KCI
ABThera OA NPT System Tip Sheet Jan 2010
Tip Sheet
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ABThera™ Open Abdomen Negative Pressure Therapy (OA NPT) System
Tip Sheet, FAQ, and System Specifications
ABThera™ OA NPT System Tip Sheet •
System/Unit The power button should be held for two seconds to activate the unit and three seconds to deactivate it.
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A full canister condition triggers the blockage alarm on the unit. Under this condition, the canister lid filter becomes occluded, triggering the alarm. Both the canister and lid should be replaced.
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Ensure customers understand how to connect the tubing set to the canister correctly. Connecting the tubing set incorrectly could cause system-related issues. The canister connectors (on the tubing set) are marked with “patient” and “vacuum” symbols to match the port markings on the canister lid. Additionally, the “patient” tubing set connector has a tethered cap that can be used as an additional point of reference. The tethered cap must be removed from the tubing lumen before connecting to the canister lid. Please see Figure 1 for additional guidance.
Dressing
Figure 1. Connecting the tubing set to the canister
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The tubing set is designed to be used with the ABThera™ Unit ONLY (this information is also presented in the IFU document). Using the tubing set with any other negative pressure source could cause system-related issues such as blockages or unit failure.
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Observing dressing draw down and fluid removal during the first three minutes of pump operation is an excellent way to ensure a seal has been established. If a leak does exist, the Leak Alarm will be triggered five minutes after power is turned on. Canister The ABThera™ System has been verified and validated for use with the ABThera™ Canister ONLY (Part # 370620). Using other types of canisters could lead to system issues. Canisters are designed for single use ONLY (this information is also presented in the IFU document). Reusing canisters can significantly impair pump performance through the creation of blockages and other potential issues.
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When troubleshooting leak alarms, the canister should first be inspected to ensure a proper lid seal and absence of hairline cracks (visual inspection of canister is recommended prior to use). The Dressing should be addressed after the canister to minimize the need for additional dressings.
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Stocking canisters in all potential patient holding areas has been recognized as a best practice. This inventory approach ensures the availability of canisters when needed and minimizes any disruptions to patient therapy.
DSL#10-0029 (01/10)CONFIDENTIAL. For KCI internal training use only. Do not copy. Do not distribute outside KCI. Page 1
ABThera™ Open Abdomen Negative Pressure Therapy (OA NPT) System
ABThera™ OA NPT System FAQ System/Unit Question How is the ABThera™ OA NPT System different from the existing V.A.C.® Abdominal Dressing System?
Why did KCI design a new therapy unit?
What are the alarm specifications for the ABThera™ Therapy Unit?
Will continuous alarming shut off the ABThera™ Unit? How long will the alarm be muted when the mute function is used? Question Why is a new dressing being introduced?
If the VPL is resized and a piece of encapsulated foam is cut, is there any risk of foam coming in contact with viscera?
Will the existing V.A.C.® Abdominal Dressing be discontinued and when?
When troubleshooting a leak alarm, how do I confirm the leak is at dressing side (vs. pump)?
Answer The ABThera™ OA NPT System was specifically engineered and designed to manage the high fluid volume needs of an Open Abdomen patient in an OR or ICU environment . Specifically, the dressing has been designed for enhanced fluid removal via a new VPL design and wider inner diameter tubing while the unit includes streamlined control options, easily visible monitoring & alarm notifications, and an ergonomic handle. Customer research indicated a strong, unmet need for a therapy unit customized to the OR and ICU environments. All alarms are audible and visual (LED): • Low battery alarm sounds with ~1 hour of battery life remaining • Leak alarm will sound after 3 minutes if the system leak (dressing, canister, tubing, therapy unit) is greater than 3 liters/minute • Blockage/Canister full alarm sounds after 3 minutes if there is a blockage or the canister is full No, unless the battery life fully expires. 5 minutes. It will restart automatically. Dressing Answer The ABThera™ Dressing is a system engineered specifically for managing patients with an open abdomen, designed for fast application and ease of use in an operating room environment. Specifically, it is thicker, more tear resistant, and easier to apply than the V.A.C.® Abdominal dressing. As indicated in the clinical guidelines, foam should not come into contact with viscera. When resizing the dressing, clinicians should cut through the center of the large foam squares and tear the remainder from the connecting piece of foam. The result will be a polyurethane flap that will minimize the exposure of foam to bowel (see IFU). Yes, the new ABThera™ OA NPT System will replace the existing V.A.C.® Abdominal Dressing. However, the phase out date of the Abdominal Dressing is not yet finalized and adequate notice will be provided to all affected customers. After completing a visual inspection of the system, perform a Tether Cap Test: 1. Remove patient connector of tubing set from canister. Attach green tethered cap to canister patient port. Continue therapy. Note: if green tethered cap is missing, a finger may be used to seal patient port on canister. 2. If pump operation slows, then the leak is at dressing side. A correctly functioning unit left in this state will eventually get a blockage alarm.
