for repair, call 714.893.2200, explain the problem, obtain a RMA (Return Merchandise Authorization) number and return the product to Curlin Medical. Should you require a loaner pump one can be provided to you.

Who is selling the Curlin pumps?
In North America (US and Canada), Curlin pumps are currently distributed exclusively by B. Braun Medical, Inc. Please call 800.227.2862 for the representative nearest to you. If you would like more information, please don't hesitate to contact us directly.

Does Curlin Medical have a trade-in program available?
Yes we do. The exact amount of the allowance for trade-ins is dependent upon the number of devices, their age and type, etc. Let us or your B. Braun sales representative review your exact situation and show you how easy it is to obtain the newest state-of-the-art device and save you considerable money on your purchase of disposable sets.

Do you have loaner pumps available?
Yes. The Company has a loaner program. Please contact the place of purchase to arrange for a loaner.

Does Curlin Medical have a lease or rental program available?
Yes. We have a very aggressive lease-to-own and rental program available.

Can I arrange for an evaluation of the product at my Company?
Yes. Please call us or our representatives to arrange for an evaluation.