DSL#10-0029 (01/10)CONFIDENTIAL. For KCI internal training use only. Do not copy. Do not distribute outside KCI. Page 2
ABThera™ Open Abdomen Negative Pressure Therapy (OA NPT) System Question Is it an issue that the ABThera™ Canister is not sterilized? Why does the canister have a port on top?
Canister Answer No, this is a standard canister used in OR environments around the world. Sterilization is not required. This provides clinicians with easy access for sampling.
Why does the canister measure up to only 800ml?
The total volume of fluid removed when the canister is full is 1000ml. The top of the canister is higher than the base of the lid (the top layer of fluid is hidden from view).
Why is there no expiration date on canisters?
Canisters are non-sterile and do not require an expiration date.
Can canisters be reused?
No, they are single use only (this is specified on the canister and in the IFU document).
DSL#10-0029 (01/10)CONFIDENTIAL. For KCI internal training use only. Do not copy. Do not distribute outside KCI. Page 3
ABThera™ Open Abdomen Negative Pressure Therapy (OA NPT) System
ABThera™ OA NPT System Specifications Dimensions Therapy Unit • Weight: 2.6 kg o 5.7 lbs • Dimensions: (H)279.40 x (L)285.75 x (D)152.40mm o (H)11 x (L)11.25 x (D)6” • Pressure Options: 100. 125 and 150mmHg o 13.3 – 20kPa Canister • 1000 cc/ml • Canister dimension with lid attached = 7.5” tall x 5.5” diameter (190.50 x 139.70mm) Visceral Protective Layer (VPL) • 665 x 802mm (oval) • 15mm thick • 2 polyurethane layers • Polyurethane encapsulated foam Tubing and Pad • 4mm lumen for delivery of negative pressure • Dual lumen (1 for vacuum/fluid removal, 1 for pressure sensing) • Antibacterial hydrophobic filters on both lumens Perforated Foam • Polyurethane Environmental Conditions Storage Temperature Range: -29⁰C (-20⁰F) to 60⁰C (140⁰F) Operating Temperature Range: 10⁰C (50⁰F) to 38⁰C (100⁰F) Altitude Range for Optimum Performance: 0 to 2438 m (0 to 8,000 ft) Electrical Specifications Power Supply Input: o 100V~, 240V~, 50/60Hz o 2.5A max (100V) o 0.9A (100V~), 0.4A (240V~) Current Leakage: <100 Microamps Battery Run Life: 2 hours (approximately) Battery Charge Time: 8 hours (approximately) IEC Classification: o Electrical Safety – Class 1 o EMC – Class B for hospital use o Class II B MD o Medical Equipment o Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or nitrous oxide o Type B Applied Part o IPX1 DSL#10-0029 (01/10)CONFIDENTIAL. For KCI internal training use only. Do not copy. Do not distribute outside KCI. Page 4
ABThera™ Open Abdomen Negative Pressure Therapy (OA NPT) System
Shipping Dimensions Canister & box • Canister box dimensions are approx 12.5” x 10.625” x 13.75” (317.5 x 269.87 x 349.25mm) • Canister dimension with lid attached = 7.5” tall x 5.5” diameter (190.50 x 139.70mm) Dressing & box • Dressing box dimension are approx 25.25 x 15.25 x 12” (647.70 x 387.35 x 304.80mm) • Dressing outer pouch dimension 15 x 25” (381 x 635mm) Unit & box • NPTU box 440 x 340 x 230mm • NPTU dimensions are 11 x 11.25 x 6” (279.40 x 285.75 x 152.40mm)
DSL#10-0029 (01/10)CONFIDENTIAL. For KCI internal training use only. Do not copy. Do not distribute outside KCI. Page 